Contract Manufacturing, General

The COVID-19 pandemic has created a rise in demand for R&D and a shift in focus for some contract organizations.

Cambrex has invested in an expansion of its flexible manufacturing facility in Sweden, which will increase the company’s flexible drug substance manufacturing capacity.

CordenPharma and Moderna extended a strategic manufacturing services agreement for the supply of lipid excipients to be used in Moderna’s vaccine against SARS-CoV-2.

Considering the potential interaction of a drug with the delivery device early on in in development is integral to achieving the best combination.

The new molecules entering the development pipeline are bringing forth exciting challenges in drug delivery.

FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.

The huge potential of biopharma is presenting an important epoch for outsourcing partners that can support the development and manufacture of biologics in an efficient way.

Contract partners must help innovators, especially smaller and virtual companies, consider manufacturability as early as possible in development. This requires focusing on technical and operational performance, as well as cost.

Careful design, planning, and record keeping are needed for cleaning and changeover in multiproduct pharmaceutical facilities.

CDMOs must consider challenges associated with the complexity of contract pharmaceutical manufacturing when approaching digitalization projects.

CDMOs and CMOs will continue to invest in biopharmaceutical services and facilities as the bio/pharmaceutical industry looks to biosimilars and personalized medicine.

Phillips-Medisize has announced that it is expanding its current Global Innovation and Development (GID) site in Struer, Denmark, to include a dedicated manufacturing development and clinical build unit.

Catalent and Ethicann Pharmaceuticals have announced a partnership aimed at developing a new combination pharmaceutical-grade CBD and THC product to treat MS spasticity using Catalent’s orally disintegrating tablet technology.

The companies announced a commercial supply agreement following FDA’s accelerated approval.

New training facilities, laboratories, packaging, gene therapy manufacturing, and biologics manufacturing highlight Thermo Fisher Scientific expansions.

Lubrizol Life Science Health adopts new name and opens commercial manufacturing facility.

Unforeseen challenges can be avoided in technology transfer by evaluating the variety of processes involved.

Contract manufacturers are making strategic partnerships and expanding services in the last quarter of 2019.

During the first day of CPhI Worldwide in Frankfurt, Germany, a panel of experts will be discussing the evolution of CDMOs in the shifting therapeutic landscape.

Biotechnology company, Avacta Group, and clinical-stage oncology-focused biotech, ADC Therapeutics, have entered into a collaboration and option agreement focused on the development of potent Affimer-drug conjugates.

Novasep has revealed in an Oct. 1, 2019 press release that is has launched a dedicated unit in Seneffe, Belgium, offering fill/finish clinical and commercial services for biological products.

Fujifilm Irvine Scientific has revealed, in an Oct. 8, 2019 press release, that it is has received CE mark approval for key Assisted Reproductive Technologies (ART) products, which are now available in Europe.

As the development pipeline becomes more saturated with complex molecules and patient experience becomes more important, developers are looking to outsourcing partners to provide more specialized expertise and solutions.

Alvotech and Prestige Biopharma, have announced the formation of a new contract manufacturing partnership for the commercial production of a biosimilar.

The latest research from GlobalData has revealed that more than two-thirds (69%) of CMOs high-containment facilities are based in the top five European Union countries and Switzerland.

An affiliate of the Permira funds has signed an agreement to purchase Cambrex in an approximately $2.4-billion transaction.

Pharmaceutical Technology Europe celebrates 30 years in publishing the latest insights, analysis, and developments of the bio/pharma industry.

The evolution of CDMOs has led to increased investment in new technologies, capabilities, and expertise.

To help customers succeed, CDMOs have moved away from the ‘fee-for-service’ model to offer flexible, full-service partnerships.

Complex and potent molecules demand greater technical and regulatory expertise to ensure safe handling.