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INNOVATOR INSIGHT

Choosing a biomanufacturing service organization: from the BSO perspective 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.

Cell & Gene Therapy Insights 2026; 12(2), 203–213 · DOI: 10.18609/cgti.2026.028

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

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approved by the Office of Therapeutic Products and listed by manufacturers (Table 1) [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 [4,5].

Manufacturing cell, gene, and tissue-derived therapies can be challenging for a variety of reasons. f

f

f

Variability of living starting materials Need for specialized cleanroom infrastructure High cost of maintaining and operating cleanrooms

f BOX 1 Readiness and selection checklist for sponsors.

Documentation and data f Complete, traceable BRs/SOPs/methods f Clear CQAs/CPPs and rationale f 21 CFR Part 11-compliant systems and data integrity

Materials and equipment f GMP-grade materials/sterile-capable components f Traceable, calibrated equipment

Process and scale f Closed-system process map f Scalability plan (Bioreactor/TFF/Fill-Finish) f In process tests strategy + deviation handling

Quality and regulatory f QMS maturity, GDP discipline f Established IQ/OQ/PQ and PPQ programs f EM program and cleanroom classification approach

Collaboration f Defined governance

f

f

f

f

f

Requirement for highly skilled personnel to ensure aseptic handling Complex and evolving regulatory expectations Difficulty in achieving consistent scale‑up or scale‑out Fragile nature of products, making them highly sensitive to processing and environmental conditions Need for extensive analytical testing to confirm identity, phenotype, potency, safety, and stability

Therefore, it is important that sponsors select a manufacturing partner who is best suited to deliver efficient, reliable, and scalable development and production for their drug products (Box 1). This paper outlines the key considerations for selecting a manufacturing partner to help ensure a seamless and efficient transition from development through to commercialization.

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f Cross-functional access f Flexibility and rapid change control

Starting materials and analytics f Donor/source material control strategy f Co-developed identity/potency assays

STAGE INTERDEPENDENCE IN THERAPY DEVELOPMENT The success of each stage in the product lifecycle depends heavily on the efficiency of the preceding stage. Early phases such as research and development (R&D), followed by preclinical studies, are typically conducted in research labs where robust experimentation establishes the product concept and safety through in vitro and in vivo testing.

When projects transition to a BSO for PD and subsequent manufacturing, they undergo rigorous operational, analytical, and functional assessments to confirm safety, efficacy, cost-effectiveness, scalability, and timely delivery to market. Projects that arrive at a BSO well-prepared tend

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innovator insight to progress through manufacturing more efficiently, accelerating their path toward market readiness.

EARLY CLINICAL TRIAL MANUFACTURING READINESS When analytical assays are inadequate or key documentation such as the bill of materials (BOM), bill of equipment (BOE), and batch record (BR) are insufficient during initial stages, timelines are often extended resulting in delays in progressing to subsequent manufacturing stages. To avoid these setbacks, it is critical to begin with the end in mind during early product/process characterization and early phase production. It is also advantageous to transition the analytical assays at the start of any project if available so that technical transfer batches have a quantifiable measure and can be compared to historical data. Designing characterization efforts to identify critical process steps, components, and parameters are vital in determining variability to critical quality attributes (CQAs) and the repeatability of the process. Utilizing a representative early‑phase or engineering batch material for assay development, qualification, and validation builds GMP quality testing platforms that enable early definition of CQAs. This early definition guides product development towards a high-quality, GMP-compliant end state.

COMMON RESEARCH & DEVELOPMENT PITFALLS f

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f

Insufficient or non-traceable documentation Non-conventional lab practices are hard to reproduce in GMP cleanrooms or scale Use of non-GMP materials or components that lack- sterile/GMP equivalents

f

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Limited process familiarity or insight Analytical assays that are not qualified or validated

IMPACT OF EARLY PREPARATION Each project arrives at a BSO in a different state of manufacturing readiness.

Under-prepared projects often encounter recurring issues, requiring frequent process updates resulting in batches with a high degree of variability. This compromises repeatability, a cornerstone of GMP manufacturing, and leads to extended timelines and higher costs.

Projects should be thoroughly evaluated when the process is still in its early stages and should be redirected to R&D before being transitioned to PD and ultimately into manufacturing.

