Articles Archive - Page 36 of 48

Topical drug delivery and the role of excipients

5 December 2022 No Comments

It is widely accepted that excipients play a crucial role in efficacy, safety and quality of medicinal products. For topical drug delivery, there are particular aspects to consider. Excipients are responsible for the perception of the product by the patient and directly impact on well-being and adherence to the therapy. They can have a direct impact on the efficacy, e.g. through moisturizing or antimicrobial effects. Indirectly, they can influence efficacy through chemical penetration enhancement. More than 500 excipients are approved for topical drug delivery by the FDA. Many of them are complex and show substantial variability in potentially critical material attributes, which may affect the quality of the resulting drug product. Therefore, appropriate characterization is essential for the development of robust products.

Titanium Dioxide: updates

5 December 2022 No Comments

This article provides some insight on the following question: why is Europe on a course that will require the removal of titanium dioxide (TiO2) from 91,000 medicines in the EU at the estimated cost of €32bn, with potentially significant delays to the approval of new medicinal products and the potential to impact the availability of medicines in the EU?
An insight into this topic can be found in the Interim Position Paper from the Committee on Toxicology (COT) (1) which provides a useful summary of the titanium dioxide story over the last 6 years.

Applications of polymeric resins in medical devices for life saving treatments

5 December 2022 No Comments

Polymeric chromatographic resin beads are extensively used in life-saving and life-supporting medical devices. Applications include liver and kidney dialysis, for detoxification relating to hepatitis, alcohol/drug misuse, cirrhosis, fatty liver or cancers or for treating kidney chronic diseases. Other application where polymeric resins find application as medical devices is enteral nutrition for patients suffering from Cystic fibrosis, or for treatment of patients before organ transplantation, to ensure higher rates of survival, or as a treatment for several autoimmune disorders by therapeutic removal of antibodies and molecules from plasma, used. Significant potential for hazards is inherent when using a device for medical purposes and thus medical devices must be proven safe and effective before regulating bodies permit the device to be marketed in their country. This paper will explore applications of chromatographic separation resins in medical devices, differentiations of classifications of medical devices, and typical regulatory compliance requirements for polymeric beads when incorporated into medical devices or diagnostics.

Building transparency into pharmaceutical supply chains with discoverable and verifiable Web3 assets

5 December 2022 No Comments

Global donor (pharmaceutical) organizations face a myriad of challenges and risks in their supply

Building skills to power a data-first regulatory ecosystem

5 December 2022 No Comments

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.

Oligonucleotides: Right Place, Right time, Right future

5 December 2022 No Comments

Nucleic acid-based therapeutics, have seen increased activity in the development of treatments for rare diseases due to the possibility of rational design and their shorter and cost-effective development cycles. Since the first approvals new compound approvals are occurring annually, and massive growth is expected over the next few years. The elimination of many barriers has contributed to their success. However, it is necessary to conquer new tissues to bring novel therapies to the market. The world’s production capacities are already full with the most advanced products in development and those on the market. To adapt to the market, the industry will have to deal with innovative production and sustainability constraints, which calls for the creation of cutting-edge strategies and processes.

Synthetic Chemistry in Nucleic Acid Drugs Recent progress in bridged nucleic acids (BNA)

5 December 2022 No Comments

The number of approved nucleic acid drugs has increased recently owing to progress in the medicinal chemistry of oligonucleotide therapeutics; the expansion of drug sales is providing new API demand opportunities for CDMO. Nucleic acid drugs utilize various chemically modified nucleotides, to avoid decomposition by nucleases in the human body and improve the RNA binding affinity. The production of modified nucleotides requires organic synthesis technology and sufficient production capacity at CDMO. This study focuses on the synthetic process of modified nucleotides, especially those comprising bridged nucleic acids (BNAs), and explains the progress in BNA research from a process chemistry perspective.

Oligonucleotide therapeutics. A long and windy road towards future medicines

5 December 2022 No Comments

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.

How to develop a CO2-neutral bioprocess

5 December 2022 No Comments

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.

A new guideline harmonises product carbon footprint calculations for chemicals

5 December 2022 No Comments

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.

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