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Cyclolab

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Budapest, HU

About Cyclolab

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CycloLab is a world-wide recognized and all-round cyclodextrin research and development company, having the longest tradition and broadest circle of customers. Since 1972, a staff of internationally acknowledged experts have been working on the fields of pharmaceutical, cosmetic and food industry, agrochemical, environmental and analytical applications of cyclodextrins. CycloLab has four main activities: - We produce sulfobutylether beta-cyclodextrin (SBECD, Dexolve™) in multiple ton scale annually under cGMP conditions based on an FDA-approved Drug Master File. - CycloLab operates as a CRO for cyclodextrin related services including: Development of products (pharma, cosmetic, food, agricultural industries), formulation development, early phase studies, bioequivalence studies, IP assessment, formulation optimization, etc Offering custom synthesis of cyclodextrins, fine-tailored for certain guest molecules (like Sugammadex) or other purposes, Performing pilot-scale cGMP compliant manufacturing of cyclodextrins to be used as APIs or excipients in clinical studies or cyclodextrin enabled formulations for the same purpose, and All analytical tasks related to the above, under GMP (method development, validation, stability studies for formulation ingredients (APIs, cyclodextrins) and final products as well). - CycloLab offers the widest variety of cyclodextrins in various grades (pharma, standard, fine chemical) in a web shop system for various purposes (research, analytics, cell cultures, formulation studies, etc). Besides “regular” derivatives, we always develop something new and special, like maltooligomers, polymers or fluorescent-tagged products. - As an R&D company, we develop next generation proprietary cyclodextrins and explore potential applications as well. CycloLab is also pioneer in supporting studies for the novel application of cyclodextrins. The company has been present from the early stage as a consultant in the realization of an application to treat the symptoms of a rare fatal disease, Niemann-Pick type C, a lysosomal storage disorder that strikes people generally before 10 years of age and is incurable. Hydroxypropyl Betadex, applied in the therapy could fundamentally change the standard of living and expand the expected lifespan of patients. This cyclodextrin has recently received an Orphan Drug designation by US FDA and EMA. Cyclolab can also boast with over 120 patents filed so far in this field, more than 450 publications from its staff over the years with cumulative citations exceeding 7000. Cyclolab publishes its own monthly journal on the advances in the field of cyclodextrins and several tutorial lectures on the applications of cyclodextrins.

Certifications & Qualifications

ISO 9001

Diversity Certificates

Small business

Our Services (27)


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Pharmaceutical Formulation

Price on request

Customization of CD enabled formulations, life-cycle management

During the lab experiments with an API/cosmetic ingredient/nutrient the need for improving certain characteristics may arise. Stability, water solubility, pharmacokinetics, bioavailability, etc. can be improved by cyclodextrins. Furthermore cyclodextrins are increasingly proving to be clinically appealing molecules by themselves. CycloLab offers conducting interaction studies to select the most effective cyclodextrin for your active, proof of concept studies and development of a new formulation with the selected cyclodextrin. The developed formulation is optimized and preliminary stability studies are performed. CycloLab also supports its customers with all analytical aspects related to the formulation, reporting to authorities, IP issues and relevant documentation.

HPLC Agilent 7820 GC Malvern Mastersizer 2000 NMR Antibiotic Development Inflammation CNS/Neurology Biology Drug Discovery Cyclodextrin Acetyl-cyclodextrin Cyclodextrin polymer Cyclodextrin sulfate Methyl-cyclodextrin Carboxymethyl-cyclodextrin sodium salt Cyclodextrin phosphate sodium salt Succinyl-cyclodextrin gram kilogram Oncology Immunology Infectious Disease Show 22 more tags Show less

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Custom Manufacturing

Price on request

CycloLab with its more than 40-year experience in cyclodextrin synthesis offers more than 150 different cyclodextrin (CD) derivatives! Upon customer's special request, our synthetic unit offers:

Custom synthesis of derivatives which are not on our standard product lists
Taylor-made cyclodextrin derivatives with special substituents or substitution pattern
Development and optimization of purification and isolation methods
Preparation of cyclodextrin derivatives optimized for a particular target guest molecule
Derivatized maltooligomers and special glucose derivatives derived from cyclodextrins
Cyclodextrin-assisted organic syntheses
Reproduction and evaluation of syntheses reported in the literature
Standardized preparation methods
Scaling-up synthetic procedures for the preparation of selected CD derivatives.

