Isolere Bio
Isolere Bio, a Donaldson Life Sciences subsidiary, develops and sells IsoTag reagents for non-chromatographic purification of AAV and lentiviral vectors used in cell and gene therapy manufacturing, serving CGT developers and CDMOs.
- Company typePrivate
- Founded2017
- HeadquartersDurham, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Isolere Bio does
Isolere Bio, operating as a subsidiary of Donaldson Company, Inc. (NYSE: DCI) since its February 2023 acquisition, develops and commercializes the IsoTag reagent platform for non-chromatographic purification of viral vectors used in cell and gene therapy manufacturing. The company's proprietary Affinity Liquid Phase Separation (ALPS) technology combines engineered stimulus-responsive biopolymers with affinity ligands that bind target biologics (AAV serotypes, VSV-G pseudotyped lentivirus, ssRNA) in solution and then phase-separate them into recoverable droplets, enabling downstream processing in under 4-8 hours using standard centrifugation or tangential flow filtration equipment. Commercial products include IsoTag AAV Reagent, IsoTag LV Reagent, an AAV Rapid Screening Kit, and complementary residual-reagent ELISA kits developed with Cygnus Technologies; pipeline development includes an IsoTag RNA reagent for mRNA therapeutics. Products are offered at prototype, research, and manufacturing grades (the latter under ISO 9001 certification with FDA-acknowledged Drug Master File) and are sold via Donaldson e-commerce and direct enterprise sales.
The company serves biopharmaceutical developers and CDMOs manufacturing adeno-associated virus and lentiviral vectors for gene therapies and CAR-T cell therapies, addressing the downstream purification bottleneck that drives high costs and 10-30% end-to-end yields in traditional chromatography-based workflows. Go-to-market combines direct enterprise sales (Business Development Managers supported by Field Application Specialists), industry conference presence (ASGCT, ACS-BIOT, ESGCT), and evaluation-kit-driven adoption cycles. Strategic alliances with Oxford Biomedica, Univercells Technologies, Aldevron, and the Ginkgo Bioworks-led BARDA consortium embed the technology into integrated upstream/downstream manufacturing platforms and government-funded biomanufacturing initiatives.
Isolere was founded in 2017 in Durham, North Carolina as a spin-out from Duke University (Kelli Luginbuhl, Ashutosh Chilkoti, Joseph McMahon) and had raised approximately $7M in equity from Northpond Ventures plus non-dilutive grants from NSF, NIH (SBIR), and the North Carolina Biotechnology Center prior to acquisition. Following the 2023 acquisition, revenue is not separately disclosed and is reported within Donaldson's Life Sciences segment.
Isolere Bio firmographics
Firmographics- Name
- Isolere Bio
- Legal name
- Isolere Bio, Inc.
- Website
- https://isolerebio.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Isolere Bio, a Donaldson Life Sciences subsidiary, develops and sells IsoTag reagents for non-chromatographic purification of AAV and lentiviral vectors used in cell and gene therapy manufacturing, serving CGT developers and CDMOs.
- Ownership category
- akta.pro rank
Isolere Bio industry classification
Industry- Product category
- Bioprocessing Reagents
- NAICS
- Biological Product (except Diagnostic) Manufacturing (325414)
- SIC
- Miscellaneous Chemical Products (2890)
- akta.pro primary industry
- Raw Materials & Critical Reagents Supply (Media/Resins/Cytokines) (HLAGAGAI)
- akta.pro secondary industries
- Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI), Gene Therapy Vector Manufacturing & CDMO Services (HLAAACAJ)
Keywords
Where Isolere Bio is headquartered
LocationHeadquarters
- HQ city
- Durham
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
Isolere Bio business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Supply Chain, Infrastructure, Marketing or Sales
Revenue model
- Reagent Product Sales: Sale of IsoTag AAV and IsoTag LV reagent evaluation kits and bulk reagent. Products available in prototype, research, and manufacturing grades. Customers purchase through shop.donaldson.com or contact sales directly.
- ELISA Kit Distribution: Residual IsoTag ELISA kits available through Cygnus Technologies partnership for quality control testing.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| One time/ perpetual license | Pay-as-you-go | 10mL Evaluation Kit for AAV purification |
| One time/ perpetual license | Pay-as-you-go | Manufacturing-grade reagent with regulatory support |
Go-to-market motion2 records
Distribution channels2 records
Marketing channels5 records
Isolere Bio product offering
Product offeringCore offering
Isolere Bio develops and manufactures proprietary IsoTag reagents that enable non-chromatographic purification of viral vectors (AAV and lentivirus) used in cell and gene therapy manufacturing. The reagents use Affinity Liquid Phase Separation (ALPS) technology, combining engineered affinity ligands with stimulus-responsive phase-separating biopolymers, and are offered across prototype, research, and manufacturing grades for sale to biopharmaceutical developers and CDMOs.
