Product Detail- High Purity Water & Buffers

GeminiBio enables our customers to optimize their process liquid & buffer manufacturing workflow to allow them to focus on core cGMP manufacturing processes.

Industry Leading High Purity Water & Buffers

Upstream and Downstream Liquids to Improve Your Workflow

Overview

GeminiBio offers commonly used solutions, such as water for injection (WFI) quality water, water for irrigation (WFIr) quality water, and cell and molecular grade water “off the shelf” and in various package sizes to streamline customer workflows. For customers requiring custom solutions, GeminiBio offers custom manufactured cGMP process liquids and buffers in batch sizes from 10-liters to 10,000-liters.

 

GeminiBio offers commonly used solutions, such as water for injection (WFI) quality water, water for irrigation (WFIr) quality water, and cell and molecular grade water “off the shelf” and in various package sizes to streamline customer workflows. For customers requiring custom solutions, GeminiBio offers custom manufactured cGMP process liquids and buffers in batch sizes from 10-liters to 10,000-liters.

 

Off The Shelf High Purity Water and Buffers

 

 

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cGMP Liquid Manufacturing

01

GeminiBio’s range of formulation tank sizes allows us to support customer’s 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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Upstream & Downstream Liquids

02

GeminiBio’s manufacturing capabilities span common upstream medias and downstream buffers, but we can also manufacturer our customer’s proprietary media formulations as well as complex downstream buffer formulations. 

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ScaleAgilitySM

03

GeminiBio’s ScaleAgilitySM offering supports customers as soon as they require cGMP manufactured process solutions. Our services can rapidly carry customers through the clinical development process and on to full scale commercial production, helping them move quicker, and with more flexibility, to achieve speed-to-clinic and speed-to-market.

Learn how we can help simplify scale up

ExpressCustom®

 

 

 

04

Our ExpressCustomSM service 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.

Learn More

TrueCustomSM

05

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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Process Water System

06

GeminiBio’s water system is a Reverse Osmosis – de-ionizing water system producing > 18 mOhm water compliant with ASTM Type 1A water.   GeminiBio’s process water system generates water that exceeds WFI water requirements and meets USP, EP, and JP specifications for water for injection (WFI) quality water. 

Learn More

cGMP Liquid Manufacturing

GeminiBio’s range of formulation tank sizes allows us to support customer’s 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. 

Learn More

Upstream & Downstream Liquids

GeminiBio’s manufacturing capabilities span common upstream medias and downstream buffers, but we can also manufacturer our customer’s proprietary media formulations as well as complex downstream buffer formulations. 

Learn More

ScaleAgilitySM

GeminiBio’s ScaleAgilitySM offering supports customers as soon as they require cGMP manufactured process solutions. Our services can rapidly carry customers through the clinical development process and on to full scale commercial production, helping them move quicker, and with more flexibility, to achieve speed-to-clinic and speed-to-market.

Learn how we can help simplify scale up

ExpressCustom®

 

 

 

Our ExpressCustomSM service 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.

Learn More

TrueCustomSM

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.

Learn More

Process Water System

GeminiBio’s water system is a Reverse Osmosis – de-ionizing water system producing > 18 mOhm water compliant with ASTM Type 1A water.   GeminiBio’s process water system generates water that exceeds WFI water requirements and meets USP, EP, and JP specifications for water for injection (WFI) quality water. 

Learn More

Who We Serve

research market, cell culture

GeminiBio enables researchers to optimize their cell culture workflow to improve productivity, reproducibility, and speed. Our product portfolio includes a comprehensive line of fetal bovine serum (FBS), human serum (HSAB), other animal serums, cell culture media, supplements and reagents, growth factors and cytokines, plus lab consumables.

 

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Scientist checking label of product

GeminiBio enables biopharma customers to optimize their upstream and downstream workflows to improve productivity and speed. Our product portfolio includes custom cGMP manufactured media, buffers, and other process liquids in batch sizes from 10-liters to 10,000-liters, and a comprehensive line of sera, including fetal bovine serum (FBS), as well as “off the shelf” water for injection (WFI) quality water.   

