Search results for " Biopharm" in Articles / App Notes
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…
Article
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
Topics covered include:
1:33 – Key regulatory guidelines for biopharma companies to follow
3:00 - Recent guidance changes/additions that impact biopharma
3:37 - Areas where additiona…
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
COVID-19 as an accelerator of adoption
The COVID-19 pandemic has impacted the biopharmaceutical industry in multiple ways. It has highlighted the dependence the world has on the industry and how i…
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…
Article
The Importance of Process Intensification and PAT for Achieving Real-Time Release
Lee and Mark Lies
Process intensification is of broad interest in the biopharmaceutical industry because of its promise and potential to increase efficiency and t…
Article
Updating Viral Clearance for New Biologic Modalities
Next-gen biopharma processing
Recent innovations, particularly in filter membranes and chromatography resins, have further helped to improve viral clearance performance.
“In general, chromatog…
Article
Cytiva and 4Tune Engineering Collaborate on Cell Therapy Quality Risk Management
The collaboration addresses the need for risk mitigation plans in cell therapies.
On Dec. 3, 2020, Cytiva and 4Tune Engineering, a manufacturing-sciences and technology company, announced that th…
Article
Akron Bio Will Install a Cytiva FlexFactory to Manufacture Plasmid DNA
Cytiva will provide the first FlexFactory to be used in the manufacture of pDNA to Akron Bio.
Cytiva will provide its FlexFactory, a flexible, single-use platform, to enable Akron Biotech to m…