Lab of the Future: Manifesto: digital technology-based capabilities for the quality control (QC) lab of the future

Quality control (QC) labs have not been enhanced with the digital enablement that is deployed in the manufacturing environment:

• In most cases, test execution is not automated, partly because a lot of lab equipment cannot yet be controlled digitally.
• Technicians use many non-integrated systems with poor user interfaces; they are not guided or assisted by technology which could reduce repetitive tasks and help to further reduce human error levels in both process and data.
• Data are not captured or shared automatically or consistently, making it very difficult to use analytics to optimize outcomes and ensure the integrity of analytical data as required by regulatory agencies.
• Technology advancements for at-line and in-line approaches are not yet well supported and could help more closely integrate QC into the manufacturing process.

Purpose of document and action plan

• Articulate a necessary, realistic and achievable vision of the QC lab of the future shared by leading biomanufacturers and inspired by Biophorum’s digital plant maturity model.
• Stimulate collaboration between biomanufacturers and vendors of lab equipment and software.
• Help laboratories and vendors of lab equipment and software construct roadmaps.

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  • Create Date 30th July 2020
  • DOI https://doi.org/10.46220/2020IT002
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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.

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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.

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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.

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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.

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