Biologic Drugs

As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.

Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.

While allogeneic therapies can use existing regulatory and quality frameworks, autologous treatments will require pharma’s adoption of true just-in-time and right-first-time concepts, says consultant James Blackwell.

Valitacell and Solentim, have announced a collaboration aimed at the acceleration of discovery and development of biologic drugs and advanced cell therapies.

Mustang intends to combine an oncolytic virus with an interleukin-13 Rα2-(IL13Rα2)-specific chimeric antigen receptor to potentially enhance efficacy in treating glioblastoma multiforme.

Teva will apply Insilico’s technology for predictive biomanufacturing to create more efficient biomanufacturing processes.

The agency clarified the process for development programs for regenerative medicine therapies.

The drug is approved in the United States specifically for treating acquired thrombotic thrombocytopenic purpura, a rare blood-clotting disorder.

The partners will collaborate on the development and commercialization of a B-cell maturation antigen-targeting immunotherapeutic for treating multiple myeloma.

The multi-year agreement will give Novartis access to AbCellera’s expertise and state-of-the-art antibody discovery technology for up to ten clinically-relevant disease targets.

New platform technologies, advanced modeling tools, and addressing patient needs are important developments.

Biosimilars, pricing strategies, and technology will influence growth in spending on drugs.

The market for biosimilars in Europe remains consistently robust, with 16 new biosimilars approved in 2018.

Novel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.

Janssen and MeiraGTx will collaborate on the development and commercialization of gene therapies for treating inherited retinal diseases.

Drug developers must understand the complex bioanalytical assays for cell- and gene-therapy drug development programs and ensure that partners have the specialized expertise needed for complex therapeutic classes.

Lonza and Takeda have furthered their multiproduct partnership through collaborative efforts on a new cancer treatment-Alunbrig (brigatinib).

The agreement gives Sanofi access to Biomunex’s proprietary bi- and multi-specific-antibody-generating platform.

The new reagents are designed to support clinical-phase and commercialization stages of cell and gene therapy production and to enhance DNA transfection.

AbbVie and immunotherapy company Tizona Therapeutics will join forces to develop and commercialize CD39-targeted therapeutics to treat cancer.

Agilent and other partners are funding development of Tapestri, a single-cell sequencing platform designed to help predict cancer relapse in individual patients and show the efficacy of gene-editing experiments.

Avacta Group and LC Chem Life Sciences have entered into a multi-target collaboration and development agreement.

GSK and TESARO have entered into a definitive agreement concerning GSK's acquisition of TESARO for an aggregate cash consideration worth approximately $5.1 billion.

Antibody-based drugs offer new mechanisms of action and greater specificity.

The partnership, co-funded by Enterprise Ireland, will develop technologies for monitoring the quality of biopharma processes.

Moving forward with gene therapy development requires a “quantum leap” in manufacturing capabilities.

The testing of raw materials is essential as raw material quality determines the outcome of biologic product quality.

The new program will provide cell and gene therapy companies a more efficient way to ensure quality compliance across collection center networks and to minimize quality system audit burden on these centers.

The company received FDA approval for Hyrimoz (adalimumab-adaz), its biosimilar referencing AbbVie’s blockbuster Humira (adalimumab).

As biologic drugs grow increasingly complex, drug delivery mechanisms such as prefilled syringes are being adapted to meet the challenges.