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Cyclolab Ltd

Company presentation of Cyclolab Ltd
by

Tamas Sohajda

on 16 February 2016

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Transcript of Cyclolab Ltd

CycloLab Ltd
Who are we?
The world's only all-round Cyclodextrin Service Provider
Cyclolab's Product and service Portfolio
Cyclolab's Evolution
Team and Resources
Getting the best out of Cyclodextrins
R&D and manufacturing kept at the same hand!
Experiences
Cyclolab started as a spin-off in 1990. Since...
over 400 scientific papers
over 7000 citation to the papers
over 600 customer reports

~ 150 CD derivatives
~ 120 patent applications
~ 40 products on the market with Cyclolab contribution (3 drug products)

Compilation of DMFs and CTDs
Expertise and Technology
Custom synthesis
Drug solubilization, stabilization
Controlled Release
Pre-formulations
Drug targeting
Cyclodextrin related analytics
Stability testing
GMP conform manufacturing
Products
pharma grade CDs
standard grade CDs
CD polymers
GMP
manufacturing
Dexolve (R)
Custom GMP Synthesis
fine chemical grade CDs
single isomer CDs
maltooligomers
Fluorescent tagged CDs
CD complexes
CD derivatives
Complexes
Investigational medicinal products

R&D Services
36 months stability data
No OOS results in over 40 batches
Annual capacity over 6,000 kgs
NO DOWN PAYMENT
NO MILESTONE PAYMENT
NO ROYALTY PAYMENT
Thank you for your
kind attention!
Team
Resources
Quality System
19 qualified scientists
8 PhDs
2 MBAs
4 members in the QA team
17 well qualified technicians


By profession: biologists, chemists, chemical engineers, pharmacists


On 2,000 sq meter self-owned property
2 technology/formulation labs

3 analytical labs (HPLC, GC, CE)

2 synthetic chemistry labs

150 sq m cGMP facility (custom projects)

350 sq m cGMP facility (Dexolve dedicated)

Freeze drying units
ISO 9001:2009

cGMP

Manufacturing authorization for production of Investigational Medicinal Prodcts (2007)
Foundation of Cyclolab Ltd. (1990)
Research and Development studies, early phase drug development, exploring potential in CDs
(1990 - ever since)
Obtaining ISO 9001 certificate

Establishment of
a smaller GMP facility
(2002)
Audited and approved by the Hungarian Pharmaceutical Regulatory Authority

Obtaining manufacturer's license for investigational medicinal products
(2007)
Development of a proprietary technology for the production of Sulfobutyl-ether-beta-cyclodextrin (SBECD, Dexolve-7)
(2006-2008)
SBECD DMF accepted by
the FDA, Health Canada
(2008, 2009)
Dedicated cGMP plant established
for the SBECD production
(2010)
EUDRAGMDP registration,
annual SBECD capacity
is over 2,500 kgs
(2014)
Early phase drug development
Customization of CD Enabled Formulations


Investigation of changes in the physico-chemical properties


Life-Cycle management
In vitro bioequivalence studies
Design and performance of in vitro studies to support bioequivalence of a CD enabled formulation
Custom cyclodextrin / complex synthesis
Exclusive manufacture


Unique synthetic routes


Tailor-made products and characteristics


Lab scale synthesis, pilot scale production
Analytical services
Method development and validation


cGMP release testing of pharma grade CDs


In-house: HPLC, CE, GC, UV, KF


Access to: MS, NMR, LC-MS, CE-MS, IR, Micro, Bioburden


ICH Stability studies
CD-guest interaction studies
Assay and impurity tests
CD-based chiral separations
Bioanalytical investigations
IP services and consultation
30 years of experience in compilation of CD related patents (synthesis, application, etc)



Patent claim analysis



Consultancy in CD related projects



Database of over 62,000 CD related papers
You may extend the patent life of your product by
transforming the "old" active

in a new, molecularly- dispersed form (novel solid state)

in a non-covalent manner

within a short time

at low cost

without making NCE -
Shorter approval process
„drug delivery, targeting, nano-sizing,
crystal engineering”
Early phase drug development
Make NCE/molecules „drugable” or
improve good molecules in their:

Water solubility

Stability

Aggregation

Taste

ADME properties

Toxicity

extend the patent life of your drug or circumvene existing patents
penetrate new markets by reformulation
Example 1
Cyclolab Service
Result
nanosizing the compound

selecting the most suitable CD

preparing a new formulation with hydrophilic coating aroud the drug
new solid phase

improved solubility and delivery

water activated formulation - delivery by dilution

enhanced bioavailability - possible dose reduction
Sporanox
Voltaren ophta
dyloject
Example 1I
Cyclolab Service
Result
putting a molecular coating around the API with a sugar nanoring to cover taste
Reduced taste of the drug

Patient compliance

Pediatric oral forms

ODT developments
Zyrtec
Nicorette
Example 1II
Cyclolab Service
Result
We package/shield your molecule - make a nano-sized barrier around your substance
Improved chemical stability (oxygen, light, hydrolysis, isomerization, etc.)

Improved physical stability (evaporation, migration, phase transition, crystallization, etc.)

Extended shelf-life (long-term stability)
Prostarmon
Prostavasin
Experience in the analysis and quantification of cyclodextrins in biological matrices

Selective and sensitive methods

Methods based on the fluorescence enhancing effect of CDs.

Protein Binding
Molecular Modeling
Computer docking
Membrane penetration
interaction studies
Comprehensive formulation characterization

Annual SBECD capacity
is over 6,000 kgs
(2016)
Full transcript