Clinical Trial Materials

The fully integrated, pre-qualified, pre-installed aseptic filling facility can be shipped globally for drug development and the manufacturing of personalized medicines and clinical trial supplies.

Catalent’s FlexDirect service offers sponsors multiple delivery options from a single inventory.

The trial will test experimental stem-cell treatments against biologic therapies for severe forms of relapsing multiple sclerosis.

Sangamo Therapeutics has revealed that the United Kingdom’s Medicines Healthcare Products Regulatory Agency (MHRA) has authorized the first in-human clinical trial evaluating a chimeric antigen receptor regulatory T cell (CAR-Treg) therapy.

The company will produce the anti-HER3 antibody drug HMBD-001for use within a clinical partnership between Cancer Research UK and Hummingbird Bioscience to test the agent in a Phase I trial.

The new location was established to ensure uninterrupted support for clients’ trials in both the United Kingdom and Europe if the UK leaves the European Union on Oct. 31, 2019, especially in the event of a no-deal Brexit.

The Phase III clinical studies for the drug candidate, elenbecestat, were discontinued based on a recommendation by a data safety monitoring board.

Personalized medicine and direct-to-patient trial models have made the difficult even more challenging.

The contract research organization has increased its US-based early phase clinical capacity and doubled its specialty lab space.

The new center will integrate biologics drug discovery, development, clinical manufacturing, and commercial manufacturing.

The expanded Frederick, MD, site will help meet global demand for diagnostic instruments and cell and gene therapies for clinical trials.

PCI Pharma Services and CSP Technologies will partner on protective packaging solutions for clinical trials and stability testing.

The pharmaceutical, clinical, and bioanalytical contract solutions provider has implemented advanced techniques for the collection and use of peripheral blood mononuclear cells (PBMCs) for early-phase clinical trials at its Clinical Pharmacology Unit in Antwerp, Belgium.

Experts from the Partnership for Research on Ebola VACcination report on progress and uncertainties regarding a safe and effective Ebola vaccine.

The National Institute of Allergy and Infectious Diseases began a first-in-human trial of an experimental live, attenuated Zika virus vaccine.

Researchers at the National Cancer Institute have developed a new approach to immunotherapy that led to the complete regression of breast cancer in a patient who was unresponsive to all other treatments.

Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.

Logistics manufacturers are adapting to explosive growth in the use of direct-to-patient clinical trials. Michael Sweeney, director of patient-centric logistics at World Courier Group, discusses the new model’s impact.

The second phase of a $5.5-million expansion adds controlled-substance and controlled-temperature storage to Catalent clinical trials facility.

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.