Clinical Manufacture

Commercial Manufacture

Drug Product Fill & Finish

Development

Testing

Discovery

Antibody Drug Conjugates

Technologies & Platforms

We offer an extensive array of formulation development services for various protein therapeutics including monoclonal antibodies, bi-specific antibodies, recombinant proteins, fusion proteins, growth factors, blood factors, cytokines, colony stimulating factors, and antibody drug conjugates in both liquid dosage forms and lyophilized powders. Our services include (but not limited to):

  • Preformulation and Formulation support for clone selection, upstream and downstream process development
  • Rapid high-throughput screening (HTS) of buffers and excipients utilizing DSC, DLS, MFI and/or spectrometry
  • Design of Experiment (DOE) to identify optimal formulation and influencing factors
  • Forced degradation studies to identify degradation pathways
  • Container/closure selection and integrity test
  • Compounding and fill finish process development including evaluation of addition order, mixing, concentration mechanisms, holding times, filtration, shear stress in filling, filling rate, crimping effect
  • Development of pre-filled syringe (PFS) configurations
  • Lyophilization cycle development
  • Technical transfer and scale-up support for GMP fill/finish
  • In-use stability studies including dilution effect and compatibility with injection kits
  • Long-term and accelerated stability studies per ICH guidance

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