Laboratory owners are constantly challenged to create new research environments with limited budgets and few resources. In addition, consideration has to be given to the “triple bottom line” (people, planet and profit), within these strict budgetary constraints. Cost-conscious owners want facilities to meet their vision and business objectives while also including flexibility, efficiency, safety, and robust utility/engineering systems.
An important measure of success of any clinical supply chain strategy is whether or not clinical sites have the necessary study medications at the ready when needed to avoid delays in new patient starts or continuance of therapy. The complex nature of some clinical trials can create challenges which can place considerable stress on the supply chain. The difficulty in ensuring the continuity of supply increases as variables are introduced into the mix. These variables can include blinded studies, those with multiple arms or dynamic designs such as adaptive studies, fluctuations in patient recruitment, insufficient or interrupted supply of the IMP or comparator drugs, and more.
Glass breakage is commonly acknowledged as a major nuisance in parenteral manufacturing. It causes a plethora of problems, such as disruption of production, particle contamination and loss of sterility.
Manufacturing biologicals is tricky. A major concern is the risk of microbial contamination, jeopardizing product safety and causing high costs. But there are solutions for decreasing the risks.
A problem with traditional mAb manufacturing is that there are so many potential entry points for microbial contamination. There are, however, ways to shut the door on contamination.
In the past 5 years, the biopharmaceutical industry has seen unprecedented change. Precipitated by the need to support a global client base with products that are more targeted, efficacious and cost effective, the challenge to have a robust manufacturing supply chain is more crucial than ever to a company’s survival.
Pharmaceutical water is key to the production of pharmaceutical drug products, many of which require high-purity water. This is water purified according to guidelines as defined by the USP or other pharmacopeias.
The sheer number of potential strategies for improving the solubility of a compound can overwhelm many developers, leaving them unsure how to choose a path forward.
When preparing your pharmaceutical product for the vial, ultra-filtration is the final step in its purification process – just before final bulk filtration. Despite the importance of the end-purification steps and the great challenges that bioprocess engineers must contend with during this phase, there isn’t much literature on the topic.
As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization.
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