Microchip electrophoresis and novel excipients: learnings and opportunities

Development Group’s (DG) mission focuses on better and faster process development of biopharmaceutical medicines. Formed in 2011, DG now has more than 700+ subject matter experts collaborating in teleconferences every month across 13 collaboration workstream topics. There are also three face-to-face meetings (currently virtual) throughout the year with subject matter experts and key opinion leaders collaborating on the key hot topics and challenges faced by the industry, such as In-Silico Modelling, Digital Strategies and Data Management, and Drug Product Development.

The 2020 program of collaboration comprises 13 workstreams, including the exciting activities discussed below.

Microchip Capillary electrophoresis

One of the recent subjects discussed by the BioPhorum Analytics Workstream is capillary electrophoresis (CE). Many organizations use traditional CE but this is expensive, labor-intensive and slow. However, advances in microchip CE mean that manufacturers could increase their throughput by an order of magnitude while significantly reducing the resource required.

Unfortunately, there are many challenges in moving to this new technology, not least because it is tough to translate into the heavily regulated quality control environment and the length of time it takes to make it work.

To delve into this cutting-edge technology and gather detailed data, the workstream ran a benchmarking survey of members that asked questions such “How successful was the transition to microchip electrophoresis? What lessons were learned from the transition to microchip electrophoresis?”

The results of the survey were discussed during recent Analytics Workstream team calls. The open debates included stories from members that had persevered with the transition and had made a success of using the new technology, and of others that had invested a lot of time and money into microchip CE projects but could not make it work.

The team took a lot of encouragement from the discussions and the benchmark data, and members sharing tips and tricks all played a big part in re-energizing members to either try microchip CE again or even attempt it for the first time.

“The survey shows that we need to invest a lot of time to get this technology to work well,” said Chaomei Lin, Director of the Analytical Resource Team at Janssen. “Some of the results of the survey are very different, showing that for some companies the new technology works well whereas other companies have different experiences. Having learned from the information shared in this survey, this gives encouragement that the method can be established for the intended use.”

One member said that the discussions were very helpful as their organization had been struggling with a potential switch and had planned to keep on working with traditional CE. However, the ideas and approaches shared by other team members might help it revisit microchip CE in the future.

“I thought that it was most helpful to hear what point in the evaluation and implementation different companies were at,” said William Grimm, Scientist at BMS. “When you go to conferences, it can sometimes seem like most people are ahead of you in these new technologies. But this call showed that not to be the case, and that there was a wide range of implementations.”

The workstream discussions show yet another benefit of the BioPhorum collaborative approach – that sharing problems, ideas and solutions can still help drive industry progress.

Novel excipients

Industry has been concerned for a while that regulatory approval for novel excipients in drug formulations is onerous and places too much risk on manufacturers. It fears that new excipients may not be discovered because of regulatory barriers, which would limit the options for formulating effective drugs, especially innovative therapies that need unique properties.

With these issues in mind, the USP ran a survey last year to identify the issues around novel excipients, better understand the views of stakeholders on the current state of innovation and determine the extent to which excipients are a factor in advancing API selection through early stages of the formulation process.

The BPDG Formulation Team members not only contributed to the survey but were able to have early sight of the findings and discuss them with USP. The FDA is aware of the survey and is interested in following-up to look at the benefits for patients. 

Some of the main findings of the survey include:

  • The majority of respondents who formulate medicines said that drug development had sometimes been limited due to the excipients currently used in approved drugs
  • More than half of respondents thought it likely that they would use novel excipients in the future, but nearly a third did not expect to use them
  • 40% of respondents said a reformulation of a drug product was needed due to excipients limitations
  • 28% of respondents experienced a discontinuation of drug development resulting from excipients limitations
  • More than 75% of users have faced challenges in using novel excipients, including regulatory issues and safety concerns.

The USP will publish the full set of data later this year but a summary of the results can be found here.

The novel excipient survey is an example of true collaboration – with BioPhorum, its members and the USP addressing current and future quality challenges and promoting biopharma innovation.

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