From Startup to Standout: Aseptic Processing Solutions for Life Science Innovators
The path to a successful life science startup is exciting, difficult, and unpredictable. Recent years have seen a volatile pattern emerge of challenge, change and innovation within the life sciences. The trend towards innovative pharmaceutical solutions is projected to continue into 2024, as breakthroughs in treatment modalities, supply chain management and patient-centered medicine are tracking at an exciting rate. The biotechnology industry alone is expected to surpass $3.44 trillion by 2030, and advancements in cell and gene therapies play a substantial part of that equation. This has all occurred against a curious backdrop of a post-pandemic market that has experienced a recent downturn, and industry-wide uncertainty regarding policy and regulatory changes set to occur in 2024. For pharmaceutical startups and smaller operations, it’s more vital than ever to have the right strategies and partners in place to navigate an unpredictable landscape.
The long-term viability of pharmaceutical startups is contingent on how efficiently and economically they traverse the drug development process. Whether the goal is to complete the full process in-house—delivering a new product commercially—or to find the right distribution partner, employing aseptic processing solutions that match your clinical and R&D needs will be a key determinant in operational success. Time to market is often a make-or-break factor for both small and startup pharmaceutical manufacturers, and fill-finish automation and robotic solutions offer the flexibility and efficiency needed for stakeholders to remain competitive and adaptable.
Preparing for Evolving Regulatory Standards
As the industry continues to evolve, regulatory guidelines will continue to be refined and come into focus. Real-time data acquisition, supply-chain best practices for current and new treatments, and the growing number of biologic treatments becoming available will all lead to well-placed regulatory scrutiny. Technology utilized by small pharmaceutical operations should be designed with cGMP principles in mind, including the new Annex 1. Batch data and process traceability are necessary for both regulatory compliance and proper tech transfer procedures.
Scaling Technology to Product Development Milestones
Technology that scales the full length of the drug development process both makes the most of an initial investment and saves on crucial monetary and time costs over the operational timeline. When fill line tools like pumps, IPC methods and robotic interventions can scale in a modular fashion from a tabletop setup to a multiformat commercial processing machine, this eliminates unnecessary friction points in product development and minimizes machine changeover and downtime. Additionally, when machines possess the same turnkey solutions across various aseptic processing lines, validation times are significantly reduced.
Front-End Expertise and Aftermarket Excellence
Having the right tools is key. But having an aseptic processing partner that understands the lay of the land and is willing to lend their expertise ensures that those tools are being utilized to their fullest. It’s not uncommon from the onset of a project to have an unclear idea of what exactly is required from an aseptic processing solution. An operation may be launching the very first clinical trial or navigating their first venture into producing a highly specialized, unique cell or gene product. Those challenges notwithstanding, the full scope of a project’s requirements and deliverables alone can be daunting to consider. It’s important to have a fill-finish partner that understands not just where you want to go, but where you are currently; who works with you to help answer the grey area questions about your project’s requirements and assists in finding tailored, turnkey solutions. The combination of innovative modular solutions specific to your goals on the front end of your project, and timely service and troubleshooting over the life of your machine is very often the difference between success and setback.
For pharmaceutical startups and other life science innovators, intuitive automation and robotics provides the flexibility and effectiveness needed to weather the obstacles and uncertainties of parenteral drug development. Learn how AST can provide your organization with flexible, high-quality aseptic processing systems – contact our experts today.
