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Gibco Rapid Prototyping Services

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Pilot-scale media manufacturing for development workflows

Moving a cell culture formulation beyond the lab is often the point when manufacturing considerations come into focus. Questions about format suitability and batch size often arise as teams prepare for technology transfer and pre-GMP development. Gibco Rapid Prototyping Services can help manufacture existing proprietary formulations,allows modification of catalog products, and supports custom media development projects at pilot scale. This step allows teams to assess manufacturability and can support the qualification of Thermo Fisher Scientific as a primary or secondary supply source before cGMP manufacturing.

Position early development for successful scale-up

Upon receiving pilot-scale material, attention shifts to decision-making. Data generated at this stage helps teams evaluate how a formulation responds at different volumes, which elements are likely to remain stable, and where adjustments may be required before scale-up. Gibco Rapid Prototyping Services offer a structured step between bench work and manufacturing by translating early development results into production planning.

Formats aligned to process need

Upstream (USP) development workflows may require different media formats as formulations move from evaluation to scale-up. Gibco Rapid Prototyping Services supports multiple formats by offering pilot-scale manufacturing in liquid media, dry powder media (DPM), and Advanced Granulation Technology (AGT) formats.

Liquid media and liquid concentrates

During process development, pilot-scale liquid media and concentrates can be produced from 1 to 600 L in standard bottles or bioprocess containers (BPCs).

Dry powder media

DPM batches from 1 to 30 kg allow teams to examine mixing behavior, handling considerations, and manufacturability before advancing formulations toward cGMP production.

Advanced Granulation Technology


AGT media, available in 1–8 kg pilot-scale batches, support the evaluation of granulated formats prior to cGMP manufacturing.

Support formulation changes with pilot-scale data

Screen different formulations during early development stages. At pilot scale, teams can test formulation adjustments, customer-specific raw materials, and format changes to gauge performance under relevant conditions. Using non-cGMP facilities with cGMP-quality inputs, Gibco Rapid Prototyping Services enables efficient evaluation of changes before locking a formulation for cGMP manufacturing.

Batch sizes and lead times for rapid iteration

Support pilot-scale batches across liquid media, DPM, and AGT formats, with standard turnaround times of about two weeks for liquid and DPM orders, and about four weeks for AGT. These batch sizes and lead times allow teams to adjust formulations, review results, and move into the next development step to help prevent extended manufacturing delays

Streamline transfer into cGMP manufacturing

After successful evaluation of non-cGMP pilot-scale materials, Gibco Rapid Prototyping Services facilitate the progression into larger-scale cGMP volumes by leveraging established Batch Records and Bills of Material. Commercial Representatives and dedicated Project Specialists within the Customer Operations and Support team help coordinate technology transfer and align next steps across Thermo Fisher Scientific’s global manufacturing network.
 

Collaborate with teams experienced in media scale-up

As formulations approach scale-up, questions shift toward feasibility, supply assurance, and how decisions made during development will translate at larger scale. Through Gibco Rapid Prototyping Services, process development teams work directly with project management specialists and feasibility scientists to review manufacturability and plan next steps, creating clearer alignment between development work and cGMP manufacturing expectations.

Frequently asked questions

Rapid prototyping fits into upstream process development when evaluating formulations prior to deciding on a final formulation. At this stage, pilot-scale manufacturing used to examine format suitability and manufacturability. The resulting data supports informed decisions before committing resources and timelines to cGMP production.

Pilot-scale work can surface risks that are easy to miss earlier, particularly around format suitability, mixing behavior. It can also reveal practical constraints tied to raw materials, processing steps, or packaging.

Upon successful evaluation of non-cGMP pilot materials, transitioning into larger-scale cGMP volumes is made easier. By leveraging the Batch Records and Bills of Material already developed by Gibco Rapid Prototyping Services, the technology transfer process into the cGMP production environment is streamlined and harmonized across our entire global manufacturing network. This process can be facilitated by your Commercial Representative and dedicated Project Specialists within the Customer Operations and Support team

Formulation changes, such as adding or reducing components, sourcing customer-specific raw materials, or converting to a different media format, can be examined at pilot scale to assess handling and manufacturability before finalizing a formulation for cGMP manufacturing.

Related media manufacturing services

Rapid prototyping is one part of a broader media manufacturing pathway that supports development through production. As formulations progress, teams can explore adjacent media manufacturing services to align pilot-scale insights with later-stage requirements.

Custom media QC testing

Add analytical insight where needed. Custom media QC testing can be used when data beyond standard tests is required to review formulation characteristics.

Media customization

Refine formulations with pilot-scale context. Pilot-scale data can inform formulation adjustments, format selection, and decisions tied to ongoing process development.

Extend customization across workflows

Connect media customization insights with broader development and analytics activities using Gibco Media by Design Services. These services enable media screening, refinement, and alignment to specific cell lines and process goals as workflows advance.
 

For research use or further manufacturing. Not for diagnostic use or direct administration into humans or animals.