Services
- Development of laboratory synthesis for new chemical entities (NCE)
- Scaling-up processes to commercial scale
- Development of analytical procedures to be used in quality control
- In-house impurities and reference standards
- Assistance for regulatory documentation
- Polymorphism studies; in-house and through our university network
- Toxicity studies of process impurities.
People
PCAS R&D team consists of dedicated and highly qualified experts in their respective fields:
- PhD's and MSc's specialized in the development and scale-up of organic synthetic routes.
- PhD's and MSc's specialized in development of analytical methods.
- Trained technicians support the project team
Specific project teams are set up to fulfil needs of each project and to take into account all aspects of the research work. The customer is regularly kept updated on progress; PCAS emphasizes the importance of mutual communication in its daily work.
Synthesis Laboratory: relevant points
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Analytics: Synthetic chemistry at PCAS is backed by state of the art comprehensive analytical technologies
- 250, 300, 400 MHz NMR
- LC-MS system
- GC-MS system
- HPLC equipment
- GC equipment
- Headspace GC
- HPIC equipment
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Special Equipment and technologies:
- Hydrogenators 0,25 L, 1L, 4L Air-moisture sensitive reactions in an inert atmosphere.
- Safe handling of cyanide
- Safe handling of hydride and Lithium reagents
- Expertise in biocatalysis integrated to chemical synthesis: enzymatic reactions
- Metalloorganic reactions and metal scavenging
- Thin film distillation
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Analytical Development
The analytical development of PCAS consists of four experienced teams one at each PCAS cGMP site: PCAS Limay, PCAS Finland, VLG Chem and Expansia
The teams make sure that the analytical development fit with the needs of our clients all throughout the lifecycle phases from early phase I to commercialized products.
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All our equipments are qualified according to cGMP guidelines
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Services of Analytical Development team include
- Analytical method development for new products
- Optimisation of known methods
- Validation of analytical methods
- Stability studies methods
- LC/MS/MS studies of impurities and products
- Analytical reference standards preparation
- Genotoxic trace detection
- Adaptation of standard Pharmacopoeia techniques
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Wide range of techniques in use
- HPLC/UV, DAD and ELSD
- HPLC/MS/MS
- HPIC/conductivity detector
- GC/FID
- GC/NPD
- GC/MS
- NMR
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Process safety studies
Safety studies are conducted in co-operation with PCAS Process Development team having in-house:
- Automated reaction calorimeter (2/3 equipments)
- DSC, RSST Equipment
Scale-Up
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Kilo-laboratory
Kilo-Lab at PCAS is a:
- Separate unit within the R&D department.
- Highly qualified people from R&D laboratory can operate in the kilo-lab production when needed. Kilo laboratory is fully operating under cGMP environment.
- Up to kg scale: fast response to customers who need development quantities for clinical trials.
Kilo-lab equipment:
- Up to 10 litre double jacketed reactors with temperature range -40°C to +180°C
- Two Kilolabs with one completely dedicated to Cytotoxic compounds
- Sensitive product kilolab, i.e. Steroid
- Hydrogenators equipment: 0.5 to 4L
- "In process" equipment control
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Pilot workshops
Integrated into R&D, the pilot is a key link in the transfer to production and fully operating under cGMP environment.
Pilots equipment:
- double jacketed reactors with temperature range -100°C- +180°C (up to 4000L)
- End Product isolation units
- Injectable Product space
- Up to 2500 L vessel
- Up to 100L drying filters
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