KEY CRITERIA FOR SELECTING A BSO f

f

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Technology transfer rigor and tailored gap-bridging Facility modularity and phase appropriate flexibility End-to-end technical capabilities Quality management system (QMS) maturity and regulatory expertise

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Collaboration and transparency

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Starting material control

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Integrated analytics co-developed with the process

TECHNOLOGY TRANSFER Technology transfer is the first formal step of the BSO and sponsor partnership, wherein the process knowledge, methods, and analytical assays are transferred from

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R&D to PD. Quality time should be dedicated to this crucial step, during which the sponsor’s process information is thoroughly reviewed, CQAs are identified, and the process is translated into the BSO’s facility and operational framework. At this step, the processes workflow is outlined per the BSO’s PD/manufacturing environment and GMP requirements.

Effective technology transfer workflow comprises multiple steps: f

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f

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Process understanding and intake (CQAs/critical performance parameters (CPPs); BRs, standard operating procedures (SOPs)) Risk assessment and gap analysis (materials, equipment/technology, personnel, compliance) Tailored solutions and planning (bridge gaps while preserving process design) Cross-functional coordination (operations, quality, engineering, analytics)

Case study A sponsor licensed a university-developed technology to generate a GMP-compliant product for Phase 1 clinical trial. Despite extensive preclinical publications, key clinical translation requirements were not defined, and the manufacturing plan had critical gaps such as a donor selection strategy, scalable process design (such as the rodent dosages did not translate to humans), and stability protocols. While timelines for completing Phase 1 clinical trials vary widely, they typically span extended periods. Given these long durations, partnering with a BSO that offers robust equipment monitoring, effective temperature‑excursion mitigation, and a comprehensive stability program is essential once the product is manufactured. This includes verifying 206

identity, assessing recovery, such as postthaw viability of cryopreserved cells, and confirming potency to ensure product integrity throughout storage.

PROCESS DEVELOPMENT Process development is a critical phase of technology transfer where the manufacturing process is replicated and optimized at the BSO facility. This step ensures process reliability and scalability that preserve critical attributes and lay the groundwork for quality and compliance in future activities. PD involves evaluating the process from multiple perspectives including equipment compatibility, facility layout, workflow, utilities, and analytics while identifying gaps and implementing tailored solutions.

A BSO’s PD team should be involved in establishing the feasibility of the installation qualification (IQ)/operational qualification (OQ)/performance qualification (PQ) as well as defining process validation strategies, such as process performance qualification (PPQ). This early involvement provides visibility into future requirements and enables a stronger foundation for downstream activities. Qualification and performance of analytical methods for in-process and release testing during technology transfer should be coordinated with the Operations, Quality, and Engineering teams to ensure reproducibility, scalability and minimize risk.

Case study Scaling mesenchymal stem cell (MSC) processes using hundreds of T-flasks introduces significant sterility risks due to numerous open handling events during routine culture feeding. To address these challenges, the BSO provided advanced scale-up solutions including multi-layer CellStack® Culture Chambers to reduce open events as well as automated closed-system bioreactors. These characterized approaches provide efficient

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innovator insight scalability, minimize contamination risk, and ensure process robustness.

ADAPTABLE FACILITY DESIGN & INFRASTRUCTURE

MANUFACTURING, SCIENCE, & TECHNOLOGY (MSAT)

The design of a BSO’s GMP biomanufacturing facility should support multi-product, multi-sponsor, and phase-appropriate manufacturing operations. A design with modular ISO class 5–9 cleanrooms and dedicated air handler units allows for flexible reconfiguration to facilitate processes across various cell types, manufacturing scales, and regulatory stages without requiring major infrastructure changes.

An ideal BSO provides both upstream and downstream capabilities, offering a comprehensive, one-stop solution for sponsors and eliminating the need for outsourcing. These capabilities should include:

Following process optimization in the PD stage, the MSAT team ensures a seamless transition from PD to GMP-compliant manufacturing by implementing optimized processes in ISO-classified cleanrooms.

MSAT members provide real-time technical support and address deviations promptly.

They oversee equipment and facility readiness, including qualification, calibration, and environmental monitoring (EM), while driving process validation strategies and readiness. MSAT should also focus on strict documentation and compliance with GMP and Good Documentation Practices (GDP), and act as a cross-functional bridge between PD, operations, and QA to facilitate technology transfer and ensure manufacturing readiness.

f

Case study The manufacturing of MSC-derived therapies from donor bone marrow, adipose tissue, or umbilical cords typically follows a similar workflow. The process begins with colony generation and progresses through scale-up to achieve the required cell quantities, often in the billions over a period of 4–6 weeks. A common pitfall in MSC manufacturing is attempting to scale directly from donor material without intermediate checkpoints, which can lead to late-stage failures due to donor variability or sterility issues, often resulting in batch loss. To mitigate these risks, the BSO employed a multi-stage strategy that included creating a Master Cell Bank (MCB) to generate multiple working cell banks (WCBs), which were then used to produce drug product batches. This approach enhances reproducibility, reduces financial risk, and has been successfully adopted by multiple sponsors.

