Manufacturing, Monoclonal Antibodies

Evaluate and BioPharm International highlight the antibody-based therapeutics that may have 2017 launch dates in the United States.

EvaluatePharma and BioPharm International highlight the antibody-based therapeutics that may gain United States Regulatory approval in 2017.

According to results from the FOURIER trial, Repatha significantly reduced the risk of cardiovascular events and death in patients with atherosclerotic cardiovascular disease.

The companies will combine expertise on T-cell therapies with two or more binding domains to create novel oncology medications.

The development of mAb formulations poses challenges at the manufacturing, stability, analytical, and administration levels.

Results from the Phase III POLLUX trial with Janssen’s Darzalex showed that the drug was effective at reducing disease progression in patients with relapsed or refractory multiple myeloma.

The companies are collaborating on the commercialization of two biosimilar candidates in the US and Canada.

Allergan entered into a licensing agreement with AstraZeneca for MEDI2070, an anti-IL-23 monoclonal antibody in phase IIB development for the treatment of patients with moderate-to-severe Crohn’s disease.

An approach to stabilize PBS-based formulations could provide a simple physiological solution for use of proteins in research, preclinical, diagnostics, and clinical studies, as well as commercial biotherapeutic products.

The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.

Industry experts discuss best practices for selecting a separation technology.

This study offers a strategy for stabilization of biotherapeutics for long-term frozen storage in PBS-based formulations.

Jacobs Engineering will provide engineering and construction services to expand the Novartis site in Huningue, France.

The study demonstrates a systematic approach to stabilize PBS-formulated mAbs against freeze-thaw degradation.

NIST’s monoclonal antibody reference material can be used as a standard for biopharmaceutical analytical quality control.

The mAb, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, was granted a Breakthrough Therapy Designation from FDA for the treatment of multiple myeloma.

The companies filed a BLA for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis.

The acquisition will give Bristol-Myers Squibb full rights to Cormorant’s HuMax-IL8 antibody program.

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.