Agilent 7820 GC HPLC NMR LC-MS/MS Malvern Drug Discovery (2-Carboxyethyl)-cyclodextrin sodium salt Acetyl-cyclodextrin Butyl-cyclodextrin Cyclodextrin Carboxymethyl-cyclodextrin sodium salt Cyclodextrin phosphate sodium salt Cyclodextrin polymer Cyclodextrin sulfate Succinyl-cyclodextrin Heptakis(2,3,6-tri-O-methyl)-cyclodextrin Methyl-cyclodextrin gram kilogram Show 19 more tags Show less

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Specialty and Fine Chemicals

Price on request

Cyclolab is a provider of a wide range of cyclodextrins and cyclodextrin derivatives. We have over 100 derivatives in out portfolio in several product categories:
Pharma Grade Cyclodextrins
Standard Grade Cyclodextrins
Nonionic Cyclodextrins
Anionic Cyclodextrins
Cationic Cyclodextrins
Maltooligomers
Single Isomer Cyclodextrins
Fluorescent Cyclodextrins
Fluorescent Polymers
Cyclodextrin Polymers
Complexes
HPLC Columns

Analytical HPLC Agilent 7820 GC LC-MS/MS NMR Malvern UV Detectors Drug Discovery (2-Carboxyethyl)-cyclodextrin sodium salt Cyclodextrin Butyl-cyclodextrin Cyclodextrin polymer, soluble Cyclodextrin sulfate Hexakis (2,3,6-tri-O-acetyl)-cyclodextrin Heptakis(2,3,6-tri-O-ethyl)-cyclodextrin Octakis (2,3,6-tri-O-methyl)-cyclodextrin Succinyl-(2-hydroxypropyl)-cyclodextrin 6-O-Maltosyl-cyclodextrin hydrate gram kilogram Show 19 more tags Show less

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Batch Release Testing

Price on request

During the development of a new cyclodextrin derivative, a formulation with cyclodextrins or even during in vivo experiments, the efficient analysis of the cyclodextrin component can be challenging especially without proper experience.
CycloLab can assist you with finding the ideal analytical method for your needs owing to its vast experience in the field of cyclodextrins: to characterize cyclodextrins, cyclodextrin complexes, to perform related analysis (API assay, formulation specific characterization).
Our experience also includes analysis of cyclodextrins in such complex biological matrices like blood plasma or liquor samples.
The applied techniques include traditional analytical techniques, HPLC, GC, MS and hyphenated-MS, NMR, IR, CE, Dynamic and Static Light Scattering, Bioburden and Bacterial Endotoxin Content and so on.
Complete or partial analysis of the following cyclodextrin derivatives according to the current pharmacopeial monographs: Alphadex, Betadex, Gammadex, Hydroxypropylbetadex and Betadex Sulfobutyl Ether Sodium.

HPLC NMR UV Detectors Agilent 7820 GC Malvern LC-MS/MS Drug Discovery Show 7 more tags Show less

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Product Stability Testing

Price on request

During the development of a new cyclodextrin derivative, a formulation with cyclodextrins or even during in vivo experiments, the efficient analysis of the cyclodextrin component can be challenging especially without proper experience.
CycloLab can assist you with finding the ideal analytical method for your needs owing to its vast experience in the field of cyclodextrins: to characterize cyclodextrins, cyclodextrin complexes, to perform related analysis (API assay, formulation specific characterization).
Our experience also includes analysis of cyclodextrins in such complex biological matrices like blood plasma or liquor samples.
The applied techniques include traditional analytical techniques, HPLC, GC, MS and hyphenated-MS, NMR, IR, CE, Dynamic and Static Light Scattering, Bioburden and Bacterial Endotoxin Content and so on.
Complete or partial analysis of the following cyclodextrin derivatives according to the current pharmacopeial monographs: Alphadex, Betadex, Gammadex, Hydroxypropylbetadex and Betadex Sulfobutyl Ether Sodium.

