Market – Gene Therapy

Gene Therapy

Two Scientist in laboratory

We Get You – We understand that gene therapy companies and CDMOs require scalable upstream and downstream process liquids to streamline plasmid DNA and viral vector manufacturing, while also reducing risk and optimizing the overall productivity of their development and production workflows.

Empowering the discovery, development and production of transformational therapies

GeminiBio enables gene 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 by providing custom manufactured cGMP media, buffers, and other process liquids in batch sizes from 10-liters to 10,000-liters.

 

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

GeminiBio’s TrueCustomSM and ExpressCustomSM service models provide gene therapy companies and CDMOs with a truly market differentiated service level. Our ability to offer short lead times, and fully custom manufacturing, provides the gene therapy market with the responsiveness needed for success.

Answering the needs of the gene therapy market

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Custom cGMP process liquid manufacturing

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GeminiBio’s range of formulation tank sizes allow us to support gene 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.

 

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ExpressCustomSM – Moving at the speed of the gene therapy market

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Our ExpressCustomSM ensures best-in-class customer experience when designing and ordering custom manufactured process liquids – which can often be a cumbersome and lengthy process.  GeminiBio has a defined process, managed by dedicated Project Managers, to ensure the product design process is completed efficiently and we can deliver on our 10-week manufacturing lead time commitment.

 

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TrueCustomSM – Flexibility to meet the needs of the gene therapy market

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GeminiBio’s  open architecture manufacturing approach – TrueCustomSM – enables us to produce truly custom products by sourcing components and consumables based on our customers’ unique and specific requirements, as well as sourcing from alternative suppliers to mitigate supply chain risk.

 

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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 gene therapy market

Quality

GeminiBio is dedicated to producing and delivering products that meet the demanding quality standards of the gene 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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Gene Therapy:  Scaling from lab to cGMP

US-based, pre-clinical stage Gene Therapy innovator scaling products from benchtop to pilot required a nimble liquid manufacturing partner to rapidly manufacture and adjust buffers for process optimization.

Learn How GeminiBio Helped

Gene Therapy: CDMO frustrated with service levels

US-based Gene/ Cell Therapy contract development and manufacturing organization (CDMO) rapidly expanding to address market needs sees customer experience decline due to poor service and long-lead times from their process liquid suppliers.

Learn How GeminiBio Helped

Gene Therapy:  Internal manufacturing cannot scale

Southeast US-based Gene Therapy company scaling to clinical stage had been making required process liquids – lab scale – internally, but required an outsourcing partner to simplify the workflow with pre-made process liquids much larger than the internal lab could manage – and can scale to cGMP when needed.

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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