Contract Manufacturing, Biopharmaceutical Production

The growing trend of partnerships between small biotech companies and CDMOs makes the need for conducting CMC due diligence increasingly important.

Increasingly complex monoclonal antibody molecules will require the right “tool box” for scaling up manufacturing.

The companies form a strategic joint venture for developing and manufacturing live biotherapeutics.

Pharmaceutical Technology and BioPharm International will present a Keynote Session on Meeting Bioprocessing Manufacturing Capacity Demands on Wednesday, April 3, 2019, during INTERPHEX 2019 at the Javits Center in New York City.

A look at the skill sets and training needed to tackle the increasing levels of automation in bioprocessing facilities.

Belgium-based CDMO MaSTherCell will expand its European manufacturing capacity for cell and gene therapy products by setting up a new facility in Belgium.

The companies aim to assess automated CAR-T cell therapy manufacturing at the point-of-care and develop technologies to facilitate patient access to immunotherapies.

Alcami Biologics formed to meet market demands for biological drug development services.

A $100-million investment will expand a range of the CDMO’s service capabilities and offerings.

The acquisition of the site in Copenhagen, Denmark, will significantly expand Fujifilm’s capacity and capabilities.

Technology vendors are strengthening their positions in China as the nation emphasizes self-sufficiency in research, development, and manufacturing.

A look at recent investments by contract manufacturers to increase single-use bioreactor capacity.

The acquisition will boost Hitachi Chemical’s presence in the European regenerative medicines market.

Suppliers address the complexity of supplying disposable components for single-use systems to the global biopharmaceutical manufacturing industry.

Single-use components for biopharmaceutical manufacturing have a lower environmental impact than reusable components, but disposal is still a consideration.

Full commercial launch of the drug is underway in the United States, with Europe to follow.

The company is set to expand biologics and fill/finish capacity at its biologics manufacturing sites in Madison, WI, and Bloomington, IN.

Fujifilm increases capacity of its Bio-CDMO business with an expansion of production in North Carolina.

The partnership provides Sarepta with capacity and manufacturing slots for GMP-grade plasmid production for its micro-dystrophin Duchenne muscular dystrophy gene therapy program, as well as plasmid capacity for future gene therapy programs.

The Massachusetts site, formerly associated with an affiliate of Shire, is Rentschler Biopharma’s first facility in the US.

The company has brought a second stream of high-throughput GMP peptide manufacturing online.

ADC Biotechnology will invest downstream formulation, fill/finish capabilities, and Lock-Release conjugation technology.

Experts believe that the contract development and manufacturing organization market will reach $17.38 billion by 2022, with disruptive business models using Industrial Internet of Things (IIot) and single-use technologies proving more profitable and efficient in the long term.

The company has rolled out the first batch of TRACON Pharmaceutical’s lead product candidate from its Singapore-based single-use bioreactor.

The expansion adds new capabilities and enhances existing service offerings for both oral and parenteral dosage forms.