Manufacturing, Biologic Drugs

Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.

CMC Biologics will manufacture monoclonal antibodies (mAbs) and provide process development services for the PATH Malaria Vaccine Initiative.

A study now underway on vaccine manufacturing examines the effects of focusing on consistency during manufacturing, instead of post-production testing.

Biologics exhibit greater variability in stability testing than do small-molecule drugs, and maintaining a stable test environment is crucial.

The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.

Despite the buzz about biologic-based drugs, small molecule-based drugs are still the mainstay treatment.

The European Pharmacopoeia addresses the need for monographs for biologicals to keep pace with recent analytical technology advances.

The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.

This new pharmaceutical stability storage facility will enable the company to expand its analytical and formulation offerings to the pharmaceutical and biotech industries.

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

AstraZeneca announces that it will invest $285 million in a new manufacturing facility in Sweden.

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

The European Pharmacopoeia defines the format and content of monographs for biologicals to keep pace with recent approaches and meet the needs of its users.

Catalent’s Zydis technology will be used to develop thermo-stable and cold-chain independent vaccines.

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

Small- to medium-sized companies are expected to drive near-term growth of the global biomanufacturing outsourcing market.

FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.

Emergent BioSolutions announced FDA approval of Anthrasil, an inhalable treatment that targets Anthrax toxins, as well as a contract with BARDA to develop NuThrax, an anthrax vaccine candidate.

The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.

Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.

BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.

Scientists and industry experts seek effective preventive therapies to combat global disease.

The fast growth of the global biopharmaceutical market has prompted global pharmaceutical and biotechnology companies to increase their R&D investment in biologics.

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high United States revenues to fund biopharmaceutical R&D.