My name is Mauricio Fernandez, and I serve as the director of quality assurance management for the Biospecimen and Cell and Gene Therapy Division at Discovery Life Sciences. In my role, I oversee product compliance, regulatory affairs and the quality management systems across our GMP sites.
Discovery Life Sciences specializes in donor management and customized, prospective collection of human-derived hematological tissues. We play a critical role in supporting the development of many cell and gene therapies by providing both GMP and RUO starting materials through our AllCells brand. One of our goals is to enable life science researchers and biomanufacturers around the world to advance complex therapies while addressing key challenges in the supply chain.
Our Alameda, Calif., facility specializes in leukapheresis collections from healthy donors, specifically supporting research, process development and manufacturing for cell and gene therapies. What sets us apart is our integrated setup; the collection center is directly connected to a processing facility and ISO 7 clean room, ensuring minimal sample degradation, faster turnaround and consistently high-quality material.
Also, our healthy donor pool is thoughtfully curated to meet the specific needs of the CGT industry. Each donor is extensively characterized, and through strong engagement and relationship-building, we maintain exceptional donor retention and recallability - both essential for longitudinal studies and repeat collections. As a result, we've achieved a best-in-class 98% deliverability rate, ensuring our partners receive consistent, high-quality starting material on time.
One of our recent achievements is earning AABB accreditation for cellular therapy services. This key milestone reflects the rigorous quality systems, donor care and operational excellence we've built into every part of our facility. It aligns directly with our mission to provide reliable, high-quality starting material for cell and gene therapy developers. It also reinforces our commitment to advancing industry standards and supporting the success of our partners.
Mauricio Fernandez, Director, CGT Quality Management, Discovery Life SciencesGoing through the AABB accreditation process has had a meaningful impact on both our team and our operations. It's helped us strengthen and refine our existing processes while aligning closely with current AABB standards and broader industry best practices. The structure and clarity of the AABB standards have allowed us to focus on the critical systems needed to uphold quality and ensure consistency across our AllCells products.
This alignment also reinforces our commitment to Discovery's mission, vision and values. For example, our vision is to be the most trusted partner in life sciences research and clinical development. One of our core values is that the customer always comes first. So, having AABB accreditation gives our clients added confidence in the reliability, quality and regulatory integrity of our products and services.
In 2025, we will launch our new AllCells GMP cryopreserved peripheral blood mononuclear cells (PBMCs), a product designed to reduce the high cost and risk of manufacturing failures in cell and gene therapy manufacturing. These high-quality GMP PBMCs are made under full donor-to-product control from rigorous donor screening and leukapheresis collection to cell processing and cryopreservation. Collections are processed in an ISO 7 cleanroom, with PBMCs isolated using a closed system to maintain quality and consistency. Our integrated donor clinic and processing lab also ensure minimal vein-to-freezer time, preserving cell integrity. It's a big step forward in streamlining CGT development, and we're looking forward to sharing more soon.
I would highly encourage it! We've seen firsthand how AABB's well-structured standards can strengthen operations and elevate quality across the board. For any facility looking to implement a framework that's both rigorous and adaptable to their specific needs, AABB accreditation is definitely worth considering.
I'd like to express our appreciation for AABB and the important role it plays in advancing quality and consistency in CGT development. Being part of this network has helped us grow and continuously improve. At Discovery, we're proud to partner with leading researchers and developers, enabling them to move faster by providing the highest-quality products and services. We look forward to our continued collaboration with AABB and to offering innovative products as the industry continues to evolve.
Discovery Life Sciences (Discovery) is a global leader in biospecimen and specialty lab services, enabling the discovery and development of groundbreaking therapeutics and diagnostics. With a robust portfolio of human biospecimens and cellular starting material, preclinical ADME-tox solutions, and cutting-edge specialty lab services, we provide our partners with the tools, data and expertise they need to succeed. From genomics and proteomics to cell biology and molecular pathology, our comprehensive service offers support for every phase of the scientific journey, from research through clinical trials.
AABB Accreditation is an international mark of excellence that demonstrates your facility's commitment to quality and safety. Biotherapies facilities can become AABB-Accredited via the Standards for Cellular Therapy Services.
Learn how AABB Accreditation can bring value to your facility.
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