Microbial Process Development
Process development expertise lays a strong foundation for your microbially-derived therapeutic’s success.
Tailoring Strains for Your Candidate’s Success
Leverage our teams’ profound expertise in biologics development, rendering them expert partners in refining processes and attaining the necessary quality for your product. Our process development expertise is fortified by exhaustive product characterization, encompassing rigorous assessments of stability and comprehensive explorations into the mechanisms of action.
Our Strengths
Tanvex shines in microbial process development, with deep expertise in optimizing and engineering robust production processes for biopharmaceuticals. With a keen understanding of microbial systems and cutting-edge methodologies, Tanvex empowers clients by delivering tailored solutions that expedite development timelines and ensure consistent, high-quality manufacturing of biologics and biosimilars.
- Highly technical staff with extensive development experience from IND to BLA submission.
- Creative and collaborative cross-functional team enabling efficient parallel development activities and extensive product characterization
- Extensive use of DOE statistical software and high throughput technologies maximizing product knowledge while minimizing experimentation requirements
- Alignment of equipment with manufacturing and QC for ease of process and method transfer
Our Capabilities
Our team collectively boasts decades of experience in microbial process development, and they excel in designing, refining, and upscaling biopharmaceutical production processes. Leveraging extensive knowledge and innovative strategies, we deliver customized solutions that enhance efficiency, quality, and rapid market entry for a wide range of microbially-derived therapeutics.
- Cell line development for microbial systems
- High throughput media screening and optimization
- Microbial fermentation development
- High throughput resin screening and chromatography development
- Filtration process development (depth, sterile, TFF)
- Inclusion body recovery and protein refold
- Conjugation and pegylation process optimization
- Technology transfer and scale up
- Process characterization
