Development

This new partnership provides access to Distributed Bio’s antibody discovery platforms.

New data highlights ability of the SQZ cell therapy platform to preserve cellular functions.

Survey results and record attendance may show positive signs for established and emerging biopharma regions.

Bioconjugation requires aseptic manufacturing and containment for cytotoxic payloads.

To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.

The companies will work together to develop Ionis-FB-LRx for the treatment of complement-mediated diseases, including Geographic Atrophy (GA), the advanced stage of dry age-related macular degeneration (AMD), in a deal worth $760 million.

Novartis plans to acquire Endocyte, a biopharmaceutical company, to accelerate the development of innovative radioligand technology for treating cancer.

The guidance describes the agency's recommendations on how to group patients with different molecular alterations and approaches for evaluating the benefits and risks of targeted therapies where some molecular alterations may occur at low frequencies.

The new guidance, Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry, discusses the planning of pre-IND meetings with FDA and sponsors.

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

The company says the new equipment will reduce sample turnaround times and increase variant detection quality and accuracy.

A new investigational vaccine, LASSARAB, shows promise for use against Lassa fever and rabies.

The companies will work together to discover, develop, and commercialize immunotherapies for patients with solid-tumor cancers in a collaboration worth $695 million per program.

The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.

Analytical exoglycosidases are transitioning from being largely academic tools to being suitable for glycan analytics in biopharmaceutical manufacturing.

The CHF 400-million (US$416-million) investment in Lonza's biopark in Visp, Switzerland, will expand Ibex Solutions with two new offerings, drug substance development and drug substance and drug product manufacturing.

The drug particle engineering and nanotechnology company offers a nanotechnology platform that can revive failed drugs in the pharma pipeline.

Colin Clarke, from the National Institute for Bioprocessing Research and Training, will lead a four-year European Industrial Doctoral Program for enhancing upstream biopharmaceutical manufacturing process development through single cell analysis.

The collaboration will explore the potential of Dyadic’s gene-expression platform to produce multiple biologic vaccines and drugs.

Andrew Bulpin, head of Process Solutions, MilliporeSigma, shares insights on characterizing CQAs in biopharmaceutical development and the different tests that should be carried out when assessing an investigational drug.

Sharing of bioprocessing know-how can help resolve pressing industry problems.

The development and optimization of an efficient conjugation process involves identifying the critical quality attributes and monitoring critical process parameters.

Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).

The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.

The companies will collaborate on the discovery, development, and commercialization of cell therapies for cancer.