Search results for " sourcing"
Article
PDA's Technical Report for Biotech Cleaning Validation
The authors encourage biotech manufacturers to consult PDA Technical Report No. 49 for a detailed perspective on current practices and issues in biotech cleaning validation.
By Anurag S. Rathore, D…
Article
Sterilization Trends for Single-Use Consumables
Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to …
Webcast
Webinar: Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics
About this talk
Full title: Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics Presented by Irina Ramos, Director, Bioprocess Technology and…
Article
Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracet…
Article
A scalable single-use two-step plasmid purification process
The current global demand for biopharmaceuticals is over USD 300 billion, with an estimated growth of ≥ 12% annually. While MAb processes have become much more efficient, production of mRN…
Article
Digitalization: The Route to Biopharma 4.0
Industry 4.0, also known as the Fourth Industrial Revolution (4IR), will result in the digital transformation of the manufacturing sector. It is propelled by transformative trends such as the prolif…
Article
Novavax Reports on Two Vaccine Efficacy Studies
Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.
Novavax announced on June 14, 2021, results from two studies of is recombinant…
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
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…