July / August 2022 Archives

Recent trends in self-administered drug delivery systems – What does 2022 have in store for self-administered injectable drug delivery?

25 August 2022 No Comments

Peter Hirst, Head of Commercial, Advanced Delivery Systems at Recipharm, discusses the fast-changing pharmaceutical market landscape and explores the latest trends driving innovation in self-administered injectable drug delivery. Some trends that are pushing growth in this area are directly linked to the COVID-19 pandemic, including the need to ease the healthcare burden. These effects will continue to be felt well into 2022, so now is the time for pharmaceutical companies to take action in order to overcome the challenges self-administration brings about, and ensure that their technology puts them in the best position to create opportunities and benefits in this space.

Scientific due diligence builds better business relationships

25 August 2022 No Comments

The biopharma sector is seeing a proliferation of mergers, partnerships and acquisitions, but deals can sometimes fail due to poor scientific due diligence. Diane Seimetz and Jörg Schneider at Biopharma Excellence outline a plan of action to help you get the most from your business relationships.

Essential use of chemicals. Opportunities or constrains

25 August 2022 No Comments

Essential use, as initially proposed by scientists and later referred to in the EU

A new paradigm of clinical research: decentralized clinical trials

25 August 2022 No Comments

INTRODUCTION Site-based clinical trials have been the gold standard of clinical research: study participants

Oteseconazole

25 August 2022 No Comments

In this issue we will present synthetic strategies towards the synthesis of oteseconazole, designed

How “Smart” are the novel biotechnology platforms based vaccines?

25 August 2022 No Comments

It was recognized, quite early, by the healthcare experts that traditional vaccine manufacturing techniques were unable to meet the rapidly growing COVID-19 vaccine demand. This prompted the biopharmaceutical firms to adopt “smart” vaccines products developed and manufactured using the novel nucleic acid and viral vector biotechnology platform technology. As the pandemic ebbs, the success of the novel platform-based vaccines will trigger a possible extension of this technology to diseases beyond COVID-19. In this context, this work explores and highlights the “smartness” of the novel biotechnology platform-based vaccines to aid the research community in their future vaccine development endeavors.

Active pharmaceutical ingredients (API) in China: Approval process, timelines, practice points

25 August 2022 No Comments

Active pharmaceutical ingredient (API) application pathways in China have evolved substantially over the past 5 years. In 2018, the drug master file (DMF) system was introduced, superseding the previous approval procedure, which had been in place for more than ten years, and which was similar to that of finished drugs and therefore very costly and time-consuming for applicants. This paper reviews key application requirements and approval pathways for API in China, and explores challenges and key practice points for applicants.

The impact of mergers and acquisitions on brand in the life sciences industry

25 August 2022 No Comments

Brand reputation is everything to a business. Your brand is what everyone thinks when

Applications of Flow Chemistry for API Synthesis

25 August 2022 No Comments

Batch production remains the mainstay of the pharmaceutical manufacturing sector, and much has been discussed about how flow chemistry has the potential to offer economic and technological advantages, as well as safety benefits when handling volatile or hazardous materials.
There are now several examples of steps in API syntheses being carried out under continuous conditions, and this article will examine real-world cases where the technology has been implemented positively; what barriers exist to wider implementation in the industry; and how flow chemistry can be utilised as an important tool for chemical process development.

Matching the potential of Process Intensification technologies like continuous manufacturing/flow chemistry with the emerging Societal and Business Challenges in Medicines Manufacture and Supply. Part 2 – Technological Solutions

25 August 2022 No Comments

Flow Chemistry and Continuous Manufacture offer a wider set of chemical transformations for industrial manufacturing processes and in doing so allows intensification and simplification of synthetic routes to complex organic molecules. This technological approach alone does not address the emerging needs for supply of products like medicines; that of a sustainable and resilient supply base that can quickly supply patients. This requires the addition of new approaches to Automation, Digitalisation, Modularity and Modelling to the functionality of Flow Chemistry to achieve a transformation of the design processes and the supply chain for medicine manufacture.

Issue: July / August 2022

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