Product Detail- Human Serum

GeminiBio’s HSAB portfolio enables researchers and advanced therapies customers to optimize their cell culture workflow – whether in research, development, or production – to improve their productivity and ability to scale.

Industry Leading Human Serum (HSAB)

Human Serum AB (HSAB)

Overview

GeminiBio offers a wide range of HSAB quality options – manufactured under cGMP – with extensive testing, and the ability to transition to non-bovine component products to meet regulatory requirements, improving advanced therapy customer workflow productivity and ability to scale.

GeminiBio offers a wide range of HSAB quality options – manufactured under cGMP – with extensive testing, and the ability to transition to non-bovine component products to meet regulatory requirements, improving advanced therapy customer workflow productivity and ability to scale.

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Research and Clinical Grades 

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We Get You – We understand that advanced therapy researchers and developers require human serum that can support their productivity and speed, and that can meet regulatory requirements when their projects move through the clinic and into commercial production

 

 

 

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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. 

 

 

 

 

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Aseptic Assurance System – Improve your workflow

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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 about our Aseptic Assurance System

Our Human Serum AB Products

HSAB Products

Product Choices – Wide Array of Quality Options

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GeminiBio’s human serum AB is collected from healthy male donors of the AB serotype in FDA-registered facilities located in the USA. Our proprietary manufacturing process removes aggregates resulting in a higher quality product that is more consistent lot-to-lot. Our human serum options range from normal human serum to Xeno-Free and Off the Clot, to meet the needs from research to development and production.

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Regulatory Choices – Meets Multiple Standards

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To help research and advanced therapies customers optimize their workflow when human serum is a key component, GeminiBio offers a range of quality options that meet U.S. and E.U. standards – with the ability to move to xeno-free options to meet increasingly stringent regulatory requirements. All human serum AB products are manufactured in our facilities under cGMP conditions.

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Packaging Choices – Standard and Custom Options

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Standard bottle sizes are 100 mL, and our clinical grade products are now available in our Aseptic Assurance System™ cryo-bags to improve customer’s aseptic processes and reduce risk.  GeminiBio is an industry leader in custom manufacturing and packaging to meet the workflow and aseptic process requirements of advanced therapy manufacturers. 

How Can We Help You?

Free Choices – Complimentary Options

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GeminiBio strives to simplify cell culture workflows, which extends to the additional complimentary services we provide with our HSAB

  • Complimentary sampling

  • Complimentary heat inactivation

  • Complimentary cold storage program

Learn More

Product Choices – Wide Array of Quality Options

GeminiBio’s human serum AB is collected from healthy male donors of the AB serotype in FDA-registered facilities located in the USA. Our proprietary manufacturing process removes aggregates resulting in a higher quality product that is more consistent lot-to-lot. Our human serum options range from normal human serum to Xeno-Free and Off the Clot, to meet the needs from research to development and production.

Order Now

Regulatory Choices – Meets Multiple Standards

To help research and advanced therapies customers optimize their workflow when human serum is a key component, GeminiBio offers a range of quality options that meet U.S. and E.U. standards – with the ability to move to xeno-free options to meet increasingly stringent regulatory requirements. All human serum AB products are manufactured in our facilities under cGMP conditions.

Learn More

Packaging Choices – Standard and Custom Options

Standard bottle sizes are 100 mL, and our clinical grade products are now available in our Aseptic Assurance System™ cryo-bags to improve customer’s aseptic processes and reduce risk.  GeminiBio is an industry leader in custom manufacturing and packaging to meet the workflow and aseptic process requirements of advanced therapy manufacturers. 

How Can We Help You?

Free Choices – Complimentary Options

GeminiBio strives to simplify cell culture workflows, which extends to the additional complimentary services we provide with our HSAB

  • Complimentary sampling

  • Complimentary heat inactivation

  • Complimentary cold storage program

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 sera, 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.

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.

 

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 sera, 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
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.

 

Learn More

Case Studies

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Research: Product Development Laboratory streamlines IND support

US government Cellular Engineering Product Development Laboratory, supporting > 50 active INDs and Phase I/II clinical trials, faced challenges and delays related to questions from the FDA.

Learn How GeminiBio Helped

Cell Therapy: Regulatory compliant human AB serum

Middle Eastern-based, clinical stage Cell Therapy company needed to reduce risk and potential concerns from the US FDA regarding cell culture products with animal components.

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

Our Integrated Quality Approach

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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
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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
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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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