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Our experts have worked on the development and scale up of processes involving crystallisations and have carried out troubleshooting, particularly for companies making the less stable polymorphic forms, in manufacturing. Advice on how to tailor the process to produce the desired form and particle size distribution has led to very successful scale ups for our clients.
We can advise on salt screening and selection of the most appropriate salt for development and formulation, whether solid or solution/suspension. This is followed by form screening for polymorphs and solvates, particularly hydrates, and advice on the best form to develop, with API manufacturing and formulation in mind. Amorphous solids are more prevalent as molecular complexity increases and we have advised on technologies to ensure efficient manufacture such as spray drying and freeze drying (lyophilisation).
We assist with and advise on the selection of a CRO where a client does not have the in-house capability or expertise for solid state work and can then help manage the project.
We teach courses on Polymorphism and Crystallisation and these courses have been particularly designed for development chemists and engineers, with emphasis on the scale up of processes to produce consistently the desired form.
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We have advised clients on choice of critical process parameters prior to validating the process and on design space. One of our associate consultants also teaches a course on Process Validation and his expertise is used in designing protocols for Validation.
We keep abreast of the latest regulatory position and technologies that can be applied, for instance the support being given to Quality by Design and use of ‘real-time’ Process Analytical Technology by the regulatory authorities, to ensure correct advice in line with a changing environment.
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Through our previous work in large pharma and contract manufacturing, we have developed a wide expertise in CMC issues (Chemical Manufacturing and Control) and this, of course, includes regulatory advice on issues such as cGMP, choice of regulatory starting material, specifications and quality control issues, batch records, process deviations etc. We have written the CMC section for regulatory documents. We also have access to more detailed regulatory expertise through our associate consultants.
We have audited CROs and CMOs for our clients not only for regulatory compliance but also for technical ability to meet targets and deliver the goods on time, within specification and to an agreed cost
One of our consultants writes the Regulatory Highlights for the journal OPR&D and keeps up-to-date with recent changes in legislation, both in USA and Europe.
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