Therapeutics Cell Production
Workflow Optimization From Research to Commercialization
Sterile-Filtered Buffers, Media, Reagents, and Solutions
Therapeutic cell manufacturing relies on controlled process materials throughout cell isolation, culture, expansion, harvest, formulation, and cryopreservation. Media, wash buffers, supplements, processing solutions, and cryopreservation formulations are integral to maintaining cell viability and consistent process performance. Each material must meet defined formulation, quality, testing, documentation, and manufacturing requirements appropriate to the process.
Biologos manufactures ready-to-use solutions to customer-defined specifications, with packaging options compatible with closed-system workflows. Production capabilities support materials used from early feasibility and process development through scale-up and commercial manufacturing, helping simplify preparation and reduce the operational burden associated with in-house solution production.
Manufacturing Flexibility for Cell Therapy Programs
Therapeutic cell manufacturing processes can require specific formulations, raw materials, and packaging configurations based on the process design and stage of development. Requirements may change as a process moves from feasibility through scale-up, making flexibility in formulation and manufacturing important to long-term program support.
Biologos works with customers to establish manufacturing approaches that align with defined process requirements. Solutions may include customer-specified formulations, established ready-to-use products, specialized raw materials, or custom packaging configurations. Formulation and production parameters can be evaluated with consideration for performance, manufacturability, lead time, and cost.
Therapeutic Cell Product Offerings
Biologos provides sterile-filtered process materials for therapeutic cell manufacturing, including media, buffers, reagents, and specialized solutions. Filtration methods can include 0.2 µm or 0.1 µm filtration based on product characteristics and process requirements.
Packaging can be configured for the intended manufacturing environment, including rigid containers, bags, single-use bioprocess containers, and customer-specific closed-system configurations. Fill volumes and batch sizes can be established to accommodate the material requirements of development programs, process scale-up, and commercial production.
Cell Culture Media and SupplementsCell Processing and Recovery SolutionsCryopreservation MediaProcess and Wash Buffers
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. Manufactured from customer-provided or established formulations and sterile-filtered as required by the process.
Featured Products
Cell Processing and Recovery Solutions
Trypsin, balanced salt solutions, dissociation-related formulations, recovery buffers, and other process solutions used during cell harvest, separation, handling, and recovery. Solutions are manufactured to customer-defined composition and process requirements.
Featured Products
Cryopreservation Media
Cryopreservation media and other customer-defined formulations used during freezing, storage, thawing, and related cell-processing steps. Manufactured to specified composition with required parameters controlled as applicable.
Featured Products
Process and Wash Buffers
Wash, dilution, and other process buffers used throughout cell handling and manufacturing. Buffers are manufactured to the defined composition, with required parameters such as pH, conductivity, and osmolality 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 therapeutic cell manufacturing customers.
Direct Access to
Technical Experts
Experienced support encompassing the entire project lifecycle.
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
Therapeutic Cell Production
Can you help determine the right container or packaging configuration?
Yes. Container selection depends on more than fill volume. Product compatibility, storage conditions, sterile connections, dispensing method, shipping requirements, and how the product will be introduced into your manufacturing process all influence the right packaging configuration. We work with customers to develop practical solutions that fit their manufacturing processes.
Can you help simplify our manufacturing process?
Yes. Many customers work with us to reduce in-house solution preparation, minimize handling steps, consolidate compatible processing components into ready-to-use formulations, and optimize packaging configurations for their manufacturing process. By reducing the number of raw materials, suppliers, preparation steps, sterile transfers, inventory items, and manufacturing activities managed internally, we simplify day-to-day manufacturing and improve operational efficiency.
Can you manufacture ready-to-use formulations?
Yes. Where formulation compatibility has been established, we manufacture customer-defined ready-to-use formulations that can combine compatible proteins, growth factors, supplements, antibiotics, and other customer-specified components into a single sterile product. This helps reduce the need for in-house weighing, supplementation, mixing, sterile filtration, and other preparation steps.
Can you support manufacturing across multiple CDMOs or manufacturing sites?
Yes. Many therapeutic cell manufacturing programs involve internal manufacturing, multiple facilities, or one or more CDMO partners. We routinely coordinate packaging configurations, documentation, inventory, and product deliveries to support each stage of the manufacturing process.
Can you support products from process development through commercial manufacturing?
Yes. We support products from early feasibility and process development through clinical and commercial manufacturing. As your process evolves, we adapt batch sizes, packaging configurations, testing, and documentation to support changing manufacturing requirements while providing continuity with the same manufacturing partner.
Do you manufacture from our formulation or your own products?
Both. Most of what we manufacture is produced from customer-owned formulations. We reproduce your formulation, processing requirements, packaging configuration, testing requirements, and documentation to support consistent manufacturing from lot to lot. We also manufacture standard products and recognized published formulations.
Do you offer xeno-free and serum-free formulations?
Yes. We manufacture xeno-free, serum-free, chemically defined, and other customer-specified formulations to support a wide range of therapeutic cell manufacturing processes.
Do you offer DMSO-free cryopreservation media?
Yes. We manufacture both DMSO-based and DMSO-free cryopreservation media. Because cryoprotectant selection is highly application-specific, the appropriate formulation depends on your cell type, manufacturing process, and performance requirements.
Do you support closed-system and single-use manufacturing?
Yes. Products are available in bottles, bags, single-use bioprocess containers, tubing assemblies, sterile connectors, and other customer-defined packaging configurations tailored to how the product will be stored, transferred, connected, and used in your manufacturing process.
What products do you manufacture for therapeutic cell production?
We manufacture classical and custom cell culture media, balanced salt solutions, xeno-free and animal-free media components, media supplements, growth factors, antibiotic additives, chemically defined feeds, cell isolation and selection buffers, activation and expansion media, wash buffers, harvest buffers, formulation buffers, cryopreservation media, microbiological media, process simulation media, sanitization buffers, and other customer-specific process formulations used throughout therapeutic cell manufacturing.
Which cell types and manufacturing platforms do you support?
CAR-T, NK, T-cell, MSC, iPSC-derived, and other therapeutic cell types, across both autologous and allogeneic programs.