Tag Archives: Biotech

Guidelines for US Citizens and Residents Living in Areas with Ongoing Zika Virus Transmission

Secure vaccine storage and distribution services protect your inventory throughout the supply chain. Sentry BioPharma Services ensures proper vaccine storage, rotation, accurate tracking and proper distribution of vaccines for routine fulfillment or pandemic response. Standard operating procedures (SOPs) and validated cold chain storage environments minimize time-out-of-refrigeration (TOR) risks, helping to reduce or eliminate waste attributable to inadequate storage methods.  Although today there is no vaccine available for Zika, several Sentry biotech clients are working to develop a vaccine for fast track clinical trials.   Sentry is providing the following information from the U.S. Centers For Disease Control and Prevention (CDC) on the Zika virus in order to update our readers concerning the prevention of the spread of this worldwide epidemic.

What is Zika?

Zika is disease caused by a virus that is primarily spread to people through the bite of an infected mosquito. Many people who get infected never have symptoms. In people who get sick, symptoms (fever, rash, joint pain, and red eyes) are usually mild and resolve completely.

Zika can cause serious birth defects in babies born to women who were infected with Zika shutterstock_363993479virus during pregnancy. Zika has also been linked to Guillain-Barré syndrome (GBS), a rare disorder that can cause muscle weakness and sometimes paralysis. Most people fully recover from GBS, but some have permanent damage and, in some cases, people have died.

Zika can also spread when a man who has Zika has sex with female or male sex partners. A man can pass Zika to his partners even if he does not have symptoms at the time, or if his symptoms have gone away. We do not know how long a man who has had Zika can pass it on to his partners from sex. The mosquitoes that spread Zika usually do not live at elevations above 6,500 feet (2,000 meters). People who live in areas above this elevation are at a very low risk of getting Zika from a mosquito unless they visit or travel through areas of lower elevation. Because there is no vaccine or treatment for Zika, people living in areas with Zika should take steps to prevent infection.

Prevent Mosquito Bites

All residents living in areas where Zika is spreading should take steps to prevent mosquito bites:

  • Cover exposed skin by wearing long-sleeved shirts and long pants.
  • Use insect repellents that are registered with the Environmental Protection Agency (EPA) and contain DEET, picaridin, oil of lemon eucalyptus, para-menthane-diol, or IR3535. Always use as directed.
    • Pregnant and breastfeeding women can use all EPA-registered insect repellents, including DEET, according to the product label.
    • Most repellents, including DEET, can be used on children older than 2 months of age. To apply, adults should spray insect repellent onto hands and then apply to a child’s face.
  • Use permethrin-treated clothing and gear (boots, pants, socks, tents). You can buy pre-treated items or treat them yourself.*
  • Stay and sleep in screened-in or air-conditioned rooms.
  • Sleep under a mosquito bed net if air conditioned or screened rooms are not available or if sleeping outdoors.
  • Mosquito netting can be used to cover babies younger than 2 months old in carriers, strollers, or cribs to protect them from mosquito bites.

*Permethrin should not be used in Puerto Rico.

Pregnant Women and Zika

Zika virus can pass from a pregnant woman to her fetus and can cause a serious birth defect of the brain called microcephaly in babies of women who had Zika virus while pregnant. Babies with microcephaly often have smaller brains that might not have developed properly. Other problems, such as eye defects, hearing loss, and impaired growth, have been detected among fetuses and infants infected with Zika virus before birth.

Pregnant women should not travel to any area with Zika. If you must travel to one of these areas, talk to your doctor or other healthcare provider first and strictly follow steps to prevent mosquito bites and practice safe sex during your trip.

For more information about pregnancy and Zika, visit https://www.cdc.gov/zika/pregnancy/.

Practice Safe Sex

Condoms can reduce the chance of getting Zika from sex. To be effective, condoms must be used correctly from start to finish, every time during vaginal, and oral sex. A man can pass Zika to his partners even if he does not have symptoms at the time, or if his symptoms have gone away. Not having sex can eliminate the risk of getting Zika from sex.