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f

Cell isolation and enrichment, cell expansion and culture optimization, bioreactor PD, and cell activation, differentiation, or simulation workflows such as cytokine expansion, differentiation of induced pluripotent stem cells (iPSCs) and tissue-derived stem cells. Program goals should encompass target yield and viability, as well as ensuring that the manufactured cells exhibit the desired phenotype, and differentiation state; Multiple in-process tests including cell count and viability, flow cytometry marker analysis, pH, osmolality, residual moisture, protein quantification, Mycoplasma PCR, sterility testing as required- are especially critical during PD to guide manufacturing decisions in and ensure the intended product profile.

These in-process tests help maintain batch consistency and enable early detection of process deviations; Downstream PD capabilities include harvest and clarification, filtration/ concentration/buffer exchange (using Tangential Flow Filtration (TFF) skids),

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and formulation of cryoprotectants, and buffers; f

Comprehensive filling, final packaging, and cryopreservation capabilities include aseptic filling across products into a wide range of final containers including bags, vials, cryovials, syringes, and dropper bottles. It should offer controlled rate freezer (CRF) and storage (LN₂, –80 °C, –20 °C, and 4 °C) options for both drug products and stability samples.

product. Beyond QMS itself, a high-performing BSO should deploy dedicated quality support teams across every stage of the process. These teams should not only provide guidance but also help sponsors develop regulatory-ready manufacturing strategies from the earliest stages of development. This approach consistently aligns manufacturing workflows with CMC expectations early in development, reducing the risk of late-stage process redesigns and minimizing regulatory delays.

Case study

Case study A BSO rescued a manufacturing process that was highly dependent on donor starting material volume by reconfiguring the batch size. This optimization enables the process to accommodate variability in starting material quantities, ensuring consistent throughput and manufacturing reliability. This flexibility and adaptability helped stabilize the manufacturing process by preventing disruptions to continuous and controlled manufacturing costs.

In parallel, the dedicated cleanroom PODs were requalified to support the logistical requirements of operating at different manufacturing scales.

QUALITY & REGULATORY COMMITMENT In a high-performing BSO; quality is never a downstream checkpoint. It is intentionally engineered into the design principle serving as a non-negotiable cornerstone of operational excellence. An established QMS must oversee the electronic batch records (eBRs), risk-based validation, supplier qualification, and real-time deviation management across all operational domains. The QMS must also control starting materials, testing, and manufacturing activities, ensuring compliance with GDP requirements, and maintaining documentation traceability from donor to final 208

Due to regulatory concerns, sponsors frequently request transitioning from animal-derived components, such as fetal bovine serum (FBS), to xeno-free culture systems that contain no animal-derived components. While the shift may appear straightforward, it can significantly affect product potency. Rather than moving to an entirely new platform, the BSO developed comprehensive test‑release panels that enabled sponsors to continue using their existing process and avoid costly delays.

Collaborative engagement combined with the BSO’s deep technical expertise, strengthened the design and development of qualification and validation packages across the program. This level of integration facilitated consistently high batch-success rates against predefined safety and quality criteria while enabling real-time risk mitigation throughout manufacturing.

STARTING MATERIALS & CLINICAL RESEARCH A leading BSO distinguishes itself through direct control over starting materials.

While CDMOs rely on external suppliers for leukopaks, cord blood units, or tissue-derived materials, a fully integrated BSO that sources these materials internally can tailor donor selection, collection parameters, and characterization assays to the precise

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innovator insight needs of each manufacturing process. This control enhances consistency, reduces variability at the source, and strengthens the overall quality profile of the final product.

toward regulatory readiness and product release.

Case study

For a sponsor developing a regulatory-facing potency assay, the BSO collaborated across analytical-development and manufacturing teams to ensure assay sensitivity was aligned with process-critical parameters. This alignment enabled the sponsor to demonstrate meaningful lot-to-lot comparability while maintaining manufacturing flexibility, accelerating regulatory readiness without over-constraining the process.

A sponsor program had variability in leukopak composition which compromised downstream expansion consistency. Instead of compensating for this variability during manufacturing, the BSO implemented upstream adjustments to donor screening criteria and apheresis parameters. This system-level intervention improved yield consistency without adding processing complexity, an outcome not possible in a siloed CDMO model.

