Solid State Centre of Excellence Identifies Optimal Process Conditions for API Production

Edition 3 / October 2022

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Author
Michael Vogel,
Head of Process R&D,
CordenPharma Switzerland

CordenPharma’s New Centre of Excellence for Solid State

CordenPharma Switzerland in Liestal, home of our new Centre of Excellence for Solid State manufacturing.

In July 2022 CordenPharma initiated the construction of our newly-designed Centre of Excellence for Solid State in CordenPharma Switzerland (Liestal, CH), with the mission to boost our capability for developing highly efficient and robust chemical and physical processes for the manufacturing of excipients, drug substances and drug products within CordenPharma’s global facility network.

Our aim and motivation is to support our customers in completing all challenging tasks that inevitably arise during the discovery and development stages of a chemical compound – notably, to identify the most suitable chemical and physical forms and process conditions for the optimal production of an API, which can then be used in completing the final drug product.

The Centre of Excellence for Solid State service offerings include:

• >> Aligned synthesis & crystallization development
• >> Final form study & decision making for achieving an optimum solid form
• >> Formulation development (in conjunction with OSD formulation at CordenPlankstadt, DE)

This overall concept is aligned with CordenPharma’s fully-integrated service enabling customers end-to-end support for seamless development and manufacturing from API to final drug product.

Problematic physical properties are often identified for chemical entities throughout their development process towards drug substance synthesis. For guaranteeing the straightforward production of a desired drug substance, it is of utmost importance to understand and control the physical properties of both its crucial intermediates and final drug substance. These measures enable its efficient usage throughout the whole life cycle as a final drug product. Ideally, the physical properties are understood at an early phase of the development work, so that a robust and cost-effective chemical process can be directed to obtain the optimal physical form.

In many cases, an unevaluated drug substance shows weak points in the form of unsuitable physical properties and solid-state issues. Therefore, our process development work in particular addresses the identification of the most suitable physical properties and solid-state characteristics of drug substances, and serves as a basis for the development of an optimal drug product formulation. Last but not least, for patents and regulatory files, and to secure customers Intellectual Property, it is crucial to offer a backup to the existing available solid forms by the discovery and production of new alternative multicomponent solid products, as salts or co-crystals.

To this end, we offer both standardized and tailored work packages, depending on customer needs and preferences. This includes:

• >> Polymorph screens
• >> Resolution screens
• >> Crystallization developments
• >> Single-structure elucidations
• >> Comprehensive solid-state analytics

Figure: Strategy for evaluating & identifying drug substance properties to create
optimal process conditions for the production of an API into the final drug product.

For our customers we most notably offer the following improvements and benefits for solid forms:

• >> Improved or optimized solubility & bioavailability
• >> Determination of thermodynamically most stable form
• >> Stability (physical & chemical)
• >> Improved physical properties such as:
  • >> Hygroscopicity (handling & storage)
  • >> Melting point
  • >> Electrostatics
  • >> Bulk density
  • >> Free-flowing properties
  • >> Compactability
  • >> Taste masking
• >> Particle size & shape
• >> Bypass problematic free form polymorphs
• >> Purification step
• >> Robust manufacturing process
• >> Patent protection

To ensure an optimal integration of solid-state development and characterization work, the Centre of Excellence for Solid State is set up as a fully-integrated service facility within our process R&D department at CordenPharma Switzerland. The facility is headed by experts in this field, embedded in the process development team for enabling streamlined development work. In addition, an efficient collaboration with our drug product site CordenPharma Plankstadt (DE) has been established, to ensure straightforward joint development work of drug substance and drug product at the earliest possible stage of a project.

Our experts will be glad to provide you with optimized solid-state development solutions for your specific requirements. Please Contact Us for more information.