BioPhorum Cell & Gene Therapy

BioPhorum Cell & Gene Therapy
Product Description

Formed in 2018, Cell & Gene Therapy (CGT) supports the quest for better and faster development of cell and gene therapies. In this collaboration, we connect 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>-specific validation issues, as well as working towards resolving the current challenges to commercializing C> products.

The business of cell and gene therapy is as diverse as the patients which it serves and for that there is no one size fits all solution.

BioPhorum

  • GB
  • 2021
    On CPHI since
  • 100 - 249
    Employees
Company types
Other
Primary activities
Biopharmaceutical
Medical Devices
Other
Regulatory Affairs
Supply Chain
Specifications

BioPhorum

  • GB
  • 2021
    On CPHI since
  • 100 - 249
    Employees
Company types
Other
Primary activities
Biopharmaceutical
Medical Devices
Other
Regulatory Affairs
Supply Chain

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BioPhorum resources (9)

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    The Digital Plant Maturity Model (DPMM)1 describes one characteristic of a Level 5: Adaptive Plant as “In-line, real-time, continuous, closed-loop, process verification and control with automated realtime quality release”. This is the pinnacle of ‘Industry 4.0’, a term coined around 2011 to outline the advantages that a wide array of digital technologies running in concert can bring to manufacturing and critical facilities. For most pharmaceutical manufacturers, the strategic advancements these technologies can deliver have not been realized.

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    This aspirational vision includes full ILM, predictive analytics and advanced process controls (APC) enabling release of product in real time, with concomitant predictive and preventative alerts and resolution of process, equipment and other production issues.

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    This paper provides an overview of the current and near-future bioprocess supply situation and trends. Prior to COVID-19 the bioprocess supply industry was growing at 12-14%. While some supply segments, such as single-use systems (SUS), have been growing faster than this average, overall, the bioprocessing industry pipeline continues to generate very strong demand for supplies and consumables for both COVID and non-COVID vaccines and therapies. However, recent order declines seen by suppliers have created concern. Challenges during the Pandemic created supply chain problems for biologics manufacturing that remain unresolved.
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  • Webinar Developing a Sustainability Roadmap for the Biopharma Industry

    Despite broad agreement across the biopharma sector on common long-term environmental sustainability goals , there remains a lack of industry specific standards, regulations, and metrics. For the past year, BioPhorum members have collaborated across the value chain to chart a roadmap for the biopharma industry; setting out the key enablers necessary to deliver decarbonization and embed circularity. All disciplines: scientists, process engineers, procurement teams, facility designers, regulatory experts can begin to explore the vital role they play in maximizing the contribution the biopharma industry can make to repairing the planet whilst at the same time accelerating access to healthcare for all.