Custom Solutions for
Your Workflow

Sterile-Filtered Serum, Media, Buffers and Reagents that Meet Your Process Demands

Biologos manufactures custom media, buffers, reagents, and serum to defined formulations and specifications. Formulation, raw materials, filtration, testing, and packaging are evaluated together to establish a manufacturing approach aligned with the process requirements.

Batch sizes range from approximately 1 L to multi-thousand-liter production, depending on formulation, process, and container configuration. Each lot is manufactured under an ISO 13485-certified quality management system, with lot-level traceability and a Certificate of Analysis documenting applicable release testing. From development and qualification batches through recurring commercial supply, Biologos supports animal health, tissue processing, cell and gene therapy, and biopharmaceutical programs as production requirements evolve.

Custom Solutions Across Media, Buffers, Reagents, and Serum

Products are available from development-scale quantities through recurring commercial volumes, with fill sizes and container configurations selected for the intended use. This flexibility supports changing demand as programs progress from development into routine production.

Buffers

Standard and custom buffers, including PBS, TRIS, HEPES, saline, wash, and dilution solutions, are manufactured and tested to agreed-upon requirements.

Liquid Media

Classical, specialty, and custom liquid media are manufactured to agreed-upon specifications, with filtration, testing, fill volume, and packaging defined for your application.

Reagents

Custom preservation and transport solutions, dissociation reagents, surfactants, wash solutions, and other specialty process materials to support critical stages in processing workflows.

Serum

Animal origin material with lot level traceability and processing options including heat inactivation and gamma irradiation.

Custom Solutions For Diverse Markets

Each market and process brings its own requirements for formulation, testing, documentation, production scale, and packaging. Biologos supports programs across animal health, tissue processing, biopharmaceuticals, and cell and gene therapy with manufacturing approaches aligned to specific process and product requirements.

Process Efficiencies with Ready-to-Use Solutions

In-house preparation of media, buffers, and reagents requires infrastructure, equipment, water systems, filtration capacity, trained personnel, and ongoing quality support. These resources also require scheduling, maintenance, calibration, qualification, cleaning, and documentation. Outsourcing ready-to-use process solutions can reduce the internal resources required for solution preparation and allow manufacturing teams to focus capacity on higher-value production activities.

Benefits of Outsourcing

Manufactured, tested, and sterile-filtered to defined requirements

  • Align supply volumes and packaging to production needs
  • Minimize infrastructure and maintenance requirements
  • Optimize production and quality resources
  • Reduce in-house preparation
  • Reduce internal testing and documentation workload

Custom Workflow Solutions in 4 Steps

Step 01

Share Your Process Needs

Share your formulation, reference product, process requirements, and intended application. We review the information needed to evaluate technical and manufacturing feasibility.

Step 02

Define the Specifications

Together, we define the formulation, raw material requirements, filtration strategy, fill configuration, testing, and documentation needed for the product and develop an agreed-upon specification for approval.

Step 03

Manufacture and Verify

Your product is manufactured and tested in accordance with the approved specification, with applicable release testing and documentation defined for the product.

Step 04

Scale and Resupply

We support scale-up, recurring production, and supply planning as your requirements evolve, including changes in batch size, fill size, packaging configuration, and delivery schedule.

Manufacturing. Documented Quality

Every lot is manufactured under controlled processes, with applicable sterile filtration, filling, release testing, and lot-level traceability. Qualified raw materials and an ISO 13485-certified quality management system support consistent manufacturing and documented quality.

Sterile Filtration

Sterile Filtration

Products are processed under controlled conditions to support consistent quality, bioburden control, and product integrity.

Release Testing

Release Testing

Lots are tested according to approved specifications, which can include pH, osmolality, appearance, bioburden, endotoxin, and sterility.

Full Lot Traceability

Full Lot Traceability

Each finished lot maintains traceability to qualified raw materials and manufacturing records, with a Certificate of Analysis provided at release.

Controlled Fill

Controlled Fill

Filling is performed under controlled conditions designed to maintain product quality following sterile filtration.

Raw Material Control

Raw Material Control

Raw materials are qualified and documented, with appropriate change control procedures in place.

Quality System

Quality System

Manufacturing operates within an established Quality Management System, ISO 13485 certified cGMP compliant facility.

Why Biologos?

A combination of technical expertise, rigorous quality systems, and flexible manufacturing supports consistent products, controlled processes, and reliable supply for all 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.

Yes. If you’re currently purchasing or making a media, buffer, reagent, or serum, we can work from your formulation or a reference product to develop a manufacturing approach and supply a sterile-filtered, ready-to-use product.

Both. We manufacture customer-provided formulations through technical transfer and can also supply standard products and published formulations. For custom projects, we work with customers to define the manufacturing, testing, packaging, and documentation requirements before production begins.

Products can be supplied in standard bottles, bags, bulk containers, or custom single-use configurations based on the product, fill volume, storage conditions, and intended use. Packaging can range from small rigid containers for precise fills to large-volume sterile bags and custom assemblies designed around your process.

Batch size and fill volume depend on the formulation, manufacturing process, and final container configuration. We support fills ranging from approximately 10 mL in small rigid containers or tubes to large-volume sterile bags and bulk configurations, including multi-thousand-liter production runs. Container selection is based on product compatibility, fill volume, handling, storage, shipping, and downstream use.

It means we take on a step in your process rather than just shipping a product. Instead of you weighing powders, making buffers, adjusting pH, sterile-filtering, and documenting each step on-site, we manufacture those liquids to agreed-upon specifications and deliver them ready to use. The media, buffers, reagents, and serum arrive ready to use; the point is to remove media-prep and filtration steps from your workflow.

We support customers across a range of life science and manufacturing markets. Our core focus areas include animal health, tissue processing, biopharmaceutical manufacturing, and cell and gene therapy. We also support diagnostics, research, academic, and other applications that require sterile-filtered serum, media, buffers, reagents, and custom process solutions.

Each lot ships with a Certificate of Analysis documenting the tests performed, which can include pH, osmolality, appearance, bioburden, endotoxin, sterility, or other testing requirements, as applicable. We maintain full lot traceability from raw material to finished product.

Outsourcing media, buffers, reagents, and other process solutions can reduce the internal labor, equipment, qualified water, filtration, testing, documentation, and scheduling required for in-house preparation. Products arrive manufactured, tested, and packaged to agreed-upon requirements, allowing your team to reduce preparation steps and focus internal resources elsewhere.

Experience That Supports Your Goals

Every project begins with a clear understanding of the formulation, timeline, specifications, and production requirements. Technical expertise and collaborative planning help establish an effective manufacturing approach, supporting a seamless transition from product development through commercial production.

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