Extractables and leachables

Extractables ecosystem​

Suppliers, integrators and users are now starting to gain the full benefits of the standardized extractables testing established as the industry practice in the last few years.  Critical to this has been the implementation by key suppliers and integrators of  a system of extractables information exchange that enables the rapid assessment of planned systems by end users.  While this ecosystem is now well established, it is not complete and there is room for more companies to join and share their information using the same model to create the seamless global system the industry needs. 

Implementation

There are three main actions that a company supplying single use systems needs to take to fully implement the BioPhorum extractables ecosystem:

Generate high quality extractables data and make it READILY AVAILABLE

Readily available means easily accessed by your customers, ideally in an automated way. The BioPhorum extractables ecosystem has some standard guidelines on how extractables study reports should be presented and related to bioprocessing equipment. Information on these requirements is available in these pages.

As data is shared within the ecosystem, the quality of that data becomes very important. With that in mind the team has generated a short document downloadable here intended as a primer to help you in generating high quality extractables data either internally or via a contract service. We would also encourage you to seek advice from your customers who have experience of, or have requested extractables testing if this type of study is new to your organization

Develop an extractables landing page including prioritization information

It’s easy for extractables data to become lost, especially in large companies where websites are covering multiple divisions and product lines. We are proposing an extractables landing page that details:

  • Your prioritization/availability of extractables data using the prioritization template
  • How your customers can access detailed extractables information

Information on the prioritization template is available by clicking here.

In addition, BioPhorum are providing an Extractables Data Portal here, which gives direct access to the landing pages of the BioPhorum member companies who have created this facility.

 

Agreeing to and implementing standardized rules for data sharing

We recommend that wherever possible, component manufacturers own the extractables information for their products and that this information is passed up the supply chain to the end user. In the past this has caused challenges with the need for non disclosure agreements (NDA)/confidential disclosure agreements (CDA) between multiple parties.  To allow this ecosystem to function effectively we promote a standard set of rules (rules of the road) to facilitate integrators collating and relaying relevant extractables information directly to their customers.

Information reporting​

There are two critical elements to hosting extractables information that add value for biomanufacturers and allow the rapid assessment of risk. These bring benefit to the whole biomanufacturing and single-use system industry by supporting more rapid and flexible adoption of single use technologies.

1. Extractables Data

Firstly it is critical that high quality extractables data, meeting the requirements specified by the end user in the BioPhorum protocol, is generated. Typically, this information is generated on one component that may represent a family of components with the same material and manufacturing characteristics but perhaps with a different physical format or size (e.g. Polypropylene T-Connector vs. Polypropylene Y-Connector). The recommendation for the BioPhorum Extractables ecosystem is that information be provided in two formats. Firstly information must be provided in a controlled document approved by the vendors quality assurance (QA). Typically this will take the form of a written document provided in a pdf format that cannot be edited by recipients.

Shaking hands

Secondly, information should also be made available in excel format using the standardized data template available here. The information is provided in this standardized format to:

  • facilitate the use of the data by end users
  • save time
  • reduce the risk of incorrectly transcribing data.

For this to work, the supplier must warrant that the information is correct at point of download, and the biomanufacturer must acknowledge that the controlled report is the verified document and accept that they are accountable for any errors introduced during manipulation of the excel data.

2. Component Information

Family

In order to make the extractables data valuable it is essential that end users can link the information to the relevant component and physical characteristics of that component. There are two situations in which an end user needs to know which extractables data is relevant to the component in use:

Component Families

This relates primarily to components which are manufactured from the same material using the same process. Suppliers are asked to generate data on one size of component and define which components the testing covers along with physical characteristics (component mass and fluid contact area) of the components. Physical characteristics of the test article must also be provided.

The component family template is the recommended format for providing this information.

Assembly families

In cases where an integrator is providing single use assemblies, possibly of different sizes, it is important that a biomanufacturer can identify which components are used in the assembly and which extractables study is relevant for that component. This information should be provided in the assembly family template.

Data Pass through

In order to make the system as efficient as possible integrators should not need to retest components that have been already tested by component manufacturers. This is achieved by component suppliers allowing integrators to pass on data to the customers. This is made frictionless by the removal of 3 way confidentiality agreements (CDA / NDA) between supplier integrator and end user. This approach is described in more details in guidelines or ‘Rules of the Road’ available here.

Data reporting guidelines

There are two critical elements to hosting extractables information that add value for biomanufacturers and allow the rapid assessment of risk. These bring benefit to the whole biomanufacturing and single-use system industry by supporting more rapid and flexible adoption of single use technologies.

To facilitate exchange of information between companies The BioPhorum team has identified a two document reporting format. This consists of:

  • A controlled report approved by the SUS equipment vendors QA function
  • A verified excel copy of the data to allow ready use of the data by biomanufacturers.

The way these two documents are used differs, there are cases where the format and content must be followed in order for the data to have most value, in other cases the information must be provided, but the format may alter, and in some cases provision of the information is recommended best practice. The table below shows what data should be provided in each document.

The data template is available to download here as an excel file. Guidance on completing the data template is available here

bioPhorum Data reporting guidelines

Cell & Gene Therapy

Maximizing the impact of the many advanced therapies under development requires that the industry comes together to improve understanding of how to develop, control and manufacture these life changing therapies.

We connect strategic thinkers in drug development and contract manufacturing organizations with the aim of ensuring harmonization and alignment around issues such as potency assays, phase-appropriate guidance for critical quality attributes, operator safety, regulatory guidelines, and C&GT-specific validation issues, as well as working toward resolving the current challenges to commercializing C&GT products. Discover more and learn about the outputs here.

