Promulgated by the Health Authorities, cGMP (current Good Manufacturing Practice) regulations and guidelines govern the manufacturing, use and testing of drug products and their components, including Active Pharmaceutical Ingredients (APIs) intended for use in humans. APIs manufactured to cGMP standards for clinical research or commercial sale must meet requirements for identity, strength, quality and purity.

Few decisions in pharmaceutical operations are as critical as selecting the right API Development process. CordenPharma’s chemical development scientists have the skill and experience to meet a wide range of outsourcing needs from the custom synthesis and scale-up of an existing route, to identification and development of new manufacturing routes from scratch. At each step of the process development cycle, complete hazard assessment tools are available to allow for safe production of your compounds.

Custom Synthesis from Milligram to Kilogram Quantities

Our R&D department has a proven track record in preparing small quantities of your target compound in a wide range of scales. Since the initial synthesis may not be suitable to prepare larger quantities, we adapt to expanding requirements by adopting a synthesis that will best suit your needs.

Scale-up of Existing Processes

If you already have a demonstrated route and need it reproduced in a timely and efficient manner, CordenPharma surpasses expectations by identifying and developing appropriate steps for scale-up or safety considerations.

Process Research, Development & Optimization

We develop new and proprietary routes to existing compounds, or take an existing synthesis and develop a scalable process using our in-house expertise and state-of-the-art technology, which includes:
  • Statistical design of experiments (DoE)
  • Real-time reaction monitoring to generate detailed reaction/impurity profiles, and
  • Reaction calorimetry for hazard assessment and further process development
Our strength in process research and scale-up, coupled with our wide range of cGMP synthesis capabilities, is well known in the industry. CordenPharma is capable of performing cGMP compliant manufacturing within a wide range of scale:
  • Small quantities (scale <10 kg) in our kilolab workshops
  • Intermediate quantities (scale < 250 kg) in our pilot plants
  • Large quantities (scale > 250 kg up) in our industrial plants
Our staff has experience in developing and transferring projects from our research laboratories to multiple cGMP manufacturing facilities.

Large-Scale Synthesis & cGMP Commercial Manufacturing

Once your project reaches a large-scale level, CordenPharma provides reliable commercial cGMP manufacturing. Your project will benefit from seamless technology transfer overseen by the same team that guided your development project.

Analytical Capabilities and Regulatory Filing Support for Our Contracted Customers

At any development stage and scale of synthesis CordenPharma’s services for contracted customers include all supporting activities that are required to be adequately cGMP compliant such as:

  • Process validation
  • Cleaning validation
  • Batch release
  • Analytical method development and validation
  • Characterization of solid state properties, eg particle size distribution and polymorphism
  • Conduction of stability studies
  • Proof of  API structure
  • Identification of impurities
  • Preparation of Analytical Reference Standards
  • Pharmaceutical writing
  • Regulatory filing support

Our facilities support customers with on-site regulatory affairs personnel for the documentation of CMC development projects in the CTD format for convenient inclusion in IND/IMPD/NDA/MAA filing dossiers.