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Host cell proteins (HCPs) are process-related impurities which could cause immunogenicity and are therefore considered Critical Quality Attributes. Removal and tight control during the manufacturing process development is required. Specific HCP regulatory guidance is provided by the European Pharmacopoeia and the US Pharmacopoeia. Regulatory decisions based on the interpretation of the regulatory framework will be highlighted. Case studies will be presented to emphasize the regulatory expectations regarding the HCP control strategy. Possible specification limits and the type of HCP assays acceptable during product development and the licensing process will be discussed.
In the last years, an extensive set of putative critical quality attributes has been discussed for antibodies. However, the selection of the correct set of critical quality attributes is crucial during product development as well as for the definition of the control strategy. In this presentation the process to identify project-specific quality attributes, the evaluation of their criticality as well as the selection of critical quality attributes measured during release and stability testing is outlined.
Biolayer Interferometry (BLI) technology based Octet® systems have been widely adopted in early research, and development of drug candidates and biotherapeutics. Now, with a comprehensive set of tools for compliance, this label-free technology is gaining traction in process development and quality control (QC) labs for concentration analysis in cell culture and purification, for kinetic and potency analysis of drug-target and drug-Fc receptor interactions, and for stability analysis by assessing changes in activity in stressed and forced degradation samples. Discover the go-to solution providing versatility and flexibility necessary in development combined with rigor and simplicity needed in a QC environment.
Introduction: Recently, the production of monoclonal antibodies as biologic drugs has expanded dramatically. Associated with this trend has been a sudden increase in the number of laboratories determining a critical and heterogeneous property of these drugs, namely their glycosylation. This, in turn, has led to a proliferation of analysis methods, including high performance liquid chromatography (HPLC), capillary electrophoresis (CE) and mass spectrometry (MS)-based. The comparability of variety of these methods, especially as they vary lab-to-lab, presents a major challenge in understanding the meaning and accuracy of these measurements.
Consequently, an interlaboratory study was conducted by NIST to determine measurement variability in identifying and quantifying N-glycans across laboratories. This work describes results from a recent study on glycosylation analysis of a NIST reference material, NISTmAb, from 73 laboratories worldwide.
Methods: Each laboratory was asked to perform glycosylation analysis of two monoclonal antibody samples, NISTmAb and a glycan-modified NISTmAb, using their own method. A template was provided to report glycan percent abundances and methods used. Laboratories were asked to create separate reports for each method of analysis.
Results: To date, 97 reports were submitted by 73 laboratories. Reports came from Europe (41%), North America (37%), Asia (20%), and Australia (2%). Almost half of the reports came from industry (46%), followed by university (33%), research (11%), government (9%), and hospital (1%) laboratories. Comparison of all the techniques will be provided.
Taking a biopharmaceutical product from concept to market can be a difficult and costly exercise, with the average development cost reported as exceeding $2 billion.1 Any method or measurement which can improve the overall cost of development or reduce the time taken to generate a final product can significantly impact the outcomes of a project. This may include improving product stability, increasing product efficacy, or increasing the reliability of the candidate selection process.
In this workshop, Malvern Panalytical has gathered a panel of industry experts to discuss some of the major pain points they have observed in their current workflows. These experts will explain the methods and techniques which they have identified and implemented to overcome these pain points and achieve cost- and time-saving improvements to their development outcomes.
1. DiMasi, J., Grabowski, H., Hansen, R. Innovation in the pharmaceutical industry: New estimates of R&D costs. J Health Econ. 2016, May 47:20-33.
Glycosylation of therapeutic proteins is of importance since it can significantly impact biological properties. Glycosylation is heterogeneous and can be subject to batch-to-batch variability. There is a variety of possibilities to influence and investigate glycosylation. In this talk, the in vitro glycoengineering (IVGE) approach will be very briefly introduced and case studies with new data will be presented, including investigation of glyco-modified antibodies incl. changes in galactosylation and sialylation and its impact on Fcy receptor binding and ADCC activity. Furthermore, new results of a recent study on the impact of certain glycan species on animal PK will be shown.
Biotherapeutics comprise a large portion of pharmaceutical development pipelines. With complex modalities ranging from monoclonal antibodies to gene therapies, better process and product understanding are keys to successful therapeutic development. Quality attribute understanding plays an important role. The complexity of biomolecules leads to a number of assays utilized to study and monitor a wide variety of quality attributes. Recently, a multi-attribute method (MAM) has been developed and implemented in order to simplify analyses. MAM uses liquid chromatography-mass spectrometry (LC-MS) peptide mapping methodology to identify and monitor multiple quality attributes simultaneously in a single assay, as well as impurities. We analyzed method performance through multiple intra-lab studies, and assessed method capability in process development and support. Here we discuss the components of MAM, and present case studies of MAM implementation in a biotherapeutics analytical laboratory.