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

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Vector Manufacturing and Testing for Gene and Cell Therapy Applications
The authors offer insight into cell therapy manufacturing, vector production, and the safety aspects of testing for characterization.
Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission.
DoE Provides Benefits, but Preparation Is Necessary
Defining critical parameters and processing large quantities of data can be a challenge.
Germany Post AMNOG: Insights for BioPharma
The authors take a look at some of the recent developments in the German pharmaceutical market.
Viral Clearance Challenges in Bioprocessing
Challenges remain for virus removal and validation.
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
GPhA Issues Statement on Generic Drug Costs
November 20, 2014
Amgen Opens Single-Use Manufacturing Plant in Singapore
November 20, 2014
Manufacturing Issues Crucial to Combating Ebola
November 20, 2014
FDA Requests Comments on Generic Drug Submission Criteria
November 20, 2014
USP Joins Chinese Pharmacopoeia Commission for Annual Science Meeting
November 20, 2014
BIOPHARM COMPANY NEWS
MedImmune Acquires Definiens
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
INDUSTRY NEWS
FDA Practices Discourage Biologic Market Competition, Says PCMA White Paper
Actavis to Acquire Allergan for $66 Billion
Grand River Aseptic Manufacturing Secures Two Contracts
USP Releases Compounding Compendium
FDA NEWS
FDA takes enforcement action against Michigan sandwich company
FDA issues additional guidance for outsourcing facilities that compound sterile human drugs
FDA approves extended-release, single-entity hydrocodone product with abuse-deterrent properties
First vaccine approved by FDA to prevent serogroup B Meningococcal disease
FDA approves new treatment for rare form of hemophilia
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
Risk-based Qualification of Sterile Drug Product Manufacturing Systems
December 8, 2014 - December 10, 2014
Bethesda, MD USA

PepTalk: The Protein Science Week
January 19, 2015 - January 23, 2015
San Diego, CA USA

SLAS 2015
February 7, 2015 - February 11, 2015

7th Annual Global Biomanufacturing Summit
February 18, 2015 - February 19, 2015
Garden Grove, CA USA

PITTCON Conference and Expo 2015
March 8, 2015 - March 12, 2015
New Orelans, LA

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