INCELL
Microbiology diagnostic, preventive and therapeutic products are developed byINCELLscientists, quality managers and manufacturing staff alone or with collaborators. The work includes GMP components manufacturing; complex formulation and packaging; identification and testing of live organisms, active ingredients, adjuvants, and excipients; evaluating natural and recombinant biotechnology-derived products; and testing of vaccines.
Graphics provide fromNational Institute of Allergy and Infectious Diseases.
Vaccines and components in development include:
- Bacteria
- Viruses
- Cell Substrates
- Adjuvants & Protectants
- GMP Media & Solutions
- Non-Needle Delivery Technologies
Specific capabilities and activities include:
- Manufacturing of vaccines as whole live, killed, subunit, or particulate organisms
- Manufacturing of small and pilot scale sterile liquid fill products
- Formulation and delivery components
- QA and QbD in product manufacturing
- Bioassays, potency, purity and QC release testing for certificates of analysis
- Defining product labeling and packaging
- Cost of goods analysis and pricing
- Reproducibility, stability, product analysis
- Diagnostic products and devices
- Follow-on laboratory studies support
- Consulting: Process and product development
- Biotechnology Applications
- Nucleic Acid Recombinant Technologies
- Molecular Testing
- Production Cells and Cell Lines
- Monoclonal Antibodies
- Diagnostics
- Collaborative Planning for Clinical Study Design Testing
INCELLRegenerative Medicine
INCELLis a GMP Contract manufacturer and services provider. Regenerative Medicine activities involve research, development, manufacturing and storage of cells and tissues and support products intended to repair, replace, renew or rejuvenate human cells, tissues and organs and to regenerate normal function. These include both autologous (self) and allogeneic donor cells and tissues.
Collection, Transport and Processing Solutions
INCELLmakes GMP solutions for tissue and cell collection, transport and processing. The ZTM™ solutions are included in the collection kits.
Cryopreservation Media
INCELLhas developed high quality GMP-manufactured cryopreservation and storage media for human cells and tissues. They are also useful with other mammalian cells and tissues.
Culture Media
General Description
Table 1 shows media designations and supplement options. M3ä Base Medium is a proprietary formula that is a serum-free, highly enriched liquid culture medium for human stem cells and other progenitor and fastidious cell types.
Proprietary Cell Lines
INCELLhas established cell lines that are used for testing and research studies. These cells are obtained through an entity signing a Cell Licensing and Material Transfer Agreement (CLMTA) and paying a licensing fee.
Special Order
Tissue Collection Kits
Tissues are collected by qualified, registered and/or certified organ and tissue procurement entities according to legal and ethical requirements. Tissues are sent toINCELLfor direct processing into products, or as a source of regenerative or stem cells. As part of the agreements for procurement, eitherINCELLor the procurement entity will collect the tissues according to specifications and guidelines.
