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

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Author Guidelines
FEATURES
Challenges in Biologic Drug and Vaccine Delivery
Prefilled syringes offer advantages to manufacturers, healthcare professionals, and patients.
Application of Quality by Design to Viral Safety
A quality-by-design approach that defines potential viral contaminants of source materials can be used to achieve viral clearance.
Continued Process Verification for Biopharma Manufacturing
The authors discuss complications of implementing continued process verification and provide recommended approaches.
Single-Use Bioreactors for the Rapid Productionof Preclinical and Clinical Biopharmaceuticals
Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.
Coupling Light Scattering with Size-Exclusion Chromatography
Adding light scattering to size-exclusion chromatography (SEC) can maximize the benefits of SEC.
BIOPHARM VIDEOS AND PODCASTS
EBOOK SERIES
Outsourcing Strategies
Trends and best practices for the use of outsourcing serivces, pricing models, contract manufacturing, facility development and location activities, and clinical trial services.
ANALYTICS AND FORMULATION
mAb/VACCINE MANUFACTURING
BIOPHARM BUSINESS
BEST PRACTICES
TOP NEWS STORIES
First Biosimilar Application Kicks Off Legal Battle
October 31, 2014
FDA Approves Pfizer's Trumenba for the Prevention of Meningitis B
October 30, 2014
EMA: Extrapolation Across Indications for Biosimilars a Possibility
October 30, 2014
Bristol-Myers Squibb Announces Agreement to Acquire HER2-Targeted Cancer Treatment
October 29, 2014
Amgen, Sanofi, and Ono Pharmaceuticals Partner with Universities on Transmembrane Protein Research
October 28, 2014
BIOPHARM COMPANY NEWS
Lilly to Close Manufacturing Facility in Puerto Rico
Sanofi Pasteur and Immune Design Collaborate to Develop Herpes Simplex Virus Therapy
GSK Fined in China Bribery Scandal
Baxter Names New Biopharmaceutical Company Baxalta
INDUSTRY NEWS
SAFC Introduces New Protein Quality Supplement for Optimized Biologics Production
FDA Approves CMO Facilities for Halozyme Product
Wuxi's Biologics Facility Receives Honorable Mention at ISPE Facility of the Year Awards 2014
Nuvilex Applies for Orphan Drug Designation for Pancreatic Cancer Treatment
FDA NEWS
First vaccine approved by FDA to prevent serogroup B Meningococcal disease
FDA approves new treatment for rare form of hemophilia
FDA approves labeling with abuse-deterrent features for third extended-release opioid analgesic
FDA approves Ofev to treat idiopathic pulmonary fibrosis
FDA approves Esbriet to treat idiopathic pulmonary fibrosis
WHITEPAPER LIBRARY
Expansion of Stem Cells in Single-Use Bioreactors
October 28, 2014
Sensitive and Reproducible Glycan Analysis of Human Immunoglobulin G
October 28, 2014
Advanced HPLC Size-Exclusion Chromatography for the Analysis of Macromolecular Proteins Using 3.5 µm Ethylene Bridged Hydrid (BEH) Particles
October 28, 2014
MFI for Particle Characterization of Biopharmaceuticals Today
October 28, 2014
CaPure-HA Resin for Aggregate Removal from Monoclonal Antibodies
October 28, 2014
EVENTS
Validation of Biotechnology-related Cleaning Processes
October 28, 2014 - October 30, 2014
Bethesda, MD USA

AAPS Annual Meeting 2014
November 2, 2014 - November 6, 2014
San Diego, CA USA

2014 Aseptic Processing Training Program - Session 5
November 3, 2014 - November 7, 2014
Bethesda, MD USA

Recommended Practices for Manual Aseptic Processes - Lab
November 12, 2014 - November 13, 2014
Bethesda, MD USA

Quality Systems for Aseptic Processing
November 17, 2014 - November 21, 2014
Bethesda, MD USA

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