Outsourcing

Data integrity has become a more serious compliance problem at pharmaceutical manufacturing plants throughout the world.

The author lists five key areas to consider when selecting a CDMO to develop highly potent formulations.

The authors provide their perspectives on shipping validation.

Cirrus Pharmaceuticals will launch services for manufacturing cGMP materials for early-phase clinical trials at its Raleigh-Durham, NC facility.

Recipharm acquires Mitim, adding scale and technology in injectable beta lactams.

PharmSource report addresses how the opportunity for antibody drug conjugates measures up to the bio/pharma industry’s expectations.

Smart glasses enhance remote troubleshooting and process management for pharmaceutical manufacturing.

3M Drug Delivery Systems, Ei Solutionworks, IDT Biologika join CMO/CDMO association

When implementing disposable technology for aseptic processing, considerations include material compatibility, material sourcing, facility layout, and training.

Heightened global uncertainty could slow bio/pharma development activity.Bio/pharmaceutical companies, and the companies that serve them, tend to think they are immune from broader macroeconomic and political developments. As populations age, emerging middle classes expand, and scientific knowledge progresses, research on new drugs and demand for new therapies seem to follow an inexorably upward trend.

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

Sustainable harvesting combined with CMO expertise helped Centroflora CMS ensure supply continuity after it acquired Boehringer Ingelheim's non-captive API phytochemicals portfolio.

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.

Transparent communications, both qualitative and quantitative data, and a clear understanding of each other’s needs are keys to collaborating on better product quality.

For successful partnerships, it’s important to take a long-term view, focus on simple designs, and address potential payer concerns up front.

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.

Despite the move to more strategic partnerships, research shows that tactical outsourcing is still alive and well.

Aging populations and increased access to healthcare translates into opportunities for biopharmaceutical companies.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Keith Moore, vice-president of analytical services, Metrics Contract Services discusses gains use in dissolution testing.

Today’s analytical laboratory equipment reflects the realities of downsizing, outsourcing, and the need for speed.

Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.

Vetter announces completion of multi-functional building for development service and IT functions.