Data Architecture

With data assets increasingly seen by biomanufacturers as strategic, business managers demand visualizations, reports and want AI to provide predictive insights and inferences. However, creating that output is only the tip of the iceberg: 80-90% of the effort has to go into preparatory work that senior managers never see. All large companies need data strategy and governance. With many systems contributing disparate data, there needs to be a data catalog to make it findable, and master data management to make it usable. That relies on a data ingestion and transformation strategy, and a stack of tools that form a data and AI platform.

Implementing data architecture frameworks is not straightforward

As manufacturing plants have been built or acquired over the years, biomanufacturers often have several systems of the same broad type, but from different vendors and different generations. Particularly in a GxP environment where filings restrict change and every update needs to be validated, the operational systems take a long time to converge, and data remains hard to use. Ownership is often local to the facility, making global insights hard to pull together.

There has been much thinking from hi-tech companies on the principles of data architecture. However, it is difficult and unclear how to implement the principles of data mesh and other frameworks in a biopharmaceutical setting. In order to make sense of data, it needs to be business people that take ownership of data, but skillsets and strategy are undefined. There is no best practice information architecture for the pharma industry – which limits the scope for reuse. We need systems to interoperate smoothly. There is no industry-established framework for data governance. Data quality is not improving over time. There is a plethora of tools and infrastructure technologies and it is not always clear how to use them effectively in a pharma organization.

Therefore it is difficult to meet new business needs for data products, visualizations and AIs efficiently, and empower users to make well-informed decisions.

Industry-wide approaches

By sharing the experiences in a group of practitioners with strategic oversight of data architecture in a range of biopharmaceutical organizations, we are getting a more complete and more widely agreed understanding of the distinct challenges we face. As case studies are shared, we reduce risk by learning from the experience of others and accelerate the analysis, design and build of data products. By combining those experiences into a set of guidelines, we aim to increase our maturity in producing and managing data products, increasing the impact and value gained from data assets.
Alignment between sponsors, CMOs and vendors will simplify and reduce costs of digital transformation in the extended enterprise. Once industry-wide approaches and standards become established, it creates fertile ground to innovate advanced analytics and harvest more benefits from data assets.

Data Architecture deliverables


More related workstreams

Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.

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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 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 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
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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
Delivering a Cell and Gene Therapy Outbound Supply Chain Pathway for the Industry
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A vision for the biopharmaceutical industry’s inbound supply chain
A major milestone – a harmonized approach to product carbon footprint data
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.

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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