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INCELL Microbiology & Vaccine Products

Microbiology diagnostic, preventive and therapeutic products are developed by INCELL scientists, 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.

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Graphics provide from National 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

INCELL Regenerative Medicine

INCELL is 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.

INCELL Products

Collection, Transport and Processing Solutions

INCELL makes GMP solutions for tissue and cell collection, transport and processing. The ZTM? solutions are included in the collection kits.

Cryopreservation Media

INCELL has 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 DescriptionTable 1 shows media designations and supplement options. M3? 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

INCELL has 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 to INCELL for direct processing into products, or as a source of regenerative or stem cells. As part of the agreements for procurement, either INCELL or the procurement entity will collect the tissues according to specifications and guidelines.