Manufacturing, Monoclonal Antibodies

The final guidance explains some principles for developing biosimilars and establishes some rules about extrapolation across indications for various medical conditions.

Celgene expands its oncology drug discovery and development portfolio through a new partnership with Sutro.

A Priority Review voucher Sanofi and Regeneron purchased from BioMarin pharmaceuticals may put their mAb ahead of Amgen's in the market.

Personalized immunotherapy treatments help 90% of acute lymphoblastic leukemia patients achieve remission in a new study.

Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production.

Establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.

Different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture are evaluated.

The approval and acceptance of monoclonal antibody biosimilars is necessary if the biosimilars market is to experience real growth.

A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance.

The authors discuss the evolution of the purification platform for manufacturing of mAb therapeutics.

The EMA's Committee for Medicinal Products for Human Use has recommended granting of marketing authorizations for the first two monoclonal antibody biosimilars.

Making chemically defined media work.

How to use risk assessment strategies to integrate operations.

HTPD allows rapid screening of chromatographic parameters.

This alternative purification method to chromatography is readily scalable and fits a fully disposable downstream process.

New technologies and adaptations of existing technologies can improve platform processes.

Key considerations for defining your overall control strategy.

A case study compares capital costs, operating expenses, and NPV for a new MAb plant.

The future of therapeutic MAbs lies in the development of economically feasible downstream processes.

New techniques can overcome bottlenecks in existing facilities.

A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.

A stable alternative to Protein A chromatography.

Can increase in ionic strength result in higher viscosity?

The future of therapeutic MAbs lies in the development of economically feasible downstream processes.

Altering the order of operations, using new resins, and increasing dynamic binding capacity can obviate the need for major facilty changes.