APR Sept/Oct 2023 - 48

» FORMULATION & DEVELOPMENT
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analytical bridging studies through the development process. Notably,
where assays required significant development and processes have
undergone significant change as is likely with these ATMP product
types. In addition to these studies, the development of platform
approaches to all analytics should be considered. Although these
technologies are emerging, data from similar molecules, for example
of other serotypes in gene therapy, can be leveraged to support
method development, validation and specification setting activities
where appropriate.
Despite the fact that release analytics for new modalities may have
unique challenges due to the use of new techniques, a lack of historic
data and an increasingly complex mode of actions, this is not the
case for the majority of assays used for release of these potential
new products. A significant proportion of the required analytics are
either compendial or based on well-established procedures. Time
and effort can more easily be focused by following a systematic
approach as defined in ICH Q14. Appropriate utilization of experience
and understanding will allow the generation of a suitable analytical
strategic plan to develop methods appropriately during the process
development that will be able to ensure the quality, safety and efficacy
of the product.
Author Biographies
Patrick Nieuwenhuizen is Director Senior Consultant at
PharmaLex. He is quality professional with a microbiology
and sterile manufacturing background with over 25
years' experience in the pharmaceutical industry. Worked
for several global pharmaceutical and biotechnology companies
across a variety of platforms including biologics, sterile fill finish and
solid oral dose.
Involved with several site and laboratory expansion projects from
construction design through to method transfer and operational
readiness, and has provided quality, sterility assurance and microbiology
oversight where relevant during these projects.
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| September/October 2023
In addition to site responsibilities, involved in several corporate initiatives
such as Sterility Assurance Council and the roll-out of corporate standard
programs that required collaboration and communication across multiple
diverse sites for the improvement and maintenance of organizational
quality standards. Next to that acting as a lead auditor and have been
involved with audits facing several competent authority inspections
including but not limited to the HPRA, FDA, ANVISA, Chinese FDA and
Canadian Health Authority inspections.
Acted as risk facilitator for Quality Risk Management programs and have
gained significant experience with problem-solving and management of
complex investigations.
Christopher Rogers, M.Sc. is Senior Manager, Regulatory
Affairs, CMC, PharmaLex UK. He has 20 years of experience
in biologics development and manufacturing, with a focus
on routine and advanced analytics from characterization
through analytical development and quality control for CMC. Now
supporting Regulatory CMC in projects including new product
development, EU and US submissions and regulatory interactions, lifecycle
management, and project management in monoclonal antibodies,
biosimilars and ATMP products.
Prior to becoming a regulatory consultant Chris worked in the
pharmaceutical industry for more than 15 years, with experience including
QC release, discovery and development phases on a range of products.
Chris also worked for four years as a mass spectrometrist supporting
biopharmaceutical characterization with advanced mass spectrometry
At PharmaLex Chris is a Senior Manager for the UK CMC Biologics team,
where he manages delivery of regulatory projects and contributes to a
range of ATMP and Biosimilar regulatory projects.
Chris holds a BSc in Biology (University of Hull) and a M.Sc. in Analytical
Bioscience and Drug Design (University of Salford) and is a keen cyclist.
APR Sept/Oct 2023

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