Issue: Vol. 41

Continuous flow photochemistry and green chemistry

The union of continuous flow processing and photochemistry has enabled the effective generation of target molecules of ever-increasing complexity and with growing selectivity. Inherent benefits of flow reactors are thereby exploited for better heat and mass transfer, containment of high energy light as well as scalability irrespective of reactor footprint. This short perspective article evaluates the advances of continuous flow photochemistry towards greener chemical synthesis and highlights remaining challenges that will need to be resolved to meet our sustainability goals.

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Contemporary chiral resolutions

Isolation of enantiomerically pure materials from the corresponding racemates is an ever-challenging endeavour. Many techniques have been developed over the years to increase the efficiency and improve the success rate. The isolated yield is limited to the maximum amount of enantiomer in a racemate, namely 50%. Using (in situ) racemization, the yield can be boosted to a theoretical 100%. This article provides contemporary resolution techniques that facilitate the isolation of the desired enantiomer in the most efficient manner via crystallization.

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Reflections on War and Peace (1) – A Scenario for a Multipolar World Order

The confrontation in Ukraine demonstrates that globalization has already peaked, elevating supply chain management and reshoring policies into key strategic drivers. Our earlier articles had anticipated this (2-4). With military action currently underway (5), the world seems to have passed a geopolitical turning point that businesses have remained slow to acknowledge. This article makes the case for the necessity of a deep 2023-2026 strategy review addressing the incoming “Great Disconnect” between the East (6) and the West (7). Strategic planning should factor in long forgotten risks such as persistent inflation, fragmentation of global markets and regionalization of supply chains. The transition towards a multipolar world order stokes the embers of a potential hot war. Catalytic events include the upcoming 2024 US elections and the National Congress of the Chinese Communist Party in 2027. This scenario has significant implications for companies within the chemical industry.  Invest, divest, and reposition while the window of opportunity is still open. The time to act is now.

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How Does Cost Factor into CDMO Selection and Outsourcing Approach?

The price of goods and/or services is frequently top of mind when making a purchase decision in both consumer and business transactions. However, Low cost has appeared among the top five CDMO selection metrics for small molecule drug substance manufacturing just two times in the past five years. So how does the cost of services factor into outsourcing decisions? A review of Industry Standard Research’s data on outsourcing drivers will help shed light on how and when cost comes into consideration when choosing a CDMO.

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HPAPI cleaning validation considerations – Part 1

In general, cleaning validation (CV) is a very complicated topic. The complexity is not only maneuvering within a site’s CV program, but also between industries (i.e., small molecule, biopharma, and API/finished product manufacturing). Regulatory guidelines discuss CV topics in general but not specifically to any industry. Therefore, deciphering and implementing their recommendations or expectations is often difficult.
Because high potent active pharmaceutical ingredient (HPAPI) manufacturing (API or finished product) is very high-risk from a patient safety perspective, every stage of the cleaning validation (from development to periodic monitoring) requires additional considerations and evaluation.
Every stage of the cleaning validation was assessed in respect to HPAPI manufacturing. This resulted in considerations, recommendations and solutions; which are published in this article.

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How to Select a Therapeutic Oligonucleotide CDMO

The number of oligonucleotide therapeutics in development continues to increase and so does the demand for oligonucleotide contract manufacturing services. Selecting the contract development and manufacturing organization (CDMO) best suited to manufacture a particular oligonucleotide is critical to the overall success of the drug development program. In this article, a stepwise process that can be used to select an oligonucleotide CDMO will be discussed.

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