  • Men with pregnant partners should use condoms every time during sex or not have sex during the pregnancy.
  • All pregnant women with male sex partners who live in or have traveled to an area with Zika should use condoms or not have sex during their pregnancy, even if their partners do not have Zika symptoms, or if their symptoms have gone away.
  • All men who live in or have traveled to an area with Zika should consider using condoms to protect their sex partners.

For more information about Zika and sexual transmission, visit https://www.cdc.gov/zika/transmission/sexual-transmission.html.

Zika Testing for Pregnant Women

  • All pregnant women who have visited areas with Zika should receive routine prenatal care, including an ultrasound at 18–20 weeks.
  • Pregnant women who have symptoms of Zika (fever, rash, joint pain, red eyes) and have visited areas with Zika should be tested as soon as symptoms start.
  • Pregnant women who do not have symptoms and have visited an area with Zika can be tested 2–12 weeks after travel.

Pregnant women with possible exposure to Zika virus from sex should be tested if either they or their male partners develop symptoms of Zika.

Discuss Pregnancy Planning with Healthcare Provider

Women and their partners should discuss pregnancy planning with a trusted doctor or healthcare provider. Women who want to get pregnant should talk with their healthcare provider about their goals for having children. They should also talk with their healthcare provider about the potential risk of Zika virus infection during pregnancy as well as their male partner’s potential exposures to Zika virus. As part of counseling with healthcare providers, some women and their partners living in areas with active Zika virus transmission might decide to delay pregnancy.  CDC has guidance to help doctors counsel women who live in an area with Zika who want to get pregnant. The recommended times to wait before trying to get pregnant, based on whether either partner has had symptoms, are described below:

How Long to Wait Before Trying to Have a Baby When Living in an Area with Zika Transmission
Women Men
   Zika symptoms At least 8 weeks after symptoms start At least 6 months after symptoms start
  No Zika symptoms Talk with doctor or healthcare provider Talk with doctor or healthcare provider

Women who do not want to get pregnant should talk with their doctor or healthcare provider about ways to prevent unintended pregnancy, including birth control methods. Women should consider safety, effectiveness, availability, and acceptability when choosing a birth control method.

If You or Your Partner Becomes Pregnant, Talk with Your Doctor

  • You are at risk of getting Zika throughout your pregnancy. For this reason, CDC recommends testing at the first prenatal visit and a second test in the second trimester.
  • If you have symptoms of Zika (fever, rash, joint pain, or red eyes) at any time during your pregnancy, you should be tested for Zika. A healthcare provider may also test for similar diseases, like dengue or chikungunya.
  • CDC has guidance to help doctors decide what tests are needed for pregnant women who may have been exposed to Zika.

For More Information, go to www.cdc.gov and search Zika Virus.

All Countries & Territories with Active Zika Virus Transmission

As of July 26, 2016zikamap

Americas
  • Anguilla
  • Argentina
  • Aruba
  • Barbados
  • Belize
  • Bolivia
  • Bonaire
  • Brazil
  • Colombia
  • Commonwealth of
    Puerto Rico, US territory
  • Costa Rica
  • Cuba
  • Curacao
  • Dominica
  • Dominican Republic
  • Ecuador
  • El Salvador
  • French Guiana
  • Grenada
  • Guadeloupe
  • Guatemala
  • Guyana
  • Haiti
  • Honduras
  • Jamaica
  • Martinique
  • Mexico
  • Nicaragua
  • Panama
  • Paraguay
  • Peru
  • Saba
  • Saint Barthélemy
  • Saint Lucia
  • Saint Martin
  • Saint Vincent and the Grenadines
  • Sint Eustatius
  • Sint Maarten
  • Suriname
  • Trinidad and Tobago
  • U.S. Virgin Islands
  • Venezuela

 

Oceania/Pacific Islands
  • American Samoa
  • Fiji
  • Kosrae, Federated States of Micronesia
  • Marshall Islands
  • New Caledonia
  • Papua New Guinea
  • Samoa
  • Tonga

 

Africa
  • Cape Verde

For more information about how Sentry’s proven vaccine management system can protect your vaccine throughout the global supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Content source:

Centers for Disease Control and Prevention
National Center for Emerging and Zoonotic Infectious Diseases (NCEZID)
Division of Vector-Borne Diseases (DVBD)

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.

