BioPhorum Advanced Therapy Medicinal Products

BioPhorum Advanced Therapy Medicinal Products (ATMP) supports our members to advance their cell, gene, and RNA therapies and vaccines. We work with developers, contract manufacturing, and testing organizations to streamline the industry for all.

The advanced therapeutics industry is facing several challenges that need a collaborative approach. Bringing your cell, gene, and RNA therapy developments to market and avoiding regulatory delays in this exciting area of pharmaceuticals is key to developing new business.

Are you ready to become a member? Make an enquiry today.

Join over 34 members at the cutting edge of advanced therapy to increase the speed and quality of your cell, gene and RNA products. By working with industry experts, you can put your organization at the forefront of this exciting new area of biopharmaceuticals.

Challenges

BioPhorum ATMP supports its members through five key challenges:

  • Speed of development and product to market
  • Improving existing commercial manufacturing processes
  • Analytics and standards
  • Regulatory challenges
  • Understanding the challenges from the evolving industry landscape

To tackle these broad challenges, we have high-level workstreams looking at industry trends.

These high-level workstreams are split across dedicated modality-focused areas (cell therapy; ex vivo gene therapy; in vivo gene therapy; and RNA) and across functionality-focused areas (development; analytics; commercialization; regulatory; EHS and biosafety; raw materials; and talent). There are additional in-depth workstreams drilling down into specific challenges. ATMP members continue to identify new workstreams to support the advance therapeutics arena.

Improving how our members develop, control, and manufacture these life-changing therapies through industry collaboration is more important than ever. The advanced therapies field continues to mature and learn. While there has been a downturn in record-breaking funding, there is a push for expansion and a growing list of approved products.

BioPhorum ATMP, together with our members, is addressing the specific challenges within the wider five areas above. This will bring alignment on aspects of advanced therapy development and manufacturing to drive standardization across the industry.

The phorum program supports companies developing, manufacturing, and testing these advanced therapies. Our high-level workstreams create discussion, innovation, and quickly address issues. Plus, the in-depth workstreams focus on delivering positive outcomes for specific challenges which shape the industry.

Membership collaboration

Our members gain huge value through working together to:

  • Develop responses to the challenges faced within advanced therapies
  • Improve robustness, efficiency, and consistency of development and manufacture
  • Establish industry standards and influence regulatory position
  • Share challenges, experience, and benchmark across the industry
  • Develop tools to support the advanced therapies industry

Additionally, our members have access to methodologies, research, and tools ahead of publication.

Phorum members have presented at conferences and webinars, published in newsletters, provided feedback on regulatory guidelines and produced members-only tools, benchmarks and guidance. We continue building links with ASTM International, the US Pharmacopeia, the Standards Coordinating Body, and the British Pharmacopeia and Medicines and Healthcare Products Regulatory Agency developing strong ties with these organizations.

The advanced therapies business is as diverse as the patients it serves, so there are no one-size-fits-all solutions. However, by driving harmonization and alignment in this new industry, the Phorum promotes better and faster development of therapies.

As we adapt to these new modalities, these conversations help me ask, are we on the right path? Are we thinking about this the right way? That’s where lessons are being learned, as it helps us ask where we’re aligned with each other and where we’re not. That’s the power of BioPhorum.
Head of Gene Therapy Technical Operations
Sanofi

Contact BioPhorum Advanced Therapy Medicinal Products

To find out more about how BioPhorum BioPhorum Advanced Therapy Medicinal Products can help your business, enter your details below and a member of our team will be in touch.

Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

Sustainability

Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

DOWNLOAD
An industry perspective on understanding AAV capsid content variants
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EXTERNAL-RESOURCE
An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
DOWNLOAD
The Drug Substance 2.0 Strategic Value Framework
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DOWNLOAD
BioPhorum’s holistic approach to container closure integrity
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DOWNLOAD
Digital Plant Maturity Model 3.0
NEWS
Inaugural BioPhorum Quality face to face – get involved
PODCAST
The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
PODCAST
Delivering a Cell and Gene Therapy Outbound Supply Chain Pathway for the Industry
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DOWNLOAD
A vision for the biopharmaceutical industry’s inbound supply chain
NEWS
A major milestone – a harmonized approach to product carbon footprint data
Technology Roadmap V 2.0
DOWNLOAD
BioPhorum Technology Roadmapping roadmap vision 2.0

Publications

Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.

Webinars

Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.

Podcasts

BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.

Tools

A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

Browse all

Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.

WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
Magnifying glass over a tablet all coloured blue
DOWNLOAD
Digital Plant Maturity Model 3.0
WEBINAR
Bioreactivity testing in single-use system biomanufacturing