GMP Cell Manufacturing - Creative Biolabs

Currently, the development methods of cell- and tissue-based therapies require that the quality of the raw materials or auxiliary materials (such as fluorescent antibodies, antigens, cell culture bags, cell culture media, and cytokines) used to make these cell therapeutic products meet regulatory requirements. At the same time, the master and working cell banks are required to use good manufacturing facilities to ensure the quality, safety, and efficacy of the final cell product.

The quality of the starting material significantly affects the properties of the final cellular product. Therefore, the ultimate success of your cell product depends on the quality of the raw materials used. For the development of cell-based and gene therapy products, regulators may need to use rigorous procedures in accordance with GMP regulations. Creative Biolabs‘s GMP Cell Manufacturing Working Group has more than 10 years of experience in GMP manufacturing, ensuring that our tools, reagents, and accessories for cell manufacturing are in compliance with GMP guidelines.

Fig1 HEPA

GMP Facilities and Quality Control

All procedures related to cell manufacturing require strict control of GMP facilities. Our facilities are designed and organized according to Good Manufacturing Practices for Pharmaceutical Manufacturing, including quality control, quality system methods, and control of the collection, processing, storage and release of cell therapy products.

Use high efficiency special absorption (HEPA) filters to prevent air cross-contamination
Cleanrooms are classified into four categories (AD) based on air purity, based on the number of particles in two sizes (≥ 0.5μm, ≥ 5μm)
Material and personnel flow are separate and one-way
Technicians are fully qualified for the conduct and supervision of all activities

Manufacturing Process and Quality Control

We comply with official standards such as the European Pharmacopoeia (EurPh) or the United States Pharmacopoeia (USP), and the characteristics of each batch of cell therapy products are controlled by very rigorous and specific tests. Cell product characterization tests include:

Identity
Purity/impurity
Effective
Vitality
Number of cells
Tumorgenicity
Biocompatibility testing

Cell origin (autologous and allogeneic)
Proliferation/differentiation ability
Ability to initiate an immune response
Cellular level of operation
Route of administration
Combination product
Sterility test (release phase)

Creative Biolabs Expertise

✔ Closed system and disposable reagent formulations
✔ Parallel processing of cell therapy products
✔ Isolation and tracking with a unique sample identifier
✔ Fill in and complete according to customer instructions
✔ Internal Bioburden, Sterile, Mycoplasma and Endotoxin Testing
✔ Monitor and maintain GMP compliance through KBI Quality Systems
✔ Multiple applications: T cells, NK cells, macrophages, CAR cells

For more details, please feel free to contact us for project quotations and more detailed information.