Biopharma News

PCSK9 Inhibitor from Sanofi and Regeneron Snags Priority Review

Jan 26, 2015

The potential blockbuster treatment targets a protein involved in cholesterol homeostasis.

Giovanni Caforio Named BMS CEO

Jan 21, 2015

Bristol-Myers Squibb has announced that Giovanni Caforio will be the company’s chief executive officer effective May 5; Lamberto Andreotti has been named chairman.

Zymeworks Partners with Celgene on the Development of Bispecific Antibodies

Jan 21, 2015

Under terms of the agreement, Zymeworks could earn up to $164 million per successful drug candidate.

Discovery Pipeline

Investments into T-Cell Therapies Continues to Grow

Syncona and Kite Pharma announced separate investments into T-cell therapies to fight cancerous tumors.

Yale and Gilead Extend Sequencing Initiative

The Yale School of Medicine and Gilead will continue their research on cancer targets for a minimum of three additional years.

Novartis Reports Positive Results for Secukinumab in Ankylosing Spondylitis Trials

Secukinumab is the first IL-17A inhibitor to meet its primary endpoint in two Phase III trials for patients with ankylosing spondylitis.

Supplier News

Baxter BioPharma Solutions Joins PBOA

Nelson Patterson has been elected to Pharma & Biopharma Outsourcing Association board.

Argos Partners With Saint-Gobain on Single-Use Components for Immunotherapy Manufacturing

Single-use components will be used in automated personalized therapy manufacturing.

Paragon Bioservices to Scale Up Protein Manufacturing

Under an NIH contract, Paragon Bioservices will design a manufacturing process for recombinant human rhE-selectin protein.

Top News

EMA Sets Elemental Impurities Implementation Dates

Jan 23, 2015

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

Giovanni Caforio Named BMS CEO

Jan 21, 2015

Bristol-Myers Squibb has announced that Giovanni Caforio will be the company’s chief executive officer effective May 5; Lamberto Andreotti has been named chairman.

Gene Therapy Vector Choice Affects Carcinogenicity

Jan 21, 2015

A new study conducted by the National Institutes of Health found that a certain vector used in gene therapy (and its insertion site in the genome) may be associated with an increased risk of liver cancer.

Peer-Review Research

Review of Orthogonal Methods to SEC for Quantitation and Characterization of Protein Aggregates

The use of orthogonal methods to SEC is discussed and examples are presented showing how analytical ultracentrifugation, AF4, and SEC compare in aggregate quantitation.

Single-Use Bioreactors for the Rapid Production of Preclinical and Clinical Biopharmaceuticals

Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.

Concentrating Feed—an Applicable Approach to Improve Antibody Production

Different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture are evaluated.

Upstream Processing

Argos Partners With Saint-Gobain on Single-Use Components for Immunotherapy Manufacturing

Single-use components will be used in automated personalized therapy manufacturing.

Fermentation for the Future

Improving efficiency, value chain, quality, and protein complexity with advanced bioprocess development.

Protein Sciences Considers Sourcing Flublok From Japan

Protein Sciences will evaluate sourcing Flublok from its Japanese licensee, UMN Pharma, which already runs a large-scale facility for the vaccine.

Downstream Processing

Viral Clearance Challenges in Bioprocessing

Challenges remain for virus removal and validation.

Pall ForteBio Releases Bioprocessing Contamination Detection Kit

Pall ForteBio introduces a solution for quantifying residual host cell proteins in CHO cells.

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.

Single-Use Systems

Argos Partners With Saint-Gobain on Single-Use Components for Immunotherapy Manufacturing

Single-use components will be used in automated personalized therapy manufacturing.

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.

Avid Bioservices Announces Expansion of cGMP Manufacturing Capacity

Biomanufacturing capacity expansion uses modular cleanroom design and single-use technologies.

Analytics

EMA Sets Elemental Impurities Implementation Dates

New drugs submitted for approval in Europe have 18 months to comply with new elemental impurities guidelines.

USP Elemental Impurities Implementation Set for January 2018

USP establishes Jan. 1, 2018 as the implementation date for its elemental impurities guidelines for existing drugs.

Ligand-Binding Assays and the Determination of Biosimilarity

Ligand-binding assays are fundamental to characterizing biosimilars.

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

The Biopharma Working Life

Industry professionals share the ups and downs of working in the biopharma industry.

Year in Review: Key Outsourcing Trends

Outsourcing is taking on a greater role in the biopharmaceutical manufacturing industry.

Standardizing Practices for Cellular Therapy Manufacturing

Cellular therapy developers learn process development strategies from pharma industry experiences.

Standards/Regulations

FDA Releases Photosafety Evaluation Guidance

FDA guidance discusses factors to consider in evaluation of photosafety and describes nonclinical photosafety tests.

FDA Names New Deputy Commissioner for Medical Products and Tobacco

Dr. Robert Califf is appointed FDA Deputy Commissioner for Medical Products and Tobacco.

EMA Launches Drug Safety Assessment Platform

The agency creates an electronic central repository to facilitate drug safety assessment reports.

Formulation

Eli Lilly Announces Collaborations for Cancer Treatments

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

Ligand-Binding Assays and the Determination of Biosimilarity

Ligand-binding assays are fundamental to characterizing biosimilars.

Analyzing Protein Aggregation in Biopharmaceuticals

Understanding and preventing protein aggregation is crucial to ensuring product quality and patient safety.

Videos

mAb Development

PCSK9 Inhibitor from Sanofi and Regeneron Snags Priority Review

The potential blockbuster treatment targets a protein involved in cholesterol homeostasis.

Sanofi and Boehringer Ingelheim Enter into Monoclonal Antibody Alliance

Sanofi will tap into Boehringer Ingelheim’s therapeutic monoclonal antibody manufacturing capabilities.

Janssen Beefs Up Antibody Discovery Capabilities through Agreement with Sevion

The partnership will focus on the discovery of antibodies against proteins that are not easily purified in functional form.

Vaccine Development

Ebola Treatments Ramp Up for Clinical Trials

Government and industry efforts to address manufacturing challenges move Ebola vaccine candidates into larger clinical trials.

Protein Sciences Considers Sourcing Flublok From Japan

Protein Sciences will evaluate sourcing Flublok from its Japanese licensee, UMN Pharma, which already runs a large-scale facility for the vaccine.

Manufacturing Issues Crucial to Combating Ebola

The United States government is ramping up support for formulation, production, and packaging of Ebola treatments.