Tag Archives: cold chain management

Biologics Contribute to Growth in Pharma Products Cold-Chain Market

In its September issue, Pharmaceutical Commerce details the previous and expected contributions of biologic products to its forecast of cold-chain market growth predicting sales of cold-chain drugs and biologics will outpace overall industry growth through 2022.

It is reported that “as of 2018, global sales of biotech drugs and biologic products exceed $300 billion in value, and the special logistics for maintaining the quality of such temperature-sensitive products as they are shipped from manufacturers to hospitals, clinics, pharmacies and patients around the world account for more than 17% of all biopharma logistics spending”.

The updated forecast for cold-chain logistics spending in 2018 is that “it will be more than $15 billion worldwide, in an $82 billion overall pharma logistics market, of which $10.6 billion will be transportation and $4.4 billion will be specialized tertiary packaging and instrumentation such as insulated boxes, blankets, phase-change materials, shipping containers and various temperature sensors and recorders. By 2022, cold-chain biopharma logistics spending will expand to more than $18 billion.”

To read the full article visit the following link:

https://pharmaceuticalcommerce.com/cold-chain-focus/biopharma-cold-chain-market-forecast/

Sentry BioPharma Services offers temperature sensitive biological product management to pharmaceutical companies, hospitals and organizations with need for validated  GMP storage, labeling, kitting and temperature-sensitive drug distribution services.  For more information about how Sentry’s GMP services can help protect the integrity and delivery of your biological products to patients, contact Sentry via email or by phone at 1-866-757-7400.

FDA Researchers Explore Fundamental Chemical Reaction that Could Threaten the Quality of Therapeutic Protein Products

In a recent news release the FDA described research it has conducted regarding detection of protein carbonylation, an oxidative reaction that may occur in therapeutic protein drug products during manufacture, storage, use, and transport potentially causing structural alterations and threatening stability, quality, and clinical efficacy of such products. FDA scientists have refined an antibody-binding assay with high sensitivity to detect protein carbonylation allowing many samples to be studied in a short period of time under a variety of conditions. The assay is being used to study the tendencies of various protein products to undergo oxidative carbonylation and whether containers and chemicals that contact proteins may start or speed up these reactions. The goal is to develop methods such as addition of stabilizing agents to counteract protein carbonylation in order to maintain stability, purity, and potency of therapeutic protein products and to avoid any harmful adverse reactions such as unwanted immune responses.

See https://www.fda.gov/Drugs/NewsEvents/ucm571068.htm

 

Full FDA Story:

The potential for biotechnology to transform medicine remains immense, with several therapeutic protein products already having come into widespread clinical use and hundreds of proteins under clinical investigation. For the FDA, the regulatory oversight of therapeutic protein development poses a great challenge, not only because of the increasing number of products, but also because proteins, by their very nature, are highly variable, and compared to small-molecule drugs, more likely to undergo chemical reactions over time. Chemical reactions that occur in these proteins (for example, during storage in vials before administration to patients) can have a significant impact on protein function. For FDA scientists in the CDER Office of Biotechnology Products (OBP), these reactions are of great interest because they can directly impact the quality, safety, and efficacy of protein products.

For decades—before the biotechnological revolution and the rise of therapeutic proteins—FDA drug reviewers focused primarily on small-molecule drugs. Aspirin, for example, contains only nine carbon atoms, whereas the modern protein product bevacizumab contains well over 6,000 carbon atoms. In general, proteins also contain sulfur atoms (bevacizumab has 44!), and biochemists have long known that sulfur-containing molecules are prone to undergo reactions related to the presence of unstable oxygen and other atoms in our environment. (Proteins are not the only molecules that undergo such oxidative reactions. The rusting of iron tools and statues, where iron atoms interact with oxygen atoms in the air and water, is also oxidative.) In some instances, oxidized proteins can be damaged in various ways, which could in turn trigger an unwanted immune response in patients. This feature is a unique concern with therapeutic proteins.

Recently, biochemists have begun to investigate the exact locations of oxidative reactions within large intact protein molecules. Laboratory researchers in OBP, for example, have published important new information (see References) concerning protein carbonylation, which entails the addition of a single atom of oxygen, originating from the environment, to discrete carbon atoms (rather than sulfur atoms) within protein molecules. Although protein carbonylation has been recognized within the context of disease and age-related conditions, its occurrence during the manufacture, storage, use, and transport of therapeutic proteins is a relatively new area of study. For pharmaceutical quality scientists, key issues include: understanding the different tendencies of various protein products to undergo oxidative carbonylation; identifying the role that containers and chemicals that contact proteins may have in these reactions; and discovering reliable methods for specifically and consistently detecting and controlling carbonylation.

