Clinical Trial Materials

Valerius Biopharma will use Catalent’s GPEx technology to produce cell lines for biosimilar drugs.

A $5.5-million expansion at its Philadelphia, PA clinical supplies facility gives Catalent additional packaging and storage capacity.

An expanded pharma services supply chain facility in Germany boosts Thermo Fisher’s Pharma Services footprint in Europe.

Catalent completes $4.6 million expansion at Singapore clinical supply facility and marks 20 years in the region.

The company has completed development of a first-generation production process for its chimeric antigen receptor regulatory T cell product portfolio and is selecting a CMO for clinical supply.

The Human Vaccines Project has created the Universal Influenza Vaccine Initiative, a research program that will aim to understand the human immune system’s role in the development of universal influenza vaccines.

Demand is driving expansion and consolidation of formulation and clinical trial materials services.

Novovax’s investigational vaccine targeting respiratory syncytial virus (RSV) demonstrated clinical effectiveness in animal models.

The new center represents AmerisourceBergen’s first facility erected specifically for clinical trial and commercial third-party logistics activities.

Fed-batch processes were scaled up from traditional bench-scale bioreactors to large-scale single-use systems.

ISPE’s survey is industry’s first large-scale effort to collect data on patient experiences with clinical trial materials.

It is important to understand critical aspects of the CMO's capabilities. Only by auditing certain key areas can the sponsor be assured of the quality of the materials produced.

The lack of biomanufacturer acquisitions seems surprising.