Nucleus Biologics


Nucleus Biologics is dedicated to supporting innovative cell and gene therapies by providing customizable and scalable solutions that simplify workflows, accelerate development, reduce costs, and improve patient outcomes. They focus on advanced media design, formulation, and manufacturing to address the challenges in cell and gene therapy development. The company emphasizes standardization, GMP compliance, and sustainability in their manufacturing processes, including the use of their Krakatoa media system and Vitronectin XF for regulatory approval and consistency. Their mission is to support the development of groundbreaking therapies and improve quality of life for patients.

Industries

biotechnology

Nr. of Employees

medium (51-250)


Products

Custom cell culture media (small-batch and scalable)

Bespoke media built to customer-specified components, concentrations, testing grades, and packaging to support research, development, and manufacturing workflows with small minimum order quantities and scale-up pathways.

Classical basal media (off-the-shelf) with customization options

Standard basal media formulations available as baseline products and optionally customized for components, packaging, and testing to meet experimental and process needs.

Pre-optimized starter media and cryopreservation portfolio

A portfolio of pre-optimized, customizable media and cryopreservation formulations provided as starting points to accelerate formulation development for specific cell types and applications, including DMSO-free cryoprotectants.

Custom and standard buffer and balanced salt solutions

Custom and standard buffer formulations and balanced salt solutions tailored for cell culture workflows and viral vector processing to support downstream processing and assay conditions, with supply and packaging scalable to large volumes.

Supplements, adhesion matrices, and recombinant reagents

Off-the-shelf and customizable supplements, adhesion matrices, and recombinant proteins to support cell culture performance, scalability, and regulatory transition; these reagents are provided with composition transparency and performance data to support translation and regulatory filings.

Benchtop media synthesis hardware and consumable pods

Point-of-use hardware and powder consumable pods that produce fresh media and buffers in small volumes to reduce storage needs, cold-chain reliance, and supply chain dependence.

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Services

Project-based formulation and iterative optimization of bespoke media and buffers to meet defined critical quality attributes for research, preclinical, and manufacturing use cases.

Contract manufacturing of media, buffers, and reagents under GMP or excipient-GMP conditions with certified quality systems, cleanroom facilities, and support for scale-up and regulatory documentation.

Licensing of pre-optimized media formulations and support for technology transfer to enable internal manufacture or second sourcing under controlled supply-chain arrangements.

Expertise Areas

  • Cell culture media formulation and optimization
  • GMP-compliant manufacturing for media, buffers, and excipients
  • Chemically-defined, serum-free, and xeno-free culture systems
  • Feeder-free stem cell culture and directed differentiation under xeno-free conditions
  • Show More (10)

Key Technologies

  • Cloud-based literature mining and evidence extraction for formulation
  • Web-based configurator and e-commerce workflows for custom reagents
  • Benchtop cartridge/pod powder-to-liquid media synthesis systems
  • Powder-based ambient-stable media formats and lower-plastic consumables
  • Show More (7)

News & Updates

Overview of the growth and milestones in cell and gene therapy industry in 2024, including product launches and innovations by Nucleus Biologics.

Research on how advanced media design supports CAR-T cell therapy for solid tumors.

Nucleus Biologics became the first company to achieve EXCiPACT certification for manufacturing excipient GMP quality cell culture media, supplements, and buffers.


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