CMC: Process Research & Development

Overview

A world class process research & development resource, dedicated to advancing your drug along the development spectrum from clinical candidate selection through to commercial reality. Laboratory research teams are organized and managed by experienced analytical chemists, process development chemists, and pharmacists to tackle questions that can only be answered by experiment. These teams can be anywhere in the world making it affordable to carry out a vigorous experimental program. More importantly, our experts make sure the right experiments are done and the right conclusions are drawn from the results. As part of Rondaxe, the project managers can draw on the deep pool of expertise in our consultancy.

We carry out each project following a well defined and effective road map, with the emphasis on open and consistent communication. Our structured approach to project management delivers efficient and timely monitoring of scientific progress, coupled with tight tracking of both project cost and scope.

These teams can supplement the efforts of your own development group, looking at options and ideas that might otherwise not be explored. Or they can play the role of the process and analytical development group you don’t have

Services

API Process Research and Development

• Route evaluation and selection
  • Expert review of existing routes where available
  • Novel routes suggested by process experts
  • Rigorous evaluation of cost of goods using proprietary software
  • Subsequent laboratory evaluation of strongest candidate route(s)
• Devise novel synthetic and fermentation technologies to achieve your manufacturing goals and to
• build IP
• Develop processes that operate robustly and safely at scale, ensuring security of supply
• Develop robust and appropriate analytical methods to minimize scale-up and quality issues
• Identify, develop and implement cost reduction strategies for existing API syntheses
• Rapid resolution of scale up issues to avoid costly delays in compound supply
• Salt selection studies and physical form control

Drug Product Research & Development

• Evaluation of formulation options
  • Determination of goals of drug product form
  • Formulation options suggested by pharmacy experts
  • Experimental evaluation of strongest options
• Solve formulation problems with a designed experimental program created by our experts
• Work out placebo and comparator issues

Quality by Design (QbD)

• Expertise in design and execution of critical process parameter analysis experimental plans to be
  consistent with Quality by Design concepts
• Establish proven acceptable ranges of operation
• Statistical experimental design (DoE) and focused stress tests to improve weaker synthetic steps

Test Article Synthesis

• Prepare small quantities of API following documented procedures resulting in material suitable  for
  use in a GLP non clinical safety study
• Analyse the material by scientifically sound methods and provide Certificate of Analysis

Method Development

• Develop analytical methods for API, Drug Product, stability analysis, in-process controls, and
  impurities

Benefits

• Place the work in the best laboratories to suit the project
  • Our experts help you select the laboratory team or teams to fit the project,, since not all projects
    have the same challenges and not all laboratories have the same skills
• All intellectual property is the property of the client