Development

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.

The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.

Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.

A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software.

The acquisition will support the accelerated commercialization of Kyslecel (autologous pancreatic islets), Koligo’s personalized cell therapy for treating pancreatitis.

Moderna and Chiesi Group are collaborating on the discovery and development of mRNA therapeutics to treat pulmonary arterial hypertension.

The collaboration will expand the manufacturing capacity for lenzilumab, a COVID-19 therapeutic candidate, in advance of a potential Emergency Use Authorization in 2020.

The agreement will Increase global manufacturing capacity for Novavax’s vaccine candidate, NVX-CoV2373, to more than two-billion annualized doses when at full capacity in 2021.

The agreement between the two companies will significantly increase global supply capacity for Lilly's potential COVID-19 treatments.

The companies will focus on the development and commercialization of Seattle Genetics’ ladiratuzumab vedotin and TUKYSA (tucatinib).

Catalent’s Redwood Bioscience subsidiary will develop antibody-drug conjugates (ADCs) for Exelixis using Catalent’s proprietary SMARTag site-specific bioconjugation technology.

As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.

The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.

Amid high expectations for a COVID-19 vaccine, biopharma readies production capacity, weighs external pressures.

The collaboration includes an integrated program that encompasses formulation development, drug substances, and drug product manufacturing.

The register supports cross-functional teams of chemists and biologists in developing non-natural, chemically-modified therapeutics for drug discovery.

AbCellera’s recent acquisition of the OrthoMab bispecific platform is expected to accelerate antibody product development.

Avacta Group has expanded its drug development partnership with LG Chem Life Sciences to include new programs incorporating Avacta’s Affimer XT technology.

The company will use the acquisition to further its drug development pipeline in women’s healthcare.

PPD announced it will provide drug development services to advance Pfizer’s portfolio.

Many antibody-drug conjugate therapies are in the pipeline; only a handful have been approved. What are the bottlenecks?

Innovate UK has awarded Epsilogen with further grant funding for the development of the next generation antibody treatments for ovarian cancer.

GSK and CureVac will collaborate on mRNA-based vaccines and mAbs. Separately, the EIB and others provided CureVac with financing for development of its CVnCoV vaccine candidate and expansion of manufacturing.

Catalent has unveiled plans to invest in a European center of excellence for clinical biologics formulation development and drug product fill/finish services at its facility in Limoges, France.

Study reports immune and T-cell response from CanSino COVID-19 vaccine candidate.