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Drug Product Formulation and Process Development

We offer extensive end-to-end services for parenteral formulation/process development for biologics and small molecules. Our team assists from early stage molecular assessments to development of First-in-Human (FIH) formulations to enable clinical trial starts. Additionally, we further provide commercial formulations lock and process/device development in preparation for product launches. 

 

We have developed hundreds of drug product formulation for a wide variety of protein therapeutics, including monoclonal antibodies, bispecific antibodies, recombinant proteins, fusion proteins, and antibody drug conjugates. We are experts in developing liquid, frozen or lyophilized dosage forms filled into vials, pre-filled syringes and cartridges, as well as special dosage forms for products containing nanoparticle and other advanced molecular complexes. In addition, we have extensive experience in developing high-concentration formulations.

 


Our services include, but are not limited to:

 

  • Developability assessment  for candidate evaluation and clone selection 
  • Forced degradation studies to identify product degradation pathways
  • High-throughput screening (HTS) for formulation development utilizing biophysical methods, such as turbidity, Differential Scanning Calorimetry (DSC) and Dynamic Light Scattering (DLS)
  • Design of Experiment (DOE) to identify the optimal formulations
  • Container and closure selection and integrity testing
  • End-to-end fill and finish process development from drug substance thawing through mixing, filtration, filling, stoppering and capping to final visual inspection
  • Processes development for both RABS (Restricted Access Barrier Systems) and isolator-based filling systems
  • Formulation and process development for injectable small molecule therapeutics and nano-drug delivery systems
  • Pilot scale (non-GMP) fill finish and lyophilization services for pre-clinical toxicology studies, non-GMP stability studies and scale-down process development
  • Development of pre-filled syringe (PFS) configurations
  • Lyophilization cycle development and optimization
  • Fill finish and lyophilization process scale-up and/or technology transfer, from development to clinical phase or commercial manufacturing 
  • In-use compatibility and stability studies to support clinical administration or toxicology studies
  • Stability studies to support formulation and process development under long-term, accelerated or stressed conditions


Cutting-edge Instruments and Equipment for Formulation and Process Development

  • MFI – sub visible particles
  • HIAC – sub visible particles
  • Flex-P – automated visible particle imaging system
  • FTIR microscope – particle identification
  • DLS – nano scale size distribution
  • DLS plate reader – high throughput testing of size, Tagg and Kd
  • Freeze-drying microscope – Tc for lyophilization cycle development 
  • mDSC – Tg’
  • PEAQ DSC / VP DSC – conformational stability evaluation
  • cIEF – charge heterogeneity testing
  • Material tester – break-loose force, gliding force, cap removal force
  • Rheometer – viscosity and rheology
  • Densitometer – density measurement
  • HPLC / UPLC – SEC, CEX, RP analysis 
  • High throughput work station for buffer exchange
  • Automated sample preparation and testing system
  • High throughput protein quantification system – testing of concentration and turbidity
  • CG-MALS – mechanism of aggregation and nucleation 
  • Freeze / thaw system – freeze & thaw process development and stability studies using a minimal amount of product
  • Microfluidizer – nanocrystalline / nanoparticle / nanoemulsion formation
  • Headspace analyzer – container and closure integrity testing
  • Silicone oil distribution analyzer – for PFS