Biopharma Manufacturing
From Development to Commercial Scale
Sterile Filtered Custom Buffers, Media and Reagents
Biopharmaceutical manufacturing encompasses a broad range of biologic products and production platforms, from monoclonal antibodies and fusion proteins to recombinant proteins and emerging biologic modalities. Across these processes, large volumes of upstream media and downstream buffers may be required throughout development, scale-up, and commercial production, creating significant demands on internal preparation, resources, and production capacity.
Biologos manufactures upstream media and downstream buffers to defined formulations and specifications under an ISO 13485-certified quality management system. Outsourcing media and buffer preparation can reduce internal processing requirements while providing a consistent external supply. Established formulations can be supported from process development through commercial-scale production, helping maintain continuity as production volumes and manufacturing requirements evolve.
Biopharmaceutical Manufacturing Product Offerings
Sterile-filtered fluids are manufactured for biopharmaceutical manufacturing, using 0.2 µm or 0.1 µm filtration based on product and process requirements, with bioburden and endotoxin controls established throughout production. Packaging options include rigid containers, bags, single-use bioprocess containers, and bulk formats, with fill volumes and batch sizes supporting development, scale-up, and commercial production.
Cell Culture MediaChromatography and Process BuffersFormulation and Dilution BuffersProcess and Specialty Solutions
Cell Culture Media
Classical and custom cell culture media, feeds, and supplements used in upstream production of monoclonal antibodies, recombinant proteins, and other biologics. Manufactured from customer-provided or established formulations and sterile-filtered for use in the manufacturing process.
Featured Products
Chromatography and Process Buffers
Equilibration, wash, elution, and neutralization buffers for the purification steps at the heart of downstream processing. Manufactured to a defined composition and controlled for required parameters such as pH, conductivity, and concentration.
Featured Products
Formulation and Dilution Buffers
Buffers and process solutions used for dilution, adjustment, intermediate processing, and other customer-defined manufacturing steps. Manufactured to specified composition with required parameters such as pH, conductivity, concentration, and osmolality controlled as applicable.
Featured Products
Process and Specialty Solutions
Wash solutions, buffer concentrates, balanced salt solutions, and other customer-specific media, buffers, reagents, and process solutions used throughout upstream and downstream biopharmaceutical manufacturing.
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.
Digital 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
Biopharmaceutical Manufacturing
Are your media and buffers manufactured under a quality system?
Yes. We manufacture under an ISO 13485-certified quality management system and test in accordance with approved specifications, as applicable.
Can you really take buffer and media prep off our floor?
Yes. This is central to the value we provide. We manufacture the media, buffers, and process solutions your operation would otherwise prepare in-house, reducing demand on manufacturing space, purified water systems, equipment, and staff. The scope can range from individual products to broader sets of recurring process solutions, depending on your manufacturing needs.
Can you scale from development to commercial volumes?
Yes. The same formulations move from development into commercial manufacturing, so you don’t re-qualify a supplier as your manufacturing process evolves.
Do you manufacture from our formulation, or your own products?
Both. We can manufacture to your formulation or supply established formulations, when appropriate.
What filtration options and packaging formats do you offer?
Products can typically be sterile filtered to 0.2 µm or 0.1 µm, depending on the formulation and application. Packaging options include rigid containers, bags, single-use bioprocess containers, and other bulk formats in a range of fill volumes.
What types of products do you make for biopharma manufacturing?
We manufacture cell culture media, feeds, and supplements; harvest and clarification buffers; chromatography equilibration, wash, and elution buffers; viral inactivation, UF/DF, and dilution buffers; and other customer-specific media, buffers, reagents, and process solutions used across upstream and downstream biopharmaceutical manufacturing.