Rohini Thevi Guntnur, Ray Rendon III, Joseph Higdon, Deidre Cacchillo, and Rogelio Zamilpa
Therapeutic efficacy, reliability, and availability of cell, gene, and tissue-derived therapies have increased the demand exponentially for effective translation of these therapies from bench-scale innovation to clinical grade manufacturing. The decision to select a biomanufacturing service organization (BSO) is critical as early translational efforts are typically limited in funding but with aggressive timelines.
While sponsor perspectives on selecting a BSO are widely available, this guide offers the BSO point of view as a foundational framework for choosing a manufacturing partner aligned with both operational excellence and patient-focused outcomes for your cell, gene, and tissue-derived products. To expedite the manufacturing process, this framework emphasizes integrated collaboration and readiness across key capabilities including process development (PD), technology transfer, facility and technical infrastructure, quality systems, regulatory expertise, and collaboration models.
What is a biomanufacturing service organization?
A biomanufacturing service organization (BSO) is similar to a CDMO in that both
provide product development and manufacturing support for therapeutic programs offering many overlapping capabilities and services.
However, a BSO has direct control of the manufacturing process including the sourcing of starting materials from properly consented donors, biomanufacturing services, advanced therapies testing, and clinical research. A BSO that operates as a full‑service biomanufacturing facility is dedicated to translating and optimizing early-stage cell and cell‑based processes to scale for commercial‑ready production.
Furthermore, this model has a collaborative process with the sponsor providing solutions from A to Z rather than contractual, which builds a more solution-driven approach.
Cell, gene, and tissue-derived therapies date back to the 19th century. The global market size for cell therapies is estimated by some to reach USD 20.07 billion [1], and for gene therapies to reach US$18.20 billion by 2030 [2]. To date, there are 47 cell, gene, and tissue-derived licensed products 204 approved by the Office of Therapeutic Products and listed by manufacturers [3].
Cell therapies exist in a variety of forms and may include autologous or allogeneic treatments, genetic modifications, specific formulations, and different forms of administration including injectables and combination products using bioscaffolds, all of which impact the manufacturing process [4]. Manufacturing cell, gene, and tissue-derived therapies can be challenging for a variety of reasons….
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Works Cited
Grand View Research. Cell Therapy Market Size, Share and Growth Report, 2030. Grand View Research, https://www.grandviewresearch.com/industry-analysis/cell-therapy-market.
Grand View Research. Gene Therapy Market Size, Share & Trends Report, 2030. Grand View Research, https://www.grandviewresearch.com/industry-analysis/gene-therapy-market.
U.S. Food and Drug Administration. Approved Cellular and Gene Therapy Products. 18 Mar. 2026, https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/approved-cellular-and-gene-therapy-products.
El-Kadiry, A. E., et al. “Cell Therapy: Types, Regulation, and Clinical Benefits.” Frontiers in Medicine, vol. 8, 2021, article 756029.
