Tag Archives: FTZ

Features & Benefits of Sentry’s Pharmaceutical Labeling & Packaging Services

Sentry BioPharma Services specializes in pharmaceutical and medical device packaging projects of varying scale, complexity and sensitivity to time and temperature. Sentry’s  full service light manufacturing through Food & Drug Administration (FDA) compliant pharmaceutical labeling and custom kitting functions provide clients the ability to store bulk products yet deliver kitted solutions to clinical sites and commercial customers across the global. This one-stop shop structure married with Sentry’s Foreign Trade Zone (FTZ) offers optimal flexibility and cost effective solutions to even the most intricate of drug development projects.

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Sentry Labeling and Packaging

Features of Sentry’s Pharmaceutical Labeling and Packaging Solutions 

GMP operation compliant with FDA regulations

o    FDA labeler code (3007066137)

o    Segregated labeling and packaging area

o    Total label operation accountability (line clearance)

 

Diverse Clinical Trial Labeling & Packaging Support

o    Open and blinded

o    Multi-lingual

o    Peel-off / Perforated

o    Serialized

 

Pharmaceutical & Medical Device Packaging

o    Bulk

o    Double-blind

o    Package inserts

o    Single / Multi-dose cartons

o    Tamper evident seals

On-Demand Services

o    Configurable stock management

o    Expiration management of individual kit components

o    Extend expiration

o    Pharmaceutical kitting

o    Reduce at-risk inventory

 

Adaptable Scheduling

o    Batch or lot specific

o    Batch size

 

Benefits of Sentry’s Pharmaceutical Labeling and Packaging Solutions 

Streamlined Production throughout Drug Development Phases – Avoid cumbersome logistics among vendors with Sentry’s full scope services from GMP pharmaceutical storage, biopharmaceutical labeling and packaging and extensive distribution.

Accurate Inventory Control from Bulk to Finish –  Sentry’s compliant, validated inventory management system and batch record process allow for accurate tracking of inventory levels during clinical trials and commercial launch.

Cost Effective Manufacture – Reduce pharmaceutical drug development costs with Sentry’s flexible storage, labeling and packaging offerings before, during and after FDA approval.

For more information about how a coordinated GMP storage, packaging and distribution model may reduce risk and strengthen the structure of your supply chain, contact Sentry via email or by phone at 1-866-757-7400.

Sentry’s New Vaccine Storage Campaign

Sentry BioPharma Services is proud to announce its new vaccine storage and distribution services campaign. Sentry’s decade long commitment to protect product integrity  married with its state-of-the-art facility provides the life sciences industry with a unique level of quality, regulatory and operational advantages that strengthen the vaccine supply chain. Sentry’s vaccine program advantages include:

Proven Track Record of Compliant Vaccine Storage, Rotation And Vaccine Drug Distribution

vaccinecampaignSentry’s long and unblemished regulatory inspection history is a reflection of its superior approach to standard operating procedures and temperature sensitive product management.

Large Scale Repository and Tracking Capabilities Through Advanced Inventory Management Systems

Live 24/7 real-time inventory tracking ensures full visibility of inventory throughout an organization and accurate tracking compliant with GMP storage regulations 21 CFR Parts 210 and 211. High-touch communication with the Sentry Operations and Quality Teams provides proper distribution of vaccines for routine fulfillment or pandemic response.

Advanced Building Management Systems That Monitor And Control Temperature Of Storage Environments

Sentry’s validated cold chain storage environments minimize time-out-of-refrigeration (TOR) risks, helping to reduce or eliminate waste attributable to deficient storage methods. The facility’s multi-tiered security structure and flexible storage options help fulfill requirements for specific seasonal or stockpile campaigns.

Trusted By Hospitals, Government Healthcare Agencies, And Manufacturers To Protect Vaccine Products And Stockpile

Over its ten years as a contract service organization, Sentry has been a trusted partner to hospitals, vaccine manufacturers and government healthcare organizations concerned with drug product integrity, vaccine storage security, risk management and timely vaccine distribution.

For more information about how Sentry’s temperature sensitive product management expertise can help you optimize your seasonal vaccine stockpile requirements, contact Sentry via email or by phone at 1-866-757-7400.

Sentry Visits Biotech Clients in the Pacific Northwest to Discuss API Importation and FTZ Benefits

Sentry recently completed a week-long trip to the Pacific Northwest region to satisfy multiple requests to learn more about the company’s foreign trade zone (FTZ) service offering.  Client interest focused on importing high value active pharmaceutical ingredients (API) into Sentry’s FTZ for an indefinite storage term.

As supply chains become more intricate in our ever shrinking world, any weak link that chain can produce devastating results for temperature-sensitive biotech drug products.  “Most of us in pharma and biotech have our stories of disasters or near calamities concerning product movements globally” stated Tim Mitchell, President of Sentry.  “In light of the tremendous investment in treasury and time required to bring a new medication to market, it is critical to not allow product safety, identity, strength, purity and quality (SISPQ) to be impacted by delays which are inherent with the standard drug importation process.”

