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
AbbVie/Shire Deal Officially Off
October 20, 2014
Amgen Sues Sanofi and Regeneron over Patent for mAb Targeting PCSK9
October 20, 2014
EMA Works to Speed Up Ebola Treatment
October 20, 2014
Lilly to Close Manufacturing Facility in Puerto Rico
October 17, 2014
BioReliance Introduces New Predictive Assays
October 17, 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
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
BioReliance Adds Advanced In-Vitro ADME and Toxicology Services
CSL Behring Announces Global Facility Expansions
FDA NEWS
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
Federal judge approves FDA consent decree with Ascend Laboratories
FDA permits marketing of urinary prosthesis device for women
WHITEPAPER LIBRARY
Production of Stem Cells in Single-use Vessels
September 30, 2014
High-Resolution Separation of a Fusion Protein
September 30, 2014
Mammalian Virus Purification Using Ceramic Hydroxyapatite
September 30, 2014
PEGylated Protein Analysis by Size-Exclusion and Reversed-Phase UPLC
September 30, 2014
Efficient, high-titer monoclonal antibody production in a fed-batch process using single-use stirred-tank and rocking bioreactor systems
September 30, 2014
EVENTS
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

20th Annual Validation Week
October 28, 2014 - October 30, 2014
Philadelphia, PA 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

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