BioQCWatch Author Insights | Merck's Dr. Adam Sutton | Learn practical strategies for developing and validating a single CZE method capable of simultaneously characterising nanoparticles, surfactants, and small molecules in multi-component pharmaceutical formulations.
BioQCOn-Demand Presentation by Paul Shrevel (Solution Too) | Understand how LIMS fits within the broader ISA-95 manufacturing application landscape, connecting laboratory workflows to ERP, QMS, and supply chain systems, and recognise the data integrity risks associated with local instrument data storage.
BioQCOn-Demand Presentation | Understand how modern LIMS function as the central hub of laboratory automation and data integrity, supporting compliance with ALCOA+ principles across development and quality control environments.
BioQCWatch Author Insights | Health Canada's Dr. Huixin Lu | Understand how key method parameters, including denaturant type, LNP disruption strategy, and sample preparation, critically influence mRNA integrity results measured by CGE-LIF.
BioQCOn-Demand Presentation by Ramon de Groot (Limes Lab Support) | Understand how modern LIMS enforces ALCOA+ principles and has evolved from basic sample tracking into a central laboratory data management platform integrating with instruments, ELN, and ERP systems.
BioQCOn-Demand Presentation | Understand how LIMS have evolved from basic sample tracking to comprehensive digital data management systems, and learn how they support ALCOA+ compliance, audit-ready traceability, and GxP-compliant laboratory operations.
BioQCWatch Author Insights | Boehringer Ingelheim's Dr. Anne Ries | Explore a practical benchmark example comparing two icIEF instruments, and gain a reusable framework to support lifecycle management of analytical methods in regulated environments.
BioQCOn-Demand Presentation by Dr. Joseph Glajch (JLG AP Consulting) | Explore the concept of fingerprint-like similarity in biosimilar development aand discover how orthogonal analytical methods applied across large reference product datasets can reduce residual uncertainty and influence the scope of clinical testing required.
BioQCOn-Demand Presentation by by Dr Michael Dong (MWD Consulting) | Examine how quality attributes and QC testing methods differ between small molecules and biologics, and understand where small-molecule CMC experience translates meaningfully to biotherapeutics and where fundamental differences require a distinct approach.
BioQCOn-demand Presentation | Understand the key differences in CMC processes, quality attributes, and testing methods between small-molecule drugs and biotherapeutics, including contrasts in manufacturing, purification, and regulatory expectations.
