Clinical Trial Services

Catalent will expand primary packaging capabilities and commission an automated, high-speed bottling line for clinical packaging of capsules and tablets.

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.

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

The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.

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.

Demand for direct-to-patient services is exploding. Michael Sweeney, senior director of patient-centric logistics at World Courier, discusses issues that the new model presents.

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

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

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.

A $800-million acquisition of MPI Research expands Charles River's offerings for early-stage contract research.

The contract development and manufacturing organization has invested £30-million (US$42 million) at its Dundalk, Ireland site to offer expanded clinical trial services.

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.

Capsugel announced on Oct. 31, 2017 that it expanded clinical trial capabilities, as well as increased development and manufacturing capabilities for specialized drug products using liquid-filled hard capsule technology, at its Edinburgh facility in Scotland.

The company has announced that it has acquired a new bioanalysis and biomarkers services facility in Laval, Montreal, Canada to support preclinical and clinical programs.

Cytel, a biometrics CRO and clinical trial software provider, announced that it will be adding a new location for clinical development in Basel, Switzerland.

PCI Pharma Services, a pharmaceutical outsourcing services provider, will acquire Millmount Healthcare, a pharmaceutical and healthcare contract packaging services provider, to expand its European services.

The existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.

FDA is in the center of the debate over developing and pricing new cancer therapies.

BMS changes its US geographic footprint with R&D investments and closures.

At the American Society of Hematology Annual Meeting, Novartis and Kite Pharma both released results from early-phase clinical trials with CAR-T therapies.

Catalent plans a $4.6 million investment to expand secondary packaging and storage in Asia.

Steven Denham, director of biostatistics at MPI Research, discusses the impact the Standard for Exchange of Nonclinical Data may have on the pharmaceutical industry.

Mergers and acquisitions have changed the shape of the contract services market as big players seek to build full-service capabilities.

Only half of new drugs make it past Phase III. Adopting best practices and collaborating more closely with contract research organizations can help ensure success.

The partners will collaborate on a project to capture and integrate clinical trial data metrics on investigational cancer medications.

EMA confirms its recommendation to suspend medicines approved based on GVK Biosciences studies.