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|13:05～13:25||Overview of current bio-analytical trends with focus on label-free assays for characterization and QC||弊社スタッフ|
The potential of biophysical assays to support the pharmaceutical development of Spiegelmer® therapeutics
Dr. Christian Maasch
Biosimilar Characterisation: A data-rich approach incorporating SPR analysis
Dr. Sarah Stone
Applications of SPR assays to CMC activities
伊東 久仁 様
High Throughput Immunoassays in Microbial Biomanufacturing using the Gyrolab workstation
Dr. Axel Erler
|17:45～18:00||パネルディスカッション & 質疑応答|
Dr. Christian Maasch
Director Biophysical Analysis, NOXXON Pharma AG
Dr. Christian Maasch is a director of biophysical analysis and certified project manager at NOXXON Pharma AG in Germany, Berlin. He has more than 14 years of professional experience in drug discovery and development with projects from various therapeutic areas, like oncology, inflammation and metabolic disorders.
As a co-inventor of several clinical stage Spiegelmers he accompanied the development of these drug candidates from idea to clinical proof-of-concept.
He is an expert in developing assays and bio-analytical methods from drug discovery to clinical testing with a deep knowledge and track record of methods like SPR/Biacore (since 1998), ELISA, cell-based assays, HPLC, ITC, DSC, ESI-MS, FACS and of-the-wall assay setups.
Spiegelmer scaffolds are a new class of PEGylated therapeutics combining the affinity and selectivity of a biological with the synthetic ease of a chemical. As a new class of therapeutics, Spiegelmers present a challenge and a chance to develop regulatory conform biophysical methods supporting preclinical characterization, quality control, formulation, and stability testing for both the active pharmaceutical ingredient (API) and the investigational medicinal product (IMP). Furthermore newly established biophysical methods allow the simultaneous evaluation of the Spiegelmer integrity (by its PEG and oligonucleotide moiety) and activity (potency) in one sample. Quantification of the Spiegelmer and its target in the blood, as well as determination of the bound-free/ saturation status of these scaffold drugs allow predicting the drug dosing frequency to achieve best pharmacodynamics. Moreover, biophysical analyses with their high accuracy and precision - compared to biological assays - increasingly gain importance as surrogate potency assays.
Dr. Sarah Stone
Scientist BioAnalytical, BioOutsource Ltd
Dr. Sarah Stone joined BioOutsource Ltd in 2012, following a successful academic career, and quickly became a key member of the Biosimilars department. During a period of rapid growth for the company, Sarah developed expertise in the characterisation of biosimilar monoclonal antibody-based therapies for some of the blockbuster molecules, including Rituximab, Etanercept, Adalimumab, Trastuzumab and Bevacizumab; using SPR-based technologies, namely the Biacore T200 and Biacore 4000 systems. Currently, Sarah leads the Biacore department at BioOutsource, working on a wide range of commercial and R&D projects to develop a range of new Biacore assays. Although initially focussed on characterisation of Fc binding characteristics, the work of the department has increasingly started to focus on the challenges of analysing the high affinity Fab-antigen interaction which can be particularly problematic for receptor-Fc fusion proteins and affinity matured molecules.
The use of therapeutic strategies based on monoclonal antibodies has revolutionized the current drug market for diseases ranging from cancer and arthritis through to macular degeneration. The use of Herceptin (Trastuzumab) to treat aggressive breast cancer and of soluble TNFα antagonists such as Humira (Adalimumab), Remicade (Infliximab) and Enbrel (Etanercept) to treat inflammatory disorders have been particularly successful. These triumphs in the clinic have resulted in a number of biopharmaceutical companies becoming involved in the manufacture of biosimilar therapies.
The biosimilar market is forecast to be worth billions and would increase the availability of these blockbuster molecules to the patient. Therefore it is of little surprise that the biosimilar market is growing rapidly and companies are having to adapt to the different approaches required for biosimilar characterisation. During “traditional” drug development, the mechanism of drug product action and potential safety risks may be unknown and need to be demonstrated extensively. In contrast, biosimilar drugs require extensive characterisation in order to demonstrate “fingerprint-like similarity” to the licensed drug product at earlier stages of development in order to reduce the scope of clinical work required to demonstrate their safety and efficacy.
Here we will explore methodologies and approaches which we consider when performing comparability studies for every stage of biosimilar development, focussing on the monoclonal antibody-based therapeutics. In particular, we will emphasise the importance of orthogonal approaches to gathering characterisation data and how the use of cutting edge technologies such as SPR can add value to this process, particularly when compared to more functional assays such as antibody-dependent cell cytotoxicity.
Dr. Axel Erler
Head of Analytical Development – Biopharmaceuticals, Lonza AG
Dr. Axel Erler is a Biotech Professional in manufacturing of biopharmaceuticals with expertise in process development, process characterization and process validation as well as analytical support.
I work since several years in customer facing roles ranging between initial project evaluations to the delivery of drug substance for clinical and commercial supply, also including manufacturing processes for Biosimilars and the generation of quality target product profiles (QTPP).
A main area is the use of systematic design of experiments (DoE)-based characterization approaches to study the performance and robustness of manufacturing processes as well as analytical procedures. Such concepts allow an optimization between costly experimental efforts and the generation of the required data density and process knowledge.
The second area is the development and qualification of analytical procedures for in-process manufacturing stages as well as release testing of drug substances and drug products to ensure identity, strength, quality, purity and potency.
Microbial biomanufacturing of protein-based pharmaceuticals requires immunoassays for in-process controls as well as the release of the drug substances and drug products. For example, the clearance of process-related impurities like host cell proteins (HCPs) is critical and hence needs to be well controlled. Regulatory and technical requirements build a framework for immunoassay developments. Recently, the USP and EP were drafting new general chapters on HCP quantification. These guidelines set the future expectations for early and late stage manufacturing processes. Analytical testing is constantly challenged to improve method performance criteria including, measurement range, antibody coverage, throughput as well as limits of quantification. The Gyrolab technology at nanoliter scale today is a valuable part of Lonza`s immunoassay toolbox which enables making rapid data driven decisions and not having to manufacture or continue the biomanufacturing process at risk. The broad dynamic range allows accurate quantification and minimizing reanalysis and the automation allows generation of high quality data and high sample throughput.
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