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Custom Media QC Testing Services

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Support custom media release with QC testing

Finished media manufactured under cGMP conditions require verification against predefined specifications before batch release and shipment. Quality control (QC) testing serves as the final checkpoint, confirming that manufactured media conform to established acceptance criteria and can support consistent bioprocess performance. This release-focused testing applies specifications defined before manufacturing begins, with no formulation changes or assay development at this stage. At Thermo Fisher Scientific, custom media QC testing is designed to verify product attributes, including sterility, composition, and performance, supporting shipment readiness and supply continuity as biologics programs scale.

Release testing against established specifications

QC testing is performed against specifications and acceptance criteria defined before cGMP manufacturing begins. Test methods are established, qualified, and approved upfront as part of the manufacturing strategy. Testing follows predefined protocols aligned with the customer-specified critical quality attributes.

Finished media testing for cGMP manufacturing

Finished media are produced under cGMP conditions and are integrated into manufacturing operations to support efficient batch release and shipment readiness. Media can be tested in liquid media, dry powdered media (DPM), and Advanced Granulation Technology (AGT) formats. Testing is conducted by experienced teams operating within established quality systems at ISO 13485-, CFR 820-, and ISO 9001-certified facilities. 

QC testing performed to support media release

QC testing supports batch release of media, which may include sterility and microbiology, physicochemical, and performance assay testing. Cell culture media testing categories are selected based on specifications defined before manufacturing.

Sterility, microbiology, and safety testing

Standard sterility and microbiological tests confirm product safety and compliance with release requirements. Testing includes sterility per USP protocols, bioburden determination, endotoxin detection, and mycoplasma screening using direct inoculation and indirect methods.

 

Physicochemical testing


Physicochemical tests verify formulation accuracy and consistency. Tests include pH measurement, osmolality determination, solubility assessment, and appearance evaluation. Compositional analyses, such as amino acid profiling and HPLC quantification of water-soluble vitamins, can also be performed.

Performance assay testing


Performance assays are predefined and verified to confirm expected media performance against specifications. Assays test media quality using cell growth, viability, and passage number assessments with relevant mammalian or microbial cell lines. Testing does not optimize or modify formulations.

 

Integrated QC testing within media manufacturing

QC testing can be integrated within media manufacturing services to support release processes. Cell culture media testing is performed in QC laboratories operating under cGMP conditions using qualified test methods executed by technical specialists. Global manufacturing redundancy across Gibco facilities in Grand Island, Paisley, and Miami enables continuous testing capacity and supply continuity. Test lead times vary by method and assay type and are confirmed during manufacturing and release planning.

Testing for customer-owned formulations

QC release testing can be performed on customer-owned or transferred formulations using the same release-focused approach. Test methods and specifications are defined by the customer based on their quality attributes and process requirements. Testing is executed according to approved protocols, generating documentation to enable batch release while maintaining confidentiality and protection of intellectual property.

Leverage benefits of Electronic Certificates of Analysis

 

Electronic Certificates of Analysis (eCoA) support documentation access, traceability, and release record management following QC testing. The Gibco VeriCert Exchange Services platform is designed to facilitate digital delivery and management of product documentation, including test results and certificates. eCoAs can help streamline documentation workflows, reduce manual processes, and enable audit readiness. The platform enables access to historical data and lot-specific information.

Work with teams experienced in QC testing

Experienced teams operating within established quality systems and cGMP environments perform QC testing. Specialists are trained in qualified test methods and quality control procedures, with testing executed according to approved protocols.

 

Frequently asked questions

QC testing verifies that finished media meet predefined specifications before batch release and shipment. Testing is performed on media manufactured under cGMP conditions using established methods and acceptance criteria before production begins. The testing confirms conformance to quality attributes, including sterility, composition, and performance. QC testing does not involve formulation development or optimization. It focuses instead on release decisions for manufactured batches.

QC tests performed to support media release include sterility testing per USP protocols, pH and osmolality measurement, endotoxin detection, mycoplasma screening, and bioburden determination. Additional tests, such as amino acid analysis, solubility assessment, and cell growth performance assays, may be included based on customer-defined specifications.

QC test methods and specifications are established before cGMP media manufacturing begins. Methods are established and approved as part of the manufacturing strategy, with acceptance criteria aligned to critical quality attributes defined by the customer or established through development work. Testing is executed according to predefined protocols, with no assay development or method changes occurring during the QC release testing phase.

QC testing focuses on batch release by verifying that finished media conform to predefined specifications before shipment. Testing uses methods to confirm product attributes required for release decisions. Bioprocess analytics services connect media composition to cell behavior and product attributes. Analytics services inform development decisions, while QC testing supports release and compliance.

QC testing generates formal documentation, including CoAs to support batch release. Documentation includes test results, specifications, acceptance criteria, and release decisions, maintained in compliance with quality systems and regulatory requirements. eCoAs can be delivered through the Gibco VeriCert Exchange Services platform, allowing digital access, traceability, and audit readiness.

Explore media manufacturing services

Media manufacturing services span rapid prototyping, cGMP manufacturing, and media customization to advance bioprocess development and commercialization. Capabilities include liquid media, DPM, and AGT formats, with global facilities supporting supply continuity and redundancy.

Employee wearing PPE working with white powder from a large blue drum

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