Vitas - Analytical Services
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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