For pharma and biotech companies, regardless of size, there are numerous challenges involved in the fill and finish process of drugs for clinical development and any subsequent scale-up steps. Increased complexity of regulatory requirements and processes, regulatory approvals, as well as the need for financial backing are but a few of the challenges. To be successful, companies must find innovative ways to navigate these roadblocks. Without expert support, a company's attention is more often deflected away from the critical functions of discovery, development and marketing aspects of their drug candidates.
In the case of choosing the appropriate drug delivery system, for example, there are a variety of factors to consider, particularly the sensitive nature of many drug substances. Drug manufacturers must answer important questions regarding various market and manufacturing aspects of their product. Ask yourself, is the product liquid or lyophilized? What are the therapy requirements? Is it a self-administered therapy? What is the product lifecycle and cost? What does the competition look like?
There are many questions, unexpected challenges and decisions to be carefully and thoughtfully addressed as they may have a potential impact on your drug product's success. Conducting a clinical development project successfully requires that a company consider aspects such as ensuring packaging material compatibility, developing efficient processes, meeting crucial timelines for clinical trials, expediting regulatory approvals and streamlining scale-up to commercial manufacturing.
The value of what will come out at the end of a process is often dependent on the quality and thoroughness put in from the start i.e. quality in, quality out. When executing drug development in an organized and careful manner, and with as much expert support as possible, the outcome is more likely to be successful for the benefit of the patients who desire a treatment for their disease.
At the end of the day, it is the pharma or biotech company itself which has to find the best balance in development and manufacturing based on various parameters, including company size and character. Some companies strive to keep capital costs to a minimum while others see strategic value in obtaining a strong in-house manufacturing competency. Defining and following this individualized pathway is critical when navigating an increasingly competitive and challenging market environment. Given all the uncertainties of fill and finish in clinical development, one thing is certain – there is little room for failure, and rarely a second chance.
Dr. Claus Feussner is Senior Vice President of Vetter Development Service, responsible for the company's development centers in both Ravensburg and Chicago. Vetter is an independent international contract development and manufacturing organization (CDMO), headquartered in Ravensburg, Germany, with a clientele that includes the world's leading pharmaceutical and biotechnology companies. His responsibilities encompass the divisions of Manufacturing Sciences & Process Development, Technology & Process Transfer, Project & Service Analytics, Drug Delivery Systems, as well as Product Development & Design. He joined Vetter in 2010 as Vice President, Quality Control. Dr. Feussner was named to his current position in September 2014. Dr. Feussner began his career in 1997, and held a variety of positions of increasing importance at international pharmaceutical companies, including head of aseptic manufacturing, director of Quality Control, and Qualified Person. He holds a PhD in Natural Sciences from the Julius Maximilians University in Wurzburg, Germany. Dr. Feussner is a member of the German Pharmaceutical Society and the Parenteral Drug Association (PDA), as well as a member of the German and European QP association.