Blueprint for Breakthroughs is a LinkedIn newsletter published by Adrienne B. Mendoza, MHA, SVP BioBridge Global and Chief Operating Officer (COO), BBG Advanced Therapies
Originally published on LinkedIn on June 3, 2025
Imagining a Connected, Decentralized Future for Gene and Cell Therapy
When the Internet was first developed, its strength came from how it was built, not as one powerful computer, but as a decentralized network of connected nodes (a “network of networks”). Each could operate independently, but they shared a common language and worked together to deliver something far greater than the sum of their parts.
That same idea of interoperability, local access, and systemic coordination could unlock the next major leap in advanced therapies.
We’re entering an era where more cell and gene therapies are being developed than ever before. But the systems in place to collect, manufacture, and deliver them are still rooted in central facilities, limited clinical access points, and legacy infrastructure that can’t scale fast enough.
So…It’s time to rethink how we deliver innovation.
From Centralized Bottlenecks to Local, Connected Systems
Imagine a future where, like the internet, CGT runs off a network of networks:
- Patient or Donor Cells are collected in their communities, at qualified, mobile, or regional sites
- Manufacturing happens nearby, using closed-system platforms that minimize space and complexity
- Therapies are delivered at more accessible clinical centers, not just academic and research hubs
- And all of it is connected by digital systems that manage quality, identity, traceability, and real-time oversight
“This future isn’t just possible – it’s becoming necessary. And the technologies to support it are already emerging.”
The more standardized and portable these tools become, the more viable a truly decentralized model becomes, one that shortens timelines, reduces the burden on patients and sites, and enables equitable access.
A Crucial Enabler: Closed-System Manufacturing
For this decentralized future to work at peak capacity and cost efficiency, we will need to move away from manufacturing models that rely on custom cleanrooms, large footprints, and intensive operator interventions.
The solution is in closed, automated manufacturing systems, which:
- Minimize the need for dedicated GMP clean room spaces
- Reduce training burden and human introduction of environmental contamination
- Make it easier to replicate processes consistently across locations with a data flow that allows for real-time, automated adjustments
- Allow co-location with collection sites—reducing freeze-thaw cycles and shipping risk
“The more consistent the manufacturing process, the more accessible the delivery model becomes.”
This evolution will lay the foundation for a therapy network that can scale as quickly and as locally as patients need it to.
Our Role at BBG Advanced Therapies
The team at BBG Advanced Therapies is focused on supporting the systems required not only for today’s therapies, but for tomorrow’s delivery models.
We serve as an institute of innovation, bridging the gap between discovery and delivery by complementing emerging manufacturing technologies with real-world, scalable infrastructure.
We do this by:
- Donor and patient cell sourcing, supported by regulatory-aligned workflows that ensure compliance, consistency, and clinical and commercial readiness.
- Analytical method development to establish quality and comparability standards—covering potency, efficacy, safety, identity, and characterization across cell-based and gene-modified therapies.
- Industry-leading turnaround times for both assay development and routine testing, accelerating timelines across all phases.
- Flexible testing and bioprocess support with the capabilities of a full-service CDMO, spanning preclinical, clinical, and commercial stages.
- GAMP-compliant validation services, CMC package development, and data management tools to support device, tool, and closed-system platform developers.
“Whether you’re launching a first-in-human trial or scaling for commercial delivery, we bring the infrastructure and expertise needed to make advanced therapies feasible, flexible, and future-ready.“
Laying the Foundation for a New Care Model
We are actively preparing for a healthcare future where individualized, timely access to advanced therapies is not the exception…but the standard.
The infrastructure we’re building today is designed to serve:
- Autologous and allogeneic cell therapies, delivered faster and closer to the patient
- Personalized or stratified therapeutics, requiring flexible access points for screening and eligibility
- Emerging modalities, including gene editing and nucleic acid-based therapies, that demand agile patient screening and monitoring platforms
Most recently, we’ve also launched our Mobile Leukapheresis Center. This fully equipped, mobile cell collection unit can serve both clinical trials and commercial programs in geographies that currently lack access to collection sites.
“This portable capability is an essential early step toward decentralized access. But we believe it’s also a platform for what comes next.”
Another Role for Leukapheresis in Matching and Monitoring
Even as some therapies shift toward in vivo delivery or systemic gene editing, cell collection remains critical, not only at the start of treatment but throughout the therapeutic journey.
Mobile or distributed leukapheresis networks may play an expanding role in:
- Immune function monitoring following gene therapy infusion, especially where immune reconstitution or adverse responses must be tracked longitudinally
- Biomarker or immune profiling to help identify patients who are most likely to respond, or who may need tailored approaches
- Pre-treatment functional assays and genetic screening, where viable leukocytes are required to inform eligibility, stratification, or therapeutic customization
“In this way, mobile access points become not just collection hubs, but precision medicine enablers, supporting patient matching, longitudinal care, and real-world data generation.”
What’s Next in This Blueprint Series
In upcoming editions of Blueprint for Breakthroughs, we’ll take a closer look at the essential elements of a decentralized advanced therapies ecosystem, including:
- The rise of closed-system platforms and their role in portable, repeatable manufacturing
- How regional cell collection and processing hubs can extend trial and therapy reach
- What’s needed to ensure clinical site readiness, including SOP harmonization and training
- And how digital quality and identity frameworks will ensure trust, traceability, and compliance across the entire network
We look forward to building this future alongside partners, developers, and the broader CGT community.
