APR January/February 2022 - 28

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DRUG DEVELOPMENT
»
Process Steps from Cell-Line Preparation to
Manufacture of Personalized Medicines
Robert Dream
Managing Director
HDR Company LLC
Compliance with Good Manufacturing Practice ( " GMP " ) is mandatory
for all medicinal products that have been granted a marketing
authorization. Likewise, the manufacture of investigational medicinal
products must be in accordance with GMP. Advanced therapy
medicinal products that are administered to patients under Article
3(7) of Directive 2001/83/EC1 (so called " hospital exemption " )
must be manufactured under equivalent quality standards to the
manufacturing of advanced therapy medicinal products with a
marketing authorization.1
As outlined by the Alliance for Regenerative Medicine global
sector report;2
* There are an estimated 300 million patients suffering from rare
diseases worldwide.
* There are currently 647 ongoing clinical trials utilizing
regenerative medicines.
* There are more than 400 companies worldwide active in
developing regenerative medicines and advanced therapies for
rare diseases.
* Companies developing regenerative medicine for rare diseases
raised more than $6Billion in total financings globally in 2019.
Value Propagation -
Drug Development Space
Alongside validation, the concept of applicability domain (AD) is
probably one of the most important aspects which determines the
quality as well as the reliability of the established quantitative structure-
activity relationship (QSAR) models. A variety of approaches for AD
estimation have been devised which can be applied to particular types
of QSAR models and their practical utilization is extensively elaborated
in the literature; Figure 1 and 2 depicts the value propagation.
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| January/February 2022
Starting Cell to Produce and
Populate Cell Line for Master
and Working Cell Banks
Cell-based advanced therapies starting material for Advanced Therapy
Medicinal Products (ATMPs) span the donor selection and screening,
procurement,
processing, immunological matching and clinical
transplantation seen in cells and tissues transplantation and the level
of manufacturing seen in the pharmaceutical and biotechnological
Figure 1. Value Propagation Drug Development Space

APR January/February 2022

Table of Contents for the Digital Edition of APR January/February 2022

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