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Drug products such as biologics, vaccines and products whose chemical and physio-chemical stability depends on temperature put an added emphasis on pharmaceutical manufacturers to ensure proper handling, storage, transportation and dispensing. Maintaining a secure “cold chain” during the storage, handling and transportation of temperature-sensitive drugs, vaccines and blood products not only assures product quality and integrity for the benefit of the patient, but also helps to keep the manufacturer, hospital, pharmacist, physician and nurse in compliance with various laws, regulations, guidelines and codes.
Cold chain products need to be packed in such a way that ensures that the required temperatures are maintained throughout their labeled shelf-life. Any deviation from the ideal environment can affect safety and jeopardize the drug’s quality, resulting in loss of potency, efficacy, or even the need to discard the product entirely.
Examples of drugs that require refrigeration may include:
West’s contract manufacturing group offers drug handling and cold chain solutions for pharmaceutical manufacturers that are looking for a complete integrated approach to device manufacturing and assembly to help ensure that drugs are stored within the desired temperature range throughout the cold chain.
Contact us today to determine how West Contract Manufacturing can support cold chain solutions.
Members of the West Pharmaceutical Services, Inc. (West) Marketing Unit had the pleasure of attending the recent FDA Public Meeting on Tuesday, May 21, 2019 regarding 503B Compounding Pharmacies and the cGMP draft guidance, as well as office stock issues which had generated many comments.
Many of the newer biologic products being developed are for long-term administration in chronic disease conditions, including oncology, autoimmune disorders and high cholesterol. Historically, these biologics have been administered by costly intravenous (IV) injection in a hospital, clinic or doctor’s office.
The challenge of assuring integrity of a sterile package is more complicated than many realize. As such, drug formulators in pharmaceutical and biotechnology companies often times underestimate the potential impact of the primary packages they select. A critical aspect to understand is container closure integrity (CCI) and leakage (i.e., failure of CCI or package integrity), is a major quality issue for sterile injectable products, as shown below.
In today’s increasingly complex drug delivery and device development landscape, a reliable contract manufacturing partner can become a distinct competitive advantage for pharmaceutical and device companies. West brings together the right combination of insights and infrastructure to help our customers reduce costs, mitigate risk and accelerate path to market.
In December, team members from West’s Medimop subsidiary spent a half-day with children with special needs. The group traveled to their school and kindergarten where they celebrated the Chanukah holiday with them. The celebration included arts and crafts, music, cakes and drinks.
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