INTEGRATED ANALYTICS DEVELOPMENT TO DRIVE DATA-INFORMED MANUFACTURING A BSO’s integration with in-house analytical and assay development capabilities allows for development, characterization, identity, and potency assays to run in parallel with manufacturing. This coordinated approach ensures that manufacturing decisions are guided by critical biological insights that support the verification of product quality, safety, and compliance.

In addition, the BSO’s analytical team should work closely with PD scientists to identify CQAs early in the workflow. They design and execute assays using samples at appropriate dose‑response dilutions, to ensure analytical readouts remain within the correct dynamic range. This approach allows the team to detect potential issues earlier and refine methods to match the intended product and avoid downstream troubleshooting. This integrated model can transform assay development by generating accurate, consistent analytical results and creating a more predictable path

Case study

CONCLUSION: WHERE MISSION MEETS MOTION The faster a cell, gene, and tissue-derived therapy enters the market, the greater its potential to impact a larger patient population. This creates intense pressure to accelerate every phase of development from R&D through PD, manufacturing, clinical trials, US FDA approval, and market authorization. The efficiency of a BSO directly influences how quickly and successfully a product progresses through this pathway.

A fully integrated BSO represents a fundamentally new model for biomanufacturing, one that integrates infrastructure, quality systems, analytics, starting-material control, and patient access into a single, interconnected ecosystem. By operating beyond the inherent limitations of a traditional CDMO framework, this model enables advanced therapies to progress from concept to clinic with greater resilience, transparency, and strategic intent. In doing so, it reinforces that biomanufacturing is not simply the act of producing cells, but the creation of reliable pathways that allow transformative therapies to reach the patients who need them most.

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f TABLE 1 List of cell and gene therapy licensed products approved by the Office of Therapeutic Product.

Product and trade name

Manufacturer

ABECMA™ (idecabtagene vicleucel)

Celgene Corporation, a Bristol-Myers Squibb Company

ADSTILADRIN® (nadofaragene firadenovec-vcng)

Ferring Pharmaceuticals A/S

ALLOCORD® (HPC Cord Blood)

SSM Cardinal Glennon Children’s Medical Center

AMTAGVI® (lifileucel)

Iovance Biotherapeutics, Inc.

AUCATZYL (obecabtagene autoleucel)

Autolus Limited

BEQVEZ™ (fidanacogene elaparvovec-dzkt)

Pfizer, Inc.

BREYANZI™ (lisocabtagene maraleucel)

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

CARVYKTI® (ciltacabtagene autoleucel)

Janssen Biotech, Inc.

CASGEVY® (exagamglogene autotemcel [exa-cel])

Vertex Pharmaceuticals Incorporated

CLEVECORD™ (HPC Cord Blood)

Cleveland Cord Blood Center

Ducord® (HPC Cord Blood)

Duke University School of Medicine

ELEVIDYS™ (delandistrogene moxeparvovec-rokl)

Sarapeta Therapeutics, Inc.

ENCELTO™ (revakinagene taroretcel-lwey)

Neurotech Pharmaceuticals, Inc.

GINTUIT™ (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)

Organogenesis Incorporated

HEMACORD® (HPC, cord blood)

New York Blood Center

HEMGENIX® (etranacogene dezaparvovec-drlb)

CSL Behring LLC

HPC, Cord Blood

Clinimmune Labs, University of Colorado Cord Blood Bank

HPC, Cord Blood – MD Anderson Cord Blood Bank

MD Anderson Cord Blood Bank

HPC, Cord Blood – LifeSouth

LifeSouth Community Blood Centers, Inc.

HPC, Cord Blood – Bloodworks

Bloodworks

IMLYGIC® (talimogene laherparepvec)

BioVex, Inc., a subsidiary of Amgen Inc.

ITVISMA® (onasemnogene abeparvovec-brve)

Novartis Gene Therapies, Inc.

KEBILIDI™ (eladocagene exuparvovec-tneq)

PTC Therapeutics

KYMRIAH™ (tisagenlecleucel)

Novartis Pharmaceuticals Corporation

LANTIDRA™ (donislecel)

CellTrans Inc.

LAVIV™ (Azficel-T)

Fibrocell Technologies

LENMELDY™ (atidarsagene autotemcel)

Orchard Therapeutics (Europe) Limited

LUXTURNA® (voretigene neparvovec-rzyl)

Spark Therapeutics, Inc.

LYFGENIA™ (lovotibeglogene autotemcel [lovo-cel])

bluebird bio, Inc.

MACI® (Autologous Cultured Chondrocytes on a Porcine Collagen Membrane)

Vericel Corp.

®

Data from [3].

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innovator insight f TABLE 1 (CONT.) List of cell and gene therapy licensed products approved by the Office of Therapeutic Product (cont.).

