Analytical Services: Ensuring Quality, Safety, and Efficacy
Analytical Services: Ensuring quality, safety and efficacy
SmaBio Labs offers comprehensive analytical services that support our customers from drug discovery through commercial product release. Our services include method development, validation, and transfer, as well as in-process control, release tests, and stability studies. Our analytical teams are equipped to assist throughout the drug development process, characterizing drug substances, supporting formulation development and drug discovery, and managing clinical trial materials for both early and late phase studies.
1. Method Development and Validation
Providing robust analytical methods tailored to your needs, from early development to commercial release.
Techniques and Tools: Utilization of LC, GC, LC/MS, and GC/MS for comprehensive analysis.
Phase-Based Validation: Ensuring compliance with FDA, EMA, and ICH guidelines through tailored validation studies.
2. Release Testing and Stability Studies
Ensuring product integrity and compliance through meticulous testing and well-defined stability studies.
Release Testing: Conducting thorough testing of drug substances and drug products using validated methods.
Stability Studies: Following ICH/FDA/EMA guidelines to design stability protocols, including various testing conditions.
3. Identification and Quantitation of Impurities
Identifying and quantifying impurities to ensure product safety and efficacy throughout the development process.
Advanced Techniques: Employing LC/MS, GC/MS, NMR, FTIR, and UV for accurate impurity identification and quantitation.
Risk Assessment: Evaluating the impact of impurities on product safety and effectiveness.
4. Extractables & Leachable
Offering comprehensive assessments to ensure safety and compliance regarding extractables and leachables.
Standard & Customized Studies: Utilizing LC-QTOF and GC-QQQ for detailed E/L analyses.
Risk Management: Assisting in the evaluation and mitigation of potential risks from E/L.
5. Reference Standards
Providing essential services for the qualification and management of reference standards during drug development.
Qualification Services: Ensuring reference standards are well characterized and analyzed for research phases.
Storage and Management: Helping manage the use and storage of reference standards effectively.
6. Raw Material Testing
Guaranteeing the quality and safety of raw materials used in pharmaceutical manufacturing.
Comprehensive Testing: Covering chemical testing, identification, and outsourced microbiological testing.
Stability Testing: Ensuring raw materials maintain their quality and efficacy throughout their use.