Search results for " design"
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Best Practices in Qualification of Single-Use Systems
Typically, the development engineers at biopharmaceutical companies then work closely with the design engineers and application engineers from suppliers to select components and standard assemblies as…
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Selecting a Comprehensive Bioburden Reduction Plan
Understanding potential sources of contamination for a given facility and manufacturing process is key to planning for design, preventative maintenance, bioburden monitoring, and remedial actions. Eff…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
Advances in single-use technologies designed specifically for microbial systems may, however, lead to their greater use in the future.
Galliher agrees that single-use technologies are not a panace…
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Continuous Manufacturing: A Changing Processing Paradigm
To standardize downstream operations, he says one option would be “the rational design of highly specific ligands for the capture step analogous to Protein A in mAb purification” (3).
Costs of ado…
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Improving PAT for Biologics
The recent emphasis on establishing a thorough understanding of the manufacturing process from the earliest process design stages through the use of process characterization studies is, however, a key…
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Manufacturers Struggle with Breakthrough Drug Development
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs” that offer exceptional promise in treating patients with serious medical needs. Such designa…
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Operational Excellence: More Than Just Process Improvement
With carefully designed, executed, and sustainable operational excellence programs—and with improved quality and compliance targeted as one of the goals from the outse—companies can ensure they reap t…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Key considerations such as LEAN, multipurpose and flexibility was designed and built in to the facility from start, ensuring high capacity, microbial control and tracing of all filled vials. During th…
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The Development and Application of a Monoclonal Antibody Purification Platform
This process is designed to meet the purification needs for 80% of the antibody products in our pipeline, which means the majority of the purification processes can be verified without further develop…
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Advancing QbD in the EU
This knowledge becomes a basis for achieving quality by ensuring pre-defined quality criteria are met through design rather than ad-hoc testing. However, EMA has not been a strong driving force behind…