Trade associations, manufacturers, academia and researchers have offered their opinions on the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) draft strategy for crafting pharmacopeial standards for biologics, according to a report issued Monday.
In general, MHRA says the responses supported the value of standardization, and found that areas where standards could add value included providing guidance and ensuring consistency for product characterization and quality control, ensuring analytical method performance and facilitating bioanalytical method development.
Last January, MHRA sought feedback on its strategy as more biologics came to market and as the regulator sought to be an “early adopter and driver of new and innovative approaches in standards setting for biological medicines.”
MHRA has set out a five-year strategy for biological pharmacopeial standards, with a first step to compare its current approach to the development of monographs for biologics to alternative procedures. The regulator also plans to identify gaps and weaknesses in its current portfolio of standards and to bolster its understanding of such needs, specifically by tightening ties to industry and gaining knowledge of how manufacturers control product quality.
These and other activities will require MHRA and its standards-setting units — the National Institute for Biological Standards and Control and British Pharmacopoeia — to pool their resources.
Earlier this year, a group of government agencies was established to help implement the strategy, including experts from MHRA, the UK Innovation Office, British Pharmacopoeia and NIBSC.
MHRA says, “It was clear that many stakeholders considered both the type and function” of standards “critical to ensuring that they are fit for purpose.”
For instance, for biotechnologically-produced proteins, comments said that standards “should not be unnecessarily restrictive and allow for the development of new products and technologies over time,” while recognizing the process-specific character of these products and focusing on broader and more flexible concepts of standardization.
For advanced therapy medicinal products (ATMPs), commenters said: “Due to the emerging nature and complexity of this class of products it would be important that any standards developed were not unnecessarily restrictive and did not act to inhibit innovation. Key areas where standards could add value would be in the development of shared understanding and consistency of testing methodologies.”
MHRA also noted that for ATMPs, “There was a strong preference for non-mandatory guidance including standards for specific analytical technologies and techniques supported, where appropriate, by physical standards.”
A number of stakeholders also proposed the exploration of two novel concepts for complex biological medicines, such as monoclonal antibody products, though MHRA notes these were previously advocated for in a joint International Federation of Pharmaceutical Manufacturer Associations (IFPMA) and European Generics Association (EGA) reflection paper from 2014.
The establishment of standards for raw materials was also “widely recommended,” MHRA said. “Control of raw materials were considered important as their properties could influence the critical quality attributes of biological bulk substances.”
Moving forward, MHRA says it will host a symposium in 2018 on the progression of its pharmacopeial biological standards work and annual updates will be provided either through symposia or online events.
Consultation outcome: Strategy for pharmacopoeial public quality standards for biological medicines