Top News

FDA Approves Repatha, Amgen’s PCSK9 Inhibitor

Aug 28, 2015

The drug was the first PCSK9 inhibitor approved in Europe and the second approved in the US.

FDA Releases Guidance on Biosimilar Nomenclature, Requests Comments on Interchangeable Product Naming

Aug 27, 2015

In a new draft guidance, FDA proposes the use of a nonproprietary name plus a four-letter suffix to identify all biologic products, both new and old.

MD Anderson Forms New Company with Immatics to Develop Cellular Therapies

Aug 26, 2015

The new company, Immatics US, will develop autologous and allogeneic adoptive cellular therapies for various types of tumors based on novel immunotherapy targets.

Biopharma News

FDA Approves Repatha, Amgen’s PCSK9 Inhibitor

Aug 28, 2015

The drug was the first PCSK9 inhibitor approved in Europe and the second approved in the US.

GSK to Divest Ofatumumab to Novartis Pharma

Aug 27, 2015

GSK announces plan to divest its rights in ofatumumab for auto-immune indications for up to $1 billion.

Merus Obtains Financing and Progresses in Clinical Trials of Bispecific Antibodies

Aug 26, 2015

Merus announced new investors and the sale of $80.5 million in shares to advance its immuno-oncology programs.

Industry News

Fluctuating Capacity and Demand Conditions in Biomanufacturing

Contract manufacturers are essential players that allow biopharmaceutical companies the flexibility to address fluctuating product demand and the ability to outsource projects that are not strategically critical.

Biosimilars and Follow-on-Biologics Market to Hit $35 Billion Globally by 2020

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

Knowledge-Sharing and Networking at the CPhI Pre-Connect Congress

The Pre-Connect Congress will explore pharma industry trends, such as mergers and acquisitions, the biologics market outlook, and innovation in drug delivery among others.

Supplier News

Sartorius Stedim Biotech to Supply Membrane Adsorber Technologies to GE Healthcare

Under the terms of the agreement, Sartorius Stedim Biotech will manufacture membrane adsorber technologies for GE, which will be marketed as part of GE’s ReadyToProcess product offerings.

WuXi PharmaTech Supplies Laboratory Testing Services to Lee's Pharm

WuXi's Laboratory Testing Division will be the exclusive supplier of laboratory testing services for Hong Kong-based Lee's Pharm.

IDT Biologika Acquires Gallant Custom Laboratories

The acquisition will give IDT Biologika access to the veterinary vaccines market.

CPhI Biopharma News

2015 CPhI Pharma Awards

The 2015 CPhI Pharma Awards honors innovation in all phases of small-molecule and large-molecule drug development. Deadline: 14 August, 2015.

Experts Join CPhI Panel

Industry experts from Biocon, PBOA, PCI, and Pharmatech Associates join CPhI annual report for 2015.

Upstream Processing

Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility

Taking immediate steps to address misidentified and contaminated cultured cell lines will improve the reproducibility of preclinical research.

BeiGene Plans First cGMP Manufacturing Facility in Suzhou, China

Biopharmaceutical company BeiGene plans to build facility in Suzhou to expand its clinical capability and prepare for commercial manufacturing.

Mastering Cell Bank Production

A thorough cell-bank testing plan is necessary to certify the safety and purity of a resulting biopharmaceutical product.

Downstream Processing

Avitide Secures Financing for Novel Affinity Purification Platform

The company’s purification platform is thought to reduce the number of purification steps that are currently required for the manufacture of complex therapeutics.

Optimizing Cation-Exchange Chromatography with High-Throughput Process Development for mAb Purification

Optimization of each phase in a chromatographic cycle has a positive impact on productivity.

Selecting a Comprehensive Bioburden Reduction Plan

Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.

Formulation

Minimization of Freeze/Thaw-Induced Protein Aggregation and Optimization of a Drug Substance Formulation Matrix

The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.

New Humira Formulation May Extend Patent Life of Blockbuster

Will AbbVie stave off biosimilar competitors by following Teva’s model for Copaxone?

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.

Analytics

Stability Testing in Biopharma

Three case studies illustrate some analytical methods important for stability testing.

Quantitative Post-Processing Characterization Techniques for Freeze-Dried Products

Subjective visual evaluation of freeze-dried products can be quantified through mechanical methods of characterizing the properties these materials.

Robust Optimization, Simulation, and Effective Design Space

Approaches to the generation of process models, optimization techniques, and application of a design space are explored.

Videos

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Peer-Review Research

Minimization of Freeze/Thaw-Induced Protein Aggregation and Optimization of a Drug Substance Formulation Matrix

The authors explore the use of statistical experimental design and multivariate analysis to develop a drug substance formulation matrix.

Endotoxin Test Concerns of Biologics: The Role of Endotoxin as a Quality Indicator in Biologic Manufacturing Processes

Low endotoxin recovery represents an opportunity to add value to the characterization of biologic drug products.

Standards/Regulations

Reagan-Udall Foundation Builds Portfolio of Drug Regulatory and Safety Projects

The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations.

Industry Responds to FDA Metrics Program

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

Continued Process Verification Key to Lifecycle Control and Continuous Improvement

Regulatory officials and industry scientists participated in a CMC Strategy Forum sponsored by CASSS in July 2015.

Single-Use Systems

Triumvirate Environmental and EMD Millipore Enter into Recycling Partnership

The partnership will help divert 840 tons of waste related to single-use products from landfills or incineration during the next year alone.

Bioreactor Harnesses Single-Use Process

Sartorius Stedim Biotech’s Sartoclear Dynamics is a clarification system designed to harvest mammalian cell cultures with high cell densities using single-use technology.

Using Single-Use Technologies in Downstream Processing

The use of single-use systems in downstream processing offers benefits in filtration and sampling and may reduce the risk of contamination.

mAb Development

CMC Biologics Secures Manufacturing Contract for mAb Treatment

CMC Biologics and River Vision Development announce manufacturing agreement for RV001, a monoclonal antibody to treat Grave’s orbitopathy.

GSK’s Investigational Asthma mAb May Beat Competitors to Market

A broad indication for GSK’s investigational mAb mepolizumab, coupled with an upcoming FDA decision date, could give the manufacturer a competitive advantage in the biologic asthma market.

BARDA Taps Emergent BioSolutions for the Manufacture of Ebola mAbs

The $19.7 million contract will assist Emergent with the development of cGMP lots of three Ebola mAbs.

Vaccine Development

CMC Biologics to Manufacture mAbs for the Treatment of Malaria

CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.

EMA Releases Positive Opinion for GSK’s Malaria Vaccine

GSK’s malaria candidate vaccine for the prevention of malaria in young children received a positive opinion from EMA.

GSK Ships Flu Vaccine

GSK accelerates delivery timeline for US quadrivalent flu vaccine.