A Foreign Trade Zone (FTZ), U.S. Customs and Border Protection (CBP) writes, is a secure area supervised by CBP, but treated as being outside United States trade boundaries. Companies utilizing an FTZ have the legal opportunity to pay lower duty rates or possibly avoid paying them altogether as...
Released by Sentry BioPharma Services
In, as it says, what now appears to be a prescient discussion described in an article written in April, 2020, Tim Gunn wrote about how vaccine cold chain supply practices were soon going to be put to the test to store and distribute COVID-19 vaccines....
How Sentry BioPharma Services supports clinical studies with just-in-time custom labeling/kitting/packaging and more.
Released by Sentry BioPharma Services Contract Pharma Staff 06.17.21As crucial to innovation as they are, clinical studies come with a unique set of logistical challenges...
The Centers for Disease Control and Prevention’s (CDC’s) National Influenza Vaccination Week (NIVW) is scheduled for December 4-10, 2016. The CDC established National Influenza Vaccination Week (NIVW) in 2005 to raise public awareness about the importance of flu vaccination. The 2016 national awareness week focuses on highlighting the importance of influenza vaccination and continuing flu vaccination through the holiday season and beyond. To learn more about what is new for the 2016-2017 flu season, view the CDC’s Factsheet by clicking HERE.
Flu vaccination coverage estimates from past years have shown that influenza vaccination activity drops quickly after the end of November.
CDC and its partners choose to December for NIVW to remind people that even though the holiday season has arrived, it is not too late to get your flu vaccine. As long as flu viruses are spreading and causing illness, vaccination can provide protection against the influenza virus and should continue.
Even if you haven’t yet received a vaccine and have already gotten sick with one flu virus, you can still benefit from vaccination since the flu vaccine protects against three or four different flu viruses (depending on which flu vaccine you get).
Flu Vaccination for People at High Risk
Another goal of NIVW is to communicate the importance of flu vaccination for people who are at high risk for developing flu-related complications. People at high risk of serious flu complications include young children, pregnant women, people with certain chronic health conditions like asthma, diabetes, heart disease or lung disease, and people aged 65 years and older. For people at high risk, getting the flu can mean developing serious flu-related complications, like pneumonia, or a worsening of existing health conditions, which can lead to hospitalization or death.
By Cheryl Pellerin, DoD News, Defense Media Activity / Published Nov. 8, 2016
A clinical trial began yesterday at the Walter Reed Army Institute of Research, where 75 participating healthy adults were vaccinated with a Zika virus vaccine that the institute’s scientists developed earlier this year, Walter Reed officials announced today.
Laboratory-confirmed Zika virus disease cases reported to ArboNET by state or territory as of Nov. 2, 2016. ArboNET is a national surveillance system for arthropod-borne virus diseases in the United States, such as those from ticks and mosquitoes.
The Phase 1 trial will test the safety and immunogenicity — the ability of the vaccine to trigger an immune response in the body — of the purified, inactivated Zika virus vaccine called ZPIV. The vaccine is being tested at WRAIR’s Clinical Trial Center in Silver Spring, Maryland.
“The Army has moved efficiently from recognizing Zika virus as a threat, producing ZPIV for use in animals and demonstrating its effectiveness in mice and monkeys, producing ZPIV for human testing, and now initiating clinical trials to establish its safety and build the case for subsequent efficacy trials,” Army Col. (Dr.) Nelson Michael, director of WRAIR’s Military HIV Research Program, or MHRP, and Zika program co-lead, said in a statement.
Efficacy refers to the vaccine’s ability to demonstrate a health effect when tested in a clinical trial. “All of this,” he added, “was done in 10 months.”
Dr. Kayvon Modjarrad, Zika program co-lead and associate director for emerging infectious disease threats at WRAIR’s MHRP, said the Army was able to move so quickly in developing, manufacturing and testing a Zika vaccine “because of its extensive experience with this vaccine platform and longstanding investments in the understanding and mitigation of flaviviruses like yellow fever, dating back to the founding of WRAIR.”
DoD Zika Response
WRAIR officials say this study is part of the Defense Department response to the ongoing Zika outbreak in North and South America and Southeast Asia.
