Avid Bioservices, Gerresheimer, Novasep Expand; Alcami Launches Testing ServiceBy
The latest news from CDMOs, CMOs, and suppliers featuring news from Alcami, Avid Bioservices, Gerresheimer, and Novasep.
Avid Bioservices Completes Process Development Lab Expansion
Avid Bioservices, a contract biologics manufacturer, has completed the expansion of its process-development capabilities and laboratory space within its CDMO campus in Orange County, California.
The expansion includes a four-fold expansion of the company’s process-development laboratory footprint and the addition of 24 advanced benchtop process development bioreactors, ranging from 3-liter to 15-liter capacity in single-use and glass.
The expansion adds to the company’s capabilities in research and development support, process development, process characterization and validation, and pilot-scale production for a range of biotechnology products.
Source: Avid Bioservices
Formulation Development/Drug-Product Manufacturing
Novasep’s Commercial Facility for Aseptic Filling and Finish Operational
Senefill, Novasep’s fill–finish aseptic commercial facility for biological products, has been commissioned as of October 1, 2019 in Seneffe, Belgium. The facility will provide standalone fill–finish services as well as integrated drug product manufacturing, from formulation to packaging.
Senefill is an 1,800-square-meter (19,000-square-foot) unit, with a 400-square-meter (4,300 square-foot) area dedicated to the filling of a wide range of biological products such as viral vectors, viruses, and monoclonal antibodies. These operations will support biopharmaceutical markets such as cell and gene therapies, oncology, and vaccination. The unit also has meeting rooms and visit zones.
The unit features semi-automatic and automatic liquid filling machines under isolator and can deliver up to 10,000 vials per session, with two to three sessions per week. Novasep says quality control and visual inspections will be carried out by highly qualified technicians.
Senefill is part of Senrise-IV, Novasep’s flagship for the manufacturing of commercial viral vectors, which allows for production and fill–finish to operate on the same site.
Gerresheimer Opens US Primary Packaging Glass Technology Center
Gerresheimer, specializing in glass and plastic packaging products for the pharmaceutical and healthcare industry, has opened a new innovation center for primary packaging glass, the Gx Glass Innovation and Technology Center, in Vineland, New Jersey.
There will be 25 experts and engineers specialized in glass technology working at the new facility, which includes an open-plan office and project and meeting rooms.
The new facility has been built next to the company’s tubular glass converting plant in Vineland, New Jersey.
Alcami Launches New Rapid Sterility Testing Services
Alcami, a contract service provider of active pharmaceutical ingredients, drug products, and analytical testing, has launched a new rapid sterility-testing offering. The Milliflex Rapid System offers microbiological testing technology using adenosine triphosphate (ATP) bioluminescence for detection of microorganisms after five days.
Rapid sterility is an alternative test method to the traditional United States Pharmacopeia General Chapter (71) sterility test that allows for shorter incubation periods and faster results. Typical sterility tests require 14 days of incubation and use analyst observations to generate results, whereas rapid sterility tests need only five days of incubation, and incorporates computer-generated results.
The new Milliflex Rapid System is housed in Alcami’s Wilmington, North Carolina advanced analytical testing technology center. The company expects its capabilities to generate efficiencies across the organization, including faster batch releases from the company’s Charleston, South Carolina clinical- and commercial-scale sterile manufacturing facility.