To detect protein carbonylation, the OBP team has refined an antibody-binding assay that takes advantage of the reactivity of the “carbonyl group,” which is the name given to the carbon- and oxygen-atom grouping that occurs upon protein carbonylation. Carbonyl groups that form in proteins can make the entire protein molecule less stable and lead to damage after degradation or aggregation. By exposing the carbonyl groups that are formed in proteins to a laboratory reagent known as DNPH, the OBP team found that different proteins undergo carbonylation at different levels and at specific sites. The rate and site of carbonylation can depend on temperature, time, and other variables, such as the presence of small amounts of metals that accelerate protein oxidation reactions. The laboratory also investigated the tendency for certain additives in drug formulations to start or speed up these reactions. The methods developed by the team allow many samples, under a variety of conditions, to be studied in a short period of time. Moreover, the method is sensitive enough to detect as little as a single carbonylation modification within a large protein molecule.

The findings of the OBP team may help protein drug developers produce therapeutic proteins under optimized manufacturing conditions, potentially with structural alterations or by adding stabilizing additives that could prevent harmful carbonylation reactions. More stable protein drugs could offer a longer shelf life, reduced risk of quality problems, and more predictable clinical performance. Understanding reactions such as protein carbonylation may result in improved versions of current drugs or new drugs with superior stability, purity, and potency. Above all, the goal is to have safe and effective high-quality protein products available for patients. 

Sentry BioPharma Services offers temperature sensitive biological product management to pharmaceutical companies, hospitals and organizations with need for validated  GMP storage, labeling, kitting and temperature-sensitive drug distribution services.  For more information about how Sentry’s GMP services can help protect the integrity and delivery of your biological products to patients, contact Sentry via email or by phone at 1-866-757-7400.

EU Countries Contend to Be New Host Country of the European Medicines Agency

Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting.  Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients.

 

The European Medicines Agency, (EMA), oversees medicine regulation within the EU and evaluates applications for medicines to receive marketing authorization across the bloc. It has been based in London since it was founded in 1995.

However, as Brexit is completed the regulatory body will move from its current headquarters in London and as many as 20 EU countries may bid to host the headquarters of the EMA and its staff of almost 1000.

Portugal is the latest to join the competition and other contenders include the Netherlands, Ireland, Sweden, Austria, Denmark and Spain. Potential interest has also been expressed by Belgium, France, Germany, Luxembourg, Finland, Cyprus, Malta, Greece, Portugal, Slovenia, Slovakia, Poland and Hungary. Only the Czech Republic and Estonia have said they would not be vying for the EMA headquarters.

No precise timetable for the transfer has been set, and the EMA itself will have no direct say in the decision. Rather, representatives of the EU Member States will vote to determine the outcome.

Hosting the headquarters should be financially attractive. In addition to the large permanent staff, regulators from member countries are constantly in attendance at the headquarters for meetings and work. It could also be expected that established international big pharma companies as well as emerging European pharmaceutical businesses might locate offices or headquarters in the EMA host city.

However, a number of potential problems loom as the relocation is considered. Pharmaceutical companies fear there could be drug approval delays when the headquarters makes its move. Reportedly a large number of senior staff have left EMA since the Brexit vote and EMA is also likely to suffer a further loss because of the significant amount of review and approval work done by the UK Medicines & Healthcare Products Regulatory Agency (MHRA). And, the MHRA will face a challenge of how closely to continue to harmonize its regulations with those of the EMA which some UK critics say would allow EMA to continue to dictate the content of the regulations.

As with much of the economic and political adjustments being made during the transition period after Brexit, the one constant at this time seems to be uncertainty.

Sentry BioPharma Services offers temperature sensitive biological product management to pharmaceutical companies, hospitals and organizations with need for validated  GMP storage, labeling, kitting and temperature-sensitive drug distribution services.  For more information about how Sentry’s GMP services can help protect the integrity and delivery of your biological products to patients, contact Sentry via email or by phone at 1-866-757-7400.

