Key Product Detail 100-912- GemCell Plus Xeno Free HSAB

GemCellTM Plus Xeno-Free HSAB

GemCellTM Plus Xeno-Free HSAB

GemCellTM Plus Xeno-Free Human Serum AB enables advanced therapy researchers and developers to streamline their workflow, allowing them to bring their end products to market quickly by providing human serum that is scalable, free of bovine components, uses therapeutic-grade human thrombin, and is rigorously tested.

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For the cell culture of CAR-T and other cells where stringent regulatory requirements must be met, GeminiBio offers GemCellTM Plus Xeno-Free human AB serum.  GemCellTM Plus Xeno-Free Human Serum is sourced plasma collected from healthy male donors of the AB serotype at FDA-licensed facilities in the United States. 

Human AB serum that meets the needs of cell therapy researchers and developers.

Key Product Features

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Xeno Free – Clinical Applications

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GemCellTM Plus Xeno-Free Human Serum AB uses therapeutic grade human thrombin to convert sourced plasma to serum. This enables drug developers to use a human serum that promotes cell growth that is free of bovine components, minimizing the potential for immune reactivity, and meeting regulatory requirements. 

Extensive Viral Testing

 

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GemCellTM Plus Xeno-Free Human Serum AB offers the highest level of viral testing at the donor level, pool level, and finished product, ensuring a high-quality serum that is free of viral pathogens, improving safety, lot-to-lot consistency, and regulatory compliance.

Custom Manufacturing

 

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GemCellTM Plus Xeno-Free Human Serum AB is manufactured under cGMP and can be custom manufactured to include both package size as well as package type, including packaging into single use bioprocess containers. Our custom manufacturing streamlines customer workflows and improves their overall aseptic processes.

 

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Free Choices – Complimentary Options

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GeminiBio strives to simplify cell culture workflows, which extends to the additional complimentary services we provide with our GemCell Plus Xeno Free.

    • Complimentary sampling
    • Complimentary heat inactivation
    • Complimentary cold storage program

Our Integrated Quality Approach

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Certifications, Registrations and Compliance01

To meet the stringent quality requirements of our customers, GeminiBio is certified to ISO 13485:2016, maintains an FDA registration under Class I Medical Devices, and is aligned with 21 CFR Part 820: Quality System Regulation.  

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Certifications Registrations and Compliance
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Manufacturing Design02

GeminiBio’s facilities are designed with current Good Manufacturing Practices (cGMP) and our customer’s quality requirements in mind. Our animal origin free (AOF) manufacturing facility is 1/4 mile away from our animal origin (AO) manufacturing facility. In addition, our cGMP warehouse is designed with flows for both personnel and materials, including segregation of AO and AOF materials.

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Manufacturing Design
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Risk Management03

GeminiBio has developed a robust and rigorous risk management mitigation program.   Our four-step approach includes Supplier Management, Change Management, Internal Audits governed by ISO 13485:2016, and Customer Audits.

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Risk Management

Case Studies

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Cell Therapy: Improved aseptic process

Southeast Asia-based clinical stage company focused on allogeneic cell therapies for oncology applications was focused on reducing workflow steps and improving their aseptic processes to reduce contamination risk across the workflow.

Learn How GeminiBio Helped

Cell Therapy: Regulatory compliant human AB serum

Middle Eastern-based, clinical stage Cell Therapy company needed to reduce risk and potential concerns from the US FDA regarding cell culture products with animal components.

Learn How GeminiBio Helped

Cell Therapy: Simplified liquid manufacturing

Southeast Asian clinical stage Cell Therapy company focused on allogeneic cell therapies required custom aliquots of media components, including human serum, cytokines, growth factors, and other components in single use containment bags to simplify their workflow.

Learn How GeminiBio Helped

Research: Product Development Laboratory streamlines IND support

US government Cellular Engineering Product Development Laboratory, supporting > 50 active INDs and Phase I/II clinical trials, faced challenges and delays related to questions from the FDA.

Learn How GeminiBio Helped

Let’s Keep In Touch

We are committed to helping you optimize your cell culture and process liquid workflows – how can we help you?

 

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