Bormioli Pharma, global leader in pharmaceutical packaging and medical devices with a global presence
Waiting for regulators or software vendors to come up with the definitive rulebook for all future data reporting requirements is a bit like waiting for a tax office request to trigger accounts management. There will always be new compliance goals, but the real opportunity is about making good data work harder – something Life Sciences companies should be doing today. At Amplexor’s (now ArisGlobal) recent BE THE EXPERT 2023 global conference in June, Remco Munnik of Iperion – a Deloitte business, explored the broader process benefits and actionable insights that come within reach as soon as companies embrace the value of structured data in everything they do.
Bachem is leading specialist for drug substances, specializing in the development and manufacture
Continuous processing has been implemented for the intensification of manufacturing in many industries, including small molecule drug production. However, adoption of continuous processing for biopharmaceutical manufacturing has been occurring at a relative slow rate. Biophorum has been active in understanding the biomanufacturing landscape to help promote and establish implementation of continuous manufacturing technologies through a cross-industry team of end-users, suppliers and integrators. This team has identified barriers, provided innovative solutions, and collaborated with industry stakeholders to develop a consensus approach in a number of areas such as optimizing buffer management bottlenecks, defining process control strategies, and developing templates for critical process parameter evaluation. Through these activities, significant progress has been made in enabling faster implementation of continuous processes in a GMP environment, reducing time-to-market, and lowering manufacturing costs. This article provides an overview of this cross industry team’s accomplishments and highlights the impact of their efforts in driving the adoption of continuous biomanufacturing across the pharmaceutical industry.
mRNA vaccine is the newest type of vaccine available to the public and has great prospects in terms of speed from research to market. In manufacturing, some barriers observed during Covid can already be lifted up such as (A) a slow transition from research to commercialisation, (B) unequal access to vaccines across countries and (C) inadequate supply of raw materials. Solutions have already been found for (A) a quicker shift from benchwork to commercialisation with a manufacturing process based on repeat-batch production of in vitro transcription (IVT), (B) technology that is small, straightforward to use, modular and transportable to diverse locations and (C) increased number of suppliers for critical raw materials, which are reputable for reliable and predictable deliveries. RNA production with Ntensify™ starts with DNA templates which are first transcribed into RNAs and then purified, ready for encapsulation. In this process, the reaction volume of the in vitro transcription (IVT) is fixed to 20 mL. Large-scale manufacturing occurs by 20 mL increment: i.e. repeat-batch production, with the benefit of an already optimal ratio for reagents (a process co-developed with our partner eTheRNA), which avoids dedicating time to optimisation when entering production. With both high yields and low impurities RNAs, purification can be simplified to a single step. To demonstrate that our approach in 20 mL is successful, several constructs were tested using this process. Their sequence length ranges from 1999 and 4060 ribonucleotides. mRNA reaction yield is on average 5.1 mg/mL. Analysis of the data shows that all batches met the specification limits, where defined.
Indena, the leading company dedicated to the identification, development and production of high
The past decade has brought to light many important issues and as scientists we
Leaders from BioNTech, Bayer, Iperion – a Deloitte business, and Beczek.COM came together in December 2022 to discuss the critical next steps for the life sciences industry in its transition toward a data-driven future. Max Kelleher, COO of Generis, chaired the proceedings.
The 2020 EU Chemicals Strategy for Sustainability (CSS) has a strong focus on endocrine-disrupting (ED) chemicals, due to perceived concerns over their effects on human health and the environment. The CSS envisages strengthening both the CLP and REACH Regulations with respect to ED chemicals; the CLP Regulation has recently been amended to include additional classification categories for ED, and an ongoing review of REACH will introduce new ED-specific information requirements. These changes will be introduced alongside other measures, which together aim to prevent the development of ED chemicals and remove or restrict ED chemicals currently on the market.
AN INTEGRATED APPROACH TO SUSTAINABILITY The panel discussion brings together a diverse and insightful
