Top News

Hamburg's Tenure at FDA

Feb 11, 2015

The industry reacts to the departure of Commissioner Margaret Hamburg.

FDA Requests Feedback on Biosimilar Interchangeability

Feb 09, 2015

The agency seeks public comment on information collection for biosimilars and interchangeable products.

FDA Commissioner Margaret Hamburg Announces She Will Step Down

Feb 05, 2015

Margaret Hamburg announced on Feb. 5, 2015 that she will step down as FDA Commissioner after serving in the position for almost six years.

Biopharma News

Baxter's New Biopharma Baxalta to Have Headquarters in Illinois

Feb 24, 2015

Baxter announced that its new biopharmaceutical arm, scheduled to become independent from Baxter in 2015, will be located in Bannockburn, Illinois.

Sagent Pharmaceuticals Recalls Atracurium Besylate Injection

Feb 24, 2015

The company voluntarily recalls product due to FDA observations of potential sterility problems.

FDA Issues Warning Letter to India Facility

Feb 23, 2015

The agency cites Apotex’s Bangalore facility with quality system failures.

Discovery Pipeline

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.

Mylan Announces Partnership with Theravance to Develop an Investigational Treatment for COPD

Mylan announced a partnership with Theravance Biopharma to develop and commercialize TD-4208, a novel investigational COPD treatment.

Investments into T-Cell Therapies Continues to Grow

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

Supplier News

World Courier Adds New Distribution Center in Australia

The new center represents AmerisourceBergen’s first facility erected specifically for clinical trial and commercial third-party logistics activities.

Merck Animal Health and XL-protein Partner to Produce Biopharmaceuticals for Animals

The companies partnered to create more effective biopharmaceuticals through the exploitation of PASylation.

Thermo Fisher Scientific Acquires Advanced Scientifics

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

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

Rapid Early Process Development Enabled by Commercial Chemically Defined Media and Microbioreactors

The use of commercially available media to achieve high titer in early process development is discussed.

Behind the Scenes with Buffers

They may not be glamorous, but buffers play an important role in biopharma manufacturing.

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

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

Downstream Processing

Behind the Scenes with Buffers

They may not be glamorous, but buffers play an important role in biopharma manufacturing.

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.

Single-Use Systems

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.

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

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

Analytics

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.

Equivalence Testing for Comparability

Understanding the influence of change events on product performance is a necessity to routine drug development, transfer, and validation.

Tackling Analytical Method Development for ADCs

As ADCs move through the drug-development process, different analytical methods are often required.

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

Year in Review: Key Outsourcing Trends

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

The Biopharma Working Life

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

Hype vs. Health

Ebola Virus Disease (EVD) is a severe, often fatal disease that is transmitted human-to-human through bodily fluids.

Standards/Regulations

FDA Postpones Hearing for Remicade Biosimilar

FDA announced that it would postpone a meeting that would be critical for the advancement of Celltrion’s Remicade biosimilar in the US.

Manufacturers Weigh Strategies to Prevent Drug Shortages

Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers, and bio/pharmaceutical manufacturers.

Sagent Pharmaceuticals Recalls Atracurium Besylate Injection

The company voluntarily recalls product due to FDA observations of potential sterility problems.

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

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.

A Call for Antibody Quality Control

Antibodies in research should be standardized and categorized using a barcode-like classification system, according to research published in Nature.

PCSK9 Inhibitor from Sanofi and Regeneron Snags Priority Review

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

Vaccine Development

GlaxoSmithKline Promises to Keep Vaccine Prices Low for Gavi Members

The pharmaceutical manufacturer pledged to freeze vaccine prices for Gavi-eligible countries for a decade.

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.