Emergency Preparedness and You

Sentry BioPharma Services provides drug product management, global drug distribution, GMP storage and specialized services like pharmaceutical labeling, packaging and kitting.  Sentry plays a critical role in protecting temperature-sensitive product safety, identity, strength, purity and quality (SISPQ) for both clinical trials and commercial drug distribution for a wide range of pharmaceutical and biotechnology clients.

Many people are concerned about the possibility of a public health emergency such as a natural disaster, act of terrorism, or disease outbreak. You can take steps now to help you prepare for an emergency and cope if an emergency happens. To help you prepare, we’ve provided step-by-step actions you can take beforehand to protect yourself and your loved ones.

Gather Emergency Supplies

Are you Prepared

If a disaster strikes in your community, you might not have access to food, water, or electricity for several days. You may think that you will have enough time to run to the grocery store, but stores quickly sell out of important supplies following emergency warnings. Unfortunately, about half of adults in the United States do not have the resources and plans in place for a possible emergency. Preparing emergency kits for your family is an important step in keeping them safe and healthy during a disaster.

Pack an emergency supply kit. Here’s what you’ll need:

At Least a 3-day Supply of Food and Water

  • Water – one gallon per person, per day
  • Food – foods that are easy to make and won’t spoil, like canned soup, dry pasta, and powdered milk
  • Manual can opener
  • Basic utensils to prepare and serve meals

Health Supplies

  • 3-day supply of all medicines, at a minimum
  • Medical supplies like syringes, a walking cane, or hearing aids with extra batteries

Personal Care Items

  • Soap
  • Toothbrush and toothpaste
  • Baby wipes
  • Contact lenses or glasses

Safety Supplies

  • First aid kit
  • Emergency blanket
  • Multipurpose tool (that can act as a knife, file, pliers, and screwdriver)
  • Whistle

Electronics:

The National Oceanic and Atmospheric Administration (NOAA) provides weather updates during emergencies. Look for a radio labeled “NOAA Weather Radio.”

  • Flashlight
  • Radio (battery-powered, solar, or hand-crank) for updates on the situation
  • Cell phone with chargers
  • Extra batteries

Documents

Keep copies of your important documents, cash, spare keys, and maps in your emergency supply kit.

  • Copies of important documents such as insurance cards and immunization records
  • Paperwork about any serious or ongoing medical condition
  • Your completed family emergency plan, complete with family and emergency contact information.

You should also keep

  • Extra cash
  • Maps of the area
  • Extra set of car keys and house keys

Taking Care of Others

You may need additional supplies to make sure the whole family is ready

For Children

  • Baby supplies like bottles, formula, baby food, and diapers
  • Games and activities for children

For Pets

Plan ahead so you’re ready to take care of your pet during an emergency.

  • Food and Water:
    • A 3-day supply of food and water for each pet. A cat or a dog will generally need 1 gallon for three days.
    • Bowls or bottles
    • Manual can opener
  • Cleaning Supplies:
    • Depending on the pet, you may need a litter box, paper towels, plastic trash bags, grooming items, and household bleach.
  • Health and Safety:
    • Medicines and medical records stored in a waterproof container
    • First aid kit with a pet first aid book
  • Transport supplies:
    • A sturdy leash, harness, and carrier to transport pets safely. A carrier should be large enough for the animal to stand comfortably, turn around, and lie down. Your pet may have to stay in the carrier for several hours.
  • Comfort Items:
    • Pet toys and the pet’s bed, if you can easily bring it, to reduce stress.
  • Paperwork:
    • Current photos and descriptions of your pets to help others identify them, and to prove that they are your pets, in case you become separated from them.
    • Information on feeding schedules, medical conditions, behavior problems, and the name and telephone number of your veterinarian in case you have to board your pets or place them in foster care.

Keep these tips in mind!

Check and replace your supplies throughout the year.

Personalize

Every family is unique. You may have emergency needs not included in this list. Also, remember to update your kit according to changing needs of your family.

Be sure it’s ready to use

In a disaster situation, you may need to get your emergency supply kit quickly, whether you are sheltering at home or evacuating.

  • Once you have gathered your supplies, pack the items in easy-to-carry containers.
  • Clearly label the containers and store them where you can reach them easily.
  • Remember that certain items, like medications and paper documents, need to be kept in waterproof containers.

