Top News

USP Establishes Elemental Impurities Implementation Dates

Mar 31, 2015

USP announces an implementation date of Jan. 1, 2018 for General Chapters Elemental Impurities—Limits and Elemental Contaminants in Dietary Supplements.

Biogen Idec Presents Results from Promising Alzheimer's Disease Drug Trials

Mar 19, 2015

Biogen Idec says its investigational candidate is the first drug to both reduce amyloid plaque in the brain and slow cognitive decline.

Early Studies Suggest PCSK9 Inhibitors Cut Heart Attack Risk in Half

Mar 16, 2015

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

Biopharma News

CMS Provides Guidance on Reimbursement and Formulary Policies for Biosimilars

Mar 31, 2015

Physician-administered biosimilars under Medicare Part B will be reimbursed at a rate based on innovator drug prices and new changes will make costly innovator Part D drugs easier to exclude from formularies.

Merck Joins CAR T-cell Market with $941 Million Intrexon Alliance

Mar 30, 2015

Merck Serono announces that it will work with Intrexon to develop a cancer therapy using chimeric antigen receptor T-cells.

Novartis Inks $250 Million Alliance with Aduro

Mar 29, 2015

Novartis announced that it entered into a multiyear alliance with Aduro Biotech to develop cancer immunotherapies, offering up to $250 million in upfront payments and equity investments.

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

Genentech Expands Oregon Fill/Finish Site

Genentech plans to invest more than $125 million in an expansion of its fill/finish facility in Hillsboro, OR.

Rentschler Puts New Bioreactor Into Play

The new 2000-L bioreactor will double Rentschler’s single-use manufacturing capabilities.

Sigma-Aldrich to Be Exclusive Supplier of Roche Analytical Tools

Under a new agreement, Sigma-Aldrich will be the single supplier for Roche’s Biochemical Reagents product portfolio.

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

Maintaining the Stability of Biologics

It is important to understand degradation and processing to maintain product stability in biologics.

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.

Downstream Processing

CaPure-HA DoE Optimization of Elution Conditions

Design of Experiments (DoE), also called experimental design, is a statistical approach to process development that has gained wide acceptance in the biopharmaceutical industry. DoE is used to reduce development costs by speeding up the design process and to optimize the parameters of a particular step in the manufacturing process. The data presented here demonstrate the optimization of the CaPure-HA elution using a DoE approach.

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.

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

USP Establishes Elemental Impurities Implementation Dates

USP announces an implementation date of Jan. 1, 2018 for General Chapters Elemental Impurities—Limits and Elemental Contaminants in Dietary Supplements.

Hamburg Era Ends at FDA

Commissioner Margaret Hamburg discusses globalization challenges and the need for investment in regulatory science during her last weeks at the agency.

FDA Issues Guidance on NIR Analytical Procedures

The agency outlines recommendations for the development and submission of near infrared analytical procedures.

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

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

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.