AGAWAM, Mass., Aug. 12 /PRNewswire/ -- Biopharmaceutical manufacturers, responsible for an extensive repertoire of products -- including recombinant proteins, monoclonal antibodies, and vaccines -- are faced with many aspects of testing specific to the type of product being assessed. A new whitepaper from Microtest Laboratories discusses the typical routine sampling and testing requirements associated with the aseptic processing of a biopharmaceutical from the perspective of a contract aseptic manufacturer and provider of contract manufacturing testing services.
The white paper, "Where and What to Test: From Purified Bulk Drug Substance to Sterile Liquid Final Drug Product" focuses what many consider the most critical part of a biological drug product's manufacturing life cycle: going from the purified bulk drug substance ("PBDS") to the sterile final drug product ("FDP"). It is available for download at: http://www.microtestlabs.com/control-environment.
Specifically, the white paper discusses establishing the testing "where and when" (and in some instances the "why") for manufacturing formulation and fill/finish activities and how the approach is also applicable, for the most part, to small molecule drug products formulation and fill/finish.
In the white paper, the authors:
-- Warn to test only when necessary to reduce interventions.
-- Explain to test using methods that give data as quick as fittingly possible to condense processing times.
-- Discuss how to utilize a client's knowledge of the product, the contractor's knowledge of formulation and aseptic manufacturing to develop the most appropriate formulation and F/F process.
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