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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Cell & Gene Therapy

Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

We connect strategic thinkers in drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C&GT-specific validation issues, as well as working toward resolving the current challenges to commercializing C&GT products. Discover more and learn about the outputs here.

Development Group

The ever-increasing need to reduce product development lead times and the opportunities to exploit innovative technologies in development are two key industry themes that remain at the forefront of our work. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies, and molecule selection. Read some of the outputs and discover how you could benefit by getting involved.

Drug Substance

Accelerating improvement, exploiting opportunities offered by innovation, and identifying best practice approaches across all aspects of the manufacturing process – these are the essential objectives

Data and digital capabilities are at the core of many of these industry challenges. Work in BioPhorum Drug Substance is informed by BioPhorum Technology Strategy, which has summarized our industry’s market drivers and trends. Capacity, flexibility, sustainability and pace all feature as requirements to succeed in a rapidly changing environment.

Find out more about what our members are currently discussing and learn about some of the successful implementations of our output.

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Information Technology

IT and digital advances are crucial in responding to the pharmaceutical industry’s challenges around speed, cost, quality, flexibility, and sustainability. Unlocking and realizing the value in the industry’s IT opportunities is the core mission of the IT Phorum. 

The digital manufacturing facility of the future needs to consider technology advances alongside organizational perspectives while maintaining foundational security requirements. All elements must be considered in the long term to deliver systemic change toward the digital factory vision. Our members collaborate in a format that stimulates and supports industry innovation and implementation. 


BioPhorum Regulatory CMC is affording professionals the opportunity to shape their own collaboration program focused on challenges and opportunities across strategy, science, operations, submissions and compliance. Following a discovery program of work with Heads of Regulatory CMC, in which we identified some key topics of collaboration, we are giving you the opportunity to participate and help us to shape the final collaboration program. This will focus on, Filing and Review, Interactions with Health Authorities, and Harmonization. Our mission is not just to discuss, but to deliver applicable outputs and publications that will have an impact – learn more about how you can get involved.

Supply Chain to Patient

The pharmaceutical outbound supply chain was built on a blockbuster model and doesn’t fit the needs of the changing pipeline and new modalities currently being developed. The geopolitical challenges of recent years have shown that the outbound supply chain needs to evolve to become more agile, and resilient, and address a more expectant end-user bying on patient-centricity. Industry collaboration can accelerate improvements and transform performance in a way not possible when working independently. This Phorum is founded on the belief that learning from each other and challenging current thinking to re-imagine the supply chain can reduce costs and increase efficiency.

Supply Partner

BioPhorum SP members want the inbound supply chain for the biomanufacturing industry to be recognized as one of the best-understood and managed global supply chains. They intend to be not only a trusted advisory group but also the engine that drives change for the industry. Working together, we aim to achieve supply chain transformation that provides:

  • an enhanced robustness and resilience
  • accelerated capability and capacity to effect technology adoption
  • reduced cost of quality, and
  • industry-wide alignment on operational implementation

There’s an extensive list of Phorum successes and tangible benefits that have been delivered to define industry best practise.


The BioPhorum Sustainability program is jointly designed, governed, and delivered by a membership drawn from licence holders, contract manufacturers, major suppliers and niche suppliers. This dynamic partnership means that we can quickly focus on the areas that have the greatest industry impact, and we can leverage learning from each other and other sectors – the chemical industry and the built environment for example.

BioPhorum’s unique ability to build a strong coalition for change for an entire industry is now being applied to the greatest challenge of our generation. Driven by evident industry needs, Phorum members are working to develop agreed industry benchmarks, establish the ROI of sustainability investments and to increase the efficacy of implementation of members’ sustainability strategies.

Technology Strategy

With a mission to define strategies to accelerate technology transformation and support the adoption of innovative technologies, BioPhorum Technology Strategy evolved from BioPhorum Technology Roadmapping, strives to realize the technology roadmap vision 2.0.

This is being achieved through a multi-stakeholder team of member companies with collective capability and influence who are committed to driving forth industry goals associated with: Speed to market, Quality, Value, Agility and On-Demand Supply and Sustainability.

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The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.

Advanced Wound Care and Wound Management

Advanced wound care (AWC) is the medical treatment for wounds that have not healed properly using conventional wound care products such as gauze, bandages, plasters, and wadding.

AWC involves treating chronic or complex wounds using products that are not as easily obtained over the counter. AWC can be divided into three main categories: wound healing, infection prevention, and restoration.

Drug Delivery

Drug delivery products are therapeutic and diagnostic products combining drugs, devices, and/or biological products, which enable safer and more efficient treatment due to careful and precise drug targeting, local administration, and tailored treatment.

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MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

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