Our Services
API & PRODUCT DEVELOPMENT
Prague Scientific offers the best-in-class development services to our partners through knowledge, experience and innovative science.
Our end-to-end solutions range from development and manufacturing of the product to successful launch and compliant maintenance.
With our research and manufacturing sites based in the Czech Republic, we support our clients worldwide and provide them European based supply and manufacturing processes.
Our outstanding R&D Team (which consists of more than 200 experts) and modern technologies allow our partners to achieve great results within short timelines.
Our end-to-end solutions range from development and manufacturing of the product to successful launch and compliant maintenance.
With our research and manufacturing sites based in the Czech Republic, we support our clients worldwide and provide them European based supply and manufacturing processes.
Our outstanding R&D Team (which consists of more than 200 experts) and modern technologies allow our partners to achieve great results within short timelines.
API DEVELOPMENT
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DRUG PRODUCT DEVELOPMENT
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API DEVELOPMENT
Route Scouting
Services
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Process Development
and GMP Operations
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Solid Form Screening and
Analytical Development
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Route Scouting Services
- Literature search to establish current state of the art routes, as well as to identify synthetic routes options including designing novel routes
- Laboratory assessment and optimization in a small scale to select the most promising synthetic route including preparation of standards of impurities
- Synthesis of oligonucleotides
- Equipment available: Over 60 fume hoods and laminar flow boxes, Isolator for High Potent Actives (HPAPI) handling, wide range of Reactors with volumes ranging 0,1-20L, Autoclaves for pressurized reactions and hydrogenations
Process Development and GMP Operations
- Optimization of chemical reactions parameters utilizing Design of Experiments (DoE) and Quality by Design (QbD) principles (e.g. Cost of goods manufacturing, yield, cycle time, quality etc.)
- Process safety data measurement
- Designing scale-up and scale-down models
- Process validation of Development APIs for clinical trials and commercial supply
- Manufacturing of commercial APIs in the Prague kilolab, Ankleshwar (India) Pilot plant
- Equipment available: Reactors 25-2500L, Autoclaves 20-630L, Isolation and Drying Units, Sieving and Milling equipment, Spray Dryer
Solid Form Screening and Analytical Development
- Screening and process development of crystalline forms (polymorphs, hydrates, solvates, salts, cocrystals)
- Screening and process development of amorphous forms (amorphous APIs, co-amorphs and solid solutions by precipitation, hot melt extrusion (HME) or spray-drying)
- Particle size modification, API solubility increase systems
- Analytical method development, Validation and transfer
- Specification setting, Stability and Stress testing
- Preparation of CMC part of a Active substance master file (ASMF)
DRUG PRODUCT DEVELOPMENT
Preformulation
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Formulation
Development
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Analytical
Development
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Biopharmacy
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Clinical
Development
Development
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API and Powder Characterization
Reference product Characterization
- Physical and chemical stability, solubility and dissolution behavior (Intrinsic solubility)
- Basic phys-chem properties: pKa, log P, (Sirius T3 inForm), Hygroscopicity, Melting Point, TGA
- Solid form characterization: X-ray powder diffraction, infrared and Raman spectroscopy, differential scanning calorimetry, solid state nuclear magnetic resonance
- Particle size characterization: laser diffraction, optical microscopy, focused beam reflectance measurement
- Characterization of bulk powder properties and optimization of tablet composition based on powder rheology
- Troubleshooting and investigation of tablet hardening, softening, poor tablet disintegration, chemical degradation and solid form conversion
- Powder bulk and surface properties: powder rheometer, inverse gas chromatography, drop shape analyzer
- Water absorption: dynamic water sorption, thermo-gravimetric analysis
Reference product Characterization
- Reverse engineering of pharmaceutical solid dosage form product and investigation of key characteristics (e.g., stabilization, API particle size distribution) using Raman mapping, scanning electron microscopy, hot-stage microscopy
- Tablet disintegration: disintegration tester, texture analyzer
Excipients and Process Selection
Drug Delivery Dosage Form
Technology
- Drug to Excipient compatibility studies
- Process selection including Wet granulation, Dry granulation, Direct compression, Fluid Bed Pellet Processing etc
Drug Delivery Dosage Form
- Solid Oral Tablets/Capsules- Immediate release, Modified release, delayed release, Multi unit delivery systems (Pellets)
- Oral-Suspensions, solutions • Injections-Solutions, Suspensions
Technology
- Direct compression, Encapsulation, Dry granulation, Wet granulation , Wurster coating, Spray Drying, Hot melt extrusion, 3D Printing, Bi-Layer tablets, Coating
- Can handle Non-Cytotoxic Oncology OEB 1,2,3 and 4
- Equipped with Laboratory scale to Pilot scale to Commercial scale batch manufacturing with same design
- GMP/Clinical batch manufacturing and release • Process validation/Qualification and ICH Stability in all Zones
- Packaging (blisters) including nitrogen atmosphere
- Injectable ampoule/vial filling line under Nitrogen atmosphere
- Preparation of CMC part of a dossier
- Analytical method development (HPLC, UPLC, GC, IC, Dissolution, NMR, Mass, GC/MS, LC/MS etc)
- Analytical method validation and transfers
- Specification setting
- Stability and Stress testing (Heat, Moisture, Photo, Acid, Alkali, Oxidative etc)
- Evaluation and method development for various Nitrosamines impurities, Genotoxic impurities in API, Drug product, excipients
- Preparation of CMC part of a dossier
Evaluation of similarity between clinical batches
- Expanded biorelevant dissolution testing and in-vivo co-relation
- Precipitation inhibitor screening and evaluation
- Dissolution: USP 1 and 2, Biodiss (USP 3), Macroflux (dissolution-absorption), surface dissolution imaging, flow-through dissolution (USP 4), intrinsic dissolution rate
- Pilot and pivotal study design (PK, BES, PD, efficacy/safety)
