Sterogene Bioseparation

What Sterogene Bioseparation does

Sterogene Bioseparations, founded in 1985 and headquartered in Carlsbad, California, develops and manufactures stable, NaOH-sanitizable affinity chromatography resins used in the purification of human blood products and biopharmaceuticals. The company's portfolio spans affinity chromatography (Protein A/G/L Superflow 4, lectin resins, Heparin, Glutathione), IMAC resins (Nickel/Cobalt Chelating Superflow 4 in proprietary tridentate/tetra-dentate chemistries), activated resins (Actigel ALD, NHS-Activated, Epoxy, Aminogel, Carboxygel), endotoxin removal resins (ActiClean Etox, ReductEtox, DNA Etox), gel filtration base matrices (Superflow 4/6, Uniflow 4), protein cleavage resins (Papain/Pepsin Actigel), and ionic reducing resins (IonClear BigBead). The technical platform rests on proprietary cross-linked agarose bead chemistry supporting flow rates above 1020 cm/hr, pH 2–14 stability, 100+ validated cycle lifetimes, and 1M NaOH sanitization — all manufactured under cGMP and ISO 9001:2015 conditions with Drug Master Files on file at the US FDA.

The company's centerpiece is the patented Direct Capture™ method using CellThru BigBeads (200–1000 µm particles) that allow purification directly from unclarified feed streams, eliminating filtration, centrifugation, and pre-treatment steps. Sterogene monetizes through multiple streams: catalog resin product sales (50 mL–10 kg pack sizes at $166–$1,527 list price), custom resin development and manufacturing services including peptide affinity ligand design via in silico bioinformatics, OEM supply of particles used in FDA-approved affinity apheresis medical devices (Covid-19, MI, stroke treatments), and regulatory support files/DMF services for FDA and EMA filings. Distribution combines direct online sales through sterogene.com, direct enterprise sales from the Carlsbad headquarters, and authorized distributors in China (RJ Bio Process), Singapore/Malaysia (i-DNA Biotechnology), and Europe. The customer base is concentrated among the world's largest biopharmaceutical manufacturers, international plasma fractionation companies, medical device and diagnostics manufacturers, and — secondarily — small/medium biotech R&D labs, academic institutions, and cell/gene therapy developers.

Name

Sterogene Bioseparation

Legal name

Sterogene Bioseparations, Inc.

Website

https://sterogene.com

Company type

Private

Founded year

1985

Operating status

Operating

Headcount range

11–50 employees

Short description

Sterogene Bioseparations, founded in 1985 in Carlsbad, California, develops and manufactures NaOH-sanitizable affinity chromatography resins under cGMP/ISO 9001 standards, supplying the world's largest biopharmaceutical, plasma fractionation, and diagnostics companies with FDA-DMF-supported purification products.

Ownership category

akta.pro rank

Product category

Bioprocess Chromatography Resins

NAICS

Custom Compounding of Purchased Resins (325991), Resin and Synthetic Rubber Manufacturing (32521), Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Plastic Materials, Synth Resins & Nonvulcan Elastomers (2821), Pharmaceutical Preparations (2834)

akta.pro primary industry

Ion Exchange Resins & Functional Adsorbents (IMAEAIAH)

akta.pro secondary industries

Bioprocess Consumables & Reagents (resins, membranes, media components, buffers) (HLAAAJAI), Biosimilar Manufacturing & Fill-Finish (drug substance/drug product, device integration) (HLAAAHAK)

Keywords

• Chromatography resins
• Affinity chromatography products
• Bioprocess purification
• Endotoxin removal resins
• Biopharmaceutical manufacturing

Headquarters

HQ city

Carlsbad

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Supply Chain, Operations, Technology or R&D, Personnel, Infrastructure, Marketing or Sales

Revenue model

1. Catalog Resin Product Sales: Direct one-time sale of catalog chromatography resin products in standard pack sizes (50 mL, 500 mL, 1000 mL, 1 kg, 10 kg, plus prepacked columns). Products shipped via website cart or distributor orders; some products are listed at fixed price while others are quote-based.
2. Custom Resin Development and Manufacturing Services: Contract development and manufacturing services for chromatography resins, including peptide affinity ligand development, custom ligand design using in silico bioinformatics, and application-specific resin customization. Includes regulatory documentation support for FDA and EMA approval.
3. OEM Resin Supply: Supply of resins used as components in several OEM products on the market, including affinity apheresis medical devices (FDA-approved) used in Covid-19, MI, and stroke treatments.
4. Regulatory Support Files and DMF Services: Provision of Regulatory Support Files and Drug Master Files (DMF) held with the US FDA and other regulatory agencies for clients using Sterogene resins in their purification processes.

Pricing tiers

Go-to-market motion1 record

Distribution channels5 records

Marketing channels3 records

Core offering

Sterogene Bioseparations develops and manufactures proprietary agarose-based chromatography resins — including affinity, IMAC, activated, endotoxin removal, gel filtration, ionic reducing, and protein cleavage resins — built on its cross-linked Superflow and Uniflow base matrices. Its patented Direct Capture™ technology, paired with CellThru BigBeads, enables downstream purification directly from unclarified feed streams. The company also provides custom resin development, peptide affinity ligand design, and OEM supply of resin components used in FDA-approved affinity apheresis medical devices.

Product overview

Sterogene Bioseparations offers a single-product-family portfolio of chromatography resins organized into product categories that together form a complete downstream purification toolkit for biopharmaceutical and plasma protein manufacturers. The categories are: Affinity Chromatography (Protein A Superflow 4, Protein G Superflow 4, Protein L Superflow 4, Concanavalin A Superflow 4, WGA Superflow 4, Jacalin Superflow 4, GNA Superflow 4, Heparin Superflow 4, Glutathione Affinity Superflow 4, Actigel T); IMAC Resins (Nickel Chelating Superflow 4, Nickel NTA Chelating Superflow 4, Cobalt Chelating Superflow 4, IDA Chelating Superflow 4, NTA-Chelating Superflow 4); Activated Resins (Actigel ALD, Actigel ALD Superflow 4, Epoxy Activated Superflow 4, NHS-Activated Superflow 4, Aminogel, Carboxygel, ALD Coupling Solution); Endotoxin Removal (ActiClean Etox, ReductEtox, DNA Etox); Gel Filtration Resins (Superflow 4, Superflow 6, Uniflow 4, used as base matrices for many affinity products); Ionic Reducing Resins (IonClear BigBead); and Protein Cleavage Resins (Papain Actigel, Pepsin Actigel). Underpinning the portfolio is Sterogene's patented Direct Capture technology that pairs Cellthru BigBeads (and IonClear BigBead) with the rest of the resin line, enabling purification from unclarified feed streams without separate filtration or centrifugation steps. All products share the Superflow 4 cross-linked agarose base matrix, cGMP/ISO 9001:2015 manufacturing, and Drug Master Files with the USFDA where applicable.

Differentiator

Problem solved

Functional benefit

Brands

• Direct Capture: Patented scalable chromatography method developed by Sterogene Bioseparations for the rapid purification of target biomolecules from unclarified feed streams.
• CellThru
• Superflow
• Uniflow
• UltraFlow
• Etox

Products and services

• Protein A Superflow 4 Recombinant Protein A affinity resin covalently coupled via epoxy chemistry to the Superflow 4 matrix, providing one-step IgG/monoclonal antibody purification with >50 mg IgG/mL static binding capacity and high NaOH stability, intended for biopharmaceutical manufacturers.
• Protein G Superflow 4 Recombinant Protein G affinity resin for broad-range IgG subclass purification from human, mouse, and rat samples, with >35 mg IgG/mL binding capacity and pH 2-13 stability, targeted at antibody purification workflows.
• Protein L Superflow 4 Recombinant Protein L affinity resin that binds kappa light chains, enabling purification of all antibody classes (IgG, IgA, IgD, IgM, IgE), Fabs, and scFvs at 20 mg IgG/mL binding capacity.
• Concanavalin A Superflow 4 Lectin affinity resin with immobilized Con A for purification of glycoproteins, glycolipids, polysaccharides, IgM, and exosomes containing terminal α-D-mannopyranosyl or α-D-glucopyranosyl residues, with >35 mg thyroglobulin/mL binding capacity.
• WGA Superflow 4 Wheat germ agglutinin lectin affinity resin for purification of glycoproteins containing terminal N-acetyl glucosamine or sialic acid residues, including insulin receptors and various serum glycoproteins.
• Jacalin Superflow 4 Jackfruit (Artocarpus integrifolia) lectin affinity resin for purification or depletion of IgA from serum, colostrum, and other biological samples via α-D-galactose binding, with >3-5 mg human IgA/mL binding capacity.
• GNA Superflow 4 Snowdrop (Galanthus nivalis) lectin affinity resin for purification of mannose-containing glycoproteins, including envelope glycoproteins of HIV and SARS-CoV-2 for vaccine and structural studies.
• Heparin Superflow 4 Immobilized heparin affinity resin for purification of heparin-binding proteins, plasma coagulation factors, growth factors, lipoproteins, exosomes, and lentiviruses, usable as a cation exchanger as well.
• Glutathione Affinity Superflow 4 Immobilized glutathione resin for one-step affinity purification of GST-tagged recombinant proteins, manufactured under cGMP/ISO 9001:2015 with Drug Master File on file at US FDA.
• Actigel T Free sulfhydryl-containing agarose resin for reversible coupling of thiol-containing ligands and purification of thiol-containing molecules or catalytic cysteine-bearing enzymes.
• Cobalt Chelating Superflow 4 Proprietary tridentate IMAC resin pre-charged with cobalt for His-tagged protein purification, providing >60 mg protein/mL capacity, >30 mL/min flow rates, negligible metal leakage, and DMF/Regulatory Support File availability; manufactured under cGMP and ISO 9001:2015.
• Nickel Chelating Superflow 4 Proprietary tetra-dentate nickel-charged IMAC resin for His-tagged protein purification with >60 mg protein/mL binding capacity, >30 mL/min flow rate, and no measurable metal leakage.
• Nickel NTA Chelating Superflow 4 Proprietary tetra-dentate nickel-NTA IMAC resin for His-tagged protein purification with >50 mg/mL binding capacity, low nickel leaching, and 1M NaOH cleanability.
• IDA Chelating Superflow 4 Uncharged tridentate IDA IMAC resin for purification of polyhistidine-tagged proteins, allowing the user to charge with Ni, Fe, Co, Cu, or Zn ions, with >65 mg Hb/mL binding capacity.
• NTA-Chelating Superflow 4 Uncharged tetra-dentate NTA IMAC resin for purification of polyhistidine-tagged proteins with high selectivity and minimal metal leaching; user-charges with Ni, Fe, Co, Cu, or Zn ions.
• Actigel ALD Aldehyde-activated cross-linked agarose resin used to immobilize primary amine-containing ligands (small molecules to large proteins) via reductive amination; offers stable coupling chemistry with minimal ligand leaching.
• Actigel ALD Superflow 4 Aldehyde-activated Superflow 4 resin designed for high flow rates (≥680 cm/hr) and alkali-resistant coupling of primary amine ligands via reductive amination.
• Epoxy Activated Superflow 4 Epoxy-functionalized Superflow 4 resin for stable immobilization of ligands through thiol, amino, or hydroxyl groups, supporting >30 mL/min flow rates and >20 mg protein/mL coupling capacity.
• NHS-Activated Superflow 4 N-hydroxysuccinimide pre-activated agarose resin for single-step covalent coupling of proteins, peptides, and antibodies via primary amines with >80% coupling efficiency and a long spacer arm.
• Aminogel Agarose resin with primary amine groups used to couple carboxyl-containing peptides and small ligands via EDC carbodiimide chemistry with a long hydrophilic spacer arm.
• Carboxygel Agarose resin bearing carboxyl groups used to couple amine-containing peptides and small ligands via EDC carbodiimide chemistry with a long hydrophilic spacer arm.
• ALD Coupling Solution High-purity 1M sodium cyanoborohydride (NaBH3CN) solution free of NaBH4 contamination used for reduction of Schiff bases in aldehyde-activated resin coupling workflows; available in 100 mL and 1000 mL sizes.
• ActiClean Etox Cross-linked 4% agarose affinity resin that removes endotoxins (LPS) from water, buffers, cell culture media, and protein solutions including plasma proteins (albumin, Factor VIII, Factor IX, IVIG) with >20,000 EU/mL binding capacity, NaOH-sanitizable, and backed by a Drug Master File at the FDA.
• ReductEtox Hydrophilic agarose-based endotoxin removal resin with >400,000 EU/mL binding capacity, achieving >99% endotoxin removal and ~90% protein recovery, easily regenerated with 1M NaOH.
• DNA Etox Solid-phase affinity resin specifically designed for high-recovery removal of endotoxin from DNA preparations, autoclavable and regenerable with 1M NaOH, with >250,000 EU/mL binding capacity.
• Superflow 4 Proprietary highly cross-linked 4% agarose matrix offering pH 2-14 stability, autoclavability, NaOH-sanitizability, and use as both a gel filtration medium and an immobilization support for affinity ligands in the Superflow product family.
• Superflow 6 Proprietary highly cross-linked 6% agarose matrix offering pH 2-14 stability, higher mechanical rigidity than 4% beads, and use as both a gel filtration medium and an immobilization support.
• Uniflow 4 4% agarose gel filtration matrix with a 20 million Dalton molecular exclusion limit, autoclavable, NaOH-cleanable, and suitable as an affinity chromatography support with low non-specific binding.
• IonClear BigBead Large 400-1,100 µm polystyrene beads with covalently linked cationic and anionic chains for rapid desalting and ion reduction (conductivity ≤1.00 mS/cm) with minimal protein binding (≤0.3 mg/mL), used in Cellthru/Direct Capture workflows.
• Papain Actigel Immobilized papain cysteine protease resin for controlled generation of Fab fragments from IgG molecules, intended to be paired with Protein A Superflow for Fc removal.
• Pepsin Actigel Immobilized pepsin protease resin for controlled generation of F(ab')2 fragments from IgG molecules, intended to be paired with Protein A Superflow for Fc removal.
• Direct Capture with CellThru BigBeads Patented scalable method for purifying target biomolecules directly from unclarified feed streams (fermentation broth, cell cultures, plasma) using large-pore Cellthru BigBead resins (200–300 µm, 300–500 µm, 500–1000 µm) that allow cells and debris to pass while capturing the target on active ligands.
• Custom Resin Development and OEM Supply Services Contract development and manufacturing services for chromatography resins, including peptide affinity ligand development using in silico bioinformatics, custom ligand design, application-specific resin customization, and OEM supply of Chelating Superflow/CellThru particles used as components in FDA-approved extracorporeal affinity apheresis medical devices.
• Regulatory Support Files and Drug Master File Services Provision of Regulatory Support Files and Drug Master Files (DMF) held with the US FDA and other regulatory agencies for clients using Sterogene resins in their purification processes for licensed therapeutics.

Quantifiable outcome

• Protein A Superflow 4 static binding capacity: 50 mg IgG/mL of resin
• +16 more outcomes

Segments5 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature10 records

Partnerships

Four partnerships are on record, tiered core and flagship.

• RJ Bio ProcesscoreChannel Partner/ Reseller/ DistributorSterogene has teamed up with RJ Bio Process, a leading supplier of chromatography equipment, to provide Chinese customers with Sterogene products and technical support. RJ Bio is located near Shanghai at Room 101, Block A, Building 2, OetPark, 69, Wei Xin Road, Su Zhou Industrial Park, Su Zhou. Contact: Tel 0512-80912011, Fax 0512-80912009.
• i-DNA Biotechnology Pte LtdcoreChannel Partner/ Reseller/ Distributori-DNA Biotechnology provides Sterogene products to markets in South East Asia (Singapore and Malaysia). Located at 237 Pandan Loop, #07-08 Westech Building, Singapore 128424. Contact: Tel (65) 6779 0665 (x107), Fax (65) 6776 0368.
• European Sales and Technical Service Partners (unnamed)coreChannel Partner/ Reseller/ DistributorSterogene has sales and technical service partners in Europe in order to better serve European customers. Specific partner names are not publicly disclosed; customers in Europe are directed to email [email protected] for routing.
• OEM Partners (unnamed biopharmaceutical and diagnostics companies)flagshipOEM/ Whitelabel/ Licensing PartnerSterogene's chelating resins (Chelating Superflow and Chelating Cellthru™) are used in several OEM products on the market. Their particles are already part of an FDA-approved extracorporeal device, and their resins are used in affinity apheresis medical devices for treatment of patients with Covid-19 infections, MI, strokes, etc.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Cytiva: A Danaher-owned bioprocess leader offering a comprehensive chromatography resin portfolio (e.g., MabSelect Protein A, Capto resins) plus columns, instruments, and services. Directly comparable to Sterogene in Protein A and affinity resin categories but at vastly larger scale and with bundled workflow offerings.
• Merck KGaA (MilliporeSigma): Life Science arm of Merck KGaA providing Eshmuno, ProSep, and Fractogel chromatography resins, plus full bioprocess workflow solutions. Competes with Sterogene across affinity, ion exchange, and IMAC resin categories serving the same biopharma manufacturers.
• Bio-Rad Laboratories: Diversified life science tools company offering Affi-Gel and UNOsphere chromatography resins, including specialty affinity and ion exchange media. Overlaps with Sterogene in activated resins (Affi-Gel) and IMAC categories.
• Sartorius AG: Global bioprocess supplier offering a full chromatography portfolio (e.g., Sartobind membrane adsorbers, resins) bundled with filtration, fermentation, and single-use solutions. Competes with Sterogene across the downstream purification workflow.
• Thermo Fisher Scientific: Through its Patheon and BioProduction Services businesses, Thermo Fisher offers POROS chromatography resins (Protein A, ion exchange, affinity) used in commercial biopharmaceutical manufacturing. A broad incumbent competing with Sterogene across multiple resin categories and bundled bioprocess offerings.

Direct peers

• Tosoh Bioscience: Specialty chromatography resin manufacturer (TOYOPEARL, TSKgel, Ca++Pure-HA) serving mAb and plasma protein purification. Most directly comparable to Sterogene in niche specialty resins with strong Protein A and affinity offerings for licensed biopharmaceutical manufacturing.
• Repligen Corporation: Specialty bioprocessing company with a strong chromatography franchise including AVIPure Protein A resins, OPUS pre-packed columns, and ELISA-based at-line analytics. Directly comparable as a specialty-focused resin and bioprocess consumables supplier to biopharma customers.
• Purolite (an Ecolab company): Specialty resin manufacturer offering Praesto agarose-based Protein A and ion exchange chromatography resins for bioprocessing. A direct competitor in the specialty affinity resin space Sterogene targets, particularly with biosimilar manufacturers.
• JSR Life Sciences: Through its Life Sciences division (including formerly KBI Biopharma and JSR Micro), offers Amsphere Protein A chromatography resins for mAb purification. A direct specialty resin competitor with growing presence in the cGMP bioprocess resin market.

Emerging players

• Cube Biotech: European specialty resin manufacturer offering Ni-NTA, Co-NTA, GST, and Strep-Tactin purification resins plus DIBE prepacked columns. Comparable as a niche specialty affinity and IMAC resin supplier serving both research and bioprocess customers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/sterogene

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Sterogene Bioseparation