Development Group

The ever-increasing need to reduce product development lead times and the opportunities to exploit innovative technologies in development are two key industry themes that remain at the forefront of our work. The Phorum successfully connects process development organizations and provides a space where subject matter experts can work on issues such as quality by design and process characterization, cell line technologies, and molecule selection. Read some of the outputs and discover how you could benefit by getting involved.

Drug Substance

Accelerating improvement, exploiting opportunities offered by innovation, and identifying best practice approaches across all aspects of the manufacturing process – these are the essential objectives

Data and digital capabilities are at the core of many of these industry challenges. Work in BioPhorum Drug Substance is informed by BioPhorum Technology Strategy, which has summarized our industry’s market drivers and trends. Capacity, flexibility, sustainability and pace all feature as requirements to succeed in a rapidly changing environment.

Find out more about what our members are currently discussing and learn about some of the successful implementations of our output.

Fill Finish

Quality and demonstrating compliance are two priorities of BioPhorum Fill Finish. Representatives of the world’s top sterile filling operations come together to develop solutions to some of the most intractable technical and regulatory challenges.To address these challenges in drug product aseptic filling (‘fill’) and secondary packaging (‘finish’) operations, our community of industry experts is working relentlessly to continually improve the pharmaceutical quality system (PQS). Together they continue to strive towards developing and implementing safe, predictable, lean, and agile processes in drug product operations. Find out more about the Phorum output here. 

Information Technology

IT and digital advances are crucial in responding to the pharmaceutical industry’s challenges around speed, cost, quality, flexibility, and sustainability. Unlocking and realizing the value in the industry’s IT opportunities is the core mission of the IT Phorum. 

The digital manufacturing facility of the future needs to consider technology advances alongside organizational perspectives while maintaining foundational security requirements. All elements must be considered in the long term to deliver systemic change toward the digital factory vision. Our members collaborate in a format that stimulates and supports industry innovation and implementation. 

Regulatory-CMC

BioPhorum Regulatory CMC is affording professionals the opportunity to shape their own collaboration program focused on challenges and opportunities across strategy, science, operations, submissions and compliance. Following a discovery program of work with Heads of Regulatory CMC, in which we identified some key topics of collaboration, we are giving you the opportunity to participate and help us to shape the final collaboration program. This will focus on, filing and review, interactions with Health Authorities, and harmonization. Our mission is not just to discuss, but to deliver applicable outputs and publications that will have an impact – learn more about how you can get involved.

Supply Chain to Patient

The pharmaceutical outbound supply chain was built on a blockbuster model and doesn’t fit the needs of the changing pipeline and new modalities currently being developed. The geopolitical challenges of recent years have shown that the outbound supply chain needs to evolve to become more agile, and resilient, and address a more expectant end-user bying on patient-centricity. Industry collaboration can accelerate improvements and transform performance in a way not possible when working independently. This Phorum is founded on the belief that learning from each other and challenging current thinking to re-imagine the supply chain can reduce costs and increase efficiency.

Supply Partner

BioPhorum SP members want the inbound supply chain for the biomanufacturing industry to be recognized as one of the best-understood and managed global supply chains. They intend to be not only a trusted advisory group but also the engine that drives change for the industry. Working together, we aim to achieve supply chain transformation that provides:

  • an enhanced robustness and resilience
  • accelerated capability and capacity to effect technology adoption
  • reduced cost of quality, and
  • industry-wide alignment on operational implementation

There’s an extensive list of Phorum successes and tangible benefits that have been delivered to define industry best practise.

Sustainability

The BioPhorum Sustainability program is jointly designed, governed, and delivered by a membership drawn from licence holders, contract manufacturers, major suppliers and niche suppliers. This dynamic partnership means that we can quickly focus on the areas that have the greatest industry impact, and we can leverage learning from each other and other sectors – the chemical industry and the built environment for example.

BioPhorum’s unique ability to build a strong coalition for change for an entire industry is now being applied to the greatest challenge of our generation. Driven by evident industry needs, Phorum members are working to develop agreed industry benchmarks, establish the ROI of sustainability investments and to increase the efficacy of implementation of members’ sustainability strategies.

Technology Strategy

With a mission to define strategies to accelerate technology transformation and support the adoption of innovative technologies, BioPhorum Technology Strategy evolved from BioPhorum Technology Roadmapping, strives to realize the technology roadmap vision 2.0.

This is being achieved through a multi-stakeholder team of member companies with collective capability and influence who are committed to driving forth industry goals associated with: Speed to market, Quality, Value, Agility and On-Demand Supply and Sustainability.

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Introducing MediPhorum

The medical technology (MedTech) industry is a critical and complex sector. As highlighted during the Covid-19 pandemic, the MedTech industry provides a wide array of products and technologies that are vital to the safe and effective provision of care to many. Also, as seen over recent years, there is often the requirement for flexibility in supply, rapid development, and the introduction of new products to keep pace with global public health demands.

Advanced Wound Care and Wound Management

Advanced wound care (AWC) is the medical treatment for wounds that have not healed properly using conventional wound care products such as gauze, bandages, plasters, and wadding.

AWC involves treating chronic or complex wounds using products that are not as easily obtained over the counter. AWC can be divided into three main categories: wound healing, infection prevention, and restoration.

Drug Delivery

Drug delivery products are therapeutic and diagnostic products combining drugs, devices, and/or biological products, which enable safer and more efficient treatment due to careful and precise drug targeting, local administration, and tailored treatment.

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more

Introducing the new MediPhorum

MediPhorum by BioPhorum has been launched to bring together senior business leaders and subject matter experts across multiple MedTech... read more
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