Search results for "biopharm"
Article
Innovative Chromatography Resins Can Improve Purity and Quality
The strong attention around custom affinity chromatography resins for non-Fc biologics is based on the fact that the biopharmaceutical industry would like to further rely on its experience with using …
Article
Lessons Learned from the Biopharma Industry's Response to the COVID-19 Pandemic
Topic covered include:
1:38 – The typical time frame for process design and process qualification for a biopharmaceutical development program
2:10 – The driving forces for the rapid scal…
Article
Common Challenges in Cross-Functional Process Development
cross functional
Click here to view more Industry Leader Q&As >>
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…