Vaccines

Vaccine development begins at the bench. Whether your vaccine program requires the expression and purification of proteins, nucleic acids, virus-like-particles, polysaccharide conjugated vaccines, recombinant viral vectors, or live-attenuated pathogens (viruses/bacteria), Catalent will help you with your research and pre-clinical vaccine studies. As the project advances, we will also provide CGMP manufacturing services to bring your vaccine candidate through clinical trials and to market. Catalent has expertise in developing and manufacturing vaccines to protect against a wide variety of infectious diseases and cancers, including working with multiple partners on all major classes of COVID-19 vaccines in development.

Mammalian Cell Culture Capabilities Include:

• Multiple modalities and cell lines
  • Nucleic acid-based (ex. mRNA), Protein-based
  • CHO, HEK293, etc.
• Complete development and manufacturing capabilities
  • Pre-clinical to clinical and commercial stage
  • Cell line development
  • Process development
  • Manufacturing up to 4,000L batches
  • Analytical development

Viral Capabilities Include:

• • VLP Candidate Vaccines (E. coli, Mammalian, Insect)
    • Influenza, HPV, Rotavirus, HIV, Ebola, JCV, CMV, BKV
  • Antigen Candidate Vaccines (including Conjugated Vaccines)
    • Salmonella, S. Pneumoniae, Cholera, Chlamydia
  • VEE – Replicons (Ebola – Zaire, Sudan & Marburg Virus)
  • Live & Live-attenuated Viral & Bacterial Vaccines
    • RSV, CMV, Zika, Shigella, S. Pneumoniae (15 strains), C .Diphtheriae, Chlamydia

Drug Product Capabilities Include:

• • Comprehensive development and manufacturing capabilities
    • Formulation development
    • Process development
    • Analytical development
    • Vial filling and lyophilization
    • Syringe filling
    • Device assembly and packaging

Clinical Supply Capabilities Include:

• • Clinical supply planning and forecasting
  • Prefilled syringe finishing and vial labeling
  • Cold room packaging
  • Secondary packaging and clinical labeling
  • Cold storage and global cold chain distribution