Navigating microbiome innovations
BIO
Supporting your live biotherapeutic product with flexibility and unmatched experience
Live biotherapeutic products (LBPs) are changing the lives of patients with conditions affecting the gut, including inflammatory bowel disease (IBD) and Clostridioides difficile infection (CDI).
ReciBioPharm leverages expertise gained from over 13 years of experience to develop and manufacture your LBP and deliver it to patients with certainty.
Leveraging our experience working with more than 225 species, we provide the flexibility to support your LBP through every step of the journey, from process development to clinical supply to commercial manufacturing.
Opening the door to innovative LBPs for patients
Drawing on unparalleled experience and capabilities in LBP production, we supported the commercial approval of the first orally administered faecal microbiota product for CDI, VOWST.
Explore our LBP services and capabilities
We provide flexible support to your microbiome project by drawing on unparalleled experience and capabilities in LBP development and manufacturing.
Services
- Integrated process development and manufacturing
- Drug substance process development
- Drug product formulation development
- Analytical development, qualification and validation
- cGMP clinical and commercial manufacturing drug substance and drug product
- QC release and stability testing
- cGMP cell banking
- Process characterisation
- CMC regulatory services
- Custom process establishment, manufacturing and strategic partnerships
Core competencies
- Single strains or multi-strain consortia
- Liquid or dried bulk drug substance
- Solid oral dose
- Other drug product finished dosage forms
Organisms
- Aerobic organisms
- Obligate and facultative anaerobes
- Genetically engineered strains
- BSL-2 and spore-forming species
LBP analytical development and quality control
We offer dedicated LBP analytical and quality control laboratories and are committed to innovation. As LBPs move towards commercialisation, we are leading the way with advanced analytical methods for LBP characterisation. This includes new molecular tools for quantifying and identifying LBPs, higher throughput viability testing and more advanced potency assays.
From clinical to commercial LBP manufacturingÂ
We offer cGMP clinical and commercial manufacturing of LBP drug substances and drug products that allow us to provide microbiome support throughout your project cycle. Our capacity has been built specifically for developing and manufacturing advanced biologic therapies where we can support LBPs that require up to BSL-2 segregation.
Process and formulation development
During our time partnering with LBP innovators, we’ve generated a vast reservoir of knowledge and best practices that enable us to consistently achieve high yields and viability, even for difficult-to-grow microbes. We understand that timelines are critical and we offer proprietary formulations, process platforms and high-throughput approaches where possible to keep CMC off the critical path.
Want to know more about our full biologics service offering?