ISIA

The Global Standard for Serum Traceability

For more than two decades, ISIA has played a leading role in promoting responsible sourcing, product integrity, and transparency across the global fetal bovine serum (FBS) industry.

The internationally recognised ISIA Traceability Certification Programme provides independent auditing of member companies to verify robust systems for:

ISIA certification demonstrates an organisation's commitment to internationally recognised best practice throughout the FBS supply chain.

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Strengthening Traceability Through Independent Scientific Verification

Traceability provides an essential record of where products have travelled throughout the supply chain.

Scientific origin verification provides independent evidence that the product itself is consistent with its declared origin.

Together they provide stronger assurance than either approach alone.

TeraTrace complements ISIA's internationally recognised Traceability Certification Programme by applying advanced laboratory science, authenticated Origin Reference Databases, and proprietary statistical modelling to independently assess product origin.

This additional layer of scientific assurance strengthens confidence throughout the supply chain.

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Confidence in Origin™ for ISIA Members

Through this partnership, ISIA members have access to independent scientific origin verification programmes that support their existing quality and traceability systems.

Current verification programmes include FBS originating from:

Using authenticated reference samples collected directly from verified source regions, TeraTrace establishes scientifically validated Origin Reference Baselines against which submitted samples are independently assessed.

The outcome is objective scientific evidence that complements existing traceability documentation and strengthens customer confidence.

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Supporting the Entire Serum Industry

The partnership benefits every participant in the global FBS supply chain.

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Serum Producers

Strengthen confidence in origin claims while demonstrating commitment to product integrity and transparency.

Manufacturers

Support supplier qualification and strengthen confidence in critical biological raw materials.

Biopharmaceutical Companies

Gain additional assurance when sourcing premium FBS products used in research and manufacturing.

Quality & Regulatory Teams

Support quality systems and supplier oversight with independent scientific evidence.

Researchers & End Users

Increase confidence in the origin and integrity of the FBS products they rely upon every day.

Why Join ISIA?

ISIA membership demonstrates a commitment to internationally recognised standards that benefit both individual organisations and the broader life sciences community.

Members benefit from:

As customer expectations continue to evolve, membership demonstrates leadership, accountability, and commitment to continuous improvement.

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Building the Future of Scientific Assurance

The partnership between ISIA and TeraTrace reflects a shared belief that transparency should continue to evolve alongside modern supply chains.

While traceability remains fundamental, independent scientific verification represents the next step in strengthening confidence throughout the global serum industry.

Together, ISIA and TeraTrace are helping establish higher standards that support manufacturers, customers, regulators, and ultimately patients who depend on safe, high-quality biological materials.

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Looking Beyond Serum

Although the partnership initially focuses on serum products, the principles underpinning scientific origin verification extend well beyond FBS.

As life science supply chains continue to evolve, opportunities exist to apply independent origin verification across a broader range of biological materials and animal-derived products.

Future programmes may support:

The vision shared by ISIA and TeraTrace is to help build greater transparency and confidence across the wider biological materials industry.

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A Shared Commitment to Industry Leadership

ISIA and TeraTrace share a common objective:

To strengthen trust through science.

By combining internationally recognised traceability standards with independent scientific verification, the partnership helps organisations demonstrate authenticity, reinforce customer confidence, and support responsible sourcing throughout the global serum industry.

Together, we are helping build stronger supply chains based on transparency, integrity, and Confidence in Origin™.

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Become Part of the Global Standard

Whether you are a serum producer, processor, distributor, manufacturer, supplier, or end user, participating in internationally recognised quality and traceability programmes strengthens confidence across the entire industry.

By combining ISIA Traceability Certification with independent scientific origin verification, organisations can demonstrate leadership, reduce supply chain risk, and provide greater assurance to customers worldwide.

Because the future of the serum industry depends on trust—and trust is strongest when it can be verified.

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Build Confidence in Origin™

Scientific verification complements traceability.

Together they provide stronger confidence for everyone involved in the global FBS supply chain.

TeraTrace is proud to partner with the International Serum Industry Association in helping shape the future of scientific assurance for biological materials.

Learn more about ISIA membership or contact TeraTrace to discuss Origin Verification programmes for your organisation.

Learn About ISIA MembershipContact TeraTrace