Solutions – Process Liquid

Empowering Process Liquid Workflows – Regardless of Batch Size

Accelerating development of life-enhancing biotherapeutics

GeminiBio’s market-leading breadth of bioprocess liquid manufacturing capabilities, as well as our TrueCustomSM and ExpressCustomSM service models, allows us to address the varied needs of traditional biologic drug manufacturers, cell and gene therapy developers, and life sciences tools manufacturers so they can focus on what matters most.

Overview

GeminiBio has the capability to custom manufacture cGMP media, buffers, water for injection (WFI) quality water, and other process liquids in small and large volume batch sizes in our 25,000 square foot ISO 13485 certified and animal origin-free liquid manufacturing facility. Customization isn’t limited to batch size – GeminiBio will manufacture based on customer-specific specifications regardless of the raw material or containment requirements.  For customers requiring media hydration with animal origin components, GeminiBio has a separate cGMP facility for processing animal origin containing products.

Custom Manufacturing Capabilities

Overview

GeminiBio is uniquely positioned to help customers scale their process liquids.  From RUO to cGMP products, preclinical to clinical scale cGMP batch sizes, and ultimately to commercial production scale cGMP batch sizes, GeminiBio has the capabilities required. In addition to custom manufacturing, GeminiBio offers a broad portfolio of off the shelf high purity water, including water for injection quality water, water for irrigation quality water, purified water, as well as cell and molecular grade water.

 

 

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cGMP Liquid Manufacturing

Market Leading Batch Sizes

Overview

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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Overview

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 and Downstream Liquids

Market Leading Capabilities

Overview

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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Product Class V2

Overview

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

Market Leading Speed and Agility

Overview

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

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Overview

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

Talk to a Specialist

ExpressCustom®

 

Market Leading Service 

Overview

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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Express Custom

Overview

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.

 

Talk to a Specialist

TrueCustomSM

Market Leading Customization

Overview

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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True Custom

Overview

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

Meets USP, EP, & JP WFI Requirements

 

Overview

GeminiBio’s water system is a Reverse Osmosis – de-ionizing water system producing > 18 MΩ-cm 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.

 

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WFI QUality Water System

Overview

GeminiBio’s water system is a Reverse Osmosis – de-ionizing water system producing > 18 MΩ-cm 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.

 

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Products and Services

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GemPureTM Select WFI Quality Water

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For cell culture and other applications across the bioproduction workflow, GeminiBio offers GemPureTM Select Water for Injection (WFI) Quality Water. GemPure Select meets the USP monograph for Water for Injection packaged in bulk for commercial use. Readily available in 1-liter, 10-liter, 20-liter, 100-liter, and 200-liter package sizes.  Custom manufacturing options are available.

Custom media hydration and buffer manufacturing

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Manufacturing media and other upstream and downstream process liquids is a significant manufacturing bottleneck for biotech drug developers and manufacturers. To help customers improve manufacturing productivity and speed, whether in development or commercial production, GeminiBio has the capability to custom manufacture cGMP media and other process liquids in batch sizes from 10-liters to 10,000-liters in our 25,000 square foot ISO 13485 certified and animal origin-free manufacturing facility.

Contract manufacturing (private label) service

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GeminiBio’s contract manufacturing service 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, while simultaneously optimizing the productivity of their existing self-manufacturing assets.

High Purity Water

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GeminiBio offers a wide range of high purity water products to meet the requirements of your workflow.  Our diverse portfolio of GemPure waters offers packaging and testing options to support research, development and manufacturing workflows.

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, as well as 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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Scientist checking a container

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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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, as well as 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
Scientist checking a container

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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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

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

Life Science Tools:  Expanded US manufacturing capacity

EU-based, > $10B market cap, global bioprocess tools and solutions manufacturer needed increased US-based capacity to reduce lead times and improve customer experience.

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

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

Our Integrated Quality Approach

01

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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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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