Tag Archives: healthcare packaging companies

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

vaccine storageSentry’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’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.

controlled substance program

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 IndustryForeign Trade Zone

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

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
Clinical Trial of Chikungunya Vaccine

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.

HPV (Human Papillomavirus) Vaccine – Gardasil®-9: What You Need to Know

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.  Sentry provides the following vaccine information statement updated recently by the Centers For Disease Control and Prevention (CDC) concerning the human papillomavirus.

Friends

HPV (Human Papillomavirus) Vaccine – Gardasil®-9: What You Need to Know

1. Why get vaccinated?

Gardasil-9 prevents human papillomavirus (HPV) types that cause many cancers, including:

  • cervical cancer in females,
  • vaginal and vulvar cancers in females,
  • anal cancer in females and males,
  • throat cancer in females and males, and
  • penile cancer in males.

In addition, Gardasil-9 prevents HPV types that cause genital warts in both females and males.

In the U.S., about 12,000 women get cervical cancer every year, and about 4,000 women die from it. Gardasil-9 can prevent most of these cases of cervical cancer.

Vaccination is not a substitute for cervical cancer screening. This vaccine does not protect against all HPV types that can cause cervical cancer.  Women should still get regular Pap tests.

HPV infection usually comes from sexual contact, and most people will become infected at some point in their life. About 14 million Americans, including teens, get infected every year.  Most infections will go away and not cause serious problems. But thousands of women and men get cancer and diseases from HPV.

2. HPV vaccine

Gardasil-9 is an FDA-approved HPV vaccine. It is recommended for both males and females. It is routinely given at 11 or 12 years of age, but it may be given beginning at age 9 years through age 26 years.

Three doses of Gardasil-9 are recommended with the second dose given 1-2 months after the first dose and the third dose given 6 months after the first dose.

3. Some people should not get this vaccine:

  • Anyone who has had a severe, life-threatening allergic reaction to a dose of HPV vaccine should not get another dose.
  • Anyone who has a severe (life threatening) allergy to any component of HPV vaccine should not get the vaccine.
  • Tell your doctor if you have any severe allergies that you know of, including a severe allergy to yeast.
  • HPV vaccine is not recommended for pregnant women. If you learn that you were pregnant when you were vaccinated, there is no reason to expect any problems for you or your baby. Any woman who learns she was pregnant when she got Gardasil-9 vaccine is encouraged to contact the manufacturer’s registry for HPV vaccination during pregnancy at 1-800-986-8999. Women who are breastfeeding may be vaccinated.
  • If you have a mild illness, such as a cold, you can probably get the vaccine today. If you are moderately or severely ill, you should probably wait until you recover. Your doctor can advise you.

4. Risks of a vaccine reaction

With any medicine, including vaccines, there is a chance of side effects. These are usually mild and go away on their own, but serious reactions are also possible.

Most people who get HPV vaccine do not have any serious problems with it.

Mild or moderate problems following Gardasil-9:

  • Reactions in the arm where the shot was given:
  • Soreness (about 9 people in 10)
  • Redness or swelling (about 1 person in 3)
  • Fever:
  • Mild (100°F) (about 1 person in 10)
  • Moderate (102°F) (about 1 person in 65)
  • Other problems:
  • Headache (about 1 person in 3)

Problems that could happen after any injected vaccine:

  • People sometimes faint after a medical procedure, including vaccination. Sitting or lying down for about 15 minutes can help prevent fainting, and injuries caused by a fall. Tell your doctor if you feel dizzy, or have vision changes or ringing in the ears.
  • Some people get severe pain in the shoulder and have difficulty moving the arm where a shot was given. This happens very rarely.
  • Any medication can cause a severe allergic reaction. Such reactions from a vaccine are very rare, estimated at about 1 in a million doses, and would happen within a few minutes to a few hours after the vaccination.

As with any medicine, there is a very remote chance of a vaccine causing a serious injury or death.

The safety of vaccines is always being monitored.  For more information, visit: www.cdc.gov/vaccinesafety/.

5. What if there is a serious reaction?

What should I look for?

Look for anything that concerns you, such as signs of a severe allergic reaction, very high fever, or unusual behavior.

Signs of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness. These would usually start a few minutes to a few hours after the vaccination.

What should I do?

If you think it is a severe allergic reaction or other emergency that can’t wait, call 9-1-1 or get to the nearest hospital. Otherwise, call your doctor.

Afterward, the reaction should be reported to the “Vaccine Adverse Event Reporting System” (VAERS). Your doctor should file this report, or you can do it yourself through the VAERS web site at www.vaers.hhs.gov, or by calling 1-800-822-7967.  VAERS does not give medical advice.

6. The National Vaccine Injury Compensation Program

The National Vaccine Injury Compensation Program (VICP) is a federal program that was created to compensate people who may have been injured by certain vaccines.

Persons who believe they may have been injured by a vaccine can learn about the program and about filing a claim by calling 1-800-338-2382 or visiting the VICP website at www.hrsa.gov/vaccinecompensation. There is a time limit to file a claim for compensation.

7. How can I learn more?

  • Ask your health care provider. He or she can give you the vaccine package insert or suggest other sources of information.
  • Call your local or state health department.
  • Contact the Centers for Disease Control and Prevention (CDC):
  • Call 1-800-232-4636 (1-800-CDC-INFO) or

Visit CDC’s website at www.cdc.gov/hpv 

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.

 

Global Drug Supply Disruptions

Sentry BioPharma Services is a leading service provider for pharmaceutical companies needing to diversify their critical drug safety stocks, thereby reducing their risk of drug shortages brought on by unforeseen calamities.

“In the aftermath of the devastating earthquake and tsunami on March 11, 2011, our company entered into numerous agreements with Japanese pharmaceutical manufacturers,” stated Tim Mitchell, Sentry’s President.  “In support of their risk mitigation programs, companies divided their critical drug supplies between their facilities and Sentry’s central Indiana U.S. GMP facility”.

Global Drug Supply Disruptions

April 2016 Earthquake area: Traced from a report of The Geospatial Information Authority of Japan. 

The article below is provided for information purposes. 

Japan Today AFP

Plants shut down after quake, fueling economic fears

Apr. 16, 2016 – 06:10AM JST

TOKYO —

Some of Japan’s biggest firms including Sony and Toyota shut down operations in southern Japan Friday after the region’s deadly earthquake…

Read more…

Sentry provides GMP validated temperature product management and global distribution of high value drug products, from API to finished vaccines.  Sentry’s validated temperatures range from +15°C to -90°C with multiple temperature set points in between.

To learn more about how Sentry can help your company lower product loss risks contact Sentry via email or by phone at 1-866-757-7400.