Bench to BLA

 

GeminiBio® is the global leader in human serum for cell therapy research, development, and manufacturing.

Bench to BLASM

De-Risk, Streamline, and Scale With Confidence

GeminiBio® offers unmatched products and capabilities to help cell therapy developers de-risk their development, manufacturing, and commercialization – Bench-to-BLA.

Industry Leading Human Serum Portfolio

GeminiBio® is the global leader in human AB serum for cell therapy research, development, and manufacturing. Starting with GeminiBio’s research-grade human AB serum ensures cell therapy developers can rapidly and confidently scale their technologies from Bench to BLA.

For clinical development and commercial manufacturing, GeminiBio offers an Off-the-Clot product and two plasma derived products, including the industry’s only limited donor pool HABS – GemCellTM Plus Xeno-Free, World Grade.

Regulatory Support – Reducing risk and rework

GeminiBio empowers cell therapy developers by offering comprehensive regulatory support—including a Drug Master File for our clinical-grade products, a gamma irradiation validation supporting all human serum 100mL bottle catalog products, and direct scientific support. Through our partnership with Compliance Insight, Inc., customers can access resources, at a discount, to help them confidently navigate the global regulatory environment.

 

Download White Paper: Supply Chain and Regulatory Considerations for Human Serum

Aseptic Assurance System® – Closed system manufacturing

GeminiBio’s clinical grade human AB serum products are available in Aseptic Assurance System® cryo-bags to improve aseptic processes and reduce process risk – supporting closed system manufacturing.

 

Read More about Aseptic Assurance

Custom Manufacturing – Optimizing production workflows

GeminiBio’s custom manufacturing can simplify workflows by providing human serum products that meet unique fill size, custom containment, or other requirements. In addition, GeminiBio can manufacture media or cell culture supplements containing human serum based on customer’s specific formulations and packaging requirements.

 

Explore Custom Manufacturing with GeminiBio

GeminiBio offers a complete Bench to BLA ecosystem supporting every phase of development.  

Learn More about the products: 

GemCell™ Human Serum (100-512)

Research Grade:  Collected from healthy male donors of the AB serotype. Product is defibrinated from source plasma using recombinant human thrombin. Supports basic research and development applications.

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Human Serum AB Off-The-Clot (100-318)

Clinical Grade:  Collected from healthy male donors of the AB serotype. Off-the-clot serum is collected from blood that is allowed to coagulate naturally after collection, so there are no anticoagulants or preservatives. Based on extensive testing, supports clinical and commercial applications.

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GemCell™ Plus Xeno-Free (100-912)

Clinical Grade:  Collected from healthy male donors of the AB serotype. Based on extensive testing and manufacturing process that is Xeno-Free, supports clinical and commercial applications. Larger lots available to support commercial production.

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GemCell™ Plus Xeno-Free World Grade (100-916)

Clinical Grade:  Collected from a maximum of 16 healthy male donors of the AB serotype. Based on extensive testing and manufacturing process that is Xeno-Free, supports clinical and commercial applications.

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Platform with GeminiBio – De-Risk Your Future

Ready to begin your journey from bench to BLA?

Contact our Experts Today