Sentry can help prevent time-out-of-temperature excursions through the utilization of its Foreign Trade Zone (FTZ), subzone 11 of zone 72 located at its facility in Indianapolis, Indiana.

What is a Foreign Trade Zone?ftza

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 Industry

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 FTZ 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 U.S. Customs and Border Protection agency (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.

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.

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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

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 Attends CBP’s International Trade Meeting for Q2-2016

Several members of Sentry BioPharma Services’ compliance team voluntarily attended the Q2-2016 international trade meeting hosted by the U.S. Customs and Border Protection (CBP) on Wednesday, June 8, 2016 at the Indianapolis International Airport (IND).   James Moore presently serves as Port Director for Indianapolis, Indiana and opened the meeting by welcoming guests and reviewing the agenda.

The three main topics were discussed during the event:international

H.R. Bill 644 was passed by the 114th Congress on February 24, 2016.  Section 101 of the bill states, “This bill directs the U.S. Customs and Border Protection (CBP) to ensure that CBP partnership programs, such as the Customs-Trade Partnership Against Terrorism, provide trade benefits to importers, exporters, and certain other private sector entities that meet program requirements.”

Port Director Moore reinforced the CBP’s position by saying, the CBP port in Indianapolis, Indianapolis will make every effort to protect your brand and run as smoothly as possible.

Director Moore commented, “The U.S. Customs and Border Protection (CBP) enforces Intellectual Property Rights (IPR), most visibly by seizing products that infringe IPR such as trade­marks, copyrights, and patents. The theft of intel­lectual property and trade in fake goods threaten America’s economic vitality and national security, and the American people’s health and safety. Trade in these illicit goods funds criminal activities and orga­nized crime.

To protect both private industry and consumers, CBP has made IPR enforcement a priority trade issue. CBP has developed a multi-layered, strategic approach to IPR enforcement. In addition to seizing goods at U.S. borders, the strategy includes expanding the border through post-import audits of companies that have been caught bringing fake goods into the United States, collaboration with our trading part­ners, and partnering with industry and other federal agencies to enhance these efforts. CBP also issues civil fines and, where appropriate, refers cases to other law enforcement agencies for criminal investigation.

CBP uses technology to increase interdiction of fake goods, facilitate partnerships with industry, and enhance enforcement efforts through the sharing of information and intelligence. CBP is refining its risk modeling technology to more accurately identify sus­pected shipments of counterfeit and pirated goods for inspection.

Rights holders can use our web-based tool, e-Recordation, to record their trademarks and copyrights with CBP. Recordation makes information on protected rights available to CBP offices through­out the United States.

Our online trade violation reporting system, e-Allegations, makes it easier for the private sector to notify CBP of possible IPR violations and other trade violations.

In IPR audits, an innovative enforcement practice, CBP audits the business records of companies at high risk for importing counterfeits, issues penalties for infringing goods uncovered in the audits, and works with companies to improve their internal controls.

CBP is a partner at the interagency National Intellectual Property Rights Coordination Center (IPR Center). The IPR Center is designed to leverage the resources and authorities of partner agencies for criminal enforcement of IPR.”

Learn more about Customs and Border Protection and the Indianapolis port at https://www.cbp.gov/contact/ports/indianapolis.

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

Five Benefits of a Self-Directed FTZ Audit

On Thursday, April 21, 2016, Sentry BioPharma Services completed a self-directed (voluntary) inspection of the company’s foreign trade zone (FTZ) and compliance with 15 CFR Part 400.  Randall L. Higgins, Sentry’s Senior Manager of Compliance and Validation, defines five main benefits of an independent compliance evaluation as follows:

Establishes a Professional Relationship

Sentry BioPharma Services establishes a professional relationship with an experienced and specialized service provider for several reasons.  Familiarization with Sentry’s organization, employees, facility layout, policies, procedures, daily activity and compliance history facilitates the uptake of tacit knowledge.   Clear communication channels streamline response time when trouble-shooting a problem or developing a new business opportunity.  Having an established relationship also creates a new avenue for gaining important information and insight, which is especially important as new regulations evolve.

Builds Regulatory Alignment

Tapping the knowledge and experience of a foreign trade zone expert helps a company build stringent alignment with requirements of various regulatory agencies (DEA, FDA & CBP).  Normally, the specialized consultant starts with an unbiased gap analysis to test the company’s system for robustness.  This analysis offers a realistic picture of the present state of affairs.  It also simulates the way a regulatory agency may conduct an impromptu CBP inspection.  The non-threatening environment fosters collaboration to proactively reveal unknown deficiencies and opportunities for improvement.

Drives a Competitive Advantage

Teaming up with a foreign trade zone specialist serves as a competitive advantage.  The FTZ consultant identifies operational inefficiencies and offers suggestions to improve routine and in some cases repetitive tasks.  The import/export professional advice can lead to the elimination of non-value added tasks, simplification of paperwork and the reduction of redundancies.  In some cases, the objective analysis minimizes or eliminates duties, processing fees, violations, fines and penalties.

