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Vaccine Development and Manufacturing Services

Vaccines and Biologics

Piramal offers development and manufacturing services for large molecules through our associate company Yapan Bio. Based in Hyderabad, India, Yapan Bio has a proven track record in the successful development and manufacturing of various large molecules. Yapan specializes in process development, scale-up, and GMP-compliant manufacturing of vaccines and biologics, including high-containment product classes (up to BSL-2+), recombinant vaccines, viral vector-based vaccines, gene therapies, monoclonal antibodies, therapeutic proteins, and other complex biologics for Phase I/II human clinical trials.

Product Class:

Vaccines:

  • Recombinant vaccines
    • Protein antigens
    • Virus-like particles
    • Nano-particles, etc.
  • Viral vector-based vaccines
  • RNA vaccines
  • DNA vaccines

Biologics/Bio-Therapeutics:

  • Gene therapy
    • Oncolytic viruses
    • Vectors (viral & non-viral), etc.
  • Monoclonal antibodies
  • Therapeutic proteins and other complex biologic

Services for Vaccines & Biologics

Featured Services

  • Cell line development
  • Optimization and scale-up for high product titer, stability and consistent manufacturing output
  • Analytical method development and qualification
  • Formulation development
  • Stability studies
  • Establishment and qualification of small-scale model for different unit operations for the process
  • Classification of process parameters and product Quality attributes-critical, major, minor
  • Design of experiments (DoE) to establish the appropriate ranges for the process parameters and product quality attributes
  • Execution of experiments and generation of data/reports to support regulatory filings
  • Cell and virus seed banking
  • Rocker, stirred tank and adherent cell bioreactors
  • Utilization of single-use technologies
  • Up to 1,000L bioreactor scale
  • Facility for high containment/infectious agents (BSL-2+)
  • Fill/finish on-site: aseptic formulation, fill & finish (liquid in vials)
  • Stability studies
  • Mammalian cell culture
  • Insect cell culture
  • Microbial fermentation
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Shanghai, China - Sourcing Office

Associate Company of Piramal Pharma Ltd.

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