Development

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Articles

Platform processes and effective risk assessments help overcome time and cost challenges.

Considering Process Scaling for Monoclonal Antibodies During Early Phase Development

Zara Bukhari is PhD scholar at the University of the Pacific, Stockton, CA. 

is senior downstream process development specialistat Polpharma Biologics S.A., Warsaw, Poland.

Smritie Sheth is scientific manager at SymphonyTech Biologics.

is consultant at SymphonyTech Biologics, Philadelphia, Pa.

Narendra Chirmule, PhD, is CEO at SymphonyTech Biologics.

The authors have reviewed applications of novel technologies in the major stages of biosimilars development: process development, pharmacology, toxicology, and clinical trials, with an emphasis on recent regulatory requirements.

Biosimilars Drug Development: Advances in Technologies from Molecule Design to Clinical Trials

Feliza Mirasol is the science editor for 

With the Proteologix acquisition, Johnson & Johnson gains two bispecific antibody early phase assets for immune-mediated diseases.

Johnson & Johnson Boosts Bispecifics Portfolio with Proteologix Acquisition

Editor of Pharmaceutical Technology Europe

Broken String Biosciences and the Francis Crick Institute will collaborate on research into how genome stability impacts ALS.

DNA Break-Mapping Technology to Advance ALS Research

Under a global license and collaboration agreement, AbbVie and OSE Immunotherapeutics will aim to develop OSE-230, a mAb for treating chronic inflammation.

AbbVie Partners with OSE Immunotherapeutics on Novel mAb for Chronic Inflammation

With the formation of the new R&D unit, Regeneron will assume full development and commercialization rights to 2seventy bio’s preclinical- and clinical-stage cell therapy pipeline.

Regeneron Forms R&D Cell Therapy Unit from 2seventy bio Platform Acquisition

The company is currently developing EVX-101 as an adjunctive treatment for MDD due to patients experiencing an inadequate response to first-line antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors SNRIs.

Evecxia Therapeutics and Quotient Sciences Complete Phase I Clinical Milestone

Stable producer cell lines show real promise despite continued development challenges.

Exploring Producer Cell Development for Lentiviral Vector Manufacturing

Chime Biologics, Leads Biolabs, and BeiGene have formed a three-way collaboration to advance the development and global manufacturing of Leads Biolabs’ lead mAb candidate, LBL-007.

Chime Biologics Forms mAb Development and Manufacturing Deal with Leads Biolabs and BeiGene

Despite many development challenges, stable producer cell lines show real promise.