Top News

Novartis Creates Biotech Spin-Off Mereo

Jul 29, 2015

The new biotech company, Mereo, is based in the United Kingdom, and kicks off with three mid-stage assets from Novartis.

Sanofi and Regeneron Form Immuno-Oncology Pact

Jul 28, 2015

The collaboration will focus on advancing bi-specific antibodies that target hematologic and solid cancers, either as monotherapies or in combination regimens with other immune modulating treatments.

FDA Issues Quality Metrics Draft Guidance Document for Comment

Jul 27, 2015

FDA’s quality metrics draft guidance details the types of data the agency plans to request and the quality metrics it plans to calculate.

Biopharma News

Shire Takes Baxalta Proposal to Shareholders

Aug 03, 2015

Shire takes its offer for an all-stock transaction to combine with Baxalta to shareholders after Baxalta declines to discuss the proposal.

Baxter BioPharma Solutions Loses CMO Client

Jul 29, 2015

Financial expectations for Baxter’s biopharma solutions arm will drop 10% as the result of a client’s decision to move its manufacturing in house.

arGEN-X Partners with University of Bern to Develop Combination Cancer Therapies

Jul 29, 2015

ARGX-110-based combination therapies have demonstrated potential in treatment-resistant cancers.

Industry News

FDA Outlines Fees for Drug Compounding Companies

FDA issues guidance regarding fees for drug compounding outsourcing facilities.

FDA Issues Dissolution Testing Guidance

FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.

CPhI Korea Opens as South Korea’s Biotech Sector Expands

Drug development is South Korea is being driven by the government’s R&D strategy under its Pharma 2020 Vision.

Supplier News

EMD Millipore Collaborates with celares GmbH to Offer Pegylation Services

The new service offering includes feasibility studies, process and analytical development, and scale-up from milligram to gram quantities required for pilot and subsequent commercial scale.

BioOutsource Opens New Facility in Glasgow

The investment doubles the company’s capacity to meet increasing demand for its biologics contract testing and biosimilar characterization services.

TxCell Assigns Manufacture of Lead Product Ovasave to MaSTherCell

The contract is a memorandum of understanding for the manufacturing by MaSTherCell of clinical batches of TxCell’s Ovasave.

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.

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.

Upstream Processing

Mastering Cell Bank Production

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

Catalent Licenses Excelimmune’s Antibody Combination Therapy Platform

Catalent licenses Excelimmune’s antibody combination therapy platform to enable the manufacture of multiple recombinant antibodies in a single batch culture.

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.

Downstream Processing

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.

3M Launches Production-Scale Sizes of its Upstream Purifiers

The new sizes follow the 2014 launch of the company’s fully disposable purifier.

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

Robust Optimization, Simulation, and Effective Design Space

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

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.

Another In-House Operation Gets Outsourced

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

Videos

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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.

Experts Join CPhI Panel

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

Standards/Regulations

FDA Outlines Fees for Drug Compounding Companies

FDA issues guidance regarding fees for drug compounding outsourcing facilities.

FDA Issues Dissolution Testing Guidance

FDA issues draft guidance on dissolution testing for immediate-release solid oral dosage forms.

Cleaning of Dedicated Equipment: Why Validation is Needed

This article discusses cleaning validation of equipment dedicated to the production of a single API.

Single-Use Systems

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.

Risk Assessment and Mitigation in Biopharmaceutical Manufacturing

The challenges and strategies of assessing and mitigating risk in biopharmaceutical manufacturing are discussed.

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

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.

EMA Clarifies HPV Vaccine Safety Profile

The European Medicines Agency reviews the safety of human papillomavirus vaccines.