BioPhorum Drug Substance

BioPhorum Drug Substance aims to advance manufacturing and testing excellence by collaborating with biopharmaceutical organizations. Drug Substance supports its members to accelerate technology adoption, simplify post-approval change, and increase confidence in maintaining compliance. Membership gives a voice to companies that want to be at the forefront of delivering resilient supply to patients.

We bring together biomanufacturers, major supply partners, and contract development and manufacturing organizations (CDMOs). Together, these experts develop benchmarks and frameworks which will improve operational agility, speed, quality, value, and sustainability for our members. We are proud that BioPhorum Drug Substance is shaping the regulatory and industry landscape through scientific and risk-based guidance.

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

Join most of the top 20 pharma companies to see faster adoption of technologies in commercial operations. Our members report a reduced risk through developing common approaches to change and increased process efficiency.

BioPhorum Drug Substance members have a unique and credible voice within the industry. This means that our strategies, tools and recommendations carry the gravitas needed to make impactful change.


Being future-ready is crucial for our members to give them advantages in the market.

For the factory of the future to become a reality, it will need to be:

  • Proactive – and predict future outcomes based on historical and real-time data
  • Agile – and adapt to schedule and product changes with minimal intervention
  • Optimized – and operate with minimum manual intervention and high reliability from automated workflows and synchronized assets

The smart factory will need to focus on digital plant and lab maturity with the integration of digital technology in process monitoring and control.

Therefore, Drug Substance members are focusing on:

  • Inspiring and accelerating technology adoption
  • Shaping the regulatory and industry landscape
  • Increasing process efficiency
  • Optimizing production capacity
  • Assuring safe and compliant products for patients.

Benefits of collaboration

Our members solve complex problems that cannot be done alone. By sharing best practices and experiences, members can improve operational efficiency, bring products to market faster, and create higher-quality medicines for patients.

Drug Substance members have a competitive edge in tackling current and emerging challenges. It allows leaders to better understand industry trends so they can create strategic and operational plans to address these shifts.

From new technology to material changes and mitigating risks, members work together to agree and adopt best practices.

Drug Substance members have opportunities to interact with and influence regulatory agencies as a single industry voice. Through this, we can build a consensus on new regulatory guidelines which may prevent unnecessary expenses or higher requirements.

Participating in the 14 workstreams and two communities of practice will help you develop your teams into subject matter experts by learning from others in the industry.

I saw through the BioPhorum working cell banks group that there were many common challenges – it is bigger than just cell banks; (there is) a lot of strength to have scientists and regulatory experts combine industry wide to form consensus.
Melanie Marchand
Head of Seed and Cell Bank Management, Sanofi

Contact BioPhorum Drug Substance

To find out more about how BioPhorum BioPhorum Drug Substance 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.


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 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 Resilience

Supply Resilience 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 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.

An industry perspective on understanding AAV capsid content variants
Needle On Yellow Background
An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
The Drug Substance 2.0 Strategic Value Framework
Coloured dots on teal, next to vial
BioPhorum’s holistic approach to container closure integrity
Magnifying glass over a tablet all coloured blue
Digital Plant Maturity Model 3.0
Inaugural BioPhorum Quality face to face – get involved
The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
A launchpad for an improved CGT outbound supply chain
DNA and Earth on blue background
A vision for the biopharmaceutical industry’s inbound supply chain
Building a resilient business means adopting water stewardship
Technology Roadmap V 2.0
BioPhorum Technology Roadmapping roadmap vision 2.0


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


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.


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.


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.

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