HPLC Agilent 7820 GC NMR LC-MS/MS Malvern UV Detectors Show 6 more tags Show less

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Product Development, Testing, and Packaging

Price on request

During the development of a new cyclodextrin derivative, a formulation with cyclodextrins or even during in vivo experiments, the efficient analysis of the cyclodextrin component can be challenging especially without proper experience.
CycloLab can assist you with finding the ideal analytical method for your needs owing to its vast experience in the field of cyclodextrins: to characterize cyclodextrins, cyclodextrin complexes, to perform related analysis (API assay, formulation specific characterization).
Our experience also includes analysis of cyclodextrins in such complex biological matrices like blood plasma or liquor samples.
The applied techniques include traditional analytical techniques, HPLC, GC, MS and hyphenated-MS, NMR, IR, CE, Dynamic and Static Light Scattering, Bioburden and Bacterial Endotoxin Content and so on.
Complete or partial analysis of the following cyclodextrin derivatives according to the current pharmacopeial monographs: Alphadex, Betadex, Gammadex, Hydroxypropylbetadex and Betadex Sulfobutyl Ether Sodium.

HPLC NMR LC-MS/MS UV Detectors Agilent 7820 GC Malvern Show 6 more tags Show less

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Intellectual Property Consulting

Price on request

Currently cyclodextrins are applied in more than thirty drug formulations and this number keeps increasing. Most of these products are heavily patented.
CycloLab can provide alternative solutions for circumventing the patent claims as well as strategies for life cycle management.
In case you are developing a new product, we can help you find the novel, non-infringing possibilities using a comprehensive search in our over 50.000 item large paper and patent database, saving our customers cost, time and effort.
After an extensive data mining we can provide you with an information package report targeted to your individual purposes or help you with the compilation of a patent application. Being the applicant of over 130 patents so far, Cyclolab can surely be of your help in this field.
Besides pharmaceutical applications we provide literature services in the fields of CD synthesis, complex formation, CD application in cell biology, food and cosmetic industry, agriculture, etc.


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Drug Development

Price on request

Customization of CD enabled formulations, life-cycle management

During the lab experiments with an API/cosmetic ingredient/nutrient the need for improving certain characteristics may arise. Stability, water solubility, pharmacokinetics, bioavailability, etc. can be improved by cyclodextrins. Furthermore cyclodextrins are increasingly proving to be clinically appealing molecules by themselves. CycloLab offers conducting interaction studies to select the most effective cyclodextrin for your active, proof of concept studies and development of a new formulation with the selected cyclodextrin. The developed formulation is optimized and preliminary stability studies are performed. CycloLab also supports its customers with all analytical aspects related to the formulation, reporting to authorities, IP issues and relevant documentation.

Antibiotic Development CNS/Neurology HPLC Agilent Gas Chromatograph 7890A NMR LC-MS/MS Drug Discovery Biology Oncology Inflammation Cyclodextrin Cyclodextrin polymer gram kilogram Infectious Disease Show 15 more tags Show less

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Chemical Synthesis

Price on request

CycloLab with its more than 40-year experience in cyclodextrin synthesis offers more than 150 different cyclodextrin (CD) derivatives! Upon customer's special request, our synthetic unit offers:

  • Custom synthesis of derivatives which are not on our standard product lists
  • Taylor-made cyclodextrin derivatives with special substituents or substitution pattern
  • Development and optimization of purification and isolation methods
  • Preparation of cyclodextrin derivatives optimized for a particular target guest molecule
  • Derivatized maltooligomers and special glucose derivatives derived from cyclodextrins
  • Cyclodextrin-assisted organic syntheses
  • Reproduction and evaluation of syntheses reported in the literature
  • Standardized preparation methods
  • Scaling-up synthetic procedures for the preparation of selected CD derivatives

Sugammadex and related compounds

Sugammadex is one of the greatest success in the history of cyclodextrins. There is an increasing interest for this product and for the development of generic Bridion since the recent approval by the FDA is estimated to have a 3-4-fold increase in the global sales of the product.
CycloLab has vast experience in the production of perhalogenated-γ-CD intermediates and of Sugammadex, supported by readily available sensitive analytical tools to characterize the products. Our current focus is on the isolation and declaration of primary reference standard materials including the API and its intermediates as well as a great number of custom synthesized potential process impurities.

The cyclodextrin component of a cyclodextrin-enabled medical diagnostic tool needs to be of consistent quality for reproducibility reasons. This criterion can only be met via GMP manufacturing. Likewise, cyclodextrins used in clinical trials are also essential to be manufactured under GMP conditions.
CycloLab offers manufacturing cyclodextrins and certain cyclodextrin-enabled formulations under cGMP conditions in its in-house clean area, which has been authorized for manufacturing pharmaceutical ingredients.
This offer is also ideal for cyclodextrin-based clinical investigational products where a simplified preclinical safety study is adequate.Our offer includes the compilation of the product specification and related analytical services as well as stability studies.
Once a comprehensive data package is compiled we can support our customers with every necessary information for filing DMF/CTD/IMPD dossier.The production output of our site reaches several kilograms, a capacity ideal for medical diagnostic tools and clinical investigational products.

