BioBridge Global blog

BBG Advanced Therapies Collaboration with Kite

info@bbgat.org (BBG Advanced Therapies) — Tue, 07 Jul 2026 14:00:00 GMT

SAN ANTONIO, Texas— BBG Advanced Therapies, a subsidiary of nonprofit BioBridge Global, today announced a collaboration with Kite, a Gilead Company and global leader in cell therapy, to deploy BBG Advanced Therapies’ Mobile Leukapheresis Center (MLC) across Texas—marking an important milestone in how patients can access Kite’s CAR T-cell therapies which are individualized cancer treatments made from a patient’s own cells.

Kite has helped pioneer CAR T‑cell therapies, changing the outlook for patients with certain blood cancers. Operating across Texas, the MLC is a first‑of‑its‑kind platform that brings the initial T-cell collection step directly to patients in their communities, aligning with Kite’s strategy to scale access to cell therapy and reach more eligible people closer to home. By meeting patients where they are, this model reduces travel and caregiver burdens, shortens logistical pathways, and helps clear a major hurdle to broader adoption of advanced therapies.

“Kite has treated more than 34,500 patients with CAR T-cell therapy—more than any other company—yet only about 2 in 10 eligible patients in the U.S. receive these treatments today,” said Adrienne B. Mendoza, MHA, Chief Operating Officer of BBG Advanced Therapies. “That gap underscores the need for new access models. Kite’s experience building one of the world’s most advanced cell therapy ecosystems makes it an ideal collaborator as we expand the infrastructure needed to bring these potentially curative therapies closer to more eligible patients in Texas.”

Once the initial T-cell collection or leukapheresis is complete, the T-cells are then sent to a Kite facility where a Chimeric Antigen Receptor (CAR) gene is added and where the cells proliferate. After a short period, the patient’s cells are sent back to an Authorized Treatment Center (ATC) where the patient will receive a one-time infusion.

Because these treatments are comprised of a patient’s own cells, precision, consistency, and chain‑of‑identity are non‑negotiable. BBG Advanced Therapies ensures that every collection meets rigorous quality standards and is fully integrated into Kite’s GMP manufacturing workflow, reinforcing the strength and reliability of the end‑to‑end supply chain.

For Texans today—and for regions around the world watching this model—this collaboration demonstrates how innovative infrastructure can unlock access to cutting‑edge medicine. It shows how mobile, decentralized collection can help enable more ATCs over time, so that transformative therapies are not limited by geography.

The Texas deployment will serve as an important proof‑of‑concept model for additional markets, signaling how mobile collection infrastructure can support the continued growth of cell and gene therapies while maintaining the quality and consistency required for these complex, personalized medicines.

About BBG Advanced Therapies

The newest subsidiary of San Antonio-based nonprofit BioBridge Global, BBG Advanced Therapies provides innovative and custom solutions to accelerate the development of cell and gene therapies. BBG Advanced Therapies features a fully integrated and custom portfolio of innovative solutions, including collection and processing of starting materials, testing, clinical trials support, and biomanufacturing services. Learn more at BBGAdvancedTherapies.org.  

About BioBridge Global

BioBridge Global (BBG) is a San Antonio-based 501(c)(3) nonprofit healthcare services enterprise that offers diverse services through its nonprofit subsidiaries – South Texas Blood & Tissue, QualTex Laboratories, BBG Advanced Therapies and The Blood & Tissue Center Foundation. BioBridge Global provides products and services in blood resource management, cellular therapy, donated umbilical cord blood and human tissue, as well as testing of blood, plasma and tissue products for clients in the United States and worldwide.  The enterprise enables advances in the field of regenerative medicine and advanced therapies by providing access to starting materials, testing services and biomanufacturing and clinical trials support.  BioBridge Global is committed to saving and enhancing lives through the healing power of human cells and tissue.  Learn more at BioBridgeGlobal.org.  management, cellular therapy, donated umbilical cord blood and human tissue, as well as testing of blood, plasma and tissue products for clients in the United States and worldwide. The enterprise enables advances in the field of regenerative medicine and advanced therapies by providing access to starting materials, testing services as well as biomanufacturing and clinical trials support.  BioBridge Global is committed to saving and enhancing lives through the healing power of human cells and tissue.  Learn more at BioBridgeGlobal.org.

