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Advances in Mass Spectrometry for the Analysis and Bioanalysis of Antibody-Drug

ADCs are complex compounds resulting from the coupling of cytotoxic small molecules to a monoclonal antibody. Their characterization as well as their bioanalysis (quantification in biological fluids) remains challenging. Mass spectrometry at different levels (intact, middle, peptide) can be a valuable tool, and can now be used in a regulated environment thanks to advances in both hardware and software.
Recorded Sep 12 2017 34 mins
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Presented by
Arnaud Delobel, PhD
Presentation preview: Advances in Mass Spectrometry for the Analysis and Bioanalysis of Antibody-Drug
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    Jurgen Mulberg Associate Director at Bristol Myers Squibb and Audrey Brussel at PathoQuest
    Full Title: Application of Next Generation Sequencing (NGS) Based Methods for Detection of Viral Contaminants in Biomanufacturing

    Contamination of a biological product with viruses, potentially harmful for humans, is of concern for therapeutics derived from human and animal sources, i.e. plasma, and for protein therapeutics and vaccines produced in mammalian cells.  More recent “Advanced Therapeutic Medicinal Products (ATMPs)”, such as gene and cell therapies, share the same concern.  Tests for viral contaminants are performed at several stages of manufacturing.  Current tests for detection of viruses are lengthy; cell culture based assays and animal experiments are required.  Alternative molecular tests, such as “next generation sequencing (NGS)”, provide faster results, and can eventually replace in vivo animal studies.  It is noteworthy that identification of a viral contaminant that evaded detection in classical tests, by NGS, has been demonstrated.  In addition, due to the fast turnaround time, application of targeted NGS for “in process” detection of viral contaminants can be envisioned.  Current efforts for development of unbiased and targeted NGS based viral safety assays will be discussed
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    Dr. Jincai Li, Vice President of WuXi Biologics
    Full Title: Overcoming Antibody-Drug Conjugate (ADC) Process Development & Manufacturing Challenges

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    Full Title: Development of automated chemometric platform for accelerated Raman-based model optimization in biologics

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    Himanshu Gadgil, CSO and Whole-Time Director at Enzene Biosciences Ltd.
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    Insights through case studies for developing a fully integrated mAb manufacturing process

    Integrating upstream perfusion with a connected downstream process

    Implementing the continuous process in GMP
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    Karen Zink McCullough at MMI Associates, Nicola Reid at Charles River Labs and Veronika Wills, At Associates of Cape Cod, Inc
    Full Title: Points To Consider: Demonstrating Comparability Between Recombinant and Lysate Reagent For BET Testing
  • Implementing a Quality by Design (QBD) Approach In Integrated DSP In-Line PAT... Sep 6 2021 2:00 pm UTC 120 mins
    Dejan Arzenšek, at Novartis and Maryann Cuellar at Kaiser Optical Systems, Inc.
    Full Title: Implementing a Quality by Design (QBD) Approach In Integrated DSP In-Line PAT Advanced Analytical Technologies to Monitor Critical Quality Attributes

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    Different advanced analytical technologies with the potential to accelerate process development and facilitate continuous manufacturing control strategies. The suitability of the selected techniques at scale
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    The joining of online process automation devices and data (Operational Technology or OT level) and offline laboratory management systems and data (Enterprise Information Technology or IT level) is becoming an indispensable modernization and digital maturity aspect that needs to be realized to make the Industry 4.0 paradigm an industrial reality.  This presentation describes options for the building of a sound Lab 4.0 digital laboratory environment, which consists of laboratory informatics, automation and robotics, interconnectivity, big data, analytics and machine learning to create a more holistic and better-connected, self-monitoring smart digital manufacturing ecosystem.  The digitization of laboratories, along with the IT – OT interconnectivity, makes the availability of near real-time offline laboratory methods and results an actuality in the exercise to achieve the Industry 4.0 benchmark.
  • Latest Analytical Techniques in Extractable and Leachables Recorded: May 20 2021 70 mins
    Dr. Tom van Wijk, Abbott Healthcare Products BV
    In contrast to other impurities the control of extractable and leachables is not well defined yet. Currently guidance is provided e.g. by USP and PQRI, but there is room for interpretation. New guidance (ICHQ3E) is being developed. In general, comprehensive screening is applied, using gas- and liquid chromatography techniques hyphenated with mass spectrometry, to aim for complete coverage on E&L. Although considered to be the state-of-the -art approach, in practice this approach is not as straightforward as it may seem. Many assumptions are made and for effective approach an E&L database is deemed necessary. Moreover, the strategy is completely opposite compared to the strategy applied for potential mutagenic impurities which is highly relying on a theoretical assessment (Risk based approach). The presentation will focus on the analytical technique selection, challenges of coverage of E&L in the current strategy and finally a perspective on E&L analysis.
  • Exosome Manufacture Based on the iCELLis® Bioreactor Platform Recorded: May 11 2021 118 mins
    David Haylock, CEO VivaZome Therapuetics and Roberto Ciboldi, Scientific & Laboratories Services Pall Corporation
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    and Overcome Exosomes Production Challenges.

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  • Mycoplasma Testing: Past, Current, and Future State Recorded: Apr 29 2021 122 mins
    Kenneth Tai at Kite Pharma, Lori Daane at BioMerieux and Alexander Bartes at Roche Pharma
    For nearly 30 years, mycoplasma testing for biologics have been performed using cell culture-based methods.  The compendial mycoplasma detection method has been the gold standard in the biopharma industry.  Its high sensitivity (0.1 CFU/mL detection) is achieved through multiple subcultures and observations of culture media and agar plates over the course of 28 days.  While awaiting for the results of testing, CHO-derived antibody drug substances are stored in freezers; however, long storage times have contributed to an inefficient supply chain network resulting in huge costs.    

    Pressure to reduce long turnaround times (TAT) has spurred innovation through the use of nucleic acid technologies (NAT), such as real-time PCR.  With guidance from the European pharmacopeia chapter (2.6.7), multiple biopharmaceutical companies have successfully validated real time PCR methods for testing.  In addition to the benefit of reducing TAT from 28 days to a single day, cost to the patients are reduced from lowering FTE, reducing storage costs, and creating a more agile supply chain network. 

    TAT reduction becomes even more critical in the new cell and gene therapy landscape, where some of these medicinal products are customized from the patients themselves.  Furthermore, integration of testing built into the production line can improve efficiency and further expedite live saving medicines.  As innovate therapies emerge, quality control tests must also become creative to adapt to these new modalities.  That includes mycoplasma testing.
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    Full title: Risk Assessment of Extractables and Leachables in Different Phases of Development.

    As the knowledge on the manufacturing process evolves during the development of a drug product or medical device, it is advised to include learning cycles into the development program to avoid existence of critical E&Ls. These learning cycles offer the opportunity to increase the knowledge on E&L associated with the product over its development time. Initially, chemical information should be collected on the materials used. First extraction studies will guide concerns, followed by simulation studies which are designed to mimic reality. At the end, the leachable study has to meet regulatory requirements and must cover real use conditions until end of product shelf-life, and these leachables need to be covered by a thorough toxicological risk assessment.
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  • Presented by: Arnaud Delobel, PhD
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