Subjecting your program's lead panel to risk-based selected, environmental stress factors followed by comprehensive analysis to monitor purity & impurities, aggregation & particulate matter, binding & potency
Allowing you to make an informed decision on which of your candidates are more likely to render a stable & manufacturable drug
Using established in-house & state-of-the-art platform methods we deliver a detailed overview of your products' physicochemical properties & structure, solubility, particulate matter, degradation & post-translational modifications.
Rapidly pinpointing potential weaknesses in your molecule using our scientifically sound & systematic approach hereby supporting lead selection, process development, product formulation & final presentation
Covering a broad array of technologies, such as chromatography, mass spectrometry, electrophoresis, particle analysis, flow cytometry, etc.
Using a systematic & multi-tiered approach we support identity testing & full characterization of your product with strong focus on chromatography & mass spectrometry as well as other, orthogonal techniques
Providing full product characterization, including analysis at intact protein level, fragment level, peptide level & glycan level
Delivering in-depth information on molecular weight, structural integrity, higher order structure, aggregation, N- & O-glycoslyations, disulfide bridges, deamidation, isomerization, oxidation, clipping, amino acid sequence & composition or any other modification potentially occurring in your product
Delivering a comprehensive set of custom-made, orthogonal methods for identity, quantity, potency, purity & impurity, including product- & process-specific impurities & contaminants to fully monitor product quality at all times.
Keeping in mind the objective of each method we provide robust tools with the accuracy & precision required for you to track critical quality attributes (CQAs)
Covering each critical aspect of your method through performance verification, including sample preparation, specificity, linearity, LOD/LOQ, range determination, accuracy, precision, recovery & robustness testing
Providing you with a comprehensive method development report & final method with method acceptance criteria in line with method performance
Transferring your identity, purity, quantity, potency & general quality methods for your drug substance & drug product into a controlled, GMP-compliant environment
Supporting validation throughout all phases of development (Phase I-III) & commercialization (Phase IV)
Covering method review, intake & performance verification over system suitability test establishment to ultimate assessment of method validation parameters such as specificity, linearity, LOQ/LOD, range determination, accuracy, precision, robustness & stability
Providing you with a comprehensive validation protocol, report & final validated method
Release & Stability
Supporting your GMP release & stability studies for your drug substance & drug product throughout all phases of development (Phase I-III) & commercialization (Phase IV)
According to in-house or custom-made procedures & protocols, compliant with regulatory requirements
Offering a GMP-compliant & FDA inspected facility, with full traceability by means of our LIMS labware system (from intake, throughout storage according to ICH conditions, to final analysis & reporting), dedicated quality assurance department, cross-functionality trained project teams for maximum project flexibility, and in-house engineering department to support our equipment around the clock
Leveraging our analytical & scientific expertise to help you continuously monitor quality of your products
Comparing multiple batches, different production sites, before & after specific process & process changes, etc.
Listening to your story, understanding your needs & expectations
Focusing on the analytics that matter based on our extensive experience
Helping you to connect the dots for your product across all aspects of analytics, reviewing historical data, providing scientific interpretations for new results and proposing next steps