Clean Mails – May 2022.
Manufacturing Virus Banks in cGMP conditions
Qualitative virus banks are essential components to elaborate successful virus-based manufacturing programs – vaccines, oncolytic viruses, vectors, ATMPs, etc. Expanded from an initial virus seed, they require high quality cell banks to provide a reliable and safe substrate to grow Master and Working Virus Banks (or Master and Working Virus Seeds). They also need extensive characterization to ensure the safety and potency of banks all along the bioprocesses.
Clean Cells is a GMP-qualified CDMO with extensive experience working with hundreds of cell lines and virus strains. We have set up grade A and C manufacturing areas housing cell and virus banking in cGMP conditions. Clean Cells is also a world-leader in GMP quality testing. This is effectively creating a one-stop-shop solution for sponsors with needs of readily usable virus banks in GMP processes.
Clean Cells is also part of the Clean Biologics group, notably including company Naobios which provides GMP virus-based process development and manufacturing services for biologics up to Phase III.
For 20+ years, Clean Cells has worked with hundreds of cell models as part of biosafety testing activities. We have learned valuable information relating to the growth characteristics of all types of cells – mammalian, avian, insect.
Building on this experience, we established cGMP manufacturing areas for cell banking in cGMP conditions. We have since worked with worldwide companies to provide readily available cell banks used in GMP processes. They were intended to generate monoclonal antibodies, recombinant proteins, and virus-based biologics.
With cell banks manufactured and characterized in-house, we monitor even more closely growth parameters and characteristics to manufacture high quality virus banks in cGMP conditions.
As with cell models, biosafety testing brought us valuable insight for expansion of a broad type of viruses (DNA, RNA, enveloped or non-enveloped). With dedicated GMP laboratories, Clean Cells uses this experience to grow high quality, potent and stable virus banks from R&D seeds provided by sponsors.
Technical characteristics and track record
An initial feasibility study defines the optimal growth and technical parameters in accordance with clients’ data. These parameters and expected environmental controls are included in Manufacturing Files. The files are generated per cGMP guidelines and our GMP-audited Quality Management System. A precise timeline is then generated from this initial study.
Our experience encompasses various models including wild or modified Dengue, Coxsackievirus, Enterovirus Vaccinia, Rubella, Baculoviruses, Measles, Adenovirus, Influenza manufactured in our BSL2 or BSL3 Laboratories.
Virus banks may be grown from adherent or suspension cell cultures up to 500 vials per virus bank.
Full characterization of virus banks
Characterization of cell banks ensure that the produced material is safe, potent and reliable for further use in GMP processes. The virus banks manufactured in cGMP conditions usually undergo minimal testing as per release criteria defined in Manufacturing Files.
As a quality control testing leader, Clean Cells is able to fully characterize virus banks in cGMP conditions so they can be used directly in GMP processes or safely stored. Our GMP-graded portfolio numbers more than 200 assays for biosafety, potency, identity, and purity purposes. We offer a wide range of viral detection by qPCR covering more than 250 viruses in order to ensure safety of the banks particularly if no antiserum is not available. Our GMP testing labs and experts are supported by our audited QMS. They are in direct relations with Production Managers to ensure seamless projects and timelines from initial feasibility study to final release.
Storage in cGMP environment
Released virus banks can be used or safely stored at Clean Cells. Various storage options are available to sponsors for both cell and virus banks in GMP environment.
Further IMP/IND manufacturing at Naobios
Naobios and Clean Cells, both part of the Clean Biologics group, work hand-in-hand to offer integrated solutions. As IMP (or IND) biomanufacturing expert, Naobios can take up virus banks in cGMP conditions as soon as they are released from Clean Cells. Naobios works on process development and generate the valuable virus-based products and clinical material up to Phase III.