Search results for " biopharms"
Article
Innovative Chromatography Resins Can Improve Purity and Quality
By: Feliza Mirasol
Recent innovations in chromatography resins offer promising advantages in downstream bioprocessing.
With ongoing efforts to increase monoclonal antibody (mAb) productivi…
Article
Lessons Learned from the Biopharma Industry's Response to the COVID-19 Pandemic
pandemic
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James Blackwell, President, Windshire Group, LLC, discusses the biopharma industry’s response to the COVID-19 pandemic a…
Article
Common Challenges in Cross-Functional Process Development
cross functional
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James Blackwell, President, Windshire Group, LLC, explores common challenges in cross-functional process developme…
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FDA Provides Guidance on Bispecific Antibody Development Programs
The final guidance document provides recommendations for regulatory, quality, nonclinical, and clinical considerations for bispecific antibody development programs.
FDA published final guidance …
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
STEVE
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Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory Compliance Associates, shares insight into regulatory require…
Article
Cytiva Advances Fiber Chromatography Technology with New Launch
The launch of HiScreen Fibro PrismA, the company’s newest product for early mAb purification process development strengthens Cytiva’s new fiber-based Protein A platform.
On Jan. 27, 2021, Cyti…
Article
Remote Monitoring and Big Data Advance Upstream Automation
Connected, integrated bioprocessing enterprises with greater data analytics capabilities are coming.
By Cynthia A. Challener
As upstream processing drives toward higher efficiencies in meeti…
Article
EMA Guidance on Changes to COVID-19 Vaccines to Fight Variants
The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.
The European Medicines Agency (EMA) has requested t…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Creativity and collaboration are required to overcome complex method development challenges.
By Kelvin H. Lee and Mark Lies
…
Article
Updating Viral Clearance for New Biologic Modalities
Viral clearance processes and guidance must evolve along with newer biotherapeutic modalities.
By Feliza Mirasol
Ensuring viral clearance (i.e., removal) in downstream purification has becom…