Pharmaceutical Outsourcing

Pharmaceutical Outsourcing
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Contract development and manufacturing organization (CDMO) Sterling Pharma Solutions is investing £6m into its pilot plant facility at its UK site to enhance its scale-up and small to midscale commercial API manufacturing capabilities. The expansion will increase the pilot plant’s capacity by 33% and enhance the site’s production capabilities and...

Cambrex has completed the installation of multiple continuous flow reactor platforms at its High Point, NC facility. This latest investment in continuous flow for process development will focus on the rapid development of processes to supply clinical as well as commercial demand for chemical syntheses. The investment in developmental capabilities...

Ecolab has launched its Life Sciences cleanroom program in North America. Developed specifically for pharmaceutical manufacturing, Ecolab’s cleanroom program provides comprehensive cleaning and disinfection for both sterile and non-sterile applications, and includes the company’s Klercide chemistry line and SteriShield Delivery System. Ecolab’s...

Berkeley Lights announced Sanofi purchased the Beacon platform to accelerate their cell line development (CLD) process. Based on data from the pilot study, the Beacon platform quickly and efficiently identified target secreting clones, which may save resources and expedite the discovery and development process. The four integrated workflows of...

Germfree has released bioGO. The biomanufacturing platform represents a new approach to quick and flexible production space. The company created bioGO in response to limited and rigid infrastructure options for launching biopharmaceutical projects. The Adaptive Platform delivers advanced mobile and modular bioprocess suites that provide an...

Arcinova has announced the award of a £1.5 million Innovate UK grant for the development of new flexible modular manufacturing technologies; a project which is set to demonstrate the operating feasibility of world first innovative continuous production tools. The project, which will span a three-year period, will be undertaken in collaboration with...

Labcyte has entered an agreement with Merck to utilize Acoustic-Mass Spectrometry (Acoustic-MS) in drug discovery and development. Pioneered by Labcyte, acoustic droplet ejection (ADE) technology uses the gentle energy of sound waves to move liquids at nanoliter resolution with superior precision and accuracy. The technology does not contact the...

The U.S. Food and Drug Administration (FDA) has sent a warning letter to Tris Pharma after investigators found the company had failed to properly investigate batch failures and establish quality control procedures. FDA sent a warning letter, dated March 26, 2018, to Tris Pharma Inc. after investigators inspected the company’s Monmouth Junction, NJ...

FDA is alerting health care professionals to a voluntary recall of all non-expired products marketed as sterile made by Coastal Meds due to visible particles in some of the drug vials for injection. During FDA’s recent inspection of Coastal Meds, investigators observed visible particulates and poor sterile production practices which further raise...

Amgen has announced plans to build a new state-of-the-art “next-generation” biomanufacturing plant at its campus in West Greenwich, R.I. The new plant will employ Amgen's biomanufacturing capabilities and manufacture products for the U.S. and global markets. A “next-generation” biomanufacturing plant incorporates multiple technologies into a single...