Biologic Drugs

The reporter bioassay, used to evaluate ADCC activity of therapeutic antibodies, complements the classical ADCC assay.

NICE announces plans to back biosimilar alternatives to Merck’s Remicade.

The collaboration will focus on development of novel molecules using SMARTag technology to couple different therapeutic modalities.

BioPharm highlights the monoclonal antibodies that may gain United States regulatory approval in 2016.

Boehringer Ingelheim announced it will establish a new biopharmaceutical production facility in Vienna.

Synpromics announced collaborations with Avalanche Biotechnologies and Applied Genetic Technologies Corporation to use synthetic promoters to develop gene therapies, including adeno-associated virus technology for treating eye diseases.

Collaboration between users and suppliers to increase understanding, clearly define user requirements, and mitigate risk is facilitating acceptance by industry and regulators.

Millipore Express PHF hydrophilic, sterilizing-grade filters from EMD Millipore offer faster flow rates to speed the process or reduce the process footprint.

PSL has installed several advanced contained filtration and drying facilities as part of an expansion of a pharmaceutical manufacturing plant in Singapore.

Sandoz announces that the European Medicines Agency has accepted a MAA for a biosimilar of etanercept.

Analytical methods and functional assays are used to compare molecules and relate characteristics to quality attributes.

Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.

The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.

The CEO of a US-based biosimilar manufacturer explains the legal and intellectual property issues of bringing a biosimilar to market in the United States.

While some industry trade groups are gunning for distinct, nonproprietary names for biosimilars (mostly providers, brand manufacturers, and patient advocacy groups), and others for common names (mostly biosimilar manufacturers, insurers, pharmacies, and the Federal Trade Commission [FTC]), some are requesting that no decisions be made at all at this stage in the game. Express Scripts, a large pharmacy benefit manager (PBM), submitted a comment to FDA asking that the regulatory agency hold off on naming decisions until it releases formal guidance on interchangeability first.

A study backed by the Centre of Regenerative Medicine found that laminins are crucial cell components that could help aid the commercial production of stem cell therapies.

The University of Sheffield has appointed Cobra Biologics to advance novel fusion protein technology into Phase 1 clinical trials.

BioOutsource releases informational video detailing issues associated with ADCC assays and how to effectively analyze them.

The UK’s National Biologics Manufacturing Centre will use Novasep’s BioSC Lab for protein purification.

GE Healthcare's KUBio prebuilt modules were shipped from Germany to JHL Biotech in Wuhan, China.

Biotech boom, niche markets, smaller batch sizes and high potency manufacturing are among the key trends shaping the pharmaceutical industry of the 21st century, according to Christian Treitel from Bosch Packaging Technology.

At least 70 patents for Humira will protect the legacy product from biosimilar competitors, according to information presented during the company’s third-quarter earnings call.

Better process development is creating industry benchmarks for bioprocessing.

Sartorius Stedim Biotech’s Flexsafe 3D Pre-designed Solutions meet ASTM D4169 Standard Practice requirements and are designed for storage and shipping of biopharmaceutical fluids.

ProBioGen plans to develop and scale-up production of a biosimilar to the mAb cancer drug trastuzumab and will transfer the commercial manufacturing process to Indonesia’s government-owned Bio Farma.

USP responds to FDA's draft guidance on the naming of biological products.

Catalent’s SMARTag™ technology enables biologic innovators to develop more efficacious antibody drug conjugates. It allows site-specific, programmable drug placement using proprietary cytotoxin-linkers/conjugation chemistry in an efficient and scalable process.

Despite considerable investment by biotech manufacturers in developing competitive biologics for the US market, gaining FDA approval of these products has turned out to be a slow and complex process.

Univercells will integrate its single-use bioprocess with the Takeda vaccines production platform to allow local production.

Biovest’s mAbVault provides supply-chain redundancy for antibodies that enables customers to lock in price-per-gram protein production.