Manufacturing, Monoclonal Antibodies

The authors present a robust and easy-to-implement chromatography column performance assessment method, called direct transition analysis (DTA).

MilliporeSigma will collaborate with IPS and G-CON to offer end-to-end, turnkey, modular MAb manufacturing.

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.

FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.

Binding Site has introduced a number of new monoclonal antibodies targeting infectious diseases, including cytomegalovirus, hepatitis (A, B, C, and D), herpes, human immunodeficiency virus (HIV), rubella, and toxoplasma.

The acquisition gives GE Healthcare access to a nanofiber-based platform purification technology that can offer improvements in biopharmaceutical productivity.

The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.

As part of the deal, J&J’s Janssen will pay an upfront payment of $50 million to research, develop, and commercialize up to six bispecific antibodies.

The company’s new modules offer scalable single-pass diafiltration and were exclusively showcased during its Leadership Forum series in Westborough, MA.

The companies have established a joint laboratory to develop full continuous processing to manufacture high yields of monoclonal antibodies at reduced costs.

As part of the $900-million deal, Incyte will pay $150 million upfront to develop and commercialize an anti-PD-1 drug candidate from biopharmaceutical company, MacroGenics.

AbbVie will pay a $205-million upfront payment and have the option to develop and commercialize two antibody targets globally.

The biopharmaceutical company has received a $4.2-million grant from the Bill & Melinda Gates Foundation to invest in the development of new treatments for Enterotoxigenic Escherichia coli infections, a bacterial cause of diarrhea in the developing world.

The partnership and the formation of the institute intend to bring together industry, academia, and regulators to tackle challenges and provide solutions for continuous manufacturing.

Under an agreement, ProBioGen will develop a stable cell-line for and manufacture an anti-cancer antibody for Chiome using its proprietary cancer cell-killing technology.

Under Project BioShield, the agency could provide more than $170 million in funding to purchase and support late-stage development of Ebola vaccines and therapeutic drugs.

Process analytical testing for biopharmaceuticals requires enhanced methods due to complex bioprocesses.

This study outlines methods for an alternative protein-polishing process for challenging proteins.

KBI Biopharma, a biopharmaceutical contract development and manufacturing organization, will manufacture an antibody and a fusion protein developed by Heat Biologics’ subsidiary.

The new 10,000 ft2 of laboratories will be dedicated to the company’s monoclonal antibody platform, which enables rapid access to development and manufacturing capacity.

The authors review methods for generating monoclonal antibodies for research and development.

FDA grants priority review for emicizumab, an investigational bispecific monoclonal antibody, for treating hemophilia A with factor VIII inhibitors.

With £4.5 million (US$5.8 million) in funding, the consortium is tasked with developing a new automated continuous biologics purification unit to make biologic drug manufacturing more efficient.

Horizon to make publicly available its complete annotated CHO cell-line sequence in hopes of driving bioproduction cell-line innovation.

FDA advances the progress of biosimilars with acceptance of regulatory filing for biosimilar referencing a blockbuster biologic by Roche.

Improved resin chemistries and customized separation solutions are enabling more efficient separations.

The authors present a shift toward more integrated purification processes.

Continuous processing of 100 g of monoclonal antibody in 24 hours has been demonstrated using lab-scale equipment.