Cell Therapy Development

We work with you to develop your product for cGMP manufacturing

Product characterization and assay development

We work with your scientific, clinical, and regulatory teams to develop product specifications and testing that ensure quality and meet phase-specific regulatory requirements.

Process development and technology transfer

We work with your team to develop, transfer, and validate a process that meets your needs and timeline.
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cGMP document and batch record development

Documentation and batch records are developed to meet the phase-specific cGMP quality and regulatory standards.

Stability and comparability studies

Capability for both short and long-term stability testing under multiple environmental conditions.

Pilot production and engineering lots

cGMP documentation, testing, and batch records are fine-tuned in engineering runs to de-risk and optimize before cGMP production.

Product characterization and assay development

We work with your scientific, clinical, and regulatory teams to develop product specifications and testing that ensure quality and meet phase-specific regulatory requirements.

Process development and technology transfer

We work with your team to develop, transfer, and validate a process that meets your needs and timeline.
i

cGMP document and batch record development

Documentation and batch records are developed to meet the phase-specific cGMP quality and regulatory standards.

Stability and comparability studies

Capability for both short and long-term stability testing under multiple environmental conditions.

Pilot production and engineering lots

cGMP documentation, testing, and batch records are fine-tuned in engineering runs to de-risk and optimize before cGMP production.

Development Case Study

Allogeneic MSC Development

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Performance Cell developed allogeneic MSCs from adipose tissue for a Phase 1 IND.

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The project included Donor screening, program development and production of cGMP Master Cell Banks.

Development Case Study

Autologous MSC Development

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Performance Cell developed and validated an autologous MSC cell therapy products for a Phase 1/2a clinical trial.

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The project included full IND development, filing, and manufacturing for a Phase 1/2a clinical trial.

Development Case Study

Autologous MSC Development

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Performance Cell developed and validated an autologous MSC cell therapy products for a Phase 1/2a clinical trial.

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The project included full IND development, filing, and manufacturing for a Phase 1/2a clinical trial.

Development Case Study

Allogeneic MSC IND

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Performance Cell developed, filed, and received approval for manufacturing for a Phase 1 COVID-19 clinical trial.

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The project included full IND development, manufacturing methods development, master cell bank testing and final cell product lot release testing.

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