Product Development

CMC Process Development and Optimization

Advancing your biologics development

Alira Health CMC Team helps develop technical design for biotherapeutic production and optimize manufacturing processes.

We also provide additional support for small molecule therapeutics at every stage of production:
  • Antibody engineering and developability
  • Cell line development
  • Upstream development
  • Downstream development
  • Formulation development
  • Product and process characterization

Why choose Alira Health?

Alira Health is your partner in every stage of production, working closely with you to design, optimize and deliver advanced biologics. Our subject matter experts will:

  • Advise and support process development activities including antibody engineering and developability, creation of a highly productive cell line, upstream, downstream, and formulation development
  • Actively engage in planning for scale up and cGMP manufacture of drug substance and product, analytical method development and QC
  • Provide large molecule therapeutic development expertise including microbial, mammalian, and yeast cell expression systems
  • Leverage extensive experience with monoclonal antibodies and derivatives, including bispecifics, fusion proteins, and antibody drug conjugates
  • Deliver technical expertise and support for small molecule therapeutic development

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