Transcript Vitas - Analytical Services

Vitas - Analytical Services
Kompetanse & Tjenester
Norsk Biotekforum – "Møteplass kliniske
studier"
November 2013
Norsk Biotekforum – "Møteplass kliniske studier"
November 2013
Om Vitas
www.vitas.no

Vitas ble stiftet i 1994 av:
• Prof. Rune Blomhoff
• Prof. Christian A. Drevon
• Dr. Thomas E. Gundersen
• Oslo Innovation Center AS
• For tiden 14 høyt utdannete
personer med relevant
ekspertise innen instrumentel
kjemisk analyse
As Vitas, Oslo Innovation Center, Gaustadalléen 21, 0349 Oslo, Norway
as Vitas – Analytical Services - Oslo Innovation CentrePhone: +4722958631
Mail: [email protected]
www.vitas.no
Forskingparken i Oslo
www.vitas.no
As Vitas, Oslo Innovation Center, Gaustadalléen 21, 0349 Oslo, Norway
as Vitas – Analytical Services - Oslo Innovation CentrePhone: +4722958631
Mail: [email protected]
www.vitas.no
Vår visjon & Strategi
www.vitas.no
 Vår visjon er å være en spydspiss
innen faget analytisk kjemi i Norge.
 Strategien er å være «outstanding»
innen noen få områder og dermed
være foretrukken partner også for
større utenlandske selskaper.
 Vi opplever at norske selskaper
foretrekker å benytte en norsk service
tilbyder om kvaliteten og prisen er
konkurransedyktig.
Språk, kultur, geografisk nærhet, mennesker man kjenner = God
kommunikasjon = Kvalitet og levering på tid
As Vitas, Oslo Innovation Center, Gaustadalléen 21, 0349 Oslo, Norway
as Vitas – Analytical Services - Oslo Innovation CentrePhone: +4722958631
Mail: [email protected]
www.vitas.no
Service områder
www.vitas.no
 Biomarkør analyse
 Primærhelsetjenesten i Norge, 20
år
 Universiteter, Sykehus, Biobanker
• Fire pågående EU prosjekter –
FP7
• Dried Blood Spots
• Pharma & Nutra Services
 Analytical Oil Field Services
• Utviklingsprosjekter
• Rutineanalyser
As Vitas, Oslo Innovation Center, Gaustadalléen 21, 0349 Oslo, Norway
as Vitas – Analytical Services - Oslo Innovation CentrePhone: +4722958631
Mail: [email protected]
www.vitas.no
Spesial kompetanse
www.vitas.no









“High-throughput” bioanalyse
“Dried Blood Spots!
Marine oljer
Lipidomics
Struktur utredning
Næringsstoffer
APIer in komplekse matriser
Uvanlige APIer
 Oligomere
 Polymere
 Komplekse lipider
Fettløslige vitaminer
 Retinoider & Karotenoider
 Menaquinoner (VitK2s)
Lipidomics
As Vitas, Oslo Innovation Center, Gaustadalléen 21, 0349 Oslo, Norway
as Vitas – Analytical Services - Oslo Innovation CentrePhone: +4722958631
Mail: [email protected]
www.vitas.no
Teknikker & Instrumentering
www.vitas.no












HPLC - UPLC/RRLC – High Performance Liquid Chromatography
with various detection methods
GC – Gas Chromatography (FID) and GC-Mass Spectrometry (GCMS)
Headspace GC-FID/MS
UPLC/HPLC-MS –Mass Spectrometry (SQ, MS/MS, 3Q, iontrap,
TOF)
TLC/HPTLC – Thin Layer Chromatography
ELISA, EIA..
UV-VIS Spectrophotometry
NMR – Nuclear Magnetic Resonance (13C, 1H, 15N, 31P)
SPE - Solid Phase Extraction
Water content by Karl Fischer or drying methods
Physico-chemical parameters / mechanical parameters
Dissolution Testing
As Vitas, Oslo Innovation Center, Gaustadalléen 21, 0349 Oslo, Norway
as Vitas – Analytical Services - Oslo Innovation CentrePhone: +4722958631
Mail: [email protected]
www.vitas.no
Pharma Services
www.vitas.no
Vi utfører analyser for:
• Active Pharmaceutical Ingredients (API)
• Råmaterialer
• Eksipienter
• Faste formuleringer
• Tabletter
• Kapsler
• Flytende formuleringer
• Halvfaste formuleringer
• Geler
• Kremer
• Salver
As Vitas, Oslo Innovation Center, Gaustadalléen 21, 0349 Oslo, Norway
as Vitas – Analytical Services - Oslo Innovation CentrePhone: +4722958631
Mail: [email protected]
www.vitas.no
Analytical Pharma Services
www.vitas.no
 Analysis according to official monographs (PhEur,
USP, AOCS)
 Method development/implementation/optimization &
validation
 Technology Transfer to QA at Contract Manufacturing
Site
 Batch control & Release analysis
 QP- Qualified person service
 Stability studies
 Forced degradation studies
 Impurity profiles
 Structural Elucidation of Unknowns
 Reference Standard Characterization
As Vitas, Oslo Innovation Center, Gaustadalléen 21, 0349 Oslo, Norway
as Vitas – Analytical Services - Oslo Innovation CentrePhone: +4722958631
Mail: [email protected]
www.vitas.no
Analytical Pharma Services
www.vitas.no
Solubility studies
Response factor studies
Extractables/Leachables
Residual solvent analysis
Process support
Container closure integrity testing
Dissolution and disintegration
Regulatory support
Patent Infringement – Analytical support
As Vitas, Oslo Innovation Center, Gaustadalléen 21, 0349 Oslo, Norway
as Vitas – Analytical Services - Oslo Innovation CentrePhone: +4722958631
Mail: [email protected]
www.vitas.no
Klinisk utprøvning – Analytical service
Fase I, II, III, and IV
www.vitas.no
 Tech transfer & Implementering av
eksisterende metoder
 Utvikling av metoder
 Validering av metoder (ICH, EMEA, FDA)
 ”Dose confirmation”
 Stabilitet
 Frigivelse
 ADME
 Farmakokinetiske analyser
As Vitas, Oslo Innovation Center, Gaustadalléen 21, 0349 Oslo, Norway
as Vitas – Analytical Services - Oslo Innovation CentrePhone: +4722958631
Mail: [email protected]
www.vitas.no