BioPharm International - Articles on bioprocessing methods, regulatory compliance, and biotech strategies

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Featured Section and Resources: GMPs & Validation
TAKE OUR POLL
Which of the following has the most negative impact on biopharmaceutical drug development?
Partnering between biopharmaceutical companies
Mergers/acquisitions
Globalization of drug development
Proliferation of counterfeit drugs
Reimbursement/payment plans
Regulations
Foreign competition
Partnering between biopharmaceutical companies
16%
Mergers/acquisitions
16%
Globalization of drug development
8%
Proliferation of counterfeit drugs
20%
Reimbursement/payment plans
16%
Regulations
20%
Foreign competition
4%
Author Guidelines
FEATURES
Biopharmaceuticals Approval Trends in 2013
A review of the past year's trends in biopharmaceutical approvals shows an above average approval rate.
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth.
Control Strategies for Synthetic Therapeutic Peptide APIs Part II: Raw Material Considerations
USP evaluates raw materials used in the chemical synthesis of peptides.
Raw Material Variability
The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.
Implications of Trace Levels of Redox-Active Metals in Drug-Product Formulation
The presence of minute amounts of chelators can help minimize the degradation of monoclonal antibodies.
ANALYTICS AND FORMULATION
BIOPHARM VIDEOS AND PODCASTS
mAb/VACCINE MANUFACTURING
BIOPHARM BUSINESS
BEST PRACTICES
TOP BIOPHARM NEWS
EMA Warns of Falsified Herceptin Vials
April 16, 2014
Mallinckrodt to Acquire Questcor Pharmaceuticals
April 16, 2014
American CryoStem and Rutgers University File Joint Patent on Stem Cell Platform
April 11, 2014
Center for Biologics Evaluation and Research Relocates
April 11, 2014
PhRMA Report Reveals Growth Trajectories and Policy Factors Affecting Biopharmaceutical Growth
April 11, 2014
EBOOK SERIES
Single-Use Systems
Review emerging trends in disposable systems for biopharmaceutical processing.
INDUSTRY NEWS
DepoVax Technology Selected for HPV–related Cancer Trials
Novartis's Bexsero Receives FDA Breakthrough Therapy Designation
PolyTherics and MacroGenics Extend ADC Collaboration
Desktop Human Body Developed for Toxicity Testing
FDA NEWS
FDA approves Ragwitek for short ragweed pollen allergies
FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroids
Puerto Rico bakery agrees to stop manufacturing and distributing products
FDA approves Tanzeum to treat type 2 diabetes
FDA approves expanded indication for certain pacemakers and defibrillators
WHITEPAPER LIBRARY
eBook: Troubleshooting Tips & Best Practices for Validation/Mapping
March 25, 2014
Peptide Mapping of Glycoprotein Erythropoietin by HILIC LC/MS and RP-LC/MS
March 25, 2014
Fast and Efficient Peptide Mapping of a Monoclonal Antibody (mAb): UHPLC Performance Using Superficially Porous Particles
March 25, 2014
TOYOPEARL AF-rProtein A HC-650F Host Cell Protein Removal
March 25, 2014
Agilent Bio-Monolith Protein A Monitors Monoclonal Antibody Titer from Cell Cultures
March 25, 2014
EVENTS
15th Annual Computer and Software Validation Forum
April 23, 2014 - April 25, 2014
San Diego, CA USA

Drug Delivery & Formulation Americas Summit
May 1, 2014 - May 2, 2014
San Diego, CA

CHI-PEGs Summit
May 5, 2014 - May 9, 2014
Boston, MA USA

Interpack 2014
May 8, 2014 - May 14, 2014

2014 AAPS National Biotechnology Conference
May 19, 2014 - May 21, 2014
San Diego, CA USA

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