Outsourcing

Articles

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

Fujifilm Expands Gene Therapy CDMO Capacity

Susan Haigney is lead editor of Pharmaceutical Technology and Pharmaceutical Technology Europe.

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

Evaluating the Tech Transfer Process

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

Developments in the Pharmaceutical Outsourcing Industry

Agnes Shanley is senior editor of Pharmaceutical Technology.

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. 

FDA Warning Letter to Lupin Underscores the Need for Top Management Involvement in cGMP Compliance

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

Lonza, Genmab Extend Drug Development Partnership

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.

Evaluating the Changing CDMO 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.

Avacta, ADC Therapeutics Enter Agreement for Development of 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. 

Novasep Launches Dedicated Fill/Finish Operations in Belgium

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.

Fujifilm Irvine Scientific Gains CE Mark Approval for ART Products

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

Contract Manufacturing Services