cayman pharma neratovice, czech republic€¦ · act on pharmaceuticals no. 378/2007 coll. • gmp...
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Cayman Pharma Neratovice, Czech Republic
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Cayman Pharma s.r.o. Site Layout
NORTH
C5500 warehouse
B5170
C549A
C5490
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History of CP Operations
• 1978 - Prostaglandin development was initiated in Spolana with
Chemical Institute of Technology in Prague
• 1979 - (±)-Cloprostenol production launched
• 1990 - Human PGs, Alprostadil, and Dinoprostone launched
• 1993, 1996, 2000, 2003, 2011, 2014 - FDA audits
• 2002 - NeraPharm established as an independently operating
subsidiary of Spolana
• 2006 – Acquisition of Cayman Pharma s.r.o. by Cayman Chemical
• 2007 - Production of Epoprostenol launched
• 2008 - Production of Travoprost launched
• 2009 – Production of Latanoprost launched
• 2012 – Production of Entecavir launched
• 2014 - Technology transfer of Bimatoprost from CC
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Senior Management Senior Management Team
• Frank Cox, PhD – V.P. Global GMP Operations, 28 years of
experience in the Pharmaceutical Industry
• Ing. Petra Miketová, MBA, PhD - Managing Director, 20+ years of
experience in pharmaceutical field
• Ing. Jana Hartmanová –Director of Quality, Master of Chemistry,
20 + years of experience in pharmaceutical industry
• Ing. Jan Velík– Operations Director, Master of Chemistry,
20 + years of experience in fine chemicals and API production
• Jiřina Lidová – Commercial Director, Graduated specialist, 30+
years of experience in sales and marketing
• Ladislava Tintěrová – Finance Director, Graduate economist, 30+
years of experience in a financial management, accounting, and
controlling
• Jan Pavlík, PhD – R & D Director, Doctor of Pharmacy
10+ years of experience in chemical and biochemical synthesis
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Key Competencies- Cayman Pharma s.r.o.
• API production under cGMP conditions
• Research and development of prostaglandin substances
and specialty chemicals
• Custom chemical synthesis
• Cooperation with end-user in registration procedure
• Scaling-up of production
• Validation and qualification of processes and facilities
• Development and validation of analytical methods
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Cayman Pharma APIs Portfolio
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Cayman Pharma APIs Portfolio
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Quality Management System
• Quality System was developed in compliance with the
Act on Pharmaceuticals No. 378/2007 Coll.
• GMP system based on requirements stated in Decree
No. 411/2004 Coll., ICH Q7, CFR 21 and further
guidelines EMEA / FDA
• System subjected to regular audits
• Part of Integrated Management System (IMS);
certification according to ISO norms
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Integrated Management System (IMS)
QMS (Quality Management System) ISO 9001:2008
EMS (Environmental Management System) ISO
14001:2004
SMS (Safety Management System) OHS&S 18001:2007
• QMS was certified in 2004 and extended in 2007, 2010
and 2013.
• IMS certificate was granted by Lloyd's Register Quality
Assurance (LRQA) in 2014.
• Internal policies were approved during development of
IMS; these policies define engagements of the company
members on all levels.
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GMP Audits
• Audits of regulatory authorities (SÚKL, ÚSKVBL, FDA)
• Internal audits – revision of GMP and IMS compliance in
individual departments based on annual plan
• GMP Audits performed by customers
• CP audits of key suppliers to verify fulfillment of GMP
rules
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History of GMP Audits – Regulatory Authorities
*State Institute for Drug Control, Czech Republic
**Institute for the State Control of Veterinary Biologicals and Medicaments, Czech Republic
Name Date Product Result
FDA Jun 2-4, 2003 (+/-)-Cloprostenol Na In compliance
SÚKL* Feb 10-11, 2004 PGE1 and PGE2 In compliance
ÚSKVBL** Jan 13, 2005 4 Veterinary API In compliance
SÚKL Feb 7-8, 2007 PGE1, PGE2, PGI2 Na In compliance
ÚSKVBL Feb 7-8, 2007 4 Veterinary API In compliance
SÚKL Jul 15, 2008 Travoprost In compliance
SÚKL May 14, 2009 Alprostadil-Alfadex In compliance
SÚKL Oct 6-7, 2009 PGE1, PGE2, PGI2 Na,
Travoprost, Latanoprost
In compliance
ÚSKVBL Mar 16-17, 2010 4 Veterinary API In compliance
FDA Mar 14-17, 2011 Travoprost, GMP In compliance
SÚKL Oct 14-15, 2012 Entecavir, GMP In compliance
ÚSKVBL Mar 12-13, 2013 4 Veterinary API In compliance
FDA March 24-27,2014 Epoprostenol, GMP In compliance
SUKL Dec 2-3, 2014 Bimatoprost, GMP In compliance
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Research and Development
• Expansion of product portfolio and enhancement of
competitive ability of current production (production
scale-up, identification of critical synthesis parameters,
etc.)
• Original Corey synthesis has been modified by CP’s
unique procedures; CP claimed approx. 80 original
patents
• Cooperation with drug product manufacturers regarding
marketing applications (impurity standards preparation,
impurity profile determination)
• Creating development program of the company
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Support of R&D Activities - State and EU Funds
Grant Potential
• EU fund supports the development of the Research Center –
reconstruction of the building, purchase and installation of
equipment, including safety glove boxes, which are necessary for
handling of certain active substances (incl. Epoprostenol).
Grant TIP
• Cayman Pharma has been granted a state subsidy to support
development of prostaglandins for ophthalmological purposes
(antiglaucoma APIs - Latanoprost, Bimatoprost, Travoprost).
Grant TAČR
• The Czech Technological Agency supports the development of new
veterinary derivatives.
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Thank you for Your Attention