Top News

Biosimilars May Spur Improvements in Reference Product Manufacturing Processes

Apr 22, 2015

Originator product manufacturers will have to update and improve their processing platforms to stay competitive with the biosimilars coming to market.

A Franchise Approach to the Modular Industry

Apr 22, 2015

Prequalified manufacturing suites could benefit from a new business model, say some industry executives.

Highlights from INTERPHEX 2015

Apr 21, 2015

INTERPHEX 2015 is under way and Pharmaceutical Technology and BioPharm International are in the middle of the action!

Biopharma News

EMA Recommends Authorization of Melanoma Treatment

Apr 23, 2015

The agency has recommended granting marketing authorization for Opdivo.

GSK Recalls Flu Vaccine

Apr 19, 2015

GSK notifies CDC and FDA that it is recalling the remaining doses of its 2014–2015 flu vaccine, Flulaval Quadrivalent Thimerosal-free Pre-Filled Syringes, due to decreased potency.

Combination of Yervoy and Opdivo Shrinks Melanoma Tumors Drastically in NEJM Case Report

Apr 19, 2015

The combination of two mAb drugs eradicated a large tumor, but also sparked new toxicity concerns associated with immunotherapies.

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

Sigma-Aldrich Opens Cell Culture Technical Center in Singapore

The new center will primarily support SAFC’s biopharmaceutical development and manufacturing clients in Asia.

Udit Batra to Head Combined Merck and Sigma-Aldrich Business

Udit Batra, current head of Merck KGaA’s life science business, will lead the combined life science businesses following successful completion of Sigma-Aldrich acquisition.

SAFC Introduces New Media System

The system is compatible with a wide range of industrial CHO cell lines.

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

Continuous Manufacturing: A Changing Processing Paradigm

Making the switch from batch to continuous manufacturing requires a thorough understanding of the process.

A Biopharmaceutical Industry Perspective on Single-Use Sensors for Biological Process Applications

This article presents first-hand perspectives from industry users to suppliers of single-use sensors.

Maintaining the Stability of Biologics

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

Downstream Processing

Pall Corporation Acquires BioSMB Technology

Pall’s acquisition of BioSMB from Tarpon Biosystems expands its downstream continuous processing offerings.

Continuous Manufacturing: A Changing Processing Paradigm

Making the switch from batch to continuous manufacturing requires a thorough understanding of the process.

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.

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

Use of Multivariate Data Analysis in Bioprocessing

The authors review major developments in use of MVDA in bioprocessing applications.

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.

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

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.

A Robust CAPA System for a Global Supply Chain

Enterprise quality management systems can help shift the quality emphasis from corrective to preventive actions.

Standards/Regulations

Dicerna Receives Orphan Drug Designation for PH1 Treatment

Dicerna Pharmaceuticals announces that FDA granted its primary hyperoxaluria type 1 (PH1) treatment Orphan Drug designation.

EMA Recommends Authorization of Melanoma Treatment

The agency has recommended granting marketing authorization for Opdivo.

FDA Releases Draft Guidance on Promotional Labeling and Advertising

The agency has released draft guidance on providing regulatory submissions in regards to promotional labeling and advertising materials.

Formulation

Formulating for Needle-free Jet Injection

Second-generation needle-free injection systems will make parenteral drug administration more convenient, efficient, and safe.

Novel Drug Delivery through Use of a Foamed Excipient

Ethylene vinyl acetate (EVA) drug-release technologies are explored.

Eli Lilly Announces Collaborations for Cancer Treatments

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

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

GSK Announces US Vaccine R&D Center

GlaxoSmithKline announces global vaccines research and design facility to be based in Rockville, MD, USA.

NIH Announces Positive Results for Experimental Ebola Vaccine

NIH announced positive safety results from the vaccine, VSV-ZEBOV, and found that all patients in the study experienced a strong antibody response.

Formulating for Needle-free Jet Injection

Second-generation needle-free injection systems will make parenteral drug administration more convenient, efficient, and safe.