MilliporeSigma Launches Bioprocessing Suite; Evonik ExpandsBy
The latest news from CDMOs, CMOs, and suppliers featuring MilliporeSigma, Evonik, Marken, Ori Biotech and CellGenix.
MilliporeSigma Launches Next Tool of Bioprocessing Software Suite
Millipore Sigma has launched the next component of its BioContinuum Platform, the Bio4C Software Suite, which combines process control, analytics, and plant-level automation in bioprocessing.
MilliporeSigma’s Bio4C Suite was designed based on the company’s “4C strategy”: control, connect, collect, and collaborate. Bio4C ProcessPad, under the “collect” part of the strategy, is a browser-based platform that allows users to acquire, aggregate, and analyze data from disparate sources such as equipment, batch records, databases and historians across the bioprocess. MilliporeSigma’s Bio4C ProcessPad automates the data acquisition and analysis tasks.
MilliporeSigma says it will produce further Bio4C Software Suite products and modules throughout 2020.
Ori Biotech, CellGenix Form Pact for Cell and Gene Therapy Mfg
Ori Biotech, a London- and Philadelphia, Pennsylvania-based cell and gene therapy (CGT) manufacturing technology company, and CellGenix, a Freiburg, Germany-headquartered manufacturer of GMP-grade raw materials for cell therapies, have entered into a non-exclusive strategic partnership to achieve closed-system preparation, formulation and addition of CellGenix media and growth factors within CGT manufacturing for users of the Ori platform.
The Ori platform is designed to enable more automated, more efficient CGT manufacturing in a closed system. The companies say users of the Ori manufacturing platform can eliminate process bottlenecks and open steps in media and growth factor formulation, preparation, and transfers to enable higher throughput and reduced costs by eliminating manual handling steps. Ori selected CellGenix’ raw material portfolio as a partner.
Source: Ori Biotech and Cellgenix
Formulation Development-Drug Product Manufacturing
Evonik Commissions New Biomaterials Facility in Alabama
Evonik, a specialty and fine chemicals producer, has commissioned a biomaterials facility in Birmingham, Alabama to support demand of its proprietary Resomer portfolio of bioresorbable polymers used in parenteral drug products and implantable medical devices.
With this expansion, Evonik will also begin to provide contract manufacturing services to customers seeking to outsource the production of their own proprietary excipients.
The new 2,800-square-meter facility is equipped with multiple cleanrooms, numerous reactors, specialized purification and micronization systems, and other ancillary equipment. With an adjoining facility in Birmingham, Evonik says it can provide an integrated range of biomaterial services at a single US site to support projects from initial feasibility through to the commercial production of Resomer standard or custom products.
The adjacent CDMO site, which has been successfully inspected by the US Food and Drug Administration and EU health authorities, offers formulation development and GMP manufacturing services for parenteral drug products and application development and scale-up services for implantable medical devices.
Marken Expands Direct-to-Patient Services in India
Marken, a provider of clinical-trial supply and logistics services and a subsidiary of UPS Healthcare, reports that its direct-to-patient distribution services are delivering to and from 94 cities in India and are expected to be available in 110 cities by the end of May (May 2020).
The company says the need to develop this service in India was accelerated by the Indian government’s decision to lock down the country effective March 24, 2020, which has now been extended until May 18, 2020.
Home delivery of clinical-trial medications to patient’s homes were not previously available in India prior to the outbreak of COVID-19. However, given the need to keep patients in their clinical trials, the Indian government has permitted the service to proceed, according to information from Marken. Marken has offices in India in Mumbai, New Delhi, Ahmedabad, Pune, Hyderabad, and Bangalore.