Cell and gene therapy CRDMO

Rochi Pharma has established a relevant cell bank, which can provide customers with a full range of cell and gene therapy CRDMO services such as cells, cell therapy, and viral AAV.
Cell Bank Manufacturing:
Integrated cell bank manufacturing and characterization/release services are designed to certify safety and ensure cell line longevity over the life of your biopharmaceutical.
Cell Bank Manufacturing Overview:
GMP Master, Working, or End of Production Cell Bank Capabilities
Integrated Characterization and Release from incoming seed stock QA to COA
Experience with 50 plus cell lines; human and non-human
Sequencing to characterize insert
Surplus built into expansion plan – No loss of vials from testing
Standard Batch Records for efficient regulatory review
Support – Multiple shifts and Dedicated PM
Storage solutions available
Our Platform Approach to Cell Bank Manufacturing and Release
Consultation, Batch Record Development, Process Transfer/Starting Material Release Testing/ Cell Expansion/Harvest, In-Process Testing and Characterization, Release Testing/COA, Working Cell Bank Creation
Cellular Therapies:
Our complete portfolio of integrated development, manufacturing, and testing services for autologous, allogeneic, and gene mediated cell therapies provide rapid entry to clinical trials and support commercial programs around the world.

Service Overview:
Dedicated GMP manufacturing suite model
Analytical Development – Potency and Rapid Sterility
Process Development – Scale up or out
Viral Vector Production Platform to ensure supply
Regulatory Support
More Cellular Therapies:
Technical Consultation, Collection, Preparation, Chain of Identity, Assay Development/Analytics Readiness, Expansion - GMP Manufacturing, Harvest/Formulate/Fill, Release/Stability Testing, Deliver to patient, Patient Monitoring
Viral Products:
Integrated CDMO and Testing services for viral products used in the production of biopharmaceuticals are designed to expedite time to clinic and support commercial programs around the world. By leveraging over two decades of virology expertise, we offer the following:
1.Expedited tech transfer
2.FDA Registered facilities
3.Integrated manufacturing and testing including genetic sequencing, adventitious agent screening, and stability studies
4.Process and Analytical Development
5.Scalable capacity
6.Global regulatory support
Virus experience includes:
3.Adeno-Associated Virus (AAV)

Master and Working Viral Banks
Pure viral seeds, more than starting materials used to create viral banks, they serve as the foundation for assessing the lifetime quality of your biopharmaceutical. We offer full service solutions from master viral bank creation to drug product lot release including complete characterization of genetic and phenotypic stability.
An emerging “dual threat” in the fight against cancer, oncolytic viruses are utilized as either a monotherapy or combined with existing checkpoint inhibitors/T cell therapies to provide an enhanced therapeutic response. Since 2018, we have committed significant financial resources to create the necessary manufacturing and testing infrastructure needed to facilitate rapid development.
Viral Vector Manufacturing and Testing      
Our integrated manufacturing and testing platform for viral vectors supplies clients with GMP materials faster and with greater predictability, expediting entry to first in human clinical trials.
Viral Vector Production Platform Overview
1.Ideal for Lenti, AAV, and Adenovirus Viral Vectors
2.Greater Supply Chain Control – materials are in stock, assembled, and released
3.Accelerated program start – plug and play if you meet defined criteria
4.Elements include raw materials, cell line, MCB/WCB, plasmids, upstream/downstream process, analytics, batch records, SOP’s, trained staff
5.Closed Adherent Production System utilizing Corning HyperStacks reduces contamination risks
6.Dedicated Suite Model: Upstream and Downstream performed in the same suite
7.Up to 250 L Yields (Gene of Interest Vector Dependent)
8.Integrated in-process and release testing performed onsite