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

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Author Guidelines
FEATURES
Challenges and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design
Assessing a Risk Management Program
Program review can help quality risk management live up to the promise of ICH Q9.
Challenges of Protein Aggregation during Purification
Careful selection of downstream processing conditions is a must.
Healthcare Reform in China
Chinese healthcare reforms may be a double-edged sword for foreign companies.
Evaluating Design Margin, Edge of Failure, and Process Capability
Design space generation is encouraged in new product development.
BIOPHARM VIDEOS AND PODCASTS
EBOOK SERIES
Analytical and Bioanalytical Testing
Review new technologies and best practices in testing for viral contamination and biosimilars; method transfer practices; data management strategies; and protein purification processes.
ANALYTICS AND FORMULATION
mAb/VACCINE MANUFACTURING
BIOPHARM BUSINESS
BEST PRACTICES
TOP NEWS STORIES
Pandemic Vaccine Facility Dedicated in Texas
September 19, 2014
GSK Fined in China Bribery Scandal
September 19, 2014
Guideline Delineates How to Implement GS1 Standards to Support DSCSA
September 19, 2014
GPhA Supports Restricted Access Bill
September 18, 2014
Baxter Initiates Voluntary Recall of Potassium Chloride Injection
September 17, 2014
BIOPHARM COMPANY NEWS
GSK Fined in China Bribery Scandal
Baxter Names New Biopharmaceutical Company Baxalta
AbbVie to Acquire Shire for $54.7 Billion
PlantForm and PharmaPraxis Establish Joint Biosimilar Development Venture
INDUSTRY NEWS
PCI Acquires Biotec
BioTime Subsidiary Partners with Cancer Research UK in Clinical Trial of Lung Cancer Treatment
European Commission Grants Lilly and Boehringer Ingelheim's Insulin Glargine Product Marketing in EU
ProBioGen Plans Expansion
FDA NEWS
FDA releases updated proposals to improve food safety and help prevent foodborne illness in response to public comments
FDA approves Trulicity to treat type 2 diabetes
FDA approves Movantik for opioid-induced constipation
FDA approves weight-management drug Contrave
FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas
WHITEPAPER LIBRARY
High-Resolution Separation of Cysteine-Conjugated Antibody Drug Mimics
August 26, 2014
TOYOPEARL GigaCap® Cation Exchange Resins for Aggregate Removal from Monoclonal Antibodies
August 26, 2014
Enhanced Assurance of Supply for Single-Use Bags
August 26, 2014
Determination of Protein Molecular Weight and Size
July 29, 2014
Analysis and Control of Particles in Biopharmaceuticals
July 29, 2014
EVENTS
Fundamentals of Cleaning and Disinfectant Programs for Aseptic Manufacturing Facilities
October 1, 2014 - October 2, 2014
Bethesda, MD USA

Management of Aseptic Processing
October 6, 2014 - October 8, 2014
Bethesda, MD USA

Strategies for Reducing Human Error Non-conformances
October 9, 2014
Bethesda, MD USA

Single-Use Systems for Manufacturing of Parenteral Products
October 22, 2014 - October 23, 2014
Bethesda, MD USA

Validation of Biotechnology-related Cleaning Processes
October 28, 2014 - October 30, 2014
Bethesda, MD USA

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