While forecasts can never be 100 percent accurate, the goal for biopharmaceutical forecasters should be to minimize the degree of inaccuracies as much as possible.
When building a new facility based on single-use technologies, or incorporating single-use into an existing facility, how do companies ensure they fully realize the benefits?
There is a wide array of chromatography resins available to address the evolving needs of researchers purifying a diverse set of target molecules.
Traditional Laboratory Information Management System (LIMS) implementations are notorious for keeping people awake at night. Industry analysts like Strategic Directions and ARC Advisory Group have estimated the failure rate of commercial LIMS solutions to be as high as 60 percent with many of them failing to deliver original customer requirements after lengthy and expensive deployments.
Many leading life sciences companies have introduced cost-reduction initiatives to automate routine, non-value-added tasks related to data capture, cataloguing and documentation activities as products move from discovery through development to late-stage quality control, manufacturing and commercial operations.
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 U.S. FDA approved Sandoz’s filgrastim product, Zarxio, a biosimilar of Amgen’s Neupogen. This was a big step for the Agency, and one some feel was long in coming. The same product was approved for marketing in Europe six years earlier (under the name Zarzio).
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.
Multivariate analysis is the investigation of many variables, simultaneously, in order to understand the relationships that exist between them.
If pharmaceutical production is to be outsourced, CMOs need to be identified, contracts negotiated, and, if special capabilities are required, the CMO must examine its engineering and capital investment program. In either case, processes must be transferred and validated, and stability batches manufactured. All of this demands an extended manufacturing and supply chain planning cycle.
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