Cooperates with Administrator of the Grant of Authority

Sentry BioPharma Services’ FTZ is part of Zone 72 and is identified as subzone 011.   Sentry’s zone is located at the Indianapolis International Airport (IND) and is not considered within the customs territory of the United States.  Sentry intends to continue participation in the Federal Foreign Trade Zone program for years to come.  By voluntarily completing an internal FTZ system audit, it demonstrates Sentry’s intent to maintain a good compliance record year-after-year with its grantee.

Cultivates New Business Opportunities

The advice of a foreign trade zone consultant typically brings solutions to pain points in the pharmaceutical supply chain.  In many cases, unique problems serve as opportunities to grow the business and expand the service offering. Clients with temperature-sensitive pharmaceutical products are often looking for ways to better control the pharmaceutical supply chain.  Protecting pharmaceutical product integrity tops the list.  Also high on the list of client needs are expediting shipping and/or customs clearance requests.   Customers benefit from the added level of drug product protection which results in time-saving and overarching risk mitigation.

Mr. Randy Higgins expands, “Sentry BioPharma Services has delivered a pristine regulatory compliance record to existing and prospective clients’ year-after-year.  By embracing self-directed and independent evaluations, Sentry protects the safety, identity, strength, purity and quality (SISPQ) of the pharmaceutical products and controlled substances moving through our GMP warehouse on a daily basis.”

Sentry’s active FTZ status and customs bond support import optimization and control of temperature-sensitive biological and pharmaceutical ingredients, materials, semi-finished and finished drug products.  For more information about how Sentry’s Foreign Trade Zone can help you optimize your medical and pharmaceutical import process, contact Sentry via email or by phone at 1-866-757-7400.

https://enforcement.trade.gov/ftzpage/grantee/regs.html

International Trade

 

 

 

Clinical Trial of Chikungunya Vaccine

Safeguarding the health of clinical trial participants and the progression of trial results demands strict adherence to protocols.  Sentry BioPharma Services specializes in vaccine drug product storage, labeling, kitting and effective distribution for clinical trials worldwide.   Please see the following article concerning the National Institute of Health’s (NIH) phase 2 clinical trial of Chikungunya Vaccine which is now open and seeking patients.

NIH-Sponsored Clinical Trial of Chikungunya Vaccine Opens

This digitally-colorized transmission electron micrograph (TEM) depicts numerous chikungunya virus particles, which are composed of a central dense core that is surrounded by a viral envelope.
Credit: CDC
TEM

An experimental vaccine to protect against the mosquito-borne illness chikungunya is being tested in a Phase 2 trial sponsored by the National Institutes of Health. Results from an initial trial of the vaccine, which was developed by scientists at the NIH National Institute of Allergy and Infectious Diseases (NIAID), were reported in 2014. In that study, all 25 vaccine recipients developed robust immune responses and no safety concerns were noted. The new trial is designed to enroll 400 healthy adult volunteers aged 18 to 60 years old at six sites in the Caribbean. It will continue to gather data on the candidate vaccine’s safety and ability to elicit immune responses, including antibodies.
The hallmark symptoms of chikungunya are severe joint pain accompanied by fever and headache. The pain typically eases after about a week but can persist for months or years in some cases. There are no specific treatments for chikungunya infection and no vaccine to prevent it.
Since its appearance in the Western Hemisphere in late 2013, cases of chikungunya have skyrocketed. So far in 2015, more than 621,000 suspected and confirmed cases have been reported throughout the Americas.
“The recent re-emergence of chikungunya virus in this hemisphere has rapidly become a significant health burden,” said NIAID Director Anthony S. Fauci, M.D.  “Our chikungunya vaccine development efforts are part of a broader research effort to prevent, diagnose, treat and ultimately control this painful illness, which can strike anyone unlucky enough to be bitten by an infected mosquito.”
The experimental vaccine, developed by investigators at NIAID’s Vaccine Research Center, uses virus-like particles (VLPs) instead of either inactivated or weakened whole virus. VLP vaccines can stimulate immune responses comparable to those resulting from naturally acquired immunity following infection and, because virus is not needed to produce VLP vaccines, they do not need to be prepared in high-level biocontainment facilities.
Eligible volunteers will be randomly assigned to enroll into one of two groups of 200 people each. Study participants will receive either two doses of the candidate vaccine spaced 28 days apart or two doses of an inactive placebo. Blood samples will be drawn at multiple time points following the injections to assess whether the candidate vaccine prompted the production of antibodies to chikungunya virus.

Additional details about the trial can be found at ClinicalTrials.gov  using the identifier NCT02562482.

References:

L-J Chang et al. Chikungunya virus-like particle vaccine elicits neutralizing antibodies in healthy adults in a phase I dose escalation clinical trial. The Lancet DOI: 10.1016/S0140-6736(14)61185-5 (2014).

NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Strict adherence to clinical material management protocols, in combination with proven GMP storage, secondary packaging, distribution, and shipping expertise allow Sentry to provide a variety of flexible services to our clinical trial outsourcing clients.

For more information about how Sentry can integrate your requirements into a scalable, secure, value-added clinical trial logistics solution, contact Sentry via email or by phone at 1-866-757-7400.