Raw Materials Program

A program driving more predictable raw material (RM) performance, with workstreams focusing on two technical aspects: media and analytics and standards and procedures.

Driving more predictable raw material (RM) performance, optimized testing regimes and raw material flexibility

The aim of the program is drive the adoption of the industry-aligned Raw Materials (RM) strategy by tackling the root causes of RM variability and lack of harmonized specifications. This will enable more predictable raw material performance, optimized testing regimes and greater raw material flexibility: reducing supply continuity risk and enabling greater supply chain agility.

Media and Analytics: Eliminating unnecessary tests using critical attributes

Sharing best practices, knowledge, and experience to enhance the understanding and control of general raw materials and components of cell culture media, by identifying critical material attributes. The workstream is to develop a guideline/white paper that assists biomanufacturers and suppliers in identifying critical attributes of media subcomponents and establishing controls for Certificate of Analysis (COA) and specifications, thus eliminating the need for unnecessary tests.

Standards and Procedures: Better control of endotoxin levels

Advance Industry knowledge on how to better control endotoxin levels, by understanding the raw materials and their impact on the process through benchmarking. This will generate shared learning on endotoxin limits, preferred test methods, issues/corrective actions caused by endotoxin and approaches to endotoxin and bioburden specification setting.

Raw Materials Program deliverables

DeliverableDateDetailsDownload

Standards and best practices to support trace metal quantitation in cell culture chemically defined media and hydrolysates

1 August, 2023Webinar

Raw materials strategic framework and roundtable discussion

31 July, 2023Webinar

Media fingerprinting of cell culture media a standardized analytical test method suite and three-tier approach

29 November, 2022
1.12 MB
274 downloads

Raw materials strategy

28 July, 2022
377.29 KB
388 downloads

Raw Materials: Supplier change notifications: change areas and requirements

28 June, 2022
249.63 KB
566 downloads

Media and hydrolysates

30 May, 2022
758.14 KB
150 downloads

Trace element variation for chemically defined cell culture media: biopharmaceutical industry requirements and cross-company collaboration to mitigate risks

24 March, 2022
737.84 KB
307 downloads

Raw materials: Best practice guide for preparation of cell culture media solution

19 April, 2021
297.50 KB
387 downloads

Raw Materials: Trace element variation of soy hydrolysate used in biopharmaceutical manufacturing

29 September, 2020
1.11 MB
178 downloads

Raw material: A holistic approach to raw material risk assessments through industrial collaboration

2 September, 2019
5.89 MB
1268 downloads

Raw materials: Patient-centric requirements for the supply of raw materials

26 June, 2015
506.50 KB
187 downloads

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.

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
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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