Search results for " development" in Articles / App Notes
Article
Technology Innovations Improve Process Chromatography Performance
Recent developments in process chromatography have addressed challenges in downstream separation and purification and led to improved bioprocessing.
Current challenges
The biopharmaceutical ind…
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A Plastic Pipeline for Commercial Bioprocessing?
Jenifer Wheat, head of commercial development, mammalian and microbial manufacturing business unit, Lonza Pharma & Biotech, says, “There’s enough room for all the scales out there. It’s not going to b…
Article
Fusion Proteins Pose Manufacturability Challenges
“Overall,” he adds, “a fusion protein will often have liabilities that will need to be addressed by more process development than would be typically needed for monoclonal antibodies (mABs), which are …
Article
Biopharma Manufacturers Respond to Ebola Crisis
8-9
The development of new treatments to combat the lethal Ebola virus has been slow, stymied by difficulties in testing compounds for deadly diseases and the reluctance of both public and private …
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Q&A with Eric Langer, about the evolution of the role of CMO’s in Bioprocessing
…or example, there’s been a real push for more efficiency and productivity in bio manufacturing and development. Simultaneously, it’s getting increasingly difficult to find the right talent—our study …
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
Prior to QbD, pharmaceutical development did not require the establishment of functional relationships between CPPs and CQAs. Consequently, process characterization experiments were primarily univaria…
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Historically, in biopharmaceutical development, criticality has been a frequently arbitrary categorization between important high-risk attributes or parameters and those that carry little or no risk. …
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Bioprocessing Advances in Vaccine Manufacture
Purification Technologies
Novel purification technologies are also in development. These improvements are much needed, as advances in upstream manufacturing (everything through product formation i…
Article
Evolution of the Monoclonal Antibody Purification Platform
Some process development related attributes with respect to production of mAbs include:
• Significant increase in titer levels over the past decade (from 0.5 mg/mL to 5-10 mg/mL)
• High pr…
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HTPD 2023 conference is coming up. What will be discussed and what happened last time?
As on previous conferences, HTPD 2023 will, with the support from industry leaders, cover a broad range of topics related to smarter and more efficient process development. Both the evolution of matu…