Phorums

Cell & Gene Therapy
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Development Group
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Drug Substance
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Fill Finish
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Information Technology
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Supply Partner
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Technology Strategy
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Regulatory
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Sustainability
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Supply Chain to Patient
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Cell & Gene Therapy

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.

Development Group

BioPhorum Development Group’s mission focuses on better and faster process development of biopharmaceutical medicines. Formed in 2011, the Phorum has succeeded in bringing collaboration to the drug development community while navigating the challenges of being close to intellectual property. BioPhorum Development Group’s mission focuses on better and faster process development of biopharmaceutical medicines. Formed in 2011, the Phorum has succeeded in bringing collaboration to the drug development community while navigating the challenges of being close to intellectual property.

Drug Substance

Drug Substance (DS) aims to accelerate the way our operations deliver near- term results. The program is informed increasingly by the Technology Roadmap as well as members’ immediate needs to improve manufacturers’ licenses to operate. Teams here have led the drive to make single-use technologies as easy to specify and implement as stainless steel, and continue to help members to realize step changes in microbial control, quality management systems, and the use of closed systems; as well as pushing back the barriers on post-approvals submissions with a growing number of authorities.

Fill Finish

In BioPhorum Fill Finish (FF) you will find representatives of the world’s top sterile filling operations developing solutions to some of the most intractable technical and regulatory challenges. Members have addressed the critical challenges that Annex 1 brings to final filtration integrity testing and isolator disinfection. We are now rolling out industry approaches to environmental monitoring, particle risk management, and working together to remove barriers to rapid micro adoption.

Information Technology

BioPhorum IT’s (BPIT) mission is to accelerate the delivery of information technology-impacted business goals and to help unlock the value of the pharmaceutical industry’s IT opportunities. Established in 2016, BPIT has adopted strategic positions on digital transformation in biopharmaceutical manufacturing, introduced new guidance and tools to drive efficiencies in compliance and quality management, and is actively addressing the challenges of cyber security that threaten the continuity of our operations.

Supply Partner

BioPhorum Supply Partner brings together biomanufacturers with suppliers in a collaborative partnership to create a genuine supply chain community that is unique in the biomanufacturing industry. The collaboration aims to transform the inbound supply chain for the benefit of all. The Phorum vision: the biopharmaceutical industry inbound supply chain is considered one of the best understood and managed supply chains of any industry in the world. Our mission: to be the trusted advisory and collaboration group, driving change across the global industry for all things relevant to the inbound supply chain.

Technology Strategy

Technology Roadmapping (TR) is a collaborative technology management process that accelerates innovation and development of the manufacturing processes of the future. Here biomanufacturers, supply partners, engineering partners and regional innovation hubs build and communicate the roadmap strategy. In priority areas, they enable progress through identifying technology targets and modelling solutions, for example current work includes proving through concept demonstrators and business case modelling, plug and play hardware, smaller buffer preparation footprints and driving the move for more standard facility design to accelerate capacity builds.

Regulatory

The biopharmaceutical industry continues to develop advanced best practice manufacturing processes, systems, technologies and facilities. However, we experience varying degrees of understanding and confidence across manufacturers and regulators. This can lead to uncertainty that proposed improvements will be accepted and successfully implemented in an aligned way. Therefore, to avoid perceived issues, best practice can end up being diluted, or solutions over-engineered. Ultimately, innovation and improvement is slowed, presenting a challenge to realize potential benefits such as speed to market, supply assurance and cost. To address this, the BioPhorum Regulatory Governance Team recommends, facilitates and supports an ongoing platform of informal dialogue with agencies, offering industry views and listening to wider agency perspectives, prior to implementation. We are well placed to share industry positions on priority topics with agencies and solicit feedback by developing contacts with regulators and associated standard organizations, across the regulatory networks of member companies.

Sustainability

To act as a voice of the industry to enable delivery of the industry’s sustainability ambition quickly and effectively. To lead innovative teams who have the capability and credibility to create consensus and ultimately drive real change that benefits people and planet.

Supply Chain to Patient

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