Manufacturing, Monoclonal Antibodies

In Phase III clinical trials, ixekizumab showed to be superior to etanercept and placebo in treating moderate-to-severe plaque psoriasis.

New research presented at the American Society of Clinical Oncology meeting demonstrates that atezolizumab could be a promising first-line therapy for the treatment of bladder cancer in cisplatin-ineligible patients.

The agency publishes draft guidance on assay development and validation for immunogenicity testing.

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

Inflectra is the second biosimilar to hit the market in the United States.

The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platforms.

Solutions to circumvent heterogenous mixtures of antibody-drug conjugates and to ensure uniform drug-to-antibody ratio were discussed at a recent Catalent Applied Drug Delivery Institute symposium.

Adheren relies on chemical modifications, rather than genetic engineering, to create its cell-based immunotherapies.

The BARDA-supported monoclonal antibody was approved both as a treatment after anthrax exposure and as an anthrax prophylactic.

Experts in the field share some best practices for optimizing process economics in biomanufacturing.

FDA fast-tracked the monoclonal antibody based on early clinical data from a Phase I trial.

The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.

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

The company will in-license a novel antibody, which has a conformation that is associated with increased therapeutic efficacy.

The novel antibody-engineering platform works differently than most of the currently employed antibody-modifying technologies, according to UM Baltimore.

Although the Committee for Medicinal Products for Human Use (CHMP) gave Blincyto a positive opinion, full approval of the drug in the EMA will rely on additional clinical studies.

The fully humanized monoclonal antibody is licensed to Bristol-Myers Squibb.

Under terms of the agreement, Amgen will license Xencor’s XmAb technology platform for five Amgen programs and one Xencor program.

Licenses could potentially bring antibody R&D to areas beyond oncology, such as diabetes treatments

CMC Biologics and River Vision Development announce manufacturing agreement for RV001, a monoclonal antibody to treat Grave’s orbitopathy.

A broad indication for GSK’s investigational mAb mepolizumab, coupled with an upcoming FDA decision date, could give the manufacturer a competitive advantage in the biologic asthma market.

The $19.7 million contract will assist Emergent with the development of cGMP lots of three Ebola mAbs.

Catalent’s licensing of Excelimmune’s antibody combination therapy platform can enable more consistent, cost effective production of antibody combinations.

Monoclonal antibodies can facilitate the entry of radiopharmaceuticals into cells, David Scheinberg said at BIO 2015.

An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).