Keep it Fresh

Check the expiration dates on food, water, medicine, and batteries at least two times per year. It’s extremely important that all items in your kit are functional at the time of an emergency.

Involve Children

Families can make emergencies less stressful by preparing in advance and working together as a team. Ask your kids to think of items that they would like to include in an emergency supply kit, such as books, games, and pre-packaged foods.

  • Your kids can mark the dates on a calendar for checking emergency supplies. Tell them to remind you when it’s time to check the supplies.
  • Include kids in planning and creating disaster kits for family pets.

Know Your House

Find out where your gas, electric, and water shut-off locations are, and how to turn them off.

Prepare For Everywhere

Emergencies can happen anywhere. Remember to prepare supplies for home, work, and vehicles.

For more information about how Sentry can help optimize your solutions for biopharmaceutical product storage, distribution, packaging, project management and commercial fulfillment, contact Sentry via email or by phone at 1-866-757-7400.

CDC Report: First cases of Candida auris reported in U.S.

On Friday, November 4, 2016 the U.S. Centers for Disease Control and Prevention (CDC) announced the first cases of Candida auris were reported in the United States (U.S.).candida_strain

A strain of Candida auris cultured in a petri dish at CDC.
Photo Credit: Shawn Lockhart, CDC

Thirteen cases of Candida auris (C. auris), a serious and sometimes fatal fungal infection that is emerging globally, have been identified in the United States, according to the CDC. Seven of the cases occurred between May 2013 and August 2016 and are described today in CDC’s Morbidity and Mortality Weekly Report (MMWR). The other six cases were identified after the period covered by the report and are still under investigation.

The following map displays where Candida auris cases have been identified in the United States as of November 4, 2016.

candida

Source of map: https://www.cdc.gov/fungal/diseases/candidiasis/candida-auris.html

The report is the first to describe U.S. cases of C. auris infection. C. auris is often resistant to antifungal drugs and tends to occur in hospitalized patients. In June 2016, CDC issued a clinical alert describing the global emergence of C. auris and requesting that laboratories report C. auris cases and send patient samples to state and local health departments and CDC. Since then, CDC has been investigating reports of C. auris with several state and local health departments. The agency expects to continue to investigate possible cases as awareness of the emerging infection increases.

“We need to act now to better understand, contain and stop the spread of this drug-resistant fungus,” said CDC Director Tom Frieden, M.D., M.P.H. “This is an emerging threat, and we need to protect vulnerable patients and others.”

Among the seven cases detailed in the report, patients with C. auris were reported in four states: New York, Illinois, Maryland and New Jersey. All of the patients had serious underlying medical conditions and had been hospitalized an average of 18 days when C. auris was identified. Four of the patients died; it is unclear whether the deaths were associated with C. auris infection or underlying health conditions.

In two instances, two patients had been treated in the same hospital or long-term-care facility and had nearly identical fungal strains. These findings suggest that C. auris could be spread in healthcare settings.

Six of the seven cases were identified through retrospective review of hospital and reference laboratory records. Identifying C. auris requires specialized laboratory methods because it can easily be misidentified as another type of Candida infection, in which case patients may not receive appropriate treatment. Most of the patient samples in the current report were initially misidentified as another species of Candida.

Most of the C. auris strains from U.S. patients (71 percent) showed some drug resistance, making treatment more difficult. Samples of C. auris strains from other countries have been found to be resistant to all three major classes of antifungal medications. However, none of the U.S. strains in this report were resistant to all three antifungal drug classes. Based on laboratory testing, the U.S. strains were found to be related to strains from South Asia and South America. However, none of the patients travelled to or had any direct links to those regions. Most patients likely acquired the infections locally.

“It appears that C. auris arrived in the United States only in the past few years,” said Tom Chiller, M.D., M.P.H., chief of CDC’s Mycotic Diseases Branch. “We’re working hard with partners to better understand this fungus and how it spreads so we can improve infection control recommendations and help protect people.”

CDC recommends that healthcare professionals implement strict Standard and Contact Precautions to control the spread of C. auris. Facilities should conduct thorough daily and after-discharge cleaning of rooms of C. auris patients with an EPA-registered disinfectant active against fungi. Any cases of C. auris should be reported to CDC and state and local health departments. CDC can assist in identifying this particular type of Candida if needed.

