Contract Development