Contract Manufacturing, General

The company plans to invest approximately €900 million (US$983 million) to expand its peptide platform at its Colorado, US, site and in Europe.

The companies have completed the expansion and qualification phase and now enter a stand-by phase for five years.

This article looks at the relationship between a CDMO quality organization and the client.

Key areas to invest include manufacturing process improvements, quality management, and AI.

This investment will bolster the company’s large-scale cell culture CDMO business at its planned Fujifilm Diosynth Biotechnologies manufacturing facility in Holly Springs, North Carolina.

There are considerations companies may want to consider before seeking out a service provider.

The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.

The expansion will boost solid-phase peptide synthesis total reactor volume to 32,000 L.

The new centralized hub will provide advanced testing of nucleic acids, which is expected to simplify mRNA substance testing.

These results will provide insights from more than 250 global pharma executives, including discoveries such as pharma confidence dipping below the record scores of 2022, although it has remained extremely resilient despite wider macro uncertainly, according to the press release.

Sterling is known as a global contract development and manufacturing organization, and their network spreads to a manufacturing site in Cramlington, United Kingdom, a recently GMP-licensed dedicated bioconjugation facility in Deeside, and a 111-acre site in Ringaskiddy, Ireland.

Further expansions of the pharmaceutical development and manufacturing services of ten23 are happening at the BASE and VIVA facilities to continue to support complex sterile product development, testing, and manufacturing.

WuXi XDC will provide end-to-end services to support Boostimmune’s discovery of novel bioconjugates.

More than a third of CMOs are struggling to keep skilled technical and production staff.

The more information shared, the smoother the approval process, says Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates.

The facility is based on a state-of-the-art design concept that allows maximum flexibility for a multi-product, multi-platform offering.

Outsourcing collaborations provide insight into the key drivers of market growth.

The new portfolio from the acquisition will include contract research organization solutions, contract development and manufacturing organization solutions, and KSM/API solutions.

The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines.

The technology is designed to enable patients to self-inject biologic-based therapies at home instead of a hospital setting.

Scorpion’s new facility is designed for the development and manufacturing of clinical and commercial-scale biologic drugs.

The company is expanding its contract development and manufacturing services for parenteral drugs to global customers.

In this article, the potential pitfalls of technology transfers are discussed as well as ways to ensure a smooth transition.

The CPHI Annual Report 2022 predicts cash reserves from venture capitalists and private equities will drive expansion in the demand for contract research organizations and contract development and research organizations.

Integrated project delivery can fast-track delivery targets by eliminating the waste involved in traditional approaches to project set-up and execution.

Experts divulge where the industry is outsourcing most frequently, when companies should outsource more, and when performing tasks in-house might be best.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.

To build trust and ensure a high-quality product, companies must be sure their contracts are firm and their lines of communication even firmer.

CDMOs need to consistently demonstrate agility as demand increases for newly developed therapeutic modalities.

Industry experts share their top outsourcing tips from both the perspective of companies offering outsourcing services as well as for companies looking to outsource.