In 2013, CDC issued a report describing antibiotic resistance threats in the United States that needed prompt action, including Candida infections. CDC’s Antibiotic Resistance Laboratory Network is providing additional lab support in four regional laboratories to test fungal susceptibility of Candida species and identify emerging resistance. CDC is also expanding tracking of this fungus through the Emerging Infections Program. Information gathered through these networks plays a key role in tracking resistance and informing policies and interventions.

The challenge of emerging antibiotic resistant threats like C. auris highlights the need for urgent, coordinated federal, state, local, and international public health response and the importance of CDC’s AR Solutions Initiative. The timely investments in the AR Solutions Initiative empower CDC to rapidly detect, investigate, and respond to emerging threats, like C. auris; prevent resistant infections from occurring and spreading across healthcare settings and the community; and innovate, supporting development of new diagnostics and drugs to test, treat, prevent infections, and save lives.

For more information about how Sentry can implement a custom solution to meet your unique pharmaceutical supply chain challenges, contact Sentry via email or by phone at 1-866-757-7400, for a complimentary, no obligation phone call with one of Sentry’s problem-solving experts.

For more information: https://www.cdc.gov/fungal/diseases/candidiasis/candida-auris.html

New CDC Study: Influenza Vaccination Reduces Risk of Hospitalization by More Than Half Among Seniors

Influenza season is upon us, so now is an appropriate time to remind ourselves to line up for our flu shots.  Sentry BioPharma Services provides vaccine product management services to a wide group of clients from the US Federal and State government agencies to vaccine manufacturers, with an emphasis on timely delivery of vital vaccines globally.

Recently, the US Center for Disease Control (CDC) published a study on the beneficial effects of influenza vaccines on older populations within the USA.  We have provided an overview of the study below for your review and consideration.shutterstock_351328199

August 2, 2016—A new CDC study published today in the journal Clinical Infectious Diseases (CID) provides more evidence on the benefits of flu vaccination among older adults. The study looked at flu-associated hospitalizations among people 50 and older during the 2010-2011 flu season and found that people who had received a flu vaccine reduced their risk of flu-associated hospitalization by half.

People 65 and older are at high risk of serious flu complications and account for the majority of flu hospitalizations and deaths each year. The CID study “Case-control study of vaccine effectiveness in preventing laboratory-confirmed influenza hospitalizations in older adults, United States, 2010-11,” cites data from three recent influenza seasons, during which an estimated 115,000 to 630,000 hospitalizations and 5,000 to 27,000 deaths occurred. It’s estimated that people 65 and older accounted for between 54 percent and 71 percent of hospitalizations and between 71 percent and 85 percent of deaths.

The study, which compared 368 flu-hospitalized patients and compared them against case controls selected from the community, found that vaccinated people 50 years and older were 57 percent less likely to be hospitalized from flu than unvaccinated people. The benefits were similar by age group, including adults 75 years and older. This is a notable finding since flu effectiveness studies that have looked at how well vaccine protects against flu-related doctor’s visits have generally found that effectiveness is declines with age. This study indicates that protection against hospitalization was level among older people.

Annual influenza vaccination has been recommended for adults 65 and older in the U.S. since the 1960s and for adults 50 years and older since 2000. Since 2005, CDC has conducted annual influenza vaccine effectiveness studies to assess how well the vaccine works in preventing medically attended illness. Until recently, there have been few studies that look at how well the vaccine works in preventing more serious outcomes, like hospitalization. The CID study adds to a growing body of evidence that supports the importance of vaccination in order to prevent these more serious outcomes.

Study findings also support current U.S. recommendations for annual influenza vaccination among adults, especially among adults 65 years of age and older who are at high risk of influenza-associated complications. During 2015-2016, an estimated 66% of people 65 and older got a flu vaccine. While this is the highest vaccination rate among the public for any age group, that still leaves nearly one-third of people 65 and older unvaccinated.

