White Paper

Integrated First-In-Human Services To Streamline End-To-End Development And Manufacturing

By Conrad Roten, Ph.D., Group Leader Chemical Development, and David Lyon, Ph.D., Senior Fellow, Lonza Small Molecules


The complexity of today’s growing pharmaceutical market is driven by a wide range of trends, such as an influx of highly potent molecules and specialized drugs, accelerated timelines, and uncertain market demand, all of which are putting new pressure on biomanufacturers as they face a host of unique challenges on the path to market. Small biotechs ― the innovative engines for many of today’s novel products ― face an even greater uphill climb due to a lack of resources and facilities in an increasingly competitive market.

With more focus on early drug development, CDMOs have become a critical component in overcoming these challenges by offering expertise and experience that can help develop strategies to achieve time and costs savings. CDMOs that offer end-to-end development and manufacturing services for drug substances and drug products are especially valuable, as they eliminate the risks of multiple contracts, mechanisms and protocols, and points of contact that come from working with more than one partner. A study from Tufts found that biomanufacturers can potentially shorten timelines by an average of 14 weeks, reducing costs by nearly $21 million after taxes, and increase net revenues by almost $24 million.1

At Lonza, we understand the importance of end-to-end development and manufacturing, which is why we have designed our SimpliFiH®️ Solutions offering, intended to simplify and accelerate the development pathway, even for APIs with challenging properties, such as low aqueous solubility and poor bioavailability. Access this article to learn more about the SimpliFiH®️ Solutions package and the integrated services it offers customers across drug substance and drug product, from feasibility studies through clinical trials and commercial supply.

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