NEWS

BioPhorum’s strategic framework shines a light on raw material management

30 August 2022
Advanced Therapy Medicinal Products
Drug Substance
Supply Partner
Sustainability
BioPhorum

Biopharmaceutical companies rely on a dependable supply of raw materials to ensure they can produce life-saving medicines for patients.

However, raw material variability is not fully understood between suppliers and manufacturers, which impacts yield and process continuity. There is also a poor understanding of raw material attributes, so the regulatory approach is not optimized, making changes difficult.

Addressing these issues is a huge undertaking and is why BioPhorum has launched its ground-breaking Raw Materials Strategic Framework.

This provides a solution for technical problems around raw materials management and encourages end-users and suppliers to work together to address specific raw material and end-user process needs.

The framework considers technical, regulatory, quality, and supply chain issues and will be of specific interest to stakeholders ranging from technical and supplier leadership teams to regulatory and quality staff.

It is a tool to help maximize the resilience of the raw material supply chain in line with industry standards by setting clear goals and prioritization needs to:

  • advance industry knowledge about attributes and impurities – for example, by proactively reviewing raw material performance, and sharing variances.
  • create flexibility by making second-sourcing a reality – by using pooled industry product and process knowledge and ‘quality by design’ principles
  • optimize limited lab resources – by seeking to harmonize industry standards and analytical methods
  • enable predictable raw material performance – by creating a free flow of information between suppliers and end-users.

The framework should be used as a continuous improvement model to support these goals and guide companies and the industry. Working on any of these goals will help advance the others, thus strengthening raw material management in the future.


The more direction industry can give suppliers, the more consistency and control there will be. BioPhorum’s framework aims to solve urgent technical problems in managing raw materials and will support the industry to gain greater knowledge of:

  • how raw materials are made
  • what they may contain
  • and what the performance expectations are.

The framework highlights the importance of implementing industry solutions and directs readers to BioPhorum Raw Materials Program publications. It also contains a case study highlighting the program’s value and how it can make the second sourcing of raw materials easier.

Building resilience
Program members believe there is real potential to build resilience in the global biopharmaceutical supply chain. This includes harmonizing and streamlining industry ways of working, standards, and regulations to optimize the use of limited resources.

To find solutions for how to build resilience and advance supply chain relationships, program members must be aligned on what drives the need for change. They have completed an analysis of the current state and industry drivers and have identified seven areas as key drivers of change for raw materials: patient needs, supplier landscape, knowledge understanding, technology and innovation, geopolitics, and variability.

Increased visibility and understanding of industry’s research, commercial activities, and future direction will help the supplier base respond to industry’s needs more effectively. Without advanced supply chain relationships between life sciences and biopharmaceutical partners, patients may be impacted by quality and/or supply gaps in the sector. BioPhorum’s Raw Materials Strategic Framework will be crucial to the success of these relationships.

An animation summarizing the framework is available on BioPhorum’s Raw Materials resource page.

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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.

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