HPLC Agilent 7820 GC LC-MS/MS Malvern UV Detectors NMR (2-Carboxyethyl)-cyclodextrin sodium salt Cyclodextrin Acetyl-cyclodextrin (2,6-Di-O-)ethyl-cyclodextrin Heptakis(2,3,6-tri-O-benzoyl)-cyclodextrin Methyl-cyclodextrin Octakis (6-O-t-butyldimethylsilyl)-cyclodextrin Succinyl-cyclodextrin gram kilogram ton Show 17 more tags Show less

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Analytical Chemistry Services

Price on request

During the development of a new cyclodextrin derivative, a formulation with cyclodextrins or even during in vivo experiments, the efficient analysis of the cyclodextrin component can be challenging especially without proper experience.
CycloLab can assist you with finding the ideal analytical method for your needs owing to its vast experience in the field of cyclodextrins: to characterize cyclodextrins, cyclodextrin complexes, to perform related analysis (API assay, formulation specific characterization).
Our experience also includes analysis of cyclodextrins in such complex biological matrices like blood plasma or liquor samples.
The applied techniques include traditional analytical techniques, HPLC, GC, MS and hyphenated-MS, NMR, IR, CE, Dynamic and Static Light Scattering, Bioburden and Bacterial Endotoxin Content and so on.
Complete or partial analysis of the following cyclodextrin derivatives according to the current pharmacopeial monographs: Alphadex, Betadex, Gammadex, Hydroxypropylbetadex and Betadex Sulfobutyl Ether Sodium.

Capillary HPLC HPLC Agilent 7820 GC LC-MS/MS NMR Malvern Mastersizer 2000 Perkin Elmer UV/Vis Spectrometer Lambda 25 Show 7 more tags Show less

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In vitro Bioavailability/Bioequivalence Studies

Price on request

Design and performance of in vitro studies to support bioequivalence of a CD enabled formulation

The ever spreading applications of cyclodextrins in generic pharmaceutical formulations draw the need to support the hypothesis that the generic formulation is bioequivalent to the originator one. Cyclolab has tremendous experience in the field of in vitro bioequivalence studies that can support this claim and save the huge costs and efforts of preclinical and clinical studies.

Our bioequivalence services include:

  • Regular consultancy
  • Compilation of literature data
  • Membrane penetration studies
  • Protein binding studies
  • Evaluation of binding affinity between cyclodextrin and guest
  • Physical and chemical stability studies

Antibiotic Development HPLC UV Detectors Cyclodextrin Oncology Infectious Disease Show 6 more tags Show less

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Analytical Method Development

Price on request

During the development of a new cyclodextrin derivative, a formulation with cyclodextrins or even during in vivo experiments, the efficient analysis of the cyclodextrin component can be challenging especially without proper experience.
CycloLab can assist you with finding the ideal analytical method for your needs owing to its vast experience in the field of cyclodextrins: to characterize cyclodextrins, cyclodextrin complexes, to perform related analysis (API assay, formulation specific characterization).
Our experience also includes analysis of cyclodextrins in such complex biological matrices like blood plasma or liquor samples.
The applied techniques include traditional analytical techniques, HPLC, GC, MS and hyphenated-MS, NMR, IR, CE, Dynamic and Static Light Scattering, Bioburden and Bacterial Endotoxin Content and so on.
Complete or partial analysis of the following cyclodextrin derivatives according to the current pharmacopeial monographs: Alphadex, Betadex, Gammadex, Hydroxypropylbetadex and Betadex Sulfobutyl Ether Sodium.
http://cyclolab.hu/services/40

HPLC Agilent 7820 GC NMR LC-MS/MS UV Detectors Malvern Show 6 more tags Show less

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Drug Discovery & Development

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Manufacturing Services

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Pharmacology & Toxicology

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Business Development Consulting

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Purified Proteins

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Biochemistry & Molecular Biology

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Project Management

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ADME/DMPK Studies

Drug Metabolism and Pharmacokinetics
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Formulation Services

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Protein Production

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Assay Development

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Chemistry and Materials

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Protein Services

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Synthetic Chemistry

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Biology

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Tamas Sohajda

R&D Director

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