In the biotech industry today, mergers, acquisitions, and joint ventures are announced daily. Startup companies with viable molecules must decide early how they get a drug into trials, and eventually to the marketplace, as rapidly as possible. Contract research organizations (CROs), contract development and manufacturing companies (CDMOs), and dedicated contract…
The FDA’s 12 month delay in enforcing the Drug Supply Chain Security Act (DSCSA) requirement for all RX products in cases to be serialized was meant to give industry more time to comply with the new regulation, but this extra time does not modify the Act or change the enforcement…
Your equipment is ordered. The schedule is set. The team travel plans are made. But are you ready to maximize your experience at the original equipment manufacturer’s factory floor? This post will review some key points to consider in maximizing the Factory Acceptance Testing (FAT) as part of the…
Pharmaceutical companies make huge investments in equipment, materials, and personnel to develop and manufacture life-saving products. The equipment that makes those products is designed, manufactured, and commissioned to a specific set of standards. There is an expectation that the equipment will continue to provide quality service within those parameters for…
In many ways, today’s pharma and biotech facilities share the same problem that many of the factories that supported the war effort during World War II had – a shortage of skilled and qualified operators and technicians. This lack of a skilled workforce in the early 1940’s was a crisis…
Sometimes projects are conducted as a series of disconnected efforts where each team from planning, design, construction, and testing views themselves as separate entities. With each trying to finish their portion of the work and get on to their next project. These “separate” efforts have goals to accomplish, and sometimes…
Overview Until about 2016, the majority of vectors used in gene therapy were Adenovirus and Retrovirus vectors. In recent years, a change toward Lentivirus and Adeno-associated virus (AAV) vectors has occurred. This is reflected when looking at the numbers in current clinical trials underway in the gene therapy field.
“The ultimate goal of providing a robust, safe method to transfer solutions in the Manufacturing Facility was achieved and CAI played a major role with this safety initiative.”
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