For service members, there are concerns about infection during deployment and travel, but also in the continental United States, where most military installations are concentrated in southern states. There, climate conditions and mosquito populations favor Zika transmission, WRAIR officials say.
Zika virus is transmitted to people primarily through the bite of an infected Aedes species mosquito — Aedes aegypti, shown here, and Aedes albopictus. The same mosquitoes spread dengue and chikungunya viruses. The mosquitoes typically lay eggs in and near standing water in things like buckets, bowls, animal dishes, flower pots and vases. They prefer to bite people and live indoors and outdoors near people. Mosquitoes that spread chikungunya, dengue, and Zika are aggressive daytime biters, but they can also bite at night. Mosquitoes become infected when they feed on a person already infected with the virus. Infected mosquitoes can then spread the virus to other people through bites. CDC photo by James Gathany
As of Nov. 2, according to the Centers for Disease Control and Prevention, 149 cases of Zika infection were confirmed in the military health system, including four pregnant service members and one pregnant family member.
Zika infection during pregnancy, CDC says, can cause a birth defect of the brain called microcephaly and other severe fetal brain defects.
Other problems have been detected among fetuses and infants infected with Zika virus before birth, such as defects of the eye, hearing deficits and impaired growth. And reports have increased about Guillain-Barré syndrome, an uncommon sickness of the nervous system, in areas affected by Zika, CDC says.
But even Zika infections without symptoms “can lead to severe birth defects and neurological complications,” Zika study principal investigator Army Maj. (Dr.) Leyi Lin said, adding, “A safe and effective Zika vaccine that prevents infection in those at risk is a global public-health priority.”
Zika and Other Flaviviruses
Flaviviruses like Zika are found mainly in mosquitoes and ticks and cause widespread morbidity and mortality worldwide. Other mosquito-transmitted viruses that are members of the flavivirus genus include yellow fever, or YF, dengue fever, Japanese encephalitis, or JE, and West Nile viruses, according to the CDC web page.
“We want to assess the safety and immune response of the ZPIV vaccine in JE and yellow fever YF vaccine recipients because these vaccines may alter the response to the ZPIV vaccine,” Lin said.
“Uniquely,” he added, “illness as a result of natural infection from JE, YF or Zika could be more severe when prior flavivirus infection or vaccination exists. Our study assesses co-vaccination to learn how to reduce risk when protecting against circulating flaviviruses.”
This is important for service members who are vaccinated against other flaviviruses and then stationed in or deployed to areas where Zika is becoming endemic, WRAIR scientists say.
Zika Vaccine Platform
WRAIR’s inactivated flavivirus vaccine platform was the same technology the institute used to create its Japanese encephalitis vaccine, licensed in 2009.
An earlier preclinical study found that rhesus monkeys vaccinated with ZPIV developed a strong immune response and were protected against two strains of Zika virus.
The National Institute of Allergy and Infectious Diseases, or NIAID, part of the National Institutes of Health, helped identify the viral strain used in the ZPIV vaccine, supported the preclinical safety testing and is sponsoring the conduct of this trial.
WRAIR, NIAID and the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, or BARDA, have established a joint research collaboration agreement to support the vaccine’s development.
The Pilot Bioproduction Facility at WRAIR manufactured the ZPIV vaccine being used in Phase 1 clinical studies, and the Army recently signed a cooperative research and development agreement to transfer the ZPIV technology to Sanofi Pasteur to explore larger-scale manufacturing and advanced development. BARDA recently awarded a six-year contract to Sanofi Pasteur to further develop this vaccine to licensure, according to the WRAIR release.
Other ZPIV Trials
WRAIR’s ZPIV candidate also will soon be part of an NIH trial that began in August. The NIH vaccine contains DNA that instructs volunteers’ cells to make certain Zika proteins that then illicit an immune response. As part of that study, WRAIR’s ZPIV vaccine will be given to volunteers as a booster after they receive the NIH DNA vaccine, WRAIR officials say.
Three more Phase 1 trials using ZPIV are scheduled to begin this year, the WRAIR release noted:
— St. Louis University researchers, through the NIAID-funded Vaccine and Treatment Evaluation Units network, will examine the optimal dose of the vaccine to be used in larger studies.
— Beth Israel Deaconess Medical Center and Harvard Medical School researchers will evaluate the safety and immune response from a compressed vaccine schedule.