Consultants Day at Vetter Development Services

Sentry BioPharma Services was pleased to be invited to speak at Vetter Development Services, Consultant Day which took place in Chicago, IL on June 22, 2016.

The theme for the conference was “Your Molecule’s Journey”.  The objective of the conference was to inform pharmaceutical consultants of the unified service offerings of Sentry and Vetter (see diagram below).  The combined services take a molecule after discovery from formulation to end patient.  Alongside Vetter’s and Sentry’s presentations were talks by CMC Biologics on drug discovery and development and by FedEx Custom Critical on issues surrounding drug distribution and delivery worldwide.

Sentry Vetter Brochure P2

Vetter Development Services, Inc., located in Skokie, Illinois, is a premier contract development and manufacturing organization (CDMO).  Vetter is a global leader in the fill & finish contract manufacturing of aseptically prefilled syringe systems, cartridges, and vials. It is a family-owned, independent company with facilities both in Germany and the US, as well as offices in Singapore and Japan. Vetter’s focus is on providing state-of-the-art biopharmaceutical manufacturing, from early clinical development and scale-up to commercial filling and packaging of parenteral drugs. They provide support every step of the way, guiding your drug product through development, regulatory approval, launch, and life cycle management. Vetter offers biotech and pharmaceutical companies a foundation of experience spanning more than 35 years including dozens of product approvals for novel pharmaceutical and biotech compounds.

Mr. Tim J. Mitchell, President of Sentry BioPharma Services, presented a talk entitled:  “Protecting Product Integrity Throughout the Supply Chain”.  Mr. Mitchell had this to say about the meeting, “Through our many years of experience at Sentry we have encountered numerous issues arising from the supply chain of drug products.  I shared several stories and this example highlights the key points of my talk.”

A few years ago a large multinational pharmaceutical company (“LMP”), which is a Sentry client today, contacted Sentry concerning the +2°C to +8°C GMP storage and distribution of a sizable quantity of a new commercial vaccine which was to be imported from Europe.  We were told that LMP would handle all pharmaceutical cold chain logistics activities and we should be ready to receive the product on a certain date.  The receipt date came and went with no vaccine delivery.

The vaccine was held up in customs at O’Hare International Airport, the port of entry.  Ten days go by and finally the product arrives at Sentry.  There was concern about the vaccine strength, identity, safety, purity and quality (SISPQ) because the LMP knew that the temperature data loggers would have stopped working days earlier.  However, this issue became moot.

The pharmaceutical company ultimately had hired “Bob’s Trucking” to pick up the vaccine at O’Hare and delivery it to Sentry.  The shipping manifest called for a refrigerated truck with a temperature set point of +5°C.  Unfortunately, Bob was unclear on the differences between Centigrade and Fahrenheit so he placed the shipment in a reefer truck with a temperature set point of +5°F.

“It is a dismal situation for a company to devote the significant resources to develop and manufacture an expensive medication which can save lives and have it all ruined by avoidable mistakes during the last miles of the pharmaceutical supply chain to patients,” Mr. Mitchell pointed out.

“The scenario above is too common today regardless of present day technical advancements.  Sentry’s foreign trade zone (FTZ) could have provided a different and much better outcome for the vaccine distribution process.  Instead of clearing customs at the airport, the vaccine could have been sent directly to Sentry and placed in its validated +2°C to +8°C GMP storage environment.  While at Sentry, the product could have cleared customs and obtained FDA approval.  Once this was accomplished the vaccine would have entered U.S. commerce and could have been distributed to hospitals, clinics and ultimately to patients.”

Sentry BioPharma Services is a contract service organization (CSO) which supports the life science industry by offering GMP temperature-controlled storage, global drug distribution, FDA-compliant labeling and packaging services and importation support utilizing Sentry’s Foreign Trade Zone (FTZ).  Drug development and commercialization require continuous temperature monitoring and control.  Sentry’s diverse offerings protect product integrity throughout the pharmaceutical supply chain.  Sentry’s validated software, GMP storage and drug distribution facility, industry expertise and stringent quality standards support this objective throughout manufacturing, packaging, storage and distribution.

