Market – BioPharma

BioPharma

We Get You – We understand that biopharma companies require scalable upstream and downstream process liquids to streamline pre-production processes so they can focus on core molecule 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 biopharma customers to optimize their upstream and downstream workflows to improve productivity and speed.

Overview

GeminiBio provides biopharma customers with custom manufactured cGMP media, buffers, and other process liquids in batch sizes from 10-liters to 10,000-liters.  For customers requiring media manufactured with animal components (AC), GeminiBio has bioprocess liquid manufacturing facilities that are segregated between animal origin-free cGMP manufacturing and animal component cGMP manufacturing.

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Our TrueCustomSM and ExpressCustomSM service models provide customer’s a truly market differentiated service level. Our ability to offer short lead times, and fully custom manufacturing, provides the responsiveness needed for your success.

In addition to GeminiBio’s custom cGMP process liquid manufacturing capabilities, our product portfolio includes a comprehensive line of sera, including fetal bovine serum (FBS), and other animal sera, cell culture media, cell culture supplements and reagents, growth factors and cytokines, high purity waters, as well as lab equipment, consumables and reagents.

Answering the needs of the biopharma 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 biopharma 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 – Enabling productivity improvements and reducing risk

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Our ExpressCustom 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 your exact needs

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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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Cell Culture Solutions – Supporting workflow productivity

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GeminiBio’s Cell Culture Solutions portfolio offers a wide variety of products and grades to support the cell culture workflow, including fetal bovine serums, other animal serums, cell culture media, cell culture supplements and reagents, growth factors and cytokines, as well as lab equipment, consumables, and reagents. GeminiBio’s Cell Culture Solutions portfolio enables biopharma customers to optimize and scale their cell culture workflow – whether in research, development or production – to improve productivity, reproducibility, and speed.

 

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

Quality

GeminiBio is dedicated to producing and delivering products that meet the demanding quality standards of the biopharma 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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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.

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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.

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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.

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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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