Yapan Bio

Yapan Bio is a contract development and manufacturing organization (CDMO) specializing in process development and GMP manufacturing of complex biologics and vaccines. The company offers integrated services spanning early-stage process development and scale-up, process characterization with design-of-experiments support, and GMP manufacturing for clinical studies.

Core Capabilities

Process Development:

• Cell line development
• Upstream manufacturing optimization (mammalian cell culture, insect cell culture, microbial fermentation)
• Downstream processing including centrifugation, tangential flow filtration, depth filtration, and chromatography
• Analytical method development and qualification
• Stability studies

GMP Manufacturing:

• Cell and virus seed banking
• Bioreactor systems: rocker, stirred tank, and adherent cell bioreactors
• Up to 1000L stirred bioreactor scale with single-use disposable technologies
• Aseptic formulation, fill and finish (lyophilization and liquid in vials)
• Separate manufacturing suites for non-infectious and infectious organisms (BSL-2+ containment)

Product Classes: Experience developing recombinant vaccines, monoclonal antibodies (mAb), gene therapy products, and viral and non-viral vector-based therapeutics for global biotechnology companies.

Facilities

Yapan Bio operates three state-of-the-art facilities at Genome Valley, Hyderabad, India:

• 450 GMP Facility: ~6,360 sq ft, 2 GMP suites, up to 200L bioreactor scale, BSL-2+ containment, Class A/B/C/D areas
• Process Development Facility: ~6,825 sq ft, 3 separate upstream suites, BSL-2 containment, downstream and analytical development labs
• 270 GMP Facility: ~13,500 sq ft, 2 separate GMP manufacturing lines, up to 1000L bioreactor scale, BSL-2 containment, Class A/B/C/D areas

Service Model

Flexible partnership structures including milestone-based or FTE/retainership arrangements. Additional support includes third-party CRO management, regulatory filing support, and client engagement with regulatory agencies (USFDA, EMEA).