INCELL has developed key Innovative Platforms for new products and GMP manufacturing, including combination products. These platforms are supported by quality and capabilities in molecular, cellular, animal and clinical systems. Innovative Platforms of note are:
- manufacturing components that meet GMP and CMC requirements
- proprietary cell substrates
- in vitro cell bioassays
- adjuvants, GMP media and solutions
- cryostorage methods and protective reagents
- formulation, encapsulation and nanotechnologies
- non-needle vaccine formulations
- novel delivery technologies
- stability design, formulations and bioassays
Considerations for New Vaccines
Factors important for development of INCELL vaccines are:
- Rapid Development
- Proprietary Formulation
- Safe, Effective & Stable
- Innate, mucosal, systemic immunity stimulated
- Clear Development Path
- Reasonable Costs
- Closed Systems
- Unit Dose Packaging
- Preferred Non-needle (e.g., nasal, oral) = safety & lower cost delivery
Cell substrates include INCELL’s cell lines used to propagate virus and to investigate host cell-microbial interactions. NCM cell lines have been used extensively in host cell and microbial interactions studies, and related work in metabolism, cytokines, chemokines, environment, nutrition, gut inflammation, colon cancer and pathogenesis mechanisms. This is documented in the published literature.
NCM356D_Product_InformationINCELL2016.pdf (453.1 KiB, 499 hits)
NCM460D_Product_InformationINCELL2016.pdf (487.3 KiB, 1,987 hits)
IBHK-4 cells are the substrate for growing IMVA, INCELL’s derived strain of Modified Vaccinia Ankara (MVA) and recombinant derivatives. Important features of the IBHK-4 cell line:
- INCELL Proprietary cell substrate
- Developed and tested as substrate for I-MVA
- Derivative of BHK-21 (Baby Hamster Kidney) cell line
- Grow in suspension in INCELL’s proprietary ACE™ medium
- Can be cryostored in EZ-CPZ™ media ready for rapid response “Just-in-Time” (JITM) manufacturing in the REDIVAX Platform.
- Support high titer IMVA, or IMVA as vector with select microbe recombinant genes (e.g., viruses such as influenza, ZIKA, and Ebola; or bacterial or fungal pathogens), with peak replication in less than 72 hr.
- Components have been developed to meet GMP and CMC standards. Media and processes are in FDA Master Files.
IMVA =Vaccinia Virus/Vector for Vaccines:
- Culture, titer, purity, potency, safety, efficacy, etc.
- Missing large genomic regions allows new gene insertions to make MVA “vector construct” (e.g., with genes from influenza virus and other microbes)
- In-licensed BAC-VAC shuttle vector technology from NIH.
- Platform for Non-Needle Delivery
Examples: The figures (see right) show examples of effective non-needle, protective oral and nasal poxvirus vaccines with 100% survival and reduced morbidity (less weight loss, illness and lethargy) in animal challenge models.
Components that Meet GMP and CMC Needs
REDIVAX™ Platform to Accelerate
Quick Response Vaccine Manufacturing
INCELL’s Effective Non-Needle Vaccines
Oral Vaccine = 100% Survival
vs. IM Injection or Mock Control Groups
MVA Vaccine was formulated and delivered to Oral and Injected Vaccine Groups. The Oral Mock Controls received Oral Vehicle Only. All were challenged with live, virulent vaccinia virus. The Mock Control had a 50% survival rate with high morbidity in the survivors compared to 100% survival for oral or IM vaccines and minimal morbidity (data not shown).