Kalon Biotherapeutics, LLC


Formerly an independent biologics development and manufacturing organization operating a cGMP-focused biomanufacturing and development center in College Station, Texas. Core activities included clinical-scale GMP manufacturing and scale-up, upstream and downstream process development, analytical testing for viral vectors and cell-culture contaminants, computational antibody developability tools, and the production and distribution of research reagents and assay kits (cell culture media, ELISA/PCR kits, controls and related consumables). The organization also provided access to a modular cGMP facility, deployable cleanroom pods for on-site development and training, and maintained online/catalog distribution with regional reseller partners for laboratory consumables.

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Kalon Biotherapeutics, LLC


Products

Cell culture and organoid media catalog

Range of formulated cell culture media and organoid media for multiple tumor and tissue types, provided at defined volumes and storage conditions for research use.

Automated cartridge-based nucleic acid extraction instrument

Closed-system benchtop instrument using sealed cartridges and magnetic-bead chemistry for walk-away nucleic acid extraction from production and in-process samples.

Viral titer and antigen assay kits and external run controls

qRT-PCR kits and protocols for viral titering, ELISA-based capsid/antigen titration assays, lateral-flow rapid detection formats, and external nucleic-acid run controls for SARS-CoV-2 and other targets.

Transfer membranes and western blot consumables

Transfer membranes and related consumables for protein transfer and western blotting workflows, provided as part of the assay consumables catalog.

Research ELISA kits, biochemical detection kits and western blot consumables

Assay kits for protein quantification and detection (ELISA bundles, phosphate detection kits, collagen detection kits) and consumables for western blotting workflows.

Plasmid purification and PCR reagent kits

Plasmid purification kits and PCR reagent kits for molecular biology applications and assay development.

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Services

Clinical GMP contract manufacturing for biologics

Clinical-scale GMP manufacturing and process support for vaccines, monoclonal antibodies, and cell/gene therapies, including upstream/downstream processing and scale-up to clinical volumes.

Analytical laboratory services for viral and contaminant testing

On-site laboratory testing including nucleic-acid extraction, qRT-PCR viral titering, immunoassay titration and rapid detection methods to support in-process QC and release testing.

Project management for drug development and manufacturing

Coordinated project management from preclinical stages through clinical manufacturing with milestone planning and cross-functional coordination.

Facility access, training and workforce development

Access to a modular GMP center with cleanrooms for research, process development and GMP manufacturing plus workforce training programs.

Mobile cleanroom deployment

On-site deployment of portable modular cleanrooms configurable for upstream and downstream operations at remote or temporary locations.

Catalog supply of research reagents and assay kits

Sales and distribution of research consumables including cell culture media (2D/3D/organoid), assay kits (ELISA, phosphate assays), nucleic-acid controls, plasmid purification kits, enzymes and antibodies.

Expertise Areas

  • cGMP biologics manufacturing
  • Bioprocess development and scale-up
  • Modular GMP facility operations and deployment
  • Viral vector titering and virology testing
  • Show More (5)

Key Technologies

  • Single-use bioprocessing
  • Modular cleanroom systems
  • Upstream and downstream bioprocessing
  • Mammalian, microbial and insect cell culture
  • Show More (9)

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