Top News

21st Century Cures Act Gets a Revision

Jul 06, 2015

The amendment suggests modifications to the calculation of a drug's average manufacturing price and to the reimbursement rate for infused medications.

GSK Plans Increase in Antibiotic Production in Singapore

Jun 29, 2015

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

Bristol-Myers Squibb Makes Changes in R&D Locations and Focus

Jun 28, 2015

Bristol-Myers Squibb builds R&D facilities in Massachusetts and San Francisco and discontinues discovery research in virology.

Biopharma News

Horizon Makes Second Offer to Buy Depomed, Gets Rejected Again

Jul 06, 2015

The offer, valued at $3 billion, represents a 42% increase in Depomed’s share price.

French Hospital to Drop Remicade in Favor of a Biosimilar

Jul 06, 2015

A large health system will use the biosimilar version of infliximab from Hospira after the company offered a discount of 45%.

Biogen Plans Biologics Manufacturing Facility in Switzerland

Jul 05, 2015

Biogen plans to build a biologics manufacturing plant in northwest Switzerland using next-generation technologies to create efficiency and sustainability.

Industry News

FDA Delays Product Tracing Requirements for Dispensers

The agency gives a limited reprieve to dispensers but requires other trading partners to provide product tracing information.

BioPlan Associates Releases New Report

The 12th Annual Report and Survey of Biomanufacturing is now available.

ICH Appoints New Director of the ICH Secretariat

The International Conference on Harmonization Steering Committee appoints Dr. Dawn Ronan as the new director of the ICH Secretariat.

Supplier News

Catalent Adds Platform for Antibody Combination Therapies

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable more consistent, cost effective production of antibody combinations.

Sartorius Stedim Biotech Acquires Cellca

According to Sartorius Stedim Biotech, this acquisition expands its service offering for process development.

Capsugel Completes New Spray-Dried Dispersion Manufacturing Facility

The new facility expands the company’s commercial manufacturing capability at its Bend, Ore. site.

Peer-Review Research

Differentiation and Characterization of Protein Aggregates and Oil Droplets in Therapeutic Products

This article demonstrates how resonant mass measurement can be used not only to detect and quantify the formation of protein subvisible particles in a critically important size range but also to detect and quantify any silicone droplets in the formulation.

Advanced Liquid Particle Counters to Measure Aggregated Proteins

Liquid particle counters are ideal for protein aggregation studies.

Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers

The authors review efforts to limit polymer degradation without significantly impeding cell growth.

Upstream Processing

Biogen Plans Biologics Manufacturing Facility in Switzerland

Biogen plans to build a biologics manufacturing plant in northwest Switzerland using next-generation technologies to create efficiency and sustainability.

GSK Plans Increase in Antibiotic Production in Singapore

GSK will invest in an additional downstream isolation facility for amoxicillin production in Singapore.

Genea Biocells Builds Stem-Cell Facility in California

Australian company, Genea Biocells, will open a facility in San Diego, California for cell and culture-media manufacturing and R&D.

Downstream Processing

Natrix Introduces New Disposable mAb Purification Column

The new column features Natrix’s signature macroporous hydrogel.

Biopharma Advances Demand Specialized Expertise

Contract service providers share insights on biopharma market developments and the implications of biosimilar drug approvals.

Sterile Filtration Techniques for Optimal Microbial Retention

Removal of microorganisms is crucial when working with biologics. Sterile filtration offers a reliable, safe, and effective way to ensure product integrity.

Analytics

Another In-House Operation Gets Outsourced

Biopharma companies on both sides of the Atlantic ship more of their assay testing to outside service providers.

Use of Multivariate Data Analysis in Bioprocessing

The authors review major developments in use of MVDA in bioprocessing applications.

Advanced Liquid Particle Counters to Measure Aggregated Proteins

Liquid particle counters are ideal for protein aggregation studies.

Videos

eBooks

 

Outsourcing Resources eBook
The editors examine trends and key issues in the outsourced biopharmaceutical market: the impact of biosimilars and cell therapies, manufacturing challenges including fill/finish, risk management, IP protection, and global market activity.  View eBook

 

More eBooks
Secure Single-Use Systems
Analytical and Bioanalytical Testing

 

 

Editor's Picks

SEC in the Modern Downstream Purification Process

Recent technological advances in the way biologic therapeutics are purified may bring size-exclusion chromatography back into the modern purification process.

Re-use of Protein A Resin: Fouling and Economics

Large-scale implementation of Protein A chromatography offers several challenges.

A Robust CAPA System for a Global Supply Chain

Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.

Standards/Regulations

21st Century Cures Act Gets a Revision

The amendment suggests modifications to the calculation of a drug's average manufacturing price and to the reimbursement rate for infused medications.

FDA Delays Product Tracing Requirements for Dispensers

The agency gives a limited reprieve to dispensers but requires other trading partners to provide product tracing information.

ICH Appoints New Director of the ICH Secretariat

The International Conference on Harmonization Steering Committee appoints Dr. Dawn Ronan as the new director of the ICH Secretariat.

Single-Use Systems

Advanced Technologies Facilitate Scale-up and Technology Transfer

Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer.

Pall to be Acquired by Danaher

Pall has agreed to be acquired by Danaher for $127.20 per share.

Best Practices in Facility Design

Integrating advances in facility design can meet differing and emerging bioprocessing needs.

Formulation

Catalent Adds Platform for Antibody Combination Therapies

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable more consistent, cost effective production of antibody combinations.

Capsugel Completes New Spray-Dried Dispersion Manufacturing Facility

The new facility expands the company’s commercial manufacturing capability at its Bend, Ore. site.

Biopharma Advances Demand Specialized Expertise

Contract service providers share insights on biopharma market developments and the implications of biosimilar drug approvals.

mAb Development

Catalent Adds Platform for Antibody Combination Therapies

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable more consistent, cost effective production of antibody combinations.

Using mAbs to Access Undruggable Targets

Monoclonal antibodies can facilitate the entry of radiopharmaceuticals into cells, David Scheinberg said at BIO 2015.

FDA Panel Recommends Approval of Praluent

An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).

Vaccine Development

Aeras and IDT Biologika Partner to Develop Vaccines

IDT Biologika acquired Aeras' vaccine manufacturing facility, and the companies will work together on tuberculosis vaccine development.

Medicago Plans Vaccine Facility In Quebec City

Medicago's new production facility will make plant-based vaccines and therapeutics.

Vaccine Patch Could Eliminate Traditional Protocol for Vaccine Delivery

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.