BBG Advanced Therapies to Collaborate with VERIGRAFT to Support U.S. Development Readiness for New Vein Therapy

brooklyn.wilkinson@bbgat.org (Brooklyn Wilkinson) — Tue, 30 Jun 2026 18:30:22 GMT

SAN ANTONIO, Texas — BBG Advanced Therapies (BBG AT), a subsidiary of San Antonio based nonprofit BioBridge Global (BBG), has entered into a collaboration with VERIGRAFT to support the company's U.S. development and manufacturing readiness activities for its personalized tissue-engineered vein therapy (P-TEV).The collaboration represents an important milestone in the Swedish company’s preparations for clinical development activities in the United States."At BBG Advanced Therapies, we are dedicated to helping innovators translate promising scientific advances into therapies that can reach patients," said Adrienne Mendoza, Chief Operating Officer, BBG Advanced Therapies. “Our collaboration with VERIGRAFT is a perfect example." Under the agreement, BBG AT will provide support for key U.S. development and manufacturing readiness activities, including donor vein sourcing, manufacturing and testing-related operations, as well as operational preparation for U.S. clinical trials.

“ BBG Advanced Therapies and the BioBridge Global family of subsidiaries are in a good position to support this critical new therapy,” said Martin Landon, Chief Executive Officer, BBG. “VERIGRAFT’s approach represents an important innovation in regenerative medicine, and we look forward to contributing our capabilities to their meaningful work.”

P-TEV is VERIGRAFT's lead advanced therapy medicinal product (ATMP) and is being developed as a personalized, fully biological tissue-engineered vein designed to replace diseased vein segments and restore venous valve function. The graft starts as donated venous tissue, which is decellularized to remove immunogenic material and then personalized using components from the patient’s own blood. The approach avoids the need for immunosuppression, with the aim of reducing the risk of rejection and infection associated with conventional approaches. The therapy is intended for patients with chronic venous insufficiency (CVI), a progressive vascular disease that can lead to pain, swelling, skin changes, and venous leg ulcers. Unlike current treatment approaches that primarily manage symptoms, P-TEV is being developed to address the underlying venous valve dysfunction that contributes to disease progression.

“For people living with severe chronic venous insufficiency, the options today treat the symptoms, not the cause. P-TEV is built to change that,” said Petter Björquist, Chief Executive Officer at VERIGRAFT. “Developing clinical trials takes a partner that understand show demanding it is to deliver a personalized therapy like P-TEV. That is why we’re working with BBG Advanced Therapies. "

The collaboration builds on VERIGRAFT's clinical experience in Europe and strengthens the operational foundation needed to support future development activities in the United States.

About BBG Advanced Therapies: The newest subsidiary of San Antonio-based nonprofit BioBridge Global, BBG Advanced Therapies provides innovative and custom solutions to accelerate the development of cell and gene therapies. BBG Advanced Therapies features a fully integrated and custom portfolio of innovative solutions, including collection and processing of starting materials, testing, clinical trials support, and biomanufacturing services. Learn more at BBGAdvancedTherapies.org.

About VERIGRAFT: VERIGRAFT is a Swedish clinical-stage biotechnology company developing personalized, fully biological therapies for diseases where current treatment options are limited. Rooted in research from Karolinska Institutet and headquartered in Gothenburg, the company has built a scalable platform for industrialized tissue engineering and advanced regenerative medicine. VERIGRAFT’s lead program, P-TEV, is advancing through late-stage clinical development in chronic venous insufficiency, while the company’s broader R&D pipeline explores additional applications in cardiovascular and neuronal disease. With international investor backing and a platform designed for future product expansion, VERIGRAFT is positioned to address significant unmet medical needs in global markets. Learn more at VERIGRAFT.com.

About BioBridge Global: BioBridge Global is a San Antonio-based 501(c)(3) nonprofit healthcare services enterprise that offers diverse services through its nonprofitsubsidiaries – South Texas Blood & Tissue, QualTex Laboratories, BBG Advanced Therapiesand The Blood & Tissue Center Foundation. BioBridge Global provides products andservices in blood resource management, cellular therapy, donated umbilical cord bloodand human tissue, as well as testing of blood, plasma and tissue products for clients in theUnited States and worldwide. The enterprise enables advances in the field of regenerativemedicine and advanced therapies by providing access to starting materials, testingservices as well as biomanufacturing and clinical trials support. BioBridge Global is committed to saving and enhancing lives through the healing power of human cells and tissue.  Learn more at BioBridgeGlobal.org.

