When planning for the development of a new product, a pharmaceutical manufacturer must determine very early in the process what a product’s anticipated demand will be at the time of launch. Not only is this very difficult to do, but also the consequences of incorrect forecasts can be very costly in a number of ways. Without the ability to predict capacity needs with 100% accuracy, pharma must come up with an effective way to eliminate demand risks.
Bacterial endotoxins are the most common pyrogens found in pharmaceutical products. These substances are found in the outer membrane of Gram-negative bacteria.
How do you engage a client in a way that frees his/her mind to the prospects of an open flexible lab design? How do you lead them to see the potential within an old, tired building? Many of our clients, life sciences and otherwise, have antiquated labs in antiquated buildings on campuses that have been built to their limits.
The success of biologics for use in humans depends on the ability to effectively remove any viral contaminants. Viral Clearance from biologics is critical to their performance since they can directly infect mammalian cells and cause diseases such as AIDS, mumps, measles, herpes, hepatitis, meningitis, and shingles. And, conversely, studying these disease causing viruses can aid in the development of preventive and curative therapeutics. In this article, Bio-Rad provides snapshots of the different apatite-based media that can be effectively utilized for the process-scale purification of small to mid-sized viruses.
The road to take a drug compound from discovery to commercialization is long, expensive and often fraught with unforeseen challenges. While every project will undoubtedly face some bumps along its path, far too many programs hit insurmountable obstacles that require innovators to backtrack and correct their course before proceeding, further extending timelines and adding costs.
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.
Mixed-mode chromatography matrices are designed to present multiple interaction modes to resolve target proteins and impurities, entities that are themselves complex multimodal molecules.
As single-use systems become more widely adopted, the focus in the bioprocessing industry is shifting from acceptance of the technology to standardization.
Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies onsite. What does the pharmaceutical industry need to know — and, more importantly, do — to overcome it?
Biologic drugs have great promise, but they are complex and, as a result, are very expensive to manufacture and subject to technical pitfalls.
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