Product and trade name

Manufacturer

OMISIRGE™ (omidubicel-onlv)

Gamida Cell Ltd.

PAPZIMEOS™ (zopapogene imadenovec-drba)

Precigen, Inc.

PROVENGE® (sipuleucel-T)

Dendreon Corp.

REGENECYTE® (HPC, Cord Blood)

StemCyte, Inc.

RETHYMIC (allogeneic processed thymus tissue – agdc)

Enzyvant Therapeutics GmbH

ROCTAVIAN® (valoctocogene roxaparvovec-rvox)

BioMarin Pharmaceutical Inc

RYONCIL® (remestemcel-L-rknd)

Mesoblast, Inc.

SYMVESS™ (acellular tissue engineered vessel-tyod)

Humacyte Global, Inc.

SKYSONA™ (elivaldogene autotemcel)

bluebird bio, Inc.

STRATAGRAFT® (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat)

Stratatech Corporation

TECARTUS® (brexucabtagene autoleucel)

Kite Pharma, Inc.

TECELRA (afamitresgene autoleucel)

Adaptimmune LLC

VYJUVEK® (beremagene geperpavec-svdt)

Krystal Biotech, Inc.

WASKYRA® (etuvetidigene autotemcel)

Fondazione Telethon ETS

YESCARTA (axicabtagene ciloleucel)

Kite Pharma, Incorporated

ZEVASKYN® (prademagene zamikeracel)

Abeona Therapeutics, Inc.

ZYNTEGLO™ (betibeglogene autotemcel)

bluebird bio, Inc.

ZOLGENSMA® (onasemnogene abeparvovec-xioi)

Novartis Gene Therapies, Inc.

®

®

®

Data from [3].

REFERENCES 1. Grand View Research. Cell Therapy Market Size, Share and Growth Report, 2030. https://www.grandviewresearch.com/ industry-analysis/cell-therapy-market.

2. Grand View Research. Gene Therapy Market Size, Share & Trends Report, 2030. https://www.grandviewresearch.com/ industry-analysis/gene-therapy-market.

3. US FDA. Approved cellular and gene therapy products. Mar 18, 2026. https:// www.fda.gov/vaccines-blood-biologics/ cellular-gene-therapy-products/approvedcellular-and-gene-therapy-products.

4. El-Kadiry AE, Rafei M, Shammaa R. Cell therapy: types, regulation, and clinical benefits. Front. Med (Lausanne) 2021; 8, 756029.

5. Yi S, Wu CY, McIntosh A, Santaella ME, Robinson TM, Liao MZ. Cell and gene therapy: transforming treatment paradigms for patient-centric care. Clin. Transl. Sci. 2025; 18(12), e70430.

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AFFILIATIONS Rohini Thevi Guntnur PhD, Scientist, Manufacturing and Technology, BBG Advanced Therapies Ray Rendon III, Senior Director Industry Engagement, BBG Advanced Therapies Joseph Higdon MS MBA, ASQ CPGP, Director Quality and Compliance for Advanced Therapies, BBG Advanced Therapies Deidre Cacchillo BSN RN, Director of Marketing, BioBridge Global Rogelio Zamilpa PhD, Executive Director of Biomanufacturing, BBG Advanced Therapies BBG Advanced Therapies, a subsidiary of Biobridge Global, is a full-service biomanufacturing service organization specializing in GMP-compliant manufacturing of cells and cell-based products. It supports advanced therapy developers from early process development through clinical-ready manufacturing. Leveraging deep cell‑biology expertise, its team designs robust processes, interprets data in real time, and proactively recommends improvements to ensure a strategy aligned with product biology and regulatory expectations.

AUTHORSHIP & CONFLICT OF INTEREST Contributions: The named authors take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Acknowledgements: None.

Disclosure and potential conflicts of interest: The authors have no conflicts of interest.

Funding declaration: The authors received no financial support for the research, authorship and/or publication of this article.

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ARTICLE & COPYRIGHT INFORMATION Copyright: Published by Cell & Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Attribution: Copyright © 2026 BBG Advanced Therapies. All rights reserved. All trademarks designated herein are proprietary to their respective owners. Use of trademarks does not imply any affiliation with or endorsement by them. Published by Cell & Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0.

Article source: This article was written by the named authors and reviewed by BioInsights’ Editorial team to ensure clarity, scientific accuracy, and alignment with BioInsights’ editorial standards. The article was externally peer reviewed.

Submitted for peer review: Jan 5, 2026.

Revised manuscript received: Mar 11, 2026.

Publication date: Mar 26, 2026.

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