How We Operate

Research and development

From API screening to product lifecycle management

Crystec works with clients at each stage of the product development journey, from supporting initial compound selection decisions through to re-purposing of therapeutics to extend sales in the marketplace. Typical projects undertaken include:

  • • Removal of impurities and residual solvent from early experimental material
  • • Enhanced polymorph screens including isolation of high pressure polymorphs which can only be found using SCF techniques
  • • Generation of crystalline material and crystallisation seeds
  • • Co-crystal screens to generate scalable co-crystals
  • • Improving solubility through changes in particle size and morphology, solid form, stabilisation of amorphous forms, or co-crystallisation
  • • Enhancing permeability through modification of particle surface chemistry or creation of composite API-enhancer particles
  • • Improving retained activity and ease of reconstitution of biotherapeutics (e.g. peptides, proteins)
  • • Design of particles for enhanced delivery or performance (e.g. inhaled, taste masking)
  • • Reducing cost of goods through design of high-yielding, single-step processes and products requiring fewer excipients
  • • Supply of GMP material for clinical trials

Crystec has the ability to work at a range of scales, from small gram quantities of early research materials to larger quantities required for the clinic or product launch stocks. Typically, our business model involves working on a fee for service basis and generating material for research or clinical trials in the first instance. The ultimate aim is to transfer our technology, under license, to our clients’ chosen manufacturing facilities.

Innovation and Technology Development

Continuously improving the capability of the mSAS process

Crystec invests its own resources and works in partnership with scientific partners worldwide to continuously develop the capability of mSAS (modified supercritical anti-solvent). This work has delivered major advances, most notably in expanding the range of small and large molecule therapeutics that can be successfully processed using this technology. Examples of ongoing innovation and technology development projects include:

  • • Development of fully-scalable nozzle technologies
  • • Optimisation of CO2 and process flow control systems
  • • Optimisation of vessel geometries
  • • Crystal nucleation studies
  • • Identification of a suitable scalable co-crystal template library
  • • Selection of transient modification agents to enable control of particle habit
  • • Evaluation of surface modification agents to reduce aggregation or promote absorption

The Crystec team has the longest experience of working with SCF technology in pharmaceutical and crystal engineering. Our goal is to maintain a leading position in the application of this technology and in so doing deliver health benefits to patients worldwide.

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In-house product development

Crystec is investing in the development of its own portfolio of improved or repurposed generic products. Each of these products is exploiting specific advantages of mSAS technology, whether in designing particles capable of unprecedented levels of deep lung deposition or nasal retention, or the creation of a new generation of room temperature-stable, readily-reconstituted biotherapeutic products. In all cases, the Crystec team ensures that its own activities do not conflict with the interests of its clients.

Examples of products in development include:

  • • The first on-demand drug treatment for urge incontinence
  • • A rapidly acting therapy for Raynaud’s disease
  • • A rescue therapy for menorrhagia (heavy periods)
  • • A novel combination treatment for COPD (Chronic Obstructive Pulmonary Disease)
  • • An improved therapeutic for ischemic stroke
  • • Improved, high quality formulation of Traditional Chinese Medicine

China

Crystec is committed to developing improved therapeutics in all markets worldwide. Since the inception of the company, Crystec has maintained a research and development centre in China, working alongside its operations in the UK. The Crystec team has strong relationships with the Chinese government, with academia and the industry. Tianjin Crystec Pharmaceutical Co. Ltd is located on the site of the Chinese National Academy of Nanotechnology and Engineering (CNANE), in the Tianjin Economic Development Area (TEDA), one of China’s priority regions for the pharmaceutical industry, less than one hours’ high speed train ride from Beijing. The Tianjin lab principally focuses on modernisation of Traditional Chinese Medicines, scale-up and research and development in support of the Chinese market.

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