Biopharma
Cell and Gene Therapy
Specialized buffers, media, and reagents for advanced therapy workflows, including cell expansion, harvest, formulation, and preservation processes.
Biologos provides workflow solutions for biopharmaceutical development and manufacturing, supporting products from R&D through clinical development and commercialization. Sterile-filtered chromatography and formulation buffers, cell culture media, reagents, and process solutions are manufactured under an ISO 13485-certified quality management system to defined formulation, testing, packaging, and documentation requirements.
Flexible Solutions for Scale-Up
A formulation that performs at bench scale may require different specifications, testing, and processing as production expands. Biologos provides the flexibility to adjust formulations, packaging, and manufacturing requirements as processes move toward GMP and commercial production.
Commercial Monoclonal Antibody and Recombinant Protein Manufacturing
Chromatography, formulation and dilution buffers, upstream media, and process solutions manufactured to defined specifications, with testing and documentation to support consistent commercial production.
Process Development and Clinical-Stage Programs
Small-volume buffers and media with rapid turnaround support formulation development and process optimization, providing the flexibility needed as requirements evolve.
Biopharmaceutical Workflow
Biopharmaceutical manufacturing spans multiple workflow stages, each with distinct product needs. From cell culture and media preparation through growth, harvest, purification, formulation, and validation, we supply the solutions your process requires at every step.
Biopharmaceutical Product Offerings
We manufacture sterile-filtered media, buffers, reagents, and process solutions for biopharmaceutical manufacturing applications to agreed-upon formulation, testing, packaging, and documentation requirements. Packaging options include bottles, bags, single-use bioprocess containers, and other bulk configurations supporting production from development through commercial scale.
Cell Culture Media
Liquid cell culture media, feeds, and supplements manufactured for use in upstream biopharmaceutical production processes. Products can be manufactured from customer-provided or recognized published formulations and supplied sterile-filtered in packaging configurations appropriate for the intended manufacturing workflow.
Chromatography and Process Buffers
Equilibration, wash, elution, and neutralization buffers for the purification steps at the heart of downstream processing. Products can be produced and tested to agreed-upon requirements for pH, conductivity, concentration, and other application-specific attributes.
Formulation and Dilution Buffers
Formulation buffers, dilution solutions, and other process solutions manufactured to agreed-upon specifications for use in biopharmaceutical manufacturing. Products can be supplied with testing, documentation, and packaging requirements aligned to the customer’s established process.
Process and Specialty Solutions
Wash solutions, buffer concentrates, balanced salt solutions, and other specialty process solutions manufactured to support biopharmaceutical production workflows. Products can be supplied in the concentrations, fill volumes, and packaging configurations required for the intended manufacturing process.
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 biopharmaceutical 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.
Management for Reliable Manufacturing
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
Biopharmaceutical
Are your buffers and media manufactured under a quality system?
Yes. Biologos manufactures under an ISO 13485-certified quality management system with established controls for raw materials, production, testing, documentation, traceability, and product release. We can manufacture products to customer-defined specifications and documentation requirements for biopharmaceutical manufacturing processes.
Can you scale from clinical to commercial volumes?
Yes. We support development, engineering, validation, and commercial-scale manufacturing. As your process evolves, we can scale manufacturing, packaging configurations, testing, and documentation to support changing requirements while maintaining continuity with the same manufacturing partner.
Do you manufacture from our formulation, or only your own products?
Most of our biopharmaceutical work is manufactured from customer-provided formulations or specifications. We can also support product transfers, reformulations, and custom development efforts where needed. In addition, we manufacture standard products and recognized published formulations.
How does outsourcing buffer and media prep reduce internal costs?
Outsourcing can reduce the internal labor, equipment time, suite capacity, testing, documentation, and inventory management required to prepare media and buffers in-house. This lets your technical staff and manufacturing space stay focused on higher-value production while shifting routine solution preparation to a dedicated manufacturing partner.
How fast can you manufacture a new buffer 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 in the process and provide a realistic lead time based on the specific manufacturing requirements.
What filtration grades do you offer?
Sterile filtration to 0.2 µm or 0.1 µm depending on the application, with bioburden control upstream of the final filter.
What types of products do you manufacture for biopharmaceutical processing?
We manufacture cell culture media and feeds, chromatography and purification buffers, process and wash buffers, formulation and dilution buffers, and other customer-specific media, buffers, reagents, and process solutions used across upstream and downstream biopharmaceutical manufacturing.