Search results for " pharmaceutical"
Article
Viral Clearance Challenges in Bioprocessing
…pply all of the measurements that are important for a production site that manufactures and releases pharmaceuticals for human use,” he asserts.
Importance of communication
Meeting regulatory r…
Article
Continued Process Verification for Biopharma Manufacturing
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About the Authors
Jeff Fleming is an independent writer with over 30 years of experience in pharmaceutical manufacturing.
Robin Payne is facilitator at the BioPhorum Operations Group,…
Article
Evaluating Design Margin, Edge of Failure and Process
ICH, Q8 (R2) Pharmaceutical Development (2009).
2. ICH, Q9 Quality Risk Management (2006).
3. ISO, ISO 9000:Quality Management (2005)
4. ICH, Q6B Specifications: Test Procedures and Accept…
Article
Single-Domain Antibodies for Brain Targeting
Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production.
Smaller recombinant antibody fragments a…
Article
Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
ICH, ICH Harmonized Tripartite Guideline Q8: Pharmaceutical Development, Step 4 version (August 2009).
2. A. S. Rathore, Trends Biotechnol. 27 (12) 698-705 (2009).
3. A. S. Rathore and H. Wink…
Article
FDA Urged to Preserve Biosimilar Naming Conventions
The Generic Pharmaceutical Association (GPhA) is reporting that 32 organizations, including pharmacies and labor unions, have signed a letter urging FDA to require biologics and biosimilars to have …
Article
Gowning Practices Provide Clues to cGMP Compliance
Review gowning practices as a tool to evaluate cGMP compliance in a facility.
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMP…
Article
Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
Can you talk to us about the state of continuous processing in biotechnology?
A: Yes, the event is the International Symposium on Continuous Manufacturing of Pharmaceuticals (May 20-21, 2014…
Article
Trends in BioPharma Approvals in 2013
Ovaleap (Teva Pharmaceuticals) is the first biosimilar follicle stimulating hormone (FSH) to be approved; it will compete with two FSH products already marketed in Europe (Merck-Serono’s Gonal-f and O…
Article
Q&A with Industry Leaders: Rita Peters
Q: What trends have you seen in the drug development market as 2014 enters the second quarter?
A; At recent industry conferences and trade shows for pharmaceutical development, both educational se…