Secure GMP storage and flu vaccine distribution services protect your refrigerated inventory throughout the temperature-controlled supply chain.  For more information about how Sentry’s vaccine storage and proven vaccine management system can protect your vaccine throughout the pharmaceutical global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Sentry’s Controlled Substance Program Strengthens the Reliable and Secure Pharmaceutical Drug Supply Chain

Regulatory oversight shapes every dimension of controlled substances: licensing, registration, storage, security, use, inventory and controlled drug disposal. Finding a Drug Enforcement Administration (DEA) licensed partner to store, distribute and manage returns and destruction of Schedule III-V controlled substances while maintaining regulatory and quality standards required for a secure pharmaceutical supply chain can be a challenge. Sentry BioPharma Services provides seamless product management required to safeguard controlled substances which are brought into Sentry’s custody and care.

pills2

Features & Benefits of Sentry’s Controlled Substance Program

DEA Regulation Secure Storage – Inspected and approved by the Drug Enforcement Administration  in 2014, Sentry’s state-of-the-art controlled substance capacity provides secure and reliable storage to support your pharmaceutical supply chain needs.

Controlled Substance Importation/Exportation – Sentry’s controlled substance importation and controlled substance exportation capabilities provide pharmaceutical organizations unique flexibility in the drug supply chain. This coupled with Sentry’s high quality standards affords pharmaceutical companies a competitive advantage throughout the drug development process.

Redundant Systems and Extensive Security Measures Product safety, identity, strength, purity and quality (SISPQ) remain intact.  Sentry features which support this agenda include:

  • Auxiliary power feeds and back-up systems
  • Continuous (24/7) security monitoring
  • Foreign Trade Zone (FTZ) status which allows controlled substances to be internationally shipped directly to Sentry where DEA, Customs & Border Patrol (CBP) and FDA clearances can be obtained within the security provided by Sentry’s GMP facility
  • Physical plant security
  • Redundant HVAC systems
  • Secure data and document programs

Pharmaceutical Labeling and Packaging – Sentry’s light pharmaceutical manufacturing capabilities help streamline clinical trial distribution and commercial drug distribution with one stop shop GMP labeling and GMP secondary packaging.

Drug Product Return and Drug Disposal Services – Sentry completes the controlled substance supply chain with a full-service approach to product guardianship.  Our drug product return and drug destruction program ensures project integrity, reliable inventory tracking and public safety from development to launch.

For more information about how Sentry can provide controlled substance supply chain solutions for your project, contact Sentry via email or by phone at 1-866-757-7400.

Features & Benefits of a Pharmaceutical Foreign Trade Zone

What is a Foreign Trade Zone?

The U.S. Foreign Trade Zone program was established by the Foreign Trade Zone Act of 1934 to “expedite and encourage foreign commerce” in the United States. Certain geographical areas, in or adjacent to Customs Ports of Entry, can obtain foreign-trade zone (FTZ) status and receive commercial merchandise under the same Customs standards as if it were outside the commerce of the United States. Any merchandise, including pharmaceutical products, admitted and held in a foreign trade zone can be exempt of any Customs duties, tariffs and other ad valorem taxes. No duty or back taxes are charged on “value-added,” or foreign-sourced parts or materials incorporated into a finished product using U.S. parts and labor until the product is officially imported into the U.S. Commerce. This tariff and tax relief lowers the costs of U.S.-based organizations engaged in international trade while creating and retaining employment and capital investment opportunities that result from those operations.

Benefits to the Biopharmaceutical Industryshutterstock_367703690

Pharmaceutical and biopharmaceutical companies can take advantage of Sentry’s GMP temperature-sensitive pharmaceutical storage and light manufacturing facility, which  resides in a foreign trade zone.  Sentry’s zone allows drug product to reside within the product’s designated temperature range, (such as API, biologics, controlled substances, etc.), while awaiting clearance for importation by the CBP and approved for distribution by the Food & Drug Administration (FDA).

During its stay in the FTZ, the biopharmaceutical  product can be further labeled and secondarily packaged  while greatly mitigating the numerous logistic and economic challenges encountered throughout the  drug importation and development process.

Logistic Benefits 

Unlimited Storage Terms Term of pharmaceutical material storage in an FTZ is indefinite.
Eliminated U.S. Quota Restrictions Product previously subject to quota limitations is now exempt from such restrictions.
Strengthened Foreign Pharmaceutical Supply Chain Eliminate administrative and importation hold-ups at Customs and ports of entry by bringing product straight to our GMP pharmaceutical storage environments ensuring product integrity: safety, identity, strength, purity and quality (SISPQ) along the drug supply chain.
Uninterrupted Local Manufacture Prior to Importation Product can be labelled, kitted and packaged and stored in the United States until need for importation into U.S. Commerce and Customs Clearance.
Expedited Release to Market Product can be held in an FTZ until FDA approval, greatly reducing time and logistic hassle from manufacturer to end-user.

