Bringing new therapies to people who need them is a rewarding endeavor. However, biopharma manufacturers face many challenges in their journey to the clinic and market. Key among these are changing timelines, a high risk of attrition, and an ever-evolving regulatory environment. Because of these uncertainties, having a flexible development and manufacturing setup can be a competitive advantage in moving quickly and efficiently.
An agile and flexible business model is most effective if there is seamless coordination and communication between drug substance (DS) and drug product (DP) operations. Co-locating drug substance and drug product operations in the same place enables your teams to work together and reduce the risks of product transfer between locations. Companies that want to accelerate their biomanufacturing operations and use their resources efficiently need access to technologies and solutions that can safely and efficiently complete their workflow from discovery to delivery.
Flexible solutions in a changing market
Emerging modalities including mRNA-LNPs and gene editing technologies are all driving manufacturing to smaller batches with greater step-by-step complexity. This trend increases the need for agile manufacturing environments and flexible equipment that can economically produce smaller batch sizes and quickly adapt for a rapid response to changes in geography, product, or scale.
Modular environments, which are tailored to a product’s unique requirements, can be built anywhere in the world. A configurable FlexFactory™ biomanufacturing process train from Cytiva can be built within 9 to 24 months, up to 50% faster than traditional single-use setups. Modular facilities and smaller individual modular environments with standardized single-use manufacturing platforms enable faster batch-to-batch changeovers, streamline tech transfer, and offer flexibility for you to scale up or scale out when needed. However, modular manufacturing environments coupled with single-use manufacturing are addressing only part of your supply solution. DS and DP operations often occur at different facilities and are led by different teams. This can be the case whether the manufacturing is all in-house or the filling activities are outsourced. This separation of services increases risk to the finished drug substance and creates additional costs for staffing, analytical services, and documentation.
Co-locating DS and DP as part of your overall supply chain allows for seamless communication to occur between the two teams, with automation systems providing informatics that may drive quality and cost improvements. With these new modalities, it also makes sense to avoid unnecessary steps like repeated freeze/thaw cycles.
Integrating drug substance and drug product operations in a single facility requires organizations to build aseptic filling capacity. Because of a perception that aseptic filling requires special expertise, this step is sometimes outsourced to specialized companies. However, new robotic aseptic filling solutions can reduce the risks associated with conventional technologies while improving product quality and predictability.
Add filling capacity quickly while reducing risks
Although each product and process has unique needs, aseptic filling does not. Adopting technology that provides a closed robotic process with no human intervention substantially reduces sterility assurance risks. The standardization of such systems means you can build filling capacity faster and be more agile in your operations compared with traditional systems. This has proven true in recent years, with manufacturers making monoclonal antibodies, gene therapies, peptides, oligonucleotides, and other injectables using the same systems to manufacture vial, syringe, and cartridge dosages.
By eliminating the costs and complexities notorious with traditional, customized systems, standardized machines can substantially reduce or eliminate technology transfer by using scale-out models. Removing human intervention and replacing it with recipe-driven automation mitigates contamination risks and errors that can lead to costly delays and even recalls. These advantages drove Cytiva to add aseptic filling workcells to its complete line of products for the biomanufacturing workflow, facilitating the manufacture of drugs from discovery to delivery.
Forward-looking facilities are focused on streamlining operations by utilizing single-use technology (SUT), automation, and concepts like lean design. Designing aseptic operations for this approach supports agility and autonomy for companies of all sizes as they navigate toward product approval. Using standard configurations, filling systems from Cytiva can be changed as needed to accommodate different formats and products, using a single human-machine interface that provides process control and repeatability throughout operation. These systems are supported by a combination of aseptic process automation, single-use consumables, and ready-to-use presterilized containers and closures.
Take control of your manufacturing strategy
Following an urgent and unprecedented need for vaccines on a global scale, there is a growing need for self-sufficiency as people across the world require access to transformative therapies. The path that delivers the medicines you make to the people you promised them to is marred with obstacles, and the best chance of success is gaining autonomy over the process from idea to a finished drug product. Deploying smart solutions that help control your process ultimately allows you to control your future and react quickly to uncertainties.