Search results for " biologic" in Articles / App Notes
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
For most biologics, therefore, sterility must be assured by using aseptic processing techniques, which involve use of sterile raw materials, equipment, and processes under conditions that prevent micr…
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
England (Taylor Wessing): Increasing patent litigation is being seen concerning biosimilar versions of biological products, most often monoclonal antibody treatments. The complexity and value of these…
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Addressing the Complex Nature of Downstream Processing with QbD
The industry has been slowly adopting the QbD approach, but with the boom in the biopharma industry, how have these QbD principles fit into the complex nature of biologics? According to Gunnar Malmqui…
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Nurturing Knowledge from Disparate Data Streams
Bigger challenges for biologics
Biologic drugs pose some additional challenges beyond those associated with chemical APIs. Small molecules have one structure and composition. Because biologi…
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Advances in Engineering of Protein-Based APIs
Blincyto, a BiTE targeting CD3 and CD19, became the first bispecific biologic approved in the US market and demonstrates the impact bispecific molecules can have on treatment of disease, according to …
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Scaling Up Novel Therapies
The key to making gene therapy accessible to patients will be better manufacturing processes, Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, told attendees at the Galien …
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A Look into the Future of Biopharmaceutical Quality
Regulations
BioPharm: With the fast development of the biopharmaceutical industry over the past 30 years, how have quality regulations adapted to address the complex nature of biologics?
Ne…
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Automation Trend in Fill/Finish Reduces Contamination Risk
The rise of costly biologics over the past 20 years, however, has put greater pressure on downstream fill/finish operations to ensure that quality, safety, and cost efficiency are not compromised at t…
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Understanding Validation and Technical Transfer, Part I
Biopharmaceuticals are often complex molecules, or mixtures of molecules, produced in biological systems and it is not always possible to fully characterize these products in the laboratory. Therefore…
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N-Glycan Analysis of Biotherapeutic Proteins
…ycans) to a peptide backbone, is a common post-translational modification (PTM) that imparts various biological functions (1). More than half of all biotherapeutics are glycosylated (2), including mo…