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R&D and GMP grades share identical release specifications — develop on R&D grade, then move to GMP without repeating enzyme characterisation.

Kerry (formerly c-LEcta) Verified partner

Kerry (formerly c-LEcta) engineers and manufactures enzymes for regulated biomanufacturing at the Kerry Biotechnology Centre in Leipzig, Germany. BioHippo is the authorized US distributor for the Denarase® nuclease portfolio, the Denarase® ELISA Kit for residual endonuclease quantification, and CellTrypase animal origin-free cell dissociation enzyme — supplied in matched R&D and GMP grades for a documented path from process development to commercial supply.

Kerry (formerly c-LEcta) develops and manufactures enzymes and microbial production strains for regulated markets at the Kerry Biotechnology Centre in Leipzig, Germany. The business was founded as c-LEcta GmbH in 2004, joined Kerry Group in 2022, and is now being brought fully under the Kerry brand; c-LEcta GmbH remains the legal manufacturing entity. Its portfolio is built specifically for biopharmaceutical downstream processing.

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Its Denarase® endonucleases hydrolyse phosphodiester bonds in all forms of nucleic acid — single- and double-stranded, linear, circular and supercoiled DNA and RNA — down to fragments of roughly 3–5 base pairs. In viral vector and vaccine manufacturing this reduces lysate viscosity, clears host cell DNA, and simplifies the purification steps that follow.

Two variants cover the full process window. The standard Denarase®, referred to by the manufacturer as the wild-type variant, performs best at low to physiological salt (0–150 mM) and remains the more economical option there. Denarase® High Salt is engineered to retain activity from 0 to 500 mM, enabling salt-supplemented lysis conditions that can improve viral vector recovery.

Both variants are produced without raw materials of animal origin, without materials carrying a TSE/BSE risk and without antibiotics, in a gram-positive Bacillus sp. host that removes the endotoxin risk inherent to gram-negative expression systems. Within each product, R&D and GMP grades carry identical release specifications, and regulatory support documentation is available on request.

BioHippo is Kerry's authorized US distributor, supplying the Denarase® portfolio, the companion ELISA kit, and CellTrypase from US-facing stock — R&D grade ships from US inventory in 2–3 business days.

EU GMPISO 9001EXCiPACT® (CellTrypase GMP grade)VerifiedAuthorized US Distributor
Kerry (formerly c-LEcta)
6
Product lines
Germany
Origin
R&D grade in US stock — 2–3 business days; GMP grade 1–2 weeks
Lead time
Germany · Ships worldwide via BioHippo
Why work with them

What makes Kerry (formerly c-LEcta) different

Full salt-spectrum DNA clearance

Standard Denarase® at 0–150 mM and Denarase® High Salt at 0–500 mM, both across pH 7.4–9. High activity on single- and double-stranded, linear, circular and supercoiled DNA and RNA, cleaving to fragments of around 3–5 base pairs. Magnesium is an essential cofactor: the optimum is 1–2 mM Mg2+ for standard Denarase®, while Denarase® High Salt is run at 5 mM MgCl2 as standard and gains activity up to 25 mM. Temperature optimum 37 °C.

Matched R&D and GMP grades

Within each product, both grades are released against the same specification: activity above 250 U/µL, purity ≥ 99% for standard Denarase® and ≥ 98% for Denarase® High Salt, specific activity above 6 × 10⁵ U/mg for standard Denarase® and at least 4 × 10⁵ U/mg for Denarase® High Salt, and endotoxin below 0.25 EU/kU. R&D grade is produced under ISO 9001; GMP grade under EU GMP.

Built for regulated manufacturing

Produced without antibiotics, without raw materials of animal origin and without materials carrying a TSE/BSE risk. Gram-positive Bacillus sp. expression host. Supplied in non-pyrogenic, USP Class VI compliant vials under tamper-evident secondary packaging. Validation Guide, qualification guidance and change-control documentation available on request.

Key techniques

Where they're strong

Kerry (formerly c-LEcta) enzymes support downstream bioprocessing, viral vector and vaccine manufacturing, and residual-impurity quality control

Host Cell DNA RemovalViral Vector Production (AAV, Lentivirus)Vaccine ManufacturingDownstream Purification & Viscosity ReductionHigh-Salt Lysis ProcessingResidual Nuclease Quantification (ELISA)Animal Origin-Free Cell DissociationEnzyme Engineering & Optimization (ENESYZ®)GMP ManufacturingRegulatory Documentation Support
Catalog scope

Product lines & services

Four Kerry (formerly c-LEcta) products available from BioHippo in the United States, spanning nucleic acid clearance, clearance validation, and animal origin-free cell dissociation

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Quality & logistics

QC, documentation & shipping

Quality control & documentation

Every batch is released against a fixed specification, with the documentation qualification teams require

Quality control
Performed & documented
Batch release specificationAppearance: clear, transparent solution. Activity above 250 U/µL by photometric assay. Purity ≥ 99% (standard Denarase®) or ≥ 98% (Denarase® High Salt) by SDS-PAGE with silver staining. Specific activity above 6 × 10⁵ U/mg for standard Denarase® and at least 4 × 10⁵ U/mg for Denarase® High Salt. No protease activity detectable (standard Denarase® release specification). Endotoxin below 0.25 EU/kU by LAL per Ph. Eur. 2.6.14 Method C. Microbial count per Ph. Eur. 2.6.12: aerobic bacteria and yeast or moulds each below 5 cfu per 200 µL.
Clearance validationThe Denarase® ELISA Kit is a monoclonal antibody-based sandwich ELISA for residual Serratia marcescens endonuclease in process samples, covering standard Denarase®, Denarase® High Salt and Benzonase®. Limit of detection 4 pg/mL, limit of quantification 12 pg/mL, working range approximately 32–1,000 pg/mL, assay time approximately 130 minutes. For High Salt, apply a correction factor of 1.46. Benzonase® is a registered trademark of Merck KGaA.
Documents availableProduct Information Sheets and Product Specifications for R&D and GMP grades; Validation Guide; guidance on qualifying Denarase® in biopharmaceutical manufacturing; Change Guidance Document for grade transition; ELISA Kit user instructions, kit contents and prevalidation report.
Documentation
Available on request
Certificate of Analysis MSDS / SDS HPLC report Quality Policy

Lead time & shipping

R&D-grade enzyme is held in US stock. GMP grade is held at the manufacturer. Enzymes ship cold-chain; CellTrypase ships ambient.

Lead times
Denarase® and Denarase® High Salt, R&D grade: in US stock, ships in 2–3 business days. GMP grade: in stock at the manufacturer, 1–2 weeks. Denarase® ELISA Kit: typically 1–2 weeks depending on region. Bulk and GMP quantities above catalogue sizes may follow scheduled delivery — request a quotation.
Storage and shipping
Denarase® enzymes: store at −20 °C ± 5 °C. Shelf life is at least 36 months for standard Denarase® and at least 30 months for Denarase® High Salt — counted from the date of manufacture for GMP grade and from the date of product release for R&D grade. Do not store at −70 °C or below; deep freezing causes loss of activity. Shipped under qualified cooled conditions; transit temperature may differ from storage temperature without affecting quality. Denarase® ELISA Kit: store at 2–8 °C, 18-month shelf life. CellTrypase: store at 2–8 °C protected from light, ships ambient.

Request a quote from Kerry (formerly c-LEcta)

Tell us your target and application — a BioHippo scientist will shortlist options and pricing, usually within one business day.

One vendor, one PO — sourced through BioHippo
COA / MSDS / QC on request
Bulk & custom pricing available