Cell & Gene Therapy
Autologous Cell Therapy
Cell culture media, cryopreservation formulation, wash buffers, and process solutions for cell processing and preservation.
Cell and gene therapy development and manufacturing require consistent process materials as programs progress from R&D through larger-scale production. Media, buffers, reagents, and process solutions must accommodate evolving formulation, quality, and operational requirements.
Sterile-filtered cell culture and expansion media, process and formulation buffers, and specialized solutions are produced to defined formulations, testing requirements, packaging configurations, and documentation standards. An ISO 13485-certified quality management system provides the framework for controlled manufacturing from development through ongoing production.
Cell and Gene Therapy Solutions Built for Scale
Cell and gene therapy includes a wide range of manufacturing approaches, each with distinct requirements for media, buffers, reagents, process solutions, packaging, and documentation. Biologos supports these workflows with manufacturing flexibility and customer-specific configurations designed around process needs.
Allogeneic Cell Therapy
Media, feeds, supplements, buffers, and process solutions designed for larger-scale cell manufacturing, where standardized inputs and consistent process performance are essential.
Viral Vector Manufacturing
Process solutions designed for viral vector workflows, from upstream production and harvest through purification and downstream processing, with formulations established to meet defined process requirements.
Translational and Early-Stage Programs
Academic and emerging developers advancing new formulations and manufacturing processes from early research toward scale-up and larger-volume production.
Cell and Gene Therapy Workflow
Cell and gene therapy manufacturing requires specialized process materials that support complex workflows and evolving production requirements. Solutions for cell expansion, harvest, downstream processing, formulation, cryopreservation, and other critical manufacturing steps are available in defined formulations and formats to support development and production.
Cell and Gene Therapy Product Offerings
Sterile-filtered media, buffers, reagents, and process solutions are manufactured for cell and gene therapy workflows, using 0.2 µm or 0.1 µm filtration based on product and process requirements. Packaging configurations include rigid containers, bags, single-use bioprocess containers, and customer-specific closed systems, with fill volumes and batch sizes supporting development, scale-up, and commercial production.
Cell Culture Media and Supplements
Classical and custom cell culture media, feeds, supplements, growth factors, and other formulations used to support cell growth, expansion, and production across therapeutic cell and viral vector manufacturing.
Cell Processing, Harvest, and Wash Buffers
Wash, harvest, lysis, clarification, recovery, and other process buffers used during cell handling and early downstream processing across therapeutic cell and viral vector manufacturing. Manufactured to customer-defined composition, with required parameters such as pH, conductivity, and osmolality controlled as applicable.
Purification and Downstream Buffers
Chromatography, TFF, diafiltration, buffer exchange, and other downstream buffers used during purification and concentration steps across cell and gene therapy manufacturing. Manufactured to customer-defined composition, with required parameters such as pH, conductivity, concentration, and osmolality controlled as applicable.
Formulation and Storage Buffers
Buffers used for final buffer exchange, formulation, conditioning, and storage of cell and gene therapy process materials. Manufactured to customer-defined composition, with required parameters such as pH, conductivity, concentration, and osmolality controlled as applicable.
Cryopreservation Media
Cryopreservation media and customer-defined formulations used to support cell freezing, storage, and thawing in therapeutic cell manufacturing. Manufactured to specified composition with required parameters controlled as applicable.
Featured Products
Science, Quality, Partnership
Why Biologos? A combination of technical expertise, rigorous quality systems, and flexible manufacturing supports consistent products, controlled processes, and reliable supply for animal health customers.
Direct Access to
Technical Experts
Experienced support encompassing the entire project lifecyle.
Project
Flexibility
Supporting specification development, product transfers, and manufacturing requirements.
Disciplined Process
Management
Adherence to established document, quality, and manufacturing controls.
Supply Consistency
and Reliability
Scalability and supply assurance to support evolving needs.
Packaging Built for
Your Workflow
Bottles, bulk containers, or custom single-use assemblies, tailored packaging, labeling, and delivery to integrate into your operations.
Quality and Compliance at Every Stage
Quality is embedded throughout the manufacturing process, with every batch produced under an ISO 13485-certified quality management system and released against defined specifications. Complete lot traceability and a Certificate of Analysis (CoA) accompany each batch, while testing is established according to product specifications and customer requirements and may include pH, osmolality, conductivity, bioburden, endotoxin, sterility, identity, and other product-specific methods.
Documented change control and traceability extend from raw materials and components through packaging and finished products, maintaining visibility and control throughout the manufacturing process.
FAQS
Cell and Gene Therapy
Are you ISO 13485-certified?
Yes. We manufacture under an ISO 13485-certified quality system and with established controls for raw materials, production, testing, documentation, traceability, and product release.
Can you scale from early development through commercial-scale manufacturing?
Yes. We can support the same formulations as batch sizes, packaging configurations, testing requirements, and documentation needs evolve from development through commercial-scale production.
Can you support closed-system and single-use formats?
Yes. Products can be supplied in bags, single-use bioprocess containers, and customer-specific configurations with tubing, connectors, closures, and other components selected to support the manufacturing process.
Can you work with us during process development?
Yes. We can support customer-defined formulations, packaging configurations, testing requirements, and manufacturing needs as a process moves from development toward larger-scale production.
How fast can you manufacture a custom formulation or support a rush order?
Turnaround depends on the formulation, raw material availability, testing requirements, batch size, packaging configuration, and current production schedule. We work with customers to evaluate timing early and provide a realistic lead time based on the specific manufacturing requirements.
What types of products do you make for cell and gene therapy?
We manufacture cell culture media and supplements; cell processing, harvest, and wash buffers; purification and downstream buffers; formulation and storage buffers; and cryopreservation media used across therapeutic cell production and viral vector manufacturing.
Which cell and gene therapy applications do you support?
We support therapeutic cell production, including autologous and allogeneic workflows, as well as viral vector manufacturing and early-stage translational programs moving toward larger-scale production.