Preformulation, Formulation, & Analytical Methods Dev.

B2S Consulting offers consulting services for the pharma / biotech industries. We have deep expertise in all stages of dosage form design and analysis for preclinical and clinical drug development. Furthermore, our services include active ingredient characterization (preformulation), screening and optimization of stable clinically relevant drug formulations, application of formulations to various dosing formats and routes of administration, and development of alternative formulations and dosage forms as part of product lifecycle management.

In addition, we are leaders in biopharmaceutical drug analysis (physical and chemical characterization and impurity quantitation) and the transfer of analytical methods to GLP and GMP environments. Management support services include screening, auditing, selecting and managing contract research organizations, and performing project management duties associated with CMC-related tasks.

Services that may be applied to the needs of start-up, clinical development, or commercial organizations, specializing in polypeptide drugs, include:

Pharmaceutical Science

  • Preformulation
  • Formulation
  • Dosage form design (including controlled delivery)
  • Program design, product development for line extension (product lifecycle management;
  • improved dosage forms)

Analytical Methods

  • Spectroscopy
  • Thermal analysis
  • Chromatography (HPLC) assay methods;
  • ELISA-based assay methods
  • Method transfer to GLP and GMP laboratories

Management

  • Project management; have directed multi-organization and international teams to successfully complete CMC sections for regulatory submissions (US and Europe)
  • Selection and management, contract research organizations
B2S Life Sciences