Economic Benefits 

Duty Deferral or Duty Aversion  Import, admit and hold product without paying U.S. Customs duties.
Zero Inventory Taxes All materials held in an FTZ are exempt from state, county and local ad valorem taxes.
Country of Origin Marking and Labeling Country-of-origin labels are non-required on product admitted to an FTZ freeing companies from this expense.

Sentry BioPharma Services’ pharmaceutical supply chain management expertise and FTZ status across all storage environments ensures product integrity and project management flexibility.

For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import/export process, contact Sentry via email or by phone at 1-866-757-7400.

Read more about the Greater Indianapolis Foreign Trade Zone: inzone.org

Operation Silver Snake Sets CBP Field Operations Seizure Record in San Juan, Puerto Rico

Last month, the U.S. Customs and Border Protection (CBP) San Juan Field Operations announced that approximately 268 seizures were made of counterfeit products, valued at $2.4 million, which were illegally imported into Puerto Rico via international mail.  This is a record number of counterfeits seized by CBP in Puerto Rico during a single week.

A wide range of counterfeited products was seized during the week-long enforcement effort, called Operation Silver Snake, to include: consumer products, apparel, footwear, textiles, pharmaceuticals, and more.

CBP Operation SS (1)

International Mail packages are inspected by CBP to verify compliance with US laws

This is the second iteration of a week-long operation carried out in San Juan this year by the Mobile Intellectual Property Enforcement Team (MIPET), with the support of CBP’s Centers of Excellence and Expertise (CEEs), IPR-National Targeting & Analysis Group (NTAG), Homeland Security Investigations (HSI), and United States Postal Inspection Service (USPIS).

“Our dedicated CBP officers, Import Specialist, International Trade Specialists and Seized Property Specialists were key ingredients to this successful enforcement effort to protect the U.S. economy and consumers from counterfeit products,” said Edward Ryan, Assistant Director of Trade for Puerto Rico and the US Virgin Islands. “We are looking forward to conducting follow-up operations with our partners to further protect legitimate businesses and consumers from intellectual property thieves, said Ryan.

Various international mail packages inspected by CBP officers at the San Juan International Mail Branch revealed products that infringed intellectual property rights.  The products were shipped from vendors in China.

CBP protects businesses and consumers every day through an aggressive intellectual property rights (IPR) enforcement program.  CBP targets and seizes imports of counterfeit and pirated goods, and enforces exclusion orders on patent-infringing and other IPR goods.

CBP Operation SS (2)

CBP Officers label counterfeit products seized during the operation.

To effectively enforce intellectual property rights, CBP relies heavily on the cooperation of the owners of these rights. If your intellectual property is registered with the Patent and Trademark Office, the Copyright Office or the subject of a United States International Trade Commission exclusion order, you will want to inform CBP.

Information about counterfeit merchandise being illegally imported into the United States can be submitted to the CBP using an on-line tool called E-Allegation.  The e-Allegation provides a means for the public to anonymously report to CBP any suspected violations of trade laws or regulations related to the importation of goods into the U.S.

For more information about how Sentry’s import/export team can add value to your international supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Source: https://www.cbp.gov/newsroom/local-media-release/2016-07-20-000000/cbp-stops-millions-unsafe-counterfeits

Sentry Strengthens the Pharmaceutical Supply Chain

Biological drugs are generally more delicate and sensitive to temperature than their
pharmaceutical counterparts, thus introducing risks into the global biopharma supply chain.
Longer transit times, extreme climate change between origination and destination, and shipping delays all increase the risk profile during transport.  Product compromise due to temperature fluctuation can cause millions of dollars in revenue loss and delay delivery of drugs and therapeutics to patients.  Sentry Biopharma Services strengthens the pharmaceutical supply chain by helping clients manage these risks.

MATURITY OF PHARMACEUTICAL COLD CHAIN MANAGEMENT

15 years ago cold chain management was still a buzz phrase that only a few companies could actually deliver.  However, the unique transportation challenges of biopharma products have driven the need to control temperature variability throughout the drug supply chain which has transformed pharmaceutical cold chain management into a burgeoning industry.  Specialized providers like Sentry BioPharma Services now offer dedicated services designed to preserve the integrity of biological products throughout all phases of the pharmaceutical supply chain. Large and small biotech organizations increasingly turn to these specialized providers in a shift from the traditional in-house pharmaceutical logistics model to an outsourced one.