To learn more about how Sentry BioPharma Services can protect your products’ integrity throughout the pharmaceutical supply chain, please, contact Sentry via email or by phone at 1-866-757-7400.

Sentry Helps the DEA to Raise Public Awareness about the 11th National Prescription Drug Take-Back Day Initiative

As part of the U.S. Drug Enforcement Administration’s (DEA’s) National Prescription Drug Take-Back Day Initiative (NTBI), people will be able to dispose of expired, unwanted or unused prescription drugs on Saturday, April 30, 2016 from 10:00 a.m. to 2:00 p.m. at numerous collection sites around the U.S.

“The DEA’s program is designed to focus national attention on the proper disposal of prescription drugs and controlled substances,” said Ms. Jennifer Marcum, Sentry BioPharma Services’ chief executive officer.  Marcum continued, “During the event, people can bring their unwanted prescription pharmaceuticals and over-the-counter (OTC) medications to a participating drop-off site for proper drug disposal by law enforcement authorities with no questions asked.  The service is not only free and anonymous, but also an ideal way to preserve the environment from unwanted pharmaceutical contamination.  This is a terrific opportunity for those who missed the previous events, or who have subsequently accumulated unwanted, unused prescription drugs, to safely dispose of those medications.”

Americans that participated in the DEA’s tenth annual National Prescription Drug Take-Back Day on September 26, 2015, turned in more than 350 tons of unwanted or expired medications for safe and proper drug disposal at more than 5,000 take-back collections sites available in all 50 states and U.S. territories.  When the results of the ten prior Take-Back Days are combined, the DEA, and its state, local, and tribal law-enforcement and community partners have removed 5,525,021 pounds of drugs from circulation.

“The numbers are shocking—approximately 46,000 Americans die each year from drug-related deaths.  More than half of those are from heroin and prescription opioids,” said Acting DEA Administrator Chuck Rosenberg.  “With four out of five new heroin users starting with prescription medications, I know our take-back program makes a real difference.”  The NTBI addresses a crucial public safety and public health issue.  According to the 2014 National Survey on Drug Use and Health, 6.5 million Americans abused controlled prescription drugs.  That same study showed that a majority of abused prescription drugs are obtained from family and friends, including from the home medicine cabinet.  The DEA’s NTBI events are also a significant piece of the White House Office of National Drug Control Policy’s prescription drug abuse prevention strategy.

Sentry BioPharma Services will also continue its support of the DEA’s efforts by helping to raise public awareness of this important initiative.  For more information about the drug disposal program, general public inquiries can be made by calling the DEA toll free at: 1-800-882-9539.

Sentry BioPharma Services Confirms Attendance at BIO 2016 in San Francisco, California

Sentry BioPharma Services returns to the birthplace of biotech, San Francisco, California in June 2016. This marks Sentry’s 11th consecutive year attending the Biotechnology Innovation Organization’s (BIO’s) International Convention. Sentry leadership selects this conference annually primarily because it attracts over 15,000 biotechnology and pharma representatives from all over the world who unite for one week in the U.S. The topics discussed during this event and in the exhibit hall cover a wide spectrum of relevant life science topics as well as areas like drug discovery, GMP compliance, bio-manufacturing, genomics and cell therapy.

“BIO One-on-One Partnering™ serves as a cost effective way to interact globally without the extensive international traveling requirements” states Sentry’s President, Tim J. Mitchell. “There are 3,100+ companies participating in these meetings. We find the online scheduling tool to be exceptionally user-friendly and effective which allows us to interact with a vast number of prospective pharmaceutical partners and companies developing biological products. We efficiently present information concerning our customized pharmaceutical labeling, packaging and kitting processes. We also entertain numerous questions concerning Sentry’s international drug distribution services in the pavilions and/or at booths in the exhibit hall, all within the allotted 25-minute time frame. It’s amazing what can be accomplished in 3 1/2 days at BIO!”

The BIO One-in-One Partnering™ feature allows Sentry’s leaders to network and discover new opportunities and potential partnerships. Please meet us at the 2016 BIO International Convention in San Francisco, USA.

Contact Sentry via email or by phone at 1-866-757-7400.

https://convention.bio.org/2016/