GMP analytics

GMP analytics

Analytics

Information

Coriolis Pharma has a strong expertise in analyzing a broad range of samples, from peptides to virus-like particles, from high concentration antibodies to low concentration hormones, from early-stage drug substance to complex late-stage drug products. The specific needs are considered for every project including quality- and biosafety level requirements. We are dedicated to apply orthogonal methods based on different measurement principles, so you see the properties of your sample from multiple viewpoints. Click the link below to find out more!
Link
https://www.coriolis-pharma.com/analytical-services/gmp-analytics?etcc_cmp=Festival%20of%20Biologics%202020&etcc_med=Event&etcc_par=Terrapinn
Coriolis PharmaMore than 600 customers trust the expertise of Coriolis. We develop liquid and lyophilized formulations out of one hand: no subcontracting to third parties. For each individual project, our highly skilled scientists develop tailor-made study designs that align with our customers’ drug development strategy. We do not force your molecule through an existing platform but create knowledge-driven innovative solutions. Our formulation services support all phases of drug development and our customers rely on Coriolis for trouble-shooting, batch-release analysis and formulation optimization even beyond market approval. We are specialized in: ·        Pre-formulation and candidate selection ·        Early stage formulation development ·        Late phase formulation development ·        Lyophilization cycle optimization ·        Scale – up and transfer studies ·        Developability / manufacturability assessment ·        Support in container closure system selection ·        In-use stability studies ·        Stability testing including forced degradation studies ·        R&D and cGMP-compliant contract analytical services ·        Orthogonal analysis of subvisible aggregates and particles Coriolis can draw from a unique analytical portfolio of more than 100 different techniques – entirely performed in-house – to obtain orthogonal and meaningful data. We offer all our services under Biosafety level 1 by default and a large selection also under Biosafety level 2. Dedicated GMP facilities with full involvement of Quality Management enable us to conduct lot-release analysis and generate supportive data for market approval and allow for tailored “enhanced R&D” level studies (e.g., qualified equipment but no QA involvement). Coriolis provides state-of-the-art as well as promising new and emerging technologies in the field of: ·        Particle characterization (from nanometer to visible) ·        Aggregate analytics ·        Surfactant characterization ·        Higher order structure analysis ·        Chemical changes  

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