Why Non-Viable Particle Counters Are Critical for Contamination Control

brooklyn.wilkinson@bbgat.org (Brooklyn Wilkinson) — Tue, 23 Jun 2026 15:05:29 GMT

Technology in Biomanufacturing Cleanrooms

Cleanroom technology continues to evolve as industries face stricter regulatory requirements, higher product quality expectations, and increasing pressure to reduce contamination risks.

This blog explains what non-viable particle counters are, how they work, why they matter in cleanroom environments, and how organizations can choose the right technology for their contamination control strategy.

At the center of modern cleanroom monitoring are non-viable particle counters, which provide real-time measurement of airborne particles that can compromise product quality, process integrity, and compliance.

What Is a Non-Viable Particle Counter?

A non-viable particle counter is a monitoring instrument used to detect and count airborne particles in a controlled environment without determining whether those particles are living (microbial) or non-living, such as:

Dust

Skin flakes

Fibers

Aerosols

Process-generated particulates

Environmental contaminants

Unlike viable monitoring systems that are designed to detect living microorganisms, non-viable particle counters detect particles based on their size and quantity.

These systems are essential for ensuring compliance with cleanroom classifications such as:

ISO 14644

EU GMP Annex 1

FDA cleanroom standards

Why Are Particle Counters Important in Cleanrooms?

Cleanrooms are designed to provide a controlled environment and minimize contamination. Even microscopic particles can:

Contaminate injectable drugs

Impact sterile manufacturing

Reduce product shelf life

Cause batch failures

Trigger regulatory findings

Non-viable particle counters help facilities:

Provide real time data

Detect drifts from established operating conditions

Verify HVAC and filtration performance

Monitor cleanroom classification compliance

Support environmental monitoring programs

Reduce downtime and product loss

Real-time monitoring allows operators to respond immediately before contamination becomes a larger issue.

How Non-Viable Particle Counters Work

Most modern particle counters use laser-based optical particle counting technology.

The Process

Air is drawn into the instrument.
Particles pass through a laser beam.
Light scattering occurs when particles interrupt the beam.
Sensors measure the scattered light.
The system calculates particle size and concentration.

The results are typically displayed as:

Particles per cubic meter

Particles per cubic foot

Particle size distribution

Common measured particle sizes include:

≥0.5 µm

≥5.0 µm

Key Technologies in Modern Cleanroom Particle Monitoring

1. Real-Time Continuous Monitoring for all production fillings

Modern cleanrooms increasingly rely on continuous monitoring systems instead of periodic manual sampling.

Benefits include:

Immediate contamination alerts

Trend analysis

Reduced human intervention

Better process control

Automated reporting

Continuous systems are especially important in aseptic processing environments.

Applications of Non-Viable Particle Counters

Pharmaceutical Manufacturing

In sterile drug production, particle monitoring is essential for:

Aseptic filling

Compounding

Cleanroom qualification

GMP compliance

EU GMP Annex 1 emphasizes continuous non-viable monitoring in Grade A areas during critical operations and risk-based monitoring for Grade B, C and D areas.

BBG Advanced Therapies facilities use particle counters to protect our partners science including:

Cell cultures

Biologics manufacturing

Gene therapy production

Sensitive biologic products require highly controlled environments.

Frequently Asked Questions

What is the difference between viable and non-viable particle monitoring?

Non-viable monitoring measures airborne particulate matter, while viable monitoring detects living microorganisms such as bacteria and fungi.

Why is continuous particle monitoring important?

Continuous monitoring provides real-time contamination detection, allowing facilities to respond quickly before product quality is affected.

BBG Advanced Therapies, subsidiary of BioBridge Global, has maintained a commitment to quality since opening in 2025. BBG Advanced Therapies leverages the BioBridge Global enterprise quality management and electronic batch records.

Having this access to expert quality teams advance programs from early development through clinical evaluation and toward commercialization.

Authors: Suvarchala Syamala, Quality Control Technician, Angelica Padilla Perez Manager, Quality & Compliance, and Brooklyn Wilkinson, Digital Experience Manager

For access to a comprehensive biomanufacturing service organization Contact us.