Contract Manufacturing, General

Belgian-based bioprocessing provider, Univercells, has launched a CDMO, Exothera, that will support developers of cell and gene therapies through process development and production of viral vectors.

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

Understanding of scale-up parameters and use of process analytical technology are important to meet demand for larger batch sizes.

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.

Catalent builds on its investment in cell and gene therapy development and manufacturing with the acquisition of MaSTherCell Global.

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.

The need for manufacturing speed inspires contract manufacturers to explore advanced processing technologies.

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

Karen Flynn rejoins Catalent as president of biologics operations; regional presidents named for US and Europe.

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 completes purchase of biologics fill-finish and oral solid dose facility in Anagni, Italy

The acquisition expands Charles River’s scientific capabilities in cell therapy development.

Cambrex reports that the acquisition by the investment group will facilitate ongoing growth.

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.

Fujifilm Diosynth Biotechnologies will add a new building, including gene therapy laboratories, to its facility in College Station, TX.

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.

Over a two-year period, FDA inspections at company facilities found repeat problems with quality systems including lack of written procedures, inadequate investigation of out-of-specification conditions and corrective and preventive action, and insufficient cleaning and cleaning validation.

Lonza, through its Ibex Solutions, will now cover preclinical and clinical development and manufacturing for a significant portion of Genmab’s pipeline.

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.

The new services provide rapid production of antibody drug conjugates (ADCs) for best candidate selection.

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.