Formulation Development

End-to-end formulation development service.

Creative Biolabs is highly skilled in the development of a variety of protein therapeutics including monoclonal antibodies, bispecific antibodies, antibody drug conjugates, recombinant proteins, fusion proteins, growth factors, cytokines, blood factors, colony stimulating factors. Formulation development is provided for liquid dosage forms and lyophilized powders and is performed integrating relevant container closure systems such as vials, stoppers and caps or syringes and appropriate drug product process manufacturing design.

Formulation Development Services

We offer a full spectrum of formulation development services to help you get the most appropriate product candidates with good characteristics, potency and efficacy.

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

End-to-end Formulation Development

Fig.1 End-to-end formulation development services.

Our Advantages:

● Advanced controlled release technologies ● Potent and toxic actives
● Bioavailability enhancement ● Unstable actives
● Insoluble actives ● Taste masking (for solid and liquid presentations)

With senior scientists and extensive experience, Creative Biolabs has established one of the world’s largest and experienced formulation development team to facilitate your therapeutic protein product development. We are dedicated to assisting your program in the most efficient and cost-effective manner. Please contact us for a flexible and customized solution.

For lab research only, cannot be used for any clinical use.

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