Product Development

Product DevelopmentOnce a CHRONIJECT™ feasibility study is complete, successful prototype formulations are selected for the next step: intermediate development and scale up. Information obtained from a feasibility study provides a basis to identify, develop, and control process parameters at progressive batch scales. Typical development and scale up activities include work to:

  • Select successful feasibility prototype formulations
  • Refine API, polymer, raw material, component, and equipment specifications
  • Refine analytical tests and methods
  • Identify microbiological tests and methods for aseptic processing
  • Select product contact container/closure packaging
  • Design and configure the process equipment train at progressive batch scales suitable for aseptic manufacture
  • Produce development microsphere batches at increasing scales
  • Perform analytical tests on in-process, bulk microspheres
  • Adjust process to test and control critical parameters at increasing batch scales
  • Optimize vial-filling and lyophilizing cycle parameters
  • Select vial capping and sealing parameters
  • Perform analytical tests on lyophilized microsphere vials for potency, porosity, residual solvents, particle size, microscopy, syringeability, content uniformity, delivery uniformity, and release rates
  • Identify scale up process waste volumes
  • Perform R&D stability as required
  • Perform in-vivo animal studies as required (low bioburden material)

A series of batches are required to complete process optimization at each scale. Multiple API and polymer lots are used to ensure specification range limits are tested. Process Information obtained is used to identify and control critical parameters. Process conditions are adjusted as needed to ensure product consistency at increasing scales.

Once development and scale up activities are complete, production of cGMP material for clinical trials can be achieved.


Oakwood Labs

Oakwood Laboratories was founded as the research division of Ben Venue Laboratories, the largest and most experienced parenteral company in the world. In 1997 it was spun off as a separate entity when Ben Venue was acquired by Boehringer-Ingelheim. Oakwood's founders, Edward C. Smith and Mark T. Smith were C.E.O and the Director of Business Development of Ben Venue and were responsible for starting Ben Venue's generic division, Bedford Laboratories.