Contract Manufacturing, Chemical-based Drug Production

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

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.

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

Does the pharmaceutical industry have adequate access to contained equipment, facilities, and infrastructure for the manufacture of highly potent APIs?

Expansion at the Eberbach, Germany facility includes two Vegicap encapsulation lines, printing, inspection, and packaging capabilities.

The expansion includes a new R&D laboratory and the installation of a 12,000-liter reactor at one of the company’s manufacturing facilities on its Paullo site in Milan, Italy.

The “hands-on” seminar will be held June 12–13, 2019 and will feature educational sessions and demonstrations in the company’s process laboratory.

The $252-million acquisition is expected to strengthen Cambrex’s position as a small-molecule CDMO across the drug lifecycle.

Demand for highly potent APIs continues to rise.

Evonik completed a EUR 36 million expansion of its contract-manufacturing capabilities for API and advanced intermediates in the United States and Germany.

Determining how much containment is needed for API handling requires evaluation of multiple factors.

Heightened uncertainty means CDMO executives need to play out planning scenarios.

The glass and chemical provider will expand its synthetic pharmaceutical intermediate and API production capacity at its plant in Chiba, Japan.

Under the contract, AMRI will focus on the development and manufacture of APIs and drug product for Phase I clinical studies.

Under an Innovate UK grant for a three-year project, Arcinova and the University of Nottingham will develop a continuous, flexible modular manufacturing technology platform.

Hovione plans to continue to expand its sites in Portugal and Ireland for chemical synthesis, spray drying, and laboratory analysis.

Grand River Aseptic Manufacturing announces first planned investment in capacity expansion.

Chemical engineers and chemists each bring unique skills to API process development and optimization. Success depends on their close collaboration, at both sponsor and CDMO facilities.

For many processes involving hazardous chemistry, running in flow mode has safety and economic advantages.

Spectrum Chemical will provide BASF precious-metal-containing powder catalysts in research quantities for early product development.

Alcami will manufacture clinical supply of the API for a drug candidate targeting various hematologics and solid cancers.

CordenPharma will expand development capacity for small molecules, peptides, and carbohydrates at its Liestal, Switzerland site

Predicted areas of growth include flow chemistry, fermentation, repatriation of overseas funds, oncology, and API/product integration, but the rate of change is unclear.

Mergers and acquisitions are positive for the CDMO industry, but there is a downside.

Additional reactor capacity and a wastewater processing plant increase API manufacturing capacity at the Cambrex site in Kalskoga, Sweden.

Ajinomoto Althea opens manufacturing suites in new high potency and antibody drug conjugate commercial facility.

CDMO Micro-Sphere is investing CHF 21 million (approximately $21.63 million) into the expansion of its GMP manufacturing capabilities at its Swiss facility.

Cambrex announces expansions of its North Carolina API pilot plant and Kalskoga, Sweden large-scale manufacturing facility.

Caladrius is selling the remaining percentage of the subsidiary in order to focus on cell therapy development.

Catalent adds two softgel facilities and packaging capabilities with acquisition of Canada-based Accucaps.