Analytical solutions
Our standalone offer
Why Seqens?
Experience
- We leverage decades of experience in API’s and Drug Substances development & manufacturing to propose standalone analytical services.
Expertise
- We support our pharmaceutical customers in meeting their targets in terms of APIs Quality and Security. We are more than just an analytical service provider.
Reliability & Flexibility
- We ensure product quality, product safety, fastest delivery in our services, and can adapt to time, cost, compliance and scalability constraints.
Toxicology
In-vitro toxicology screening
- Genotoxicity
- Hepatotoxicity
- Cardiotoxicity
- Embryotoxicity
Regulatory In-vitro toxicology (GLP Formulation): genotoxicity on API
Pre-formulation
Analytical profiling
- Structural (solid state) characterization API and assay
Solid-state screening
- Polymorph study
- Salts screening
- Co-cristals
Pre-formulation
- Physicochemical characterization
- Solubility and DCS (developability classification system) assessment
- Membrane permeation (coming 2024)
- Solutions for bioavailability enhancement
- Drug excipient interaction
Synthesis & Manufacture
Route scouting
Production of lab sample for in-vitro testing
Process safety studies
Process development & optimization
- Multi-step agile chemistry
- Quality By Design (QBD)
- Biocatalysis
- Flow chemistry
- Polymerization
- Lipid chemistry
- Synthetic biology
- Purification (selective crystallization / chromatography)
- Particle engineering
Non GMP tox batches
Early-stage Synthesis (GMP) – First To Human batches
Manufacturing
- Kilo-lab
- Scale-up to commercial
- Starting Materials back integration
- 2nd Generation process development
Consulting services for program management & Regulatory Affairs
Analytics
Analytical methods
- Development
- QbD development to design optimal analytical conditions
- Validation
Impurity Reference Standards synthesis and Qualification
- Forced degradation studies
- Identification
- QSAR
- Genotoxicity
- Quantification
Nitrosamines
- Risk assessment consulting
- Screening of positive Nitrosamines
- Quantification of Nitrosamines and Nitroso drug substance related impurities (NDSRI)
- Synthesis of NDSRI standards
- Ultra traces quantification of nitrites in excipients
Analytics : cleaning validation
- Method development
- Validation
- Swabbing recovery validation
- Testing
GMP Release testing (Raw materials, In-Process and Drug substance)
Stability studies
- Analysis
- Storage
- Forced degradation
Extractables and Leachables studies
R&D is at the heart of Seqens’ strategy. With 10 centers of excellence around the world, including more than 300 researchers, 150 of whom are PhDs, Seqens has unique capabilities to support its customers in the development of complex molecules across all markets.
