ONZETRA Xsail is a Food and Drug Administration (FDA)-approved intranasal dry powder formulation developed by Avanir Pharmaceuticals.
SBW is a consolidated CRO company that provides an extensive range of world-class services for drug discovery and development from our offices in seven locations in Europe and India. SBW is equipped with state-of-the-art instrumentation operated by experienced pharma professionals from multiple disciplines. All our services can be tailor-made to fit specific customer needs. Our experience includes working with over 100 pharma / biotech customers in more than 20 countries.
SBW has six business units, each with its own area of drug development expertise: Infodix, Biodix, Toxis, novamass, Medachem and 4Pharma.
Drug candidate validation services
We offer a full range of services for drug candidate validation: SBW provides a range of in silico, in vitro and in vivo services for drug discovery, including early target identification, hit to lead, lead optimisation and pre-clinical steps.
SBW also provides a range of services for clinical trials: biostatistics and data management, warehousing and analysis.
Infodix offers biological activity and scaffold hopping (US patent pending); quantitative physico-chemical and ADME property prediction; and systemic, organ-specific, and genetic toxicity and side-effect prediction (US patent pending). Other chemoinformatics services include the following.
Structure-based drug discovery:
- Target and ligand-based as well as reverse docking / vHTS
- Pharmacophore generation and QSPR
- Analysis of proteomics, gene expression and genotyping array data including biomarker discovery, pharmacogenomics and toxicogenomics
- Pathway, protein domain and interaction network analysis
- Development of workflows using proprietary and open source software (Infosense, Accelrys Pipeline Pilot and Knime)
Data mining and tailored software development:
- Artificial intelligence and statistics method development and life-science data analysis
- Programming in R, MatLab, Java, .NET and other platforms and life science packages
Chemoinformatics services – discovery biology
- Biomarker discovery using 2-dgel, MALDI-TOF/TOF, and other MS and phage display techniques
- Biomarker quantitation and validation
- Physicochemical characterisation of proteins / peptides and post-translational modifications using MS, NMR and CD techniques
- Fragment-based drug discovery analytics
- Custom peptide synthesis
- Recombinant DNA services
- Cloning and gene expression in bacterial and mammalian systems
- Gene silencing using siRNA techniques
- Development and screening of custom protein and cell-based efficacy assays
- Hematology and clinical chemistry analytics
Disease models, in vivo PK, and safety pharmacology and toxicology
Toxis deals with disease models, in vivo PK, and safety pharmacology and toxicology.
- Cardiovascular and metabolic diseases, diabetes, oncology, dermatology, gastrointestinal diseases and CNS models (e.g. Alzheimer’s and Parkinson’s, stroke and epilepsy)
In vivo PK:
- Available species are rat, mouse, dog, rabbit and guinea pig
- Formulation for dosing (vehicle finding and vehicle stability)
Safety pharmacology and toxicology:
- Modified Irwin test in mice and rats
- Locomotor activity
- Anti and pro-convulsant activity
- Analgesic activity
- Motor coordination
- BP and HR with telemetry
- Pulmonary functions and whole body plethysmography
We have around 30 in vivo disease models, including:
- Tail-transection bleeding time test
- Renal / urinary system
- Gastrointestinal safety
- Toxicity screening and maximum tolerated dose
- GLP in vitro toxicology assays
- GLP in vivo toxicology assays, including respiratory toxicity
Metabolism studies, drug interaction studies and bioanalytical services
novamass handles metabolism studies, drug interaction studies and bioanalytical services.
- Metabolite profiling and identification: biotransformation and structural analysis in vitro and in vivo
- Metabolic stability, profiling and kinetics in vitro and in vivo
- Identification of rate-limiting CYP enzymes in vitro
- Various liver and other organ preparations available in eight species
Drug interaction studies:
- CYP inhibition: cocktail study in microsomes or in hepatocytes
- CYP induction: nuclear receptor activation or cocktail studies in hepatocytes
- Identification of rate-limiting CYP enzymes
- Bioanalytical method development and validation
- Quantitative bioanalysis from plasma / serum, urine or tissue
- Metabolite profiling and identification
Pharmacokinetic calculations, permeability studies and basic property characterisation
novamass also covers pharmacokinetic calculations, permeability studies and basic property characterisation.
- Pharmacokinetic parameters AUC, t1/2, Cl, V, Tmax and Cmax
- Caco-2, MDCK and PAMPA
- Organ-specific permeability (lung and skin)
- Transporter interaction assessment
Basic property characterisation:
- Solubility, lipophilicity and pKa
- Plasma stability
- Protein binding
Medicinal chemistry services
Medachem offers the following medicinal chemistry services:
- Comprehesive medicinal chemistry solutions for lead optimisation
- Chemistry design and coordination
- Computational chemistry
- Custom chemical library synthesis
- Custom in vitro and in vivo efficacy assays
- ADME in vitro and in vivo analytics
Biostatistics, bioinformatics, and data management and warehousing
4Pharma’s key products are biostatistics, data management, data warehousing and bioinformatics.
Medical writing, medical coding, monitoring and full clinical study
4Pharma’s medical services include medical writing, medical coding, monitoring (through partners) and full clinical study (through partners).
4Pharma’s information technology expertise includes common technical document, remote data entry, electronic data capture (through partners) and pharmacovigilance (through partners).