Parenteral drug development and manufacturing
PharmTech: What emerging technologies or practices do drug sponsors expect your organization to provide?
Peter Soelkner: Sponsors expect state-of-the-art filling lines that both enhance quality and save costs. For example, fully automatic machines to optimize yield but also reduce risk of human contamination. To meet their products’ specific needs, sponsors also demand from us high flexibility in equipment and processes. That means, for example, providing stainless steel and disposables; options in pumping and filtration systems; and the capability to handle new materials and injectable systems like polymer and pre-sterilized syringes.
PharmTech: Are you seeing shifts in demand for particular types of services? Please describe.
Peter Soelkner: We’ve seen biopharmaceutical firms return to their core competencies and seek strategic partners that can complement their services. Big Pharma/Biotech are using contract manufacturers as an extension of their fill and finish network. They seek for CDMOs to provide high-quality products and long-term market supply. Smaller companies, however, often need partners to guide them through development and regulatory approval, including the creation of product documentation, so they can quickly reach the market or attract buyers.
PharmTech: What pressing technical challenges have you seen in this market segment? What actions has your company taken to resolve the challenge? What actions does your company suggest?
Peter Soelkner: Accuracy on the filling line is one of the industry’s greater technical challenges. Precision is vital to product quality and patient safety. Combination products involving auto-injectors, safety features, and new primary packaging materials have to perform every time to prevent incomplete injection, glass breakage and other failures. Continuous investment in technology and staff training helps us meet those challenges, as well as constant monitoring of the market and environment to keep up with new manufacturing regulations.
PharmTech: What advances do you see in science or technology in this market segment in the next five years?
Peter Soelkner: Drug counterfeiting is a serious problem facing the industry. Serialization and Track & Trace technologies are undergoing implementation worldwide over the next few years to combat counterfeiting, enhance patient safety and enable a more secure drug supply chain. US and EU regulatory authorities, for example, have sets deadlines in 2017. In terms of process control and automation, the landscape will also continue to change as new technologies are introduced to meet ever-tighter quality requirements.
PharmTech: What regulatory changes have positively or negatively impacted drug development/manufacturing processes in this market segment?
Peter Soelkner: Regulatory bodies, in general, have increasingly strengthened their requirements. While it’s challenging to keep abreast of changing regulatory standards, the relentless push to increase quality is vital to patient safety. More explicit requirements like e.g. the cGMP rule for combination products from FDA gives us as a contract manufacturer a better insight into what authorities expect on a granular level. Ideally, we would like to see a move toward global harmonization of regulatory standards.
PharmTech: What business trends have positively or negatively impacted drug development/manufacturing processes in this market segment?
Peter Soelkner: The supply chain within the pharmaceutical industry has become more complex due to high market dynamics and globalization. A growing number of customers and products and a fluctuating market demand make it more challenging for contract manufacturers to plan ahead. On the plus side is the growth of the homecare sector that provides great opportunity for the industry to offer patient-friendly drug-delivery systems, such as prefilled syringes, pens and auto injectors.
PharmTech: Describe the role that quality agreements play in contract services relationships. How will FDA’s draft guidance on quality agreements affect the relationships between contract service providers and drug sponsors?
Peter Soelkner: As part of solidifying relationships in contract manufacturing, quality agreements serve all parties by defining responsibilities and key areas right from the beginning. They strengthen the relationships we have with our customers and enable us to overcome possible roadblocks and challenges that could disrupt both operations and the partnership. With the draft guideline FDA provides a standardized outline of a quality agreement and at the same time indicates the importance of this matter from a regulatory perspective.