Webinar – Highly Potent APIs – Markets, Myths and Manufacturing

The production of non-potent small molecule drugs accounts for the vast majority of API manufacturing capacity. Nonetheless, clinical successes and growing press surrounding small molecules focused on oncology indications and cancer growth inhibitors has created somewhat of a gold rush of commercial interest in highly potent active pharmaceutical ingredients (HPAPIs).

Terminology such as ‘high potency’ and ‘highly potent molecules’ have almost become cliché as the number of contract manufacturing organizations (CMOs) that claim to be able to handle them proliferates. However, just as recent as a decade ago, the list of CMOs that could legitimately manage the hazards associated with manufacturing HPAPIs could be counted on just one hand.

So how is this webinar any different to everyone else?

It can be tempting to assign high potency to a small molecule in this therapeutic class and in many cases serves as a conservative approach. Perhaps the greatest challenge for toxicological assessment at least, is that these molecules may be highly potent toward cancer cells and yet pose minimal hazard to healthy workers. This is an important departure from past toxicological assessment of legacy cancer drugs that act primarily through somewhat non-selective cytotoxicity.

HPAPIs, and in particularly small molecules being developed for oncology present a new set of challenges for CMOs charged with safe handling during process development as well as clinical and commercial production. In the context of recent developments and investments made by Cambrex in high potency manufacturing, this webinar will:

  • Provide an overview of the current HPAPI market
  • Introduce HPAPI toxicological assessment
  • Explain why there is variability between assessments
  • Discuss how variability may impact containment strategies and cost
  • Share ideas about how to tailor and customize manufacturing strategies for next-generation small molecules in targeted cancer therapy
Small Molecule Webinar

Development of Small Molecule Drugs – from the clinic to the market

In this webinar, an overview of the development and lifecycle of a small molecule drug is presented. Attention is then turned to the typical needs and requirements for an API manufacturer at each stage of the lifecycle. We then present a case study of how a CMO, such as Cambrex, has the expertise to support customers at all stages from early development to commercial launch.

A History of the API & Intermediates Contract Manufacturing Industry
(1975 – 2015)

This webinar aims to present an expert review of the last 40 years of the CMO industry for small molecules. In addition to in-depth analysis by Cambrex, performed over the period 1975-2015, a series of primary research interviews with industry experts was undertaken. In total, the views of 10 industry veterans, each of whom had no less than 25 years’ experience in the CMO industry, have been presented.

Small molecules big opportunities

Small molecule API volumes – trends from the last 15 years of NCEs

In this webinar we present a condensed review of the last 15 years of launched small molecules. We look at market consumption, resulting volumes of API and how CMOs need to be investing in their manufacturing assets in order to supply pharmaceutical innovators with the required volumes.

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Resurgence of the small molecule API market – an industry primer

In this webinar, Cambrex’s Market Intelligence group use their compiled data to outline and review the pharmaceutical market from the vantage point of chemical molecules and present an overview of the API market. The webinar attempts to present a balanced review of the competitive CMO landscape for small molecule API manufacturing and show how Cambrex is positioned within the CMO market.

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Quality, speed, flexibility and customer focus in API manufacturing: an introduction to Cambrex

In this webinar we showcase customer case studies and examine how Cambrex works with large, mid-size, emerging and niche pharmaceutical companies to meet their changing small molecule needs and bring their products to market quickly.

Managing the API Lifecycle

Managing the API lifecycle: Cambrex innovation, process and cost improvement

In this webinar, Cambrex’s Innovative Product group detail their objectives and describe how customers can benefit from their innovative API Lifecycle Management approach in developing new, sustainable and cost effective routes or processes, by which additional IP protection can be generated, cost of goods lessened, and/or environmental footprints reduced.