Market – Cell Therapy

Cell Therapy

Scientist in laboratory

We Get You – We Understand that cell therapy companies and CDMOs require scalable upstream and downstream process liquids to streamline manufacturing, as well as regulatory compliant tools and products that deliver highly effective and consistent results, while reducing risk and optimizing overall productivity and production workflows.

Empowering the discovery, development and production of transformational therapies

GeminiBio enables cell therapy customers to optimize their upstream and downstream workflows to improve productivity and speed.

Overview

GeminiBio supports the unique needs of plasmid DNA and viral vector manufacturing, as well as therapeutic cell manufacturing, by providing custom manufactured cGMP media, buffers, and other process liquids in batch sizes from 10-liters to 10,000-liters.  In addition, GeminiBio offers differentiated products to support the cell culture steps related to CAR-T cells, MSCs, T cells, and other therapeutic cells.

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Our custom and flexible cGMP manufacturing capabilities supports cell therapy company’s unique needs for both small scale and large scale process liquids.

To support cell culture for CAR-T and other cells, GeminiBio offers a comprehensive line of human serum products, including industry leading GemCell Plus Xeno Free, World Grade. GeminiBio’s clinical grade human serum products are now available in our Aseptic Assurance System™ cryo-bags to improve customer’s aseptic processes and reduce risk. For culturing of T Cells for oncology applications, GeminiBio offers Yssel’s T-Cell Media

Answering the needs of the cell therapy market

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Aseptic Assurance System – Reduce risk and improve process

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Advanced therapy developers and manufacturers have gravitated to closed systems to reduce contamination risk during manufacturing and streamline their workflow. GeminiBio’s clinical grade products are now available in our Aseptic Assurance System™ cryo-bags to improve customer’s aseptic processes and reduce risk.

 

 

Learn How Aseptic Assurance System Can Help You

Industry Leading Regulatory Compliance

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GemCellTM Plus Xeno Free, World Grade – designed to meet specific regulatory requirements, including requirements within the United States and the European Union. Source plasma is collected from a maximum of 16 healthy male donors of the AB serotype and passes extensive viral testing requirements. 

 

Details on GemCell Plus Xeno Free, World Grade

Custom cGMP process liquid manufacturing

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GeminiBio’s range of formulation tank sizes allow us to support cell therapy customers as they scale their production.  We offer custom cGMP liquid manufacturing in batch sizes from 10-liters to 10,000-liters, and can customize fill size and container type based on each customer’s needs. GeminiBio’s TrueCustomSM and ExpressCustomSM service models provide Cell Therapy companies and CDMOs with a truly market differentiated service level.

 

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GemCellTM Plus Xeno Free Human AB Serum

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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 collected from healthy male donors of the AB serotype at FDA-licensed facilities in the United States. Manufactured under cGMP, this material goes through rigorous testing and contains therapeutic-grade human thrombin to support the increasingly stringent regulatory requirements of advanced therapies.

 

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Yssel’s T-Cell Media

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For culturing of T Cells for oncology applications, GeminiBio offers Yssel’s T-Cell Media.  Yssel’s T-Cell Media allows for the proliferation of primary T Cells and can be used alone or as a basal media. Manufactured under cGMP conductions, Yssel’s T-Cell media is available in a xeno free and phenol red free formulation, and custom manufacturing and packaging options are available.

 

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 GemPure™ Water for Injection (WFI) Quality Water 

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GeminiBio’s ultrapure water is available in USP or multicompendial USP/EP/JP Grades for Water For Injection (WFI) Quality Water packed in bulk for commercial use.  Our WFI quality water meets the needs of upstream and downstream bioprocessing and manufacturing applications and complies with the Untied States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP) as indicated.  Packaged in bulk for commercial use and custom manufacturing options available.

 

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Our Integrated Quality Approach –  Our commitment to the cell therapy market

Quality

GeminiBio is dedicated to producing and delivering products that meet the demanding quality standards of the cell therapy market. GeminiBio is an ISO 13485 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820.

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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.

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Cell Therapy: Scaling to cGMP buffers 

US-based Cell Therapy company that is part of a global > $50B market cap biopharmaceutical company needed an external manufacturer who could make cGMP process liquids – cost effectively – in the small aliquots required for their current workflow process steps.

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

Cell Therapy: Assurance of supply when scaling

US-based clinical stage Cell Therapy company focused on allogeneic platform needed to secure supply for Yssel’s T-Cell media to confidently meet their manufacturing scale up following positive results from their clinical development process.

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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