 

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Two Scientist in laboratory

GeminiBio enables Gene Therapy customers to optimize their upstream and downstream workflows to improve productivity and speed.  We support 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, as well as “off the shelf” water for injection (WFI) quality water.

 

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Scientist in laboratory

GeminiBio enables Cell Therapy customers to optimize their upstream and downstream workflows to improve productivity and speed.   We support 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. GeminiBio supports therapeutic cell manufacturing with a comprehensive line of human serum products, and mesenchymal stem cell (MSC) and T-Cell media.

 

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GeminiBio enables Life Science Tools Manufacturers to significantly expand the scale – and flexibility – of their cGMP process liquid manufacturing, allowing them to better meet demanding end-customer requirements.   Through our cGMP process liquid contract (private label) manufacturing capabilities, which include cGMP batch sizes from 10-liters to 10,000-liters, and ability to fill into diverse container types, and sizes ranging from 500 mL bottles to 1,000-liter pallet tanks, life science tools manufacturers can optimize their market penetration and end-customer satisfaction.

 

Learn More
research market, cell culture

GeminiBio enables researchers to optimize their cell culture workflow to improve productivity, reproducibility, and speed. Our product portfolio includes a comprehensive line of fetal bovine serum (FBS), human serum (HSAB), other animal serums, cell culture media, supplements and reagents, growth factors and cytokines, plus lab consumables.

 

Learn More
Scientist checking label of product

GeminiBio enables biopharma customers to optimize their upstream and downstream workflows to improve productivity and speed. Our product portfolio includes custom cGMP manufactured media, buffers, and other process liquids in batch sizes from 10-liters to 10,000-liters, and a comprehensive line of sera, including fetal bovine serum (FBS), as well as “off the shelf” water for injection (WFI) quality water.   

 

Learn More
Two Scientist in laboratory

GeminiBio enables Gene Therapy customers to optimize their upstream and downstream workflows to improve productivity and speed.  We support 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, as well as “off the shelf” water for injection (WFI) quality water.

 

Learn More
Scientist in laboratory

GeminiBio enables Cell Therapy customers to optimize their upstream and downstream workflows to improve productivity and speed.   We support 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. GeminiBio supports therapeutic cell manufacturing with a comprehensive line of human serum products, and mesenchymal stem cell (MSC) and T-Cell media.

 

Learn More

GeminiBio enables Life Science Tools Manufacturers to significantly expand the scale – and flexibility – of their cGMP process liquid manufacturing, allowing them to better meet demanding end-customer requirements.   Through our cGMP process liquid contract (private label) manufacturing capabilities, which include cGMP batch sizes from 10-liters to 10,000-liters, and ability to fill into diverse container types, and sizes ranging from 500 mL bottles to 1,000-liter pallet tanks, life science tools manufacturers can optimize their market penetration and end-customer satisfaction.

 

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Case Studies

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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

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

BioPharma: Poor buffer lead times and service

EU-based global animal health biotechnology company with manufacturing operations in the US Midwest was experiencing decreased support from their traditional media hydration and buffer manufacturers due to overall market demand and capacity constraints.

Learn How GeminiBio Helped

BioPharma: Improved workflow via collaboration

US-based $1B market cap biotechnology company focused on therapeutic antibodies lacked the internal cGMP liquid manufacturing capabilities to support their projects once they reach pilot scale, and required nimble partner to rapidly manufacture and adjust buffers for process optimization.

Learn How GeminiBio Helped

BioPharma: CDMO requires quality, speed, and service

Southeast US-based biologic drug contract development and manufacturing organization (CDMO) supporting early-stage product development to cGMP commercial manufacturing had experienced significant challenges finding CMO partners willing and able to address their needs, which included small to large cGMP batch sizes, short lead times, as well as services related to stability studies for new solutions.

Learn How GeminiBio Helped

Our Integrated Quality Approach

01

Certifications, Registrations & 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
02

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
03

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

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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