SELECTING A PHARMACEUTICAL SUPPLY CHAIN PARTNER

Although outsourcing to a pharmaceutical supply chain provider can provide many benefits, not every potential partner has the capability to provide services on a global scale. A qualified cold chain logistics expert must be experienced and compliant in all facets of biopharma cold chain management.  This includes domestic and international shipping, drug product handling and tracking, GMP storage and international drug distribution. The provider must have the experience, systems and processes in place to handle the diverse and changing needs of the global biopharmaceutical industry. Criteria that biopharma manufacturers should consider when evaluating potential partners include:

  1. A robust quality systemglobe
  2. Specialized GMP storage facilities and equipment
  3. A reputation for technological innovation
  4. Compliance with global pharmaceutical cold chain regulations
  5. An efficient and reliable biopharma and logistics network
  6. Anti-counterfeiting capabilities
  7. Impeccable customer service record

PHARMACEUTICAL COLD CHAIN REGULATIONS & BEST PRACTICES

As pharmaceutical cold chain management has become a more critical component in the global biopharmaceutical supply chain, regulatory agencies and industry associations have been launched solely to develop standards for compliance in this market.  Achieving regulatory compliance was a much simpler task in traditional supply chain models of the past. Now, due to an increasingly complex set of social, scientific and political pressures, industry mandates and international regulations have become significantly more stringent. Each country has its own body of rules and guidelines governing the shipment and handling of pharmaceutical and biological products. A qualified pharmaceutical cold chain management and 3PL partner must demonstrate compliance with international guidelines.

In addition to mandates prescribed by external regulatory agencies, the industry has begun to develop its own body of industry-accepted standards for biopharmaceutical distribution and handling. Several prominent groups have been formed throughout the world to discuss regional challenges and issues; collaborate on problem-solving; examine emerging trends; and define industry best practices. A pharmaceutical cold chain management partner should be familiar with the standards being developed by leading international pharmaceutical discussion groups.

REPUTATION FOR PRISTINE QUALITY AND IMPECCABLE CUSTOMER SERVICE

A GMP-compliant third-party logistic (3PL) partner must be committed to excellence in quality control and customer service.  As an extension of the drug or vaccine manufacturer’s business, the pharmaceutical 3PL provider must operate as a vested stakeholder to protect product integrity as well as the manufacturer’s business viability and reputation in the marketplace. Measures of excellence in the pharmaceutical cold chain include:

  • A corporate culture of accountability and commitment to the mission
  • Knowledge of best practices for GMP storage, global drug distribution and vaccine management
  • Independent quality assurance personnel, processes and evaluations
  • Careful biological product handling and temperature-sensitive product shipping
  • A uniformed process for continuously improving quality, operations and customer service
  • A singular focus that allows the contract service provider to be an expert

SPECIALIZED GMP STORAGE FACILITIES

At various points in the pharmaceutical supply chain, active pharmaceutical ingredients (APIs), excipients, components, intermediates and finished pharmaceutical products may need to be stored for varying lengths of time, from a few days to a several months.  Short-term or long-term GMP storage facilities might be needed to temporarily house: inventory overflow from a primary GMP warehouse; primary or secondary packaging components that are awaiting assembly; finished drug products that are awaiting international drug distribution; and/or inbound pharmaceutical product shipments that are clearing U.S. Customs. While several pharmaceutical small molecule formulations remain stable at ambient temperature conditions, many biologic products must be maintained within tighter temperature tolerances in refrigerated (+2°C to +8°C), frozen (-10°C to -20°C) and ultra-low storage (-70 to -90°C). Traditional pharmaceutical supply chain facilities are not always designed to accommodate these conditions.

In these situations, a cold chain logistics partner can provide immediate access to a state-of-the-art GMP storage facility that has been designed to meet the unique requirements of temperature-sensitive drug products. It must offer: validated, temperature controlled storage and temperature-monitoring equipment; redundant power, cooling and environmental monitoring systems; redundant data storage capabilities; and sophisticated data security systems.

For more information about how Sentry’s cold chain management programs can ensure biological product integrity in every phase of the pharmaceutical supply chain, contact Sentry via email or by phone at 1-866-757-7400.