— The Ambulatory Center for Medical Research, part of Ponce Health Sciences University in Puerto Rico, will examine the vaccine’s safety and immune response in participants who have already been naturally exposed to Zika or dengue viruses.
The WRAIR trial that began yesterday is sponsored by NIAID and funded by the Army and the Defense Department.
Sentry BioPharma Services continues to strengthen its leadership position in providing high quality and secure pharmaceutical supply chain services to pharmaceutical clients and companies utilizing biotechnology to manufacture biological products and vaccines. Therefore, we would like to draw attention to an upcoming public meeting concerning the Drug Supply Chain Security Act (DSCSA) hosted by the FDA.
The Food & Drug Administration (FDA) will be holding a public meeting to provide members of the pharmaceutical distribution supply chain and interested stakeholders an opportunity to discuss with FDA the implementation of the Drug Supply Chain Security Act’s (DSCSA’s) product identification requirements. To be held on October 14, 2016, from 9:00 a.m. to 4:00 p.m. at FDA’s White Oak Campus in Silver Spring, MD, the meeting, “Progress Toward Implementing the Product Identification Requirements of the Drug Supply Chain Security Act,” will include presentations from the public and follow-up questions from an FDA panel. The objective of the meeting is to discuss the pharmaceutical supply chain’s progress toward implementing the DSCSA’s product identification requirements, including best practices in each sector of the pharmaceutical distribution supply chain to conduct product tracing, verification, and identification.
More Background on the Drug Supply Chain Security Act (DSCSA)
Title II of the Drug Quality and Security Act of 2013
The Drug Quality and Security Act (DQSA), was signed into law by President Obama on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act, outlines critical steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States.
Ten years after enactment, the system will facilitate the exchange of information at the individual package level about where a drug has been in the supply chain. The new system will:
enable verification of the legitimacy of the drug product identifier down to the package level;
enhance detection and notification of illegitimate products in the drug supply chain; and
facilitate more efficient recalls of drug products.
Drug manufacturers, wholesale drug distributors, repackagers, and many dispensers (primarily pharmacies) will be called on to work in cooperation with FDA to develop the new system over the next 10 years.
Among key provisions implemented over the next 10 years are requirements for:
Product identification: Manufacturers and repackagers to put a unique product identifier on certain prescription drug packages, for example, using a bar code that can be easily read electronically.
Product tracing: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) in the drug supply chain to provide information about a drug and who handled it each time it is sold in the U.S. market.
Product verification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to be able to verify the product identifier on certain prescription drug packages.
Detection and response: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to quarantine and promptly investigate a drug that has been identified as suspect, meaning that it may be counterfeit, unapproved, or potentially dangerous.
Notification: Manufacturers, wholesaler drug distributors, repackagers, and many dispensers (primarily pharmacies) to establish systems and processes to notify FDA and other stakeholders if an illegitimate drug is found.
Wholesaler licensing: Wholesale drug distributors to report their licensing status and contact information to FDA. This information will then be made available in a public database.
The law requires FDA to develop standards, guidance documents, and pilot programs and to conduct public meetings, in addition to other efforts necessary to support efficient and effective implementation. FDA is developing a schedule for implementing the law’s requirements.
This system will enhance the U.S. Food and Drug Administration’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers. Failure to comply with the requirements of the law can result in penalties.
The development of the system will be phased in with new requirements over a 10-year period. These requirements will include providing product and transaction information at each sale with lot level information, in paper or electronic format, and placing unique product identifiers on individual drug packages.
The FDA is soliciting either electronic or written comments related to this public meeting by November 14, 2016. To register or request to make a presentation, visit the public meeting web page.
For more information about how Sentry’s secure drug supply chain management programs can ensure drug product integrity in every phase of the pharmaceutical supply chain, contact Sentryvia email or by phone at 1-866-757-7400.
FluLaval Quadrivalent – ID Biomedical Corporation of Quebec
FluMist Quadrivalent – MedImmune, LLC
Fluvirin – Seqirus Vaccines Limited
Fluzone High Dose – Sanofi Pasteur, Inc.
Fluzone Quadrivalent – Sanofi Pasteur, Inc.
FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met in Silver Spring, Maryland, on March 4, 2016, to select the influenza viruses for the composition of the influenza vaccine for the 2016-2017 U.S. influenza season. During this meeting, the advisory committee reviewed and evaluated the surveillance data related to epidemiology and antigenic characteristics of recent influenza isolates, serological responses to 2015-2016 vaccines, and the availability of candidate strains and reagents.
The committee recommended that the trivalent formulation influenza vaccines for the U.S. 2016-2017 influenza season contain the following:
an A/California/7/2009 (H1N1)-like virus;
an A/Hong Kong /4801/2014 (H3N2)-like virus
a B/Brisbane/60/2008-like virus (B/Victoria lineage).
The committee also recommended that quadrivalent influenza vaccines contain the above three strains and the following additional B strain:
a B/Phuket/3073/2013-like virus (B/Yamagata lineage)
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 global supply chain, contact Sentryvia email or by phone at 1-866-757-7400.
For information on seasonal flu vaccine distribution schedules, please contact the manufacturers listed in the table above directly.
Even though nearly half of the United States (U.S.) population gets a flu vaccine annually, the impact of influenza remains high. According to the Centers for Disease Control & Prevention (CDC), the flu costs the U.S. more than $87 billion annually and is responsible for the loss of close to 17 million workdays each flu season. Tens of thousands of people are hospitalized and thousands die from flu-related illnesses each year in the U.S.
Sentry BioPharma Services gears up for the 2016 flu season by promoting three strategies to combat illness:
Get the 2016 flu vaccine.
Exercise good health habits.
See your doctor for an antiviral medication to treat the flu if you get sick.
Flu Vaccine Facts
The seasonal flu vaccine protects against the influenza viruses that research indicates will be most common during the upcoming season. Trivalent vaccines are made to protect against three flu viruses; an influenza A (H1N1) virus, an influenza A (H3N2) virus, and an influenza B virus. Quadrivalent vaccines protect against four viruses; the same viruses as the trivalent vaccine as well as an additional B virus.
Flu vaccines CANNOT cause the flu. Flu vaccines are made with either killed or weakened viruses.
Flu vaccines are safe. Serious problems from the flu vaccine are very rare. The most common side effect that a person is likely to experience is either soreness at the injection site, or runny nose in the case of nasal spray. These side effects are generally mild and usually go away after a day or two. Visit Influenza Vaccine Safety for more information.
Can the flu be treated?
Yes. There are prescription medications called “antiviral drugs” that can be used to treat influenza illness.
What are antiviral drugs?
Antiviral drugs are prescription medicines (pills, liquid, an inhaled powder, or an intravenous solution) that fight against the flu in your body. Antiviral drugs are not sold over-the-counter. You can only get them if you have a prescription from your doctor or health care provider. Antiviral drugs are different from antibiotics, which fight against bacterial infections.
What should I do if I think I have the flu?
If you get the flu, antiviral drugs are a treatment option. Check with your doctor promptly if you have a high risk condition and you get flu symptoms. Flu symptoms can include fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills and fatigue. Your doctor may prescribe antiviral drugs to treat your flu illness.
Should I still get a flu vaccine?
Yes. Antiviral drugs are a second line of defense to treat the flu if you get sick. A flu vaccine is still the first and best way to prevent influenza.
What are the benefits of antiviral drugs?
When used for treatment, antiviral drugs can lessen symptoms and shorten the time you are sick by 1 or 2 days. They also can prevent serious flu complications, like pneumonia. For people with a high risk medical condition, treatment with an antiviral drug can mean the difference between having milder illness instead of very serious illness that could result in a hospital stay.
What are the possible side effects of antiviral drugs?
Some side effects have been associated with the use of flu antiviral drugs, including nausea, vomiting, dizziness, runny or stuffy nose, cough, diarrhea, headache and some behavioral side effects. These are uncommon. Your doctor can give you more information about these drugs or you can check the CDC or the Food and Drug Administration (FDA) websites.
When should antiviral drugs be taken for treatment?
Studies show that flu antiviral drugs work best for treatment when they are started within 2 days of getting sick. However, starting them later can still be helpful, especially if the sick person has a high risk health condition or is very sick from the flu. Follow instructions for taking these drugs.
What antiviral drugs are recommended this flu season?
There are three FDA-approved influenza antiviral drugs recommended by CDC this season to treat influenza. The brand names for these are Tamiflu® (generic name oseltamivir), Relenza® (generic name zanamivir), and Rapivab® (generic name peramivir). Tamiflu® is available as a pill or liquid and Relenza® is a powder that is inhaled. (Relenza® is not for people with breathing problems like asthma or COPD, for example.) Rapivab® is administered intravenously by a health care provider.
How long should antiviral drugs be taken?
To treat the flu, Tamiflu® and Relenza® are usually prescribed for 5 days, although people hospitalized with the flu may need the medicine for longer than 5 days. Rapivab® is administered intravenously for 15 to 30 minutes.
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 global supply chain, contact Sentryvia email or by phone at 1-866-757-7400.
Today, July 28, 2016, Sentry BioPharma Services joins the World Health Organization (WHO) in promoting 2016 World Hepatitis Day by raising public awareness about this preventable and curable disease.
According to the WHO, “Viral hepatitis infection is widely spread, affecting 400 million people worldwide – over 10 times the number of people infected with HIV. Globally, about 1.4 million people die each year from hepatitis. It is estimated that only 5% of people with chronic hepatitis know of their infection, and less than 1% have access to treatment.
Yet, hepatitis is fully preventable and treatable. There are effective vaccines and treatments for Hepatitis B, and over 90% of people with Hepatitis C can be cured with treatment. The vision of eliminating hepatitis as a public health threat by 2030 can be achieved, if people and countries affected by this disease were better equipped and enabled to “know hepatitis” and “act now”.
Globally, most people who need treatment have not been treated, largely due to a lack of awareness, and access to hepatitis treatment services. Over 90% of people with Hepatitis C can be completely cured of the virus within 3–6 months. Appropriate treatment of Hepatitis B and C can prevent the development of the major life-threatening complications of chronic liver disease: cirrhosis and liver cancer.”
The U.S. Food and Drug Administration (FDA) approved seven (7) therapies to treat Hepatitis B and twelve (12) therapies to treat Hepatitis C.
FDA Approved Treatments for Hepatitis B
FDA Approved Treatments for Hepatitis C
Sentry BioPharma Services offers GMP storage and global drug distribution services to protect your refrigerated inventory throughout the pharmaceutical and biological product supply chain. For more information about how Sentry’s temperature-controlled storage and proven drug distribution system can protect the supply of your hepatitis therapy, contact Sentryvia email or by phone at 1-866-757-7400.
Sentry BioPharma Services serves pharmaceutical and biotechnology firms developing drugs for multiphase clinical trials for various indications. One such indication is muscular dystrophy (MD). According to the Muscular Dystrophy Association’s (MDA’s) website, “Muscular dystrophy, amyotrophic lateral sclerosis (ALS) and related muscle-debilitating diseases take away a person’s physical strength, independence and life.”
The National Institute of Neurological Disorders and Stroke (NINDS) indicates there is no specific prescription drug, biological product or vaccine to prevent, stop or reverse any form of MD. Treatment may include physical therapy, respiratory therapy, speech therapy, orthopedic appliances used for support, and corrective orthopedic surgery. Drug therapy includes corticosteroids to slow muscle degeneration, anticonvulsants to control seizures and some muscle activity, immunosuppressants to delay some damage to dying muscle cells, and antibiotics to fight respiratory infections. Some individuals may benefit from occupational therapy and assistive technology. Some patients may need assisted ventilation to treat respiratory muscle weakness and a pacemaker for cardiac abnormalities.
Some of the life-threatening diseases are as follows:
According to ClinicalTrial.gov, an on-line service provided to the public by the U.S. National Institutes of Health (NIH), there are approximately 125 open clinical studies in process currently.
Strict adherence to clinical trial material management protocols, in combination with proven GMP storage, clinical trial labeling, secondary packaging and global drug distribution allows Sentry to provide clinical trial outsourcing clients with a variety of flexible services.
For more information about how Sentry BioPharma Services 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.
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:
A robust quality system
Specialized GMP storage facilities and equipment
A reputation for technological innovation
Compliance with global pharmaceutical cold chain regulations
An efficient and reliable biopharma and logistics network
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 Sentryvia email or by phone at 1-866-757-7400.
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.
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 Sentryvia email or by phone at 1-866-757-7400.