Global donor (pharmaceutical) organizations face a myriad of challenges and risks in their supply
Most life sciences Regulatory teams still think and work in terms of documents, paragraphs and sentences when putting together collateral for marketing authorisation and variations submissions. Yet it is data, rather than pre-prepared dossiers, that is moving into central focus now. As the data-centric approach evolves, regulatory and product teams must review and refresh their skillsets so that they are prepared for new ways of working and able to derive the greatest benefit from a data-first approach to collecting, managing and communicating product information. Amplexor’s Renato Rjavec outlines a practical approach to developing the skills needed to meet the challenge.
Oligonucleotide-based therapeutics is considered a major drug development area for the upcoming years. Research in this field has led to the discovery of new mechanisms for the regulation of genes expression. In addition, it has allowed the development of new strategies for the preparation of drugs that act at the level of gene expression, modulating the production of proteins responsible for causing diseases. However, it took huge effort that last around 30-40 years to demonstrate the validity of this approach. In this manuscript, we will go over the main developments of the area.
The global bioeconomy is on the rise: Worldwide, dozens of start-ups (such as COLIPI, Mushlabs, Insempra, Holiferm or MicroHarvest) in the field of fermentation aim to revolutionise markets and ways of manufacturing. This offers the unique chance to replace several common chemical commodities and other products with more sustainable options, claiming that compounds produced by fermentation have a less harmful impact on the environment than current production practices. But is this really the case? Are bioprocesses indeed better than conventional (petro)chemical processes or products obtained from agricultural resources? These questions will be briefly evaluated in this contribution. In this context, particular emphasis is placed on the carbon footprint of industrial fermentation processes. Moreover, it will be outlined, from a start-up perspective, which main challenges arise in the early-stage development of bioprocesses that are economically and technically feasible at large scale but also offer advantages regarding their environmental impact. Finally, suggestions will be made on how these challenges can be tackled.
The Product Carbon Footprint Guideline for the Chemical Industry harmonises the methodology for calculating PCFs for chemical products and gives clear guidance for companies to calculate the cradle-to-gate GHG emissions of their products. Developed with the expertise of the members of the industry initiative Together for Sustainability (TfS), the Guideline highlights the chemical industry’s ability to increase transparency on their GHG emissions as a key enabler to reduce them along global supply chains. Applied widely throughout our industry, this tailored, reviewed and practical Guideline will lead to a harmonisation of PCF data that both corporations and their suppliers will benefit from. As a SteerCo member of TfS, Joachim Christ, CPO of Merck KGaA, outlines the need for its development and highlights the improvement that has been achieved by its publication.
Dear reader, This editorial is dedicated to therapeutic oligonucleotides, their existing challenges and how