Product overview
Isolere Bio by Donaldson offers the IsoTag™ platform, a novel reagent technology for non-chromatographic purification of viral vectors used in cell and gene therapies. The platform consists of two core commercial products: IsoTag™ AAV Reagent for adeno-associated virus purification and IsoTag™ LV Reagent for lentiviral vector purification. Both products use Affinity Liquid Phase Separation (ALPS) technology combining engineered affinity ligands with stimulus-responsive phase separating biopolymers. The portfolio includes the IsoTag™ AAV Rapid Screening Kit for high-throughput small-scale applications and pipeline development of IsoTag™ RNA for mRNA purification. Products are offered across three quality grades (Prototype, Research, and Manufacturing) to support customers from early development through GMP production. Complementary ELISA kits (developed with Cygnus Technologies) enable residual reagent detection for quality control.
Differentiator
Problem solved
Functional benefit
Products and services
- IsoTag AAV Reagent Affinity liquid phase separation (ALPS) reagent for non-chromatographic purification of adeno-associated virus (AAV) vectors. Achieves >90% capture and 60-85% elution recovery in under 4 hours for multiple AAV serotypes (1, 2, 6, 8, 9, PHP.B, rh10) using ALPS-CF (centrifugation) or ALPS-TFF (tangential flow filtration) processes. Sold to cell and gene therapy developers and CDMOs.
- IsoTag LV Reagent Affinity liquid phase separation reagent for non-chromatographic purification and concentration of VSV-G pseudotyped lentiviral vectors. Enables processing in under 8 hours with high functional recovery and minimal optimization, consolidating multiple unit operations into a single TFF step. Sold to lentiviral vector manufacturers and CDMOs producing gene delivery for cell therapies.
- IsoTag AAV Rapid Screening Kit Small-scale AAV purification kit enabling rapid processing of up to 24 AAV samples in parallel using a simple centrifugation-based workflow. Designed for high-throughput screening workflows to support decision-making in AAV-based therapeutic development. Sold to AAV process development scientists.
- Prototype-Grade Reagents Early access IsoTag reagent samples with representative manufacturing for testing concepts, designs, and functionality. Supported by certificate of analysis, safety data sheet, and user manuals to enable customers to evaluate compatibility and optimize performance. Sold to bioprocessing R&D teams.
- Research-Grade Reagents Enhanced reliability and quality IsoTag reagents with raw-material traceability and animal-origin-free production under ISO 9001 certified quality management system. Suitable for preclinical work, optimization, and process development. Sold to research and process development teams.
- Manufacturing-Grade Reagents IsoTag reagents produced with validated processes including regulatory support files (RSFs), validation reports, and full design history files. Drug Master File (DMF) submitted to FDA for IsoTag AAV outlining manufacturing, processing, packaging, and storage. Sold to GMP and clinical-stage manufacturers.
- IsoTag AAV ELISA Kit Validated ELISA kit, distributed via Cygnus Technologies partnership, for detecting residual IsoTag AAV reagent. Provides sensitivity to less than 1ng/mL using a polyclonal two-site immune-enzymatic method and is qualified per FDA and ICH guidelines. Sold to QC and manufacturing QA teams for residual testing.
- IsoTag LV ELISA Kit Validated ELISA kit, distributed via Cygnus Technologies partnership, for detecting residual IsoTag LV reagent in final product, supporting quality control of in-process manufacturing and final product testing for cell therapy manufacturers.
Quantifiable outcome
- 25% reduction in cost of goods for clinical AAV programs
- +5 more outcomes
Companies that use Isolere Bio
Customer profileNamed customers1 record
Segments3 records
Ideal customer profiles3 records
Isolere Bio technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature6 records
Isolere Bio partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core and minor.
- Oxford BiomedicacoreResearch collaboration agreement to develop next-generation manufacturing solutions for lentiviral vectors. Oxford Biomedica's lentiviral platform technology (used in first FDA and EMA approved CAR-T cell therapy) combined with Isolere's IsoTag reagents and phase separation technology. Aims to develop easily scalable purification process with significantly improved yields and vector quality.
- Cygnus TechnologiescoreDistribution partnership for ELISA kits to detect residual IsoTag reagent levels. Kits provide sensitivity to <1ng/mL using polyclonal two-site immune-enzymatic method. Fully qualified by FDA and ICH guidelines including precision studies, spike-recovery, dilutional linearity, interference, and cross reactivity analysis. Manufactured in ISO 9001 certified facility.
- AldevronminorAgreement to develop scalable manufacturing of IsoTag reagents.
- Univercells TechnologiescoreJoint development of integrated upstream and downstream platform for viral vector manufacturing. Combining Univercells' scale-X fixed-bed bioreactor technology with Isolere's IsoTag LV reagent. Demonstrated LVV manufacturing at half the cost of traditional processes, reducing total manufacturing time by one week.
- Ginkgo Bioworks ConsortiumminorIsolere Bio by Donaldson participates as partner in BARDA-funded BioMaP-Consortium worth up to $22.2M, led by Ginkgo Bioworks. Project focuses on biomanufacturing monoclonal antibodies for filovirus infections. Isolere contributes expertise in viral vector processing.
- Donaldson Company, Inc.coreParent company acquisition completed February 2023. Donaldson (NYSE: DCI) acquired Isolere to build Life Sciences portfolio. Isolere now operates as Donaldson Life Sciences business unit focusing on bioprocessing solutions.
Scale indicators8 records
Recent moves6 records
Expansion highlights6 records
Isolere Bio competitors and assessment
Company assessmentDirect peers
- Cytiva: Cytiva (formerly GE Healthcare Life Sciences) is the dominant supplier of chromatography resins, columns, and bioprocessing consumables for biologics and viral vector purification. Directly competes with Isolere's IsoTag reagents in AAV and lentiviral downstream processing workflows.
- Purolite (Ecolab): Purolite (now an Ecolab Life Sciences company) manufactures ion exchange and affinity chromatography resins for biologic purification. Directly competes with IsoTag reagents as an alternative capture mechanism for AAV, LV, and other biologics.
- Tosoh Bioscience: Tosoh Bioscience manufactures chromatography resins (TOYOPEARL, TSKgel) widely used in biologics purification including gene therapy vectors. Competes head-to-head with IsoTag as an alternative capture and polishing solution for viral vectors.
- Repligen Corporation: Repligen provides chromatography resins (OPUS), TFF systems, and process analytics for biologics manufacturing, with significant presence in gene therapy and viral vector purification — a direct competitor to Isolere's purification reagents and TFF-based workflows.
Broad incumbents
- Sartorius AG: Sartorius is a major bioprocessing equipment and consumables provider, including BIA Separations' monolith chromatography for viral vectors and plasmids. Offers a broader portfolio than Isolere but overlaps in AAV/LV purification applications.
- Avantor: Avantor distributes bioprocessing materials, single-use solutions, and process chemicals to gene therapy manufacturers. Sells through similar channels and serves overlapping CDMO and biopharma customers as Isolere.
- Bio-Rad Laboratories: Bio-Rad supplies chromatography media (Nuvia, UNOsphere), process analytics, and life science reagents used in biologics and gene therapy manufacturing. Comparable in reagent-based business model targeting similar bioprocess customers.
- Thermo Fisher Scientific: Thermo Fisher's Bio Production Chemicals and Services division supplies process resins, buffers, and bioprocessing reagents through Patheon. Overlaps with Isolere in serving viral vector manufacturers; the new Isolere GM (Dion Aviki) previously led this exact Thermo Fisher business.
Emerging players
- Aldevron: Aldevron manufactures plasmids, mRNA, and proteins used in cell and gene therapy production. Has an existing partnership with Isolere for scalable IsoTag reagent manufacturing; serves overlapping gene therapy customers.
- Univercells Technologies: Univercells offers scale-X fixed-bed bioreactors for viral vector and gene therapy manufacturing and is an active co-development partner of Isolere. Comparable in serving the same customer segment with adjacent upstream technology.
Market position
Strengths4 records
Weaknesses4 records
Competitive moat5 records
Key risks4 records
Key highlights6 records
Customer concentration
Isolere Bio social profiles
Digital presenceIsolere Bio compliance and trust
Trust signalCompliance1 record
Isolere Bio financial estimates
Financial estimateRevenue estimate
Valuation estimate
Isolere Bio leadership team
Management profileNumber of profiles
Profiles8 records
Isolere Bio funding detail
Funding detailFunding overview
Funding rounds6 records
Investors4 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Isolere Bio M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Isolere Bio
What does Isolere Bio do?
Isolere Bio develops and manufactures proprietary IsoTag reagents that enable non-chromatographic purification of viral vectors (AAV and lentivirus) used in cell and gene therapy manufacturing. The reagents use Affinity Liquid Phase Separation (ALPS) technology, combining engineered affinity ligands with stimulus-responsive phase-separating biopolymers, and are offered across prototype, research, and manufacturing grades for sale to biopharmaceutical developers and CDMOs.
Is Isolere Bio a public or private company?
Isolere Bio is a private company. It is classified as corporate owned and is currently operating.
When was Isolere Bio founded?
Isolere Bio was founded in 2017. It employs 11 to 50 people.
Where is Isolere Bio based?
Isolere Bio is headquartered in Durham, United States, in the North America region.
How does Isolere Bio make money?
Two revenue lines are on record. Reagent Product Sales are the primary driver. The others are ELISA Kit Distribution.
Who are Isolere Bio's main competitors?
Direct peers on record are Cytiva, Purolite (Ecolab), Tosoh Bioscience and Repligen Corporation. Broad incumbents are Sartorius AG, Avantor, Bio-Rad Laboratories and Thermo Fisher Scientific. Emerging players are Aldevron and Univercells Technologies.
Does Isolere Bio have an API?
No public API is recorded for Isolere Bio.
What industry is Isolere Bio in?
Isolere Bio's product category is Bioprocessing Reagents. Its primary akta.pro industry code is HLAGAGAI, Raw Materials & Critical Reagents Supply (Media/Resins/Cytokines), with a secondary code of HLAGAIAI, Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes). Its NAICS code is 325414 and its SIC code is 2890.