Do you think any further improvements can be made to the production of carbohydrate products for injection?
The production of carbohydrates product for injection is based on well-known technologies such as controlled hydrolysis and
purification.
Any further improvements could be driven by new sophisticated technologies in purification processes, for instance. In addition,
processes may also be influenced by European regulations, which are constantly evolving.
With the new ICH Q11 related to the development and manufacture of drug substances, the "enhanced approach" compared with
the "traditional approach", development must be based on risk management and more extensive scientific knowledge in order
to select unit operations and process parameters that impact critical quality attributes for evaluation in further studies
to establish control strategies. In the “traditional approach”, the set points and operating ranges for process parameters
are defined and the control strategies are based on demonstration of reproducibility and compliance to acceptance criteria.
Will new or changing regulations in Europe have any affect on the manufacture of carbohydrate products?
Regulations in Europe are continuously evolving.
The adoption of directive of Falsified Medicines was driven by the last events on drug medicinal products manufactured with
falsified API’s which reached the market via the legal supply chain (example; heparin case). The aim is to strengthen the
control of whole manufacture and distribution system of pharmaceutical ingredients and drug products according to GMP and
GDP.
These regulations will affect to a certain extent the development and manufacture of active ingredients. For instance, development
and manufacture of drug product based on risk-assessment approaches (ICH Q8, Q9) has been extended to API’s development and
manufacture (ICH Q11): conception of quality is definitely connected to safety of patients.
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