Top News

The Acquisition Battle Continues with Another Perrigo Rejection

Apr 29, 2015

Perrigo rejected Mylan’s second proposal for an acquisition valued at more than $34 billion, saying that the offer was too low to consider.

Mylan Rejects Teva’s $40 Billion Offer

Apr 28, 2015

In a smoldering letter, Mylan’s executive chairman announced the unanimous rejection of a $40-billion unsolicited acquisition offer from Teva.

FDA Releases Final Biosimilar Guidance

Apr 27, 2015

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

Biopharma News

The Acquisition Battle Continues with Another Perrigo Rejection

Apr 29, 2015

Perrigo rejected Mylan’s second proposal for an acquisition valued at more than $34 billion, saying that the offer was too low to consider.

Mylan Rejects Teva’s $40 Billion Offer

Apr 28, 2015

In a smoldering letter, Mylan’s executive chairman announced the unanimous rejection of a $40-billion unsolicited acquisition offer from Teva.

FDA Releases Final Biosimilar Guidance

Apr 27, 2015

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

Discovery Pipeline

Early Studies Suggest PCSK9 Inhibitors Cut Heart Attack Risk in Half

Treatment with monoclonal antibodies that inhibit the activity of PCSK9 was shown to significantly lower LDL cholesterol levels and have a strong cardiovascular benefit.

WHO to Launch Ebola Vaccine Efficacy Trial March 7

The agency will employ a ring vaccination method similar to the one used to eradicate smallpox.

NIST and MedImmune Partner on Protein Characterization Venture

MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.

Supplier News

Sigma-Aldrich Opens Cell Culture Technical Center in Singapore

The new center will primarily support SAFC’s biopharmaceutical development and manufacturing clients in Asia.

Udit Batra to Head Combined Merck and Sigma-Aldrich Business

Udit Batra, current head of Merck KGaA’s life science business, will lead the combined life science businesses following successful completion of Sigma-Aldrich acquisition.

SAFC Introduces New Media System

The system is compatible with a wide range of industrial CHO cell lines.

Peer-Review Research

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

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

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

Optimization of Protein Expression in Escherichia Coli

Choosing the optimal protein expression vector depends on strain, promoter, and a number of other factors.

Continuous Manufacturing: A Changing Processing Paradigm

Making the switch from batch to continuous manufacturing requires a thorough understanding of the process.

A Biopharmaceutical Industry Perspective on Single-Use Sensors for Biological Process Applications

This article presents first-hand perspectives from industry users to suppliers of single-use sensors.

Downstream Processing

Filtration Technologies Advance to Meet Bioprocessing Needs

Higher cell densities, greater demand for high-performance viral clearance, and desire for large-scale single-use technologies are driving development of filtration technologies.

High-Throughput Chromatography Sorbent Screening and Optimization

Use of ScreenExpert RoboColumns for high-throughput study of loading conditions on HyperCel™ STAR AX and MEP HyperCel Sorbents for mAb purification in flow-through mode.

Pall Corporation Acquires BioSMB Technology

Pall’s acquisition of BioSMB from Tarpon Biosystems expands its downstream continuous processing offerings.

Single-Use Systems

Best Practices in Facility Design

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

Thermo Fisher Scientific Acquires Advanced Scientifics

Thermo Fisher Scientific adds Advanced Scientific’s custom single-use systems and equipment to its bioprocessing offerings.

Mitigating Risk for Single-Use Assemblies in Sterile Filling

Evaluating the assembly design process, manufacture, and use helps mitigate risk.

Analytics

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.

Quality by Design and Extractable and Leachable Testing

The author discusses the various ways in which a quality-by-design program can enhance the extractable and leachable assessment of a drug product.

eBook Series

Secure Single-Use Systems

Experts discuss trends in single-use bioreactors, disposable chromatography, and best practices for reducing particulates in single-use systems.

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.

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.

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

How to Stay Abreast of Shifting Regulations and Remain Compliant

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to keep up with changing regulations.

Ensuring the Quality of Biologicals

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

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

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

Formulation

Formulating for Needle-free Jet Injection

Second-generation needle-free injection systems will make parenteral drug administration more convenient, efficient, and safe.

Novel Drug Delivery through Use of a Foamed Excipient

Ethylene vinyl acetate (EVA) drug-release technologies are explored.

Eli Lilly Announces Collaborations for Cancer Treatments

Eli Lilly collaborates with Bristol-Myers Squibb and Merck on clinical trials of oncology treatments.

Videos

mAb Development

Novartis' Cosentyx Shows Promise in the Treatment of Psoriasis

Clinical trial results suggest that monoclonal antibodies targeting the function of proinflammatory cytokine IL-17A in psoriasis may be significantly superior to other treatments.

Re-use of Protein A Resin: Fouling and Economics

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

NIST and MedImmune Partner on Protein Characterization Venture

MedImmune will provide funds and access to monoclonal antibodies to seven postdoctoral associates for the creation of protein measurement and characterization tools.

Vaccine Development

GSK Announces US Vaccine R&D Center

GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.

NIH Announces Positive Results for Experimental Ebola Vaccine

NIH announced positive safety results from the vaccine, VSV-ZEBOV, and found that all patients in the study experienced a strong antibody response.

Formulating for Needle-free Jet Injection

Second-generation needle-free injection systems will make parenteral drug administration more convenient, efficient, and safe.