Beitrag aus der Ausgabe 8/2021 der Zeitschrift pharmind

Analysis and Optimization of Two Film-Coated Tablet Production Processes by Computer Simulation

A Case Study

Stefanie Hering^1,2, Nico Schäuble², Thomas M. Buck², Brigitta Loretz³, Thomas Rillmann², Frank Stieneker⁴, Claus-Michael Lehr^1,3 · ¹Department of Pharmacy Saarland University, Saarbrücken (Germany) · ²SW Pharma GmbH, Schiffweiler (Germany) · ³Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), Saarbrücken (Germany) · ⁴Free Consultant and Qualified Person According to German Law, Badenweiler (Germany)

The pharmaceutical industry is known to be prosperous but inflexible. Regulatory authorities expect increasing standards for medicinal products, e.g., during clinical trials or production [1–3], which makes the industry less prosperous and even more inflexible. Multinational pharmaceutical companies react with various strategies, such as outsourcing or mergers and acquisitions [4], while small- and middle-sized companies need to ...

Beitrag aus der nächsten Ausgabe 09/2021 der Zeitschrift pharmind
(erscheint am 30. Sept. 2021)

Life at the periphery / How cell surface proteins can influence bioprocesses

Chinese hamster ovary (CHO) cells are currently the main production hosts for biopharmaceuticals and are adapted to growth in suspension within large fermentation units. For the improvement of production processes, it is essential to understand the interaction between CHO cells and their microenvironment. Cell surface proteins are the key junction between the intracellular compartments and the environment and are therefore of particular interest due to their potential to react to external factors and initiate cell communication and interaction pathways. CHO cells have been studied in great detail using OMICs analyses, however, generated proteome data sets revealed primarily intracellular proteins. Therefore, the current study presented here explored the surfaceome of CHO host and production cell lines and identified a set of 449 proteins mainly comprising receptors, enzymes, transporters, and adhesion molecules as well as proteins belonging to the extracellular matrix (ECM). Functional annotation revealed a significant enrichment of proteins involved in cell adhesion and cell-matrix adhesion. Since cell aggregation is an unfavourable phenotype for bioproduction in large fermentation units, the study focussed on cell surface proteins involved in molecular pathways for adhesion processes. The case study focussed on an aggregation prone cell line with the aim to use engineering of surface proteins to reduce adhesion tendencies. Among other CHO surface proteins, we identified the transmembrane protein integrin beta 1 to be enriched on the cell surface of an aggregation prone CHO production cell line. The transient knockdown of this central adhesion molecule substantially counteracted cell aggregation pointing towards novel engineering routes for aggregation reduction in biopharmaceutical production cells and exemplifying the potential of the surfaceome for specified engineering strategies.

Beitrag aus der nächsten Ausgabe 09/2021 der Zeitschrift pharmind
(erscheint am 30. Sept. 2021)

Weichenstellungen im zweiten Betriebsjahr / Reduzierung der Alarme und Verschlankung der Strukturen

securPharm e. V., die deutsche Organisation für die Echtheitsprüfung von Arzneimitteln, kann zufrieden auf das zweite Betriebsjahr des securPharm-Systems zurückblicken. Der Verein und die Betreibergesellschaften haben 2020 die Entwicklung des Systems sowie der Organisation vorangetrieben. Die Performance des securPharm- System war robust, stabil und auch in den Spitzen belastbar. Da die Entscheidungen zur weiteren Ausrichtung des Schutzsystems zunehmend auf europäischer Ebene getroffen werden, ist eine aktive Vertretung von securPharm bei der European Medicines Verification Organisation (EMVO) ein immer wichtigerer Aspekt der Arbeit von securPharm. Ein wichtiger Fokus blieb auch im Jahr 2020 die Anzahl der Fehlalarme. Diese wurde zwar deutlich reduziert, befindet sich aber weiterhin nicht im gewünschten Zielkorridor. Ein wichtiger technischer Beitrag zur Alarmreduzierung ist die Weiterentwicklung des Alarmmonitorings durch die securPharm-Weboberfläche der Netzgesellschaft Deutscher Apotheker mbH (NGDA). In eigener Sache ist der Verein im letzten Jahr ebenfalls vorangekommen. Die Organisationsstrukturen wurden verschlankt und an die neuen Aufgaben eines Pflichtbetriebs angepasst. Die Vorbereitung für den Vollzug des Brexits wurden 2020 koordiniert und die Auswirkung auf das securPharm-System minimiert.

Beitrag aus der nächsten Ausgabe 09/2021 der Zeitschrift pharmind
(erscheint am 30. Sept. 2021)

Verification of chromatographic pharmacopoeial procedures for herbal drugs and herbal drug preparations / Recommendations from industry

The suitability of validated pharmacopoeial procedures under the specific laboratory conditions has to be verified. Within a risk assessment an evaluation is performed in order to determine the extent of verification, i.e., to decide which parameters have to be considered. Focussing on the different chromatographic procedures used for identification, testing for impurities/adulterations and assay, such as thin layer chromatography/high-performance thin-layer chromatography (TLC/HPTLC), high performance liquid chromatography (HPLC), and gas chromatography (GC), recommendations are given on how to implement the requirements for herbal drugs and herbal drug preparations. Relevant chapters of the Ph. Eur. and of the USP as well as the specific needs of herbal drugs and preparations thereof are taken into consideration.