Top News

Specialty Drug Costs Higher for Americans Enrolled in Exchanges

May 27, 2015

Prescription drug usage data on more than one million Marketplace enrollees suggest that costs for specialty drugs are 36% higher for people with Obamacare.

House Committee Approves 21st Century Cures Legislation

May 20, 2015

The House Energy and Commerce Committee gave unanimous approval to the landmark 21st Century Cures Act reform bill on May 21, 2015.

Compounding Center to Pay $200 Million for Meningitis Outbreak

May 19, 2015

The former New England Compounding Center will pay $200 million to victims and creditors for the 2012 outbreak of meningitis that killed 64.

Biopharma News

Visterra Announces Partnership to Develop a Monoclonal Antibody

May 25, 2015

Visterra announces partnership with A*STAR to develop VIS513, a monoclonal antibody for the treatment of dengue fever.

Boehringer Gains FDA Approval of COPD Treatment

May 25, 2015

Boehringer Ingelheim announces FDA approval of Stiolto Respimat inhaler for the treatment of COPD.

Epirus Biopharmaceuticals and mAbxience Sign Agreement on Infliximab Biosimilar Distribution in Latin America

May 24, 2015

Epirus Biopharmaceuticals and mAbxience have entered into a development and future distribution deal for Epirus’ lead program, BOW015 (infliximab, reference biologic Remicade), for Latin American markets.

Industry News

ICH Steering Committee to Meet in Japan

The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.

Generic Opioids Create Policy Issues

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.

“Cures” Debate Far From Over

The House Energy Committee’s approval of the 21st Century Cures legislation is only a first step, with critics and collaborators alike lining up to comment.

Supplier News

CMC Biologics Expands Denmark Facility

The Denmark facility will incorporate CMC’s Bioreactor 6Pack configuration in one manufacturing line.

Circassia Invests $377 Million in Asthma Specialists

UK-based Circassia invests approximately $377 million on Aerocrine and Prosonix, two companies focused on asthma.

SAFC Expansions Address Significant Need for Enhanced Manufacturing Capabilities

SAFC’s new ADC wing in St. Louis, MO will feature commercial-scale manufacture of antibody-drug conjugates, and its Carlsbad, CA site will offer enhanced gene-therapy services.

Peer-Review Research

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.

Advanced Liquid Particle Counters to Measure Aggregated Proteins

Liquid particle counters are ideal for protein aggregation studies.

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.

Upstream Processing

Medicago Plans Vaccine Facility In Quebec City

Medicago's new production facility will make plant-based vaccines and therapeutics.

Using Multiple Techniques in Biophysical Protein Characterization

The aggregation of biopharmaceuticals is a complex process. For efficient analysis, it’s essential to carefully select orthogonal methods to minimize gaps in the data. This article discusses advantages and disadvantages of specific methods.

Optimization of Protein Expression in Escherichia Coli

Choosing the optimal protein expression vector depends on strain, promoter, and a number of other factors.

Downstream Processing

CaPure-HA™: Purification of mAb Fragments

Making use of chromatography resins with better selectivity, resolution and capacity is one approach to solving the problem not only of aggregate removal, but also that of mAb fragment and other digest products, in a column chromatography purification step. The data presented here demonstrate the capabilities of CaPure-HA to separate Fab and Fc fragments from undigested mAb in a papain digest of an IgG1 monoclonal antibody.

Process Integration and Economics of Continuous Downstream Processing with Inline Concentrators

As an important addition to the process development toolbox for platform process evaluation, Cadence™ Inline Concentrators (ILC), which utilize single-pass TFF technology, are crucial enablers of integrated, streamlined and continuous bioprocessing initiatives. ILC technology can remove constraints in existing facilities and increase the flexibility of manufacturing capabilities by increasing productivity and facilitating further use of disposables.

Filtration Technologies Advance to Meet Bioprocessing Needs

Higher cell densities, greater demand for high-performance viral clearance, and desire for large-scale single-use technologies are driving development of filtration technologies.

Single-Use Systems

Pall to be Acquired by Danaher

Pall has agreed to be acquired by Danaher for $127.20 per share.

Best Practices in Facility Design

Integrating advances in facility design can meet differing and emerging bioprocessing needs.

Thermo Fisher Scientific Acquires Advanced Scientifics

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

Analytics

Use of Multivariate Data Analysis in Bioprocessing

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

Advanced Liquid Particle Counters to Measure Aggregated Proteins

Liquid particle counters are ideal for protein aggregation studies.

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.

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

ICH Steering Committee to Meet in Japan

The ICH Steering Committee will meet from June 6–11, 2015 to discuss a variety of harmonization topics.

Physician Groups Band Together on Labeling of Biosimilars

Eight physician groups wrote to the commissioner of FDA to stress the importance of transparency in biosimilar labeling to decrease prescribing risks.

Generic Opioids Create Policy Issues

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients.

Formulation

Eagle Pharmaceuticals Wins Patent Approval for Rapid Infusion Method

The method patent covers the infusion of bendamustine hydrochloride for the treatment of certain blood cancers.

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.

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

Medicago Plans Vaccine Facility In Quebec City

Medicago's new production facility will make plant-based vaccines and therapeutics.

Vaccine Patch Could Eliminate Traditional Protocol for Vaccine Delivery

A vaccine patch may eliminate the need for traditional means of vaccine distribution, according to an article in NPR.

GSK Announces US Vaccine R&D Center

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