Biologic Drugs

A research team associated with Dr. Carl June announces it has discovered a way to engineer a patient’s own immune cells to recognize cancer-specific glycoantigens on tumor cells.

A new indication for Emergent BioSolutions’ BioThrax will give the drug market exclusivity through November 2022.

Pfizer broke ground at its Andover, Massachusetts campus on a clinical manufacturing facility for complex biologics and vaccines.

A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.

Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.

Industry experts discuss the benefits and challenges of using single-use systems in pharmaceutical manufacturing.

With technology advances, continuous manufacturing shows steady progress to more widespread adoption.

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

A new study in Nature Communications explores how to remove the bulk of the soaps that are added to injectables to make hydrophobic drugs more soluble.

The company’s method reduces the time required to crystallize antibodies from weeks to one day.

The GPhA and its Biosimilars Council expressed concern about the new proposed value-based reimbursement rules for Part B medications.

Experts discuss some of the emerging trends in bioprocessing in 2016, including 4D bioprinting, 2D-NMR, and the CAR-T design space.

Bioprocess operations-from cell line selection to final filtration-can influence the consistency and purity of biologic drug substances.

Policies for patient access to life-saving therapies must keep pace with biomedical innovation.

The company announced the launch of its first-in-class Lynx CDR connectors at INTERPHEX 2016.

The Subcommittee for Advanced Manufacturing of the National Science and Technology Council highlights biopharmaceutical manufacturing as an emerging priority.

Linker technology and drug combinations play an important role in the efficacy of ADCs.

The agency has announced the creation of the Combination Products Policy Council to address issues related to combination products.

Manufacturing highly toxic compounds in a biopharmaceutical environment tests equipment and systems.

At DCAT's annual meeting, Bill Downey, president of the market research firm High Tech Business Decisions, summarized results from its latest survey on biopharmaceutical outsourcing.

Industry is joining with academia and global health leaders to examine new approaches to biotech manufacturing.

Novo Nordisk broke ground on a facility in Clayton, NC, to manufacture APIs for GLP-1 and insulin medicines.

A team of Bristol-Myers Squibb scientists will work in a new laboratory at the National Institute of Bioprocessing Research and Training facility in Dublin, Ireland.

Asking the right questions is crucial to establishing a biopharmaceutical facility design.

The pharma company revealed in a fourth quarter call that it will improve its cell-culture capabilities by focusing on the use of naïve, highly proliferative cells to manufacture its CAR-T drug candidate.

The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.

There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.

Although switching has occurred in European markets for some biosimilars, most biosimilar manufacturers will focus on securing new users, according to Merck.

Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.

The Biosimilars Forum launched Partnership for Biosimilars Education and Access, an education initiative raising awareness of biosimilars in the US.