Fujifilm, Oxford Biomedica Expand; Lonza Adds Pyrogen Testing

By Miranda Greenberg -

October 8, 2020

The latest from CDMOs, CMOs, and suppliers featuring Lonza, Fujifilm Diosynth Biotechnologies, Stevanato Group, Oxford Biomedica, Catalent, Evonik, and CellGenix.

Biologics Manufacturing

Lonza Launches Pyrogen Testing System
Lonza Bioscience has launched a monocyte activation test (MAT) for in vitro pyrogen testing. The new service, the PyroCell MAT System, provides sensitive pyrogen detection without the use of experimental animals.

Through a collaboration with Sanquin Reagents, an Amsterdam-based blood-supply company, Lonza’s new system is comprised of pooled, cryopreserved peripheral blood mononuclear cells (PBMCs) specifically developed for use with the MAT. The company says these cryopreserved PyroCell Kit PBMCs eliminate the need to qualify blood donors and undertake cell isolation for each single test run.

Source: Lonza


Fujifilm To Expand Viral Vector CDMO Services
Fujifilm Diosynth Biotechnologies, a biologics CDMO, is adding viral vector process development and manufacturing services at its site in the UK.

Viral vector process development laboratories will be on line in the spring of 2021 and will be outfitted with equipment to support upstream (suspension and adherent) processes, downstream processing, and analytical development. The manufacturing capabilities are expected to be available from the autumn 2021 and will support bulk drug-substance production for early-stage clinical trials.

Fujifilm first established a viral vector and vaccine development and manufacturing offering in 2014 at its College Station, Texas site.

Source: Fujifilm


Oxford Biomedica Gets OK for Viral Vector Mfg Suite
Oxford Biomedica, a developer of cell and gene therapies and a contract manufacturer, reports that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued a certificate of GMP compliance for the fourth GMP manufacturing suite within the company’s new Oxbox manufacturing facility in Oxford, UK.

Oxbox is Oxford Biomedica’s new 7,800-m2 commercial manufacturing center. Phase I of Oxbox is 4,200 mof developed area consisting of six GMP manufacturing suites: four for viral vector production and two for fill–finish, along with warehousing, cold-chain facilities, and support laboratories. Construction and commissioning of Phase I was completed at the end of 2019. This approval by the MHRA follows the initial approval of the first two Oxbox suites in May 2020 and the subsequent approval of the third suite in September 2020.

The facility is suitable for the manufacture of a variety of viral vectors, and the approval of this fourth suite completes a phase of expansion that more than doubles Oxford Biomedica’s manufacturing capacity compared to 2019.

Both this suite and the suite approved in September (September 2020) will be operating at 1000-L scale and at present will be dedicated to the manufacture of a COVID-19 viral vector vaccine candidate. Equipment for these two suites has been provided by the Vaccines Manufacturing and Innovation Centre (VMIC), a not-for-profit organization established to provide the UK vaccine development and advanced manufacturing capability, following Oxford Biomedica’s agreement signed with VMIC in June 2020.

The installment of the equipment for the first fill–finish suite is expected to be completed by the end of the year (2020). Phase II will provide for the flexible expansion of up to a further six GMP cleanroom suites.

Source: Oxford Biomedica


CellGenix Completes Facility Expansion for Cytokines
CellGenix, a Freiburg, Germany-headquartered manufacturer of reagents and raw and ancillary materials for cell therapies, has completed the second phase of its facility expansion.

CellGenix has reconstructed and expanded its production facility for cytokines and implemented an automated filling and freeze-drying line. By implementing an automated filling and freeze-drying line and its increasing bulkware production footprint, the company has increased finished product capacity for cytokines.

The company completed the first phase of its expansion project in 2018 with the addition of space and personnel in its quality control, R&D, logistics, and warehouse departments.

Source: CellGenix


Formulation Development/Drug-Product Manufacturing

Catalent Launches New Oral Solid Dosage Product Service
Catalent has launched a new service for the integrated development, scale-up, and manufacturing of new oral solid dosage forms, OneXpress. OneXpress combines the knowledge at Catalent’s early-phase drug-development centers in Nottingham, UK, Somerset, New Jersey, and San Diego, California with its oral, solid dosage commercial manufacturing facilities.

Source: Catalent


Evonik Launches New Oral Drug-Delivery Technology
Evonik, a specialty and fine chemicals producer, has launched an advanced oral drug-delivery technology, Eudratec Fasteric, to provide enteric protection followed by drug release targeting the upper small intestine.

The proprietary drug-delivery technology is designed to increase gastric resistance and improve intestinal absorption for oral drug products that target sites in the upper small intestine where there is a narrow absorption window. The technology may be used for a range of oral dosage forms, including multiparticulates, tablets, and capsules.

Source: Evonik


Packaging

Stevanato, Gerresheimer in Pact for Twist-Off Closure System
Stevanato Group, a producer of glass parenteral packaging headquartered in Padua, Italy, and Gerresheimer, a provider of glass and plastic packaging products for the pharmaceutical and healthcare industries, have entered into a commercialization agreement in which Gerresheimer will be offering Luer lock syringes featuring SG Integrated Tip Cap closure (ITC).

The integrated seal cap consists of two components: (1) an elastomeric component, which is available in different formulations; and (2) a rigid, translucent polymer cap. The elastomer component is inserted into the plastic cap, screwed together with a Luer Lock adapter, and pre-assembled on a syringe. The twist-off closure system responds to the containment needs of different drugs: vaccines, hyaluronic acid, biotech drugs, and other viscous drugs. Gerresheimer will offer 1.0-mL long and 1.0-mL short Luer Lock syringes with the integrated twist-off closure in the first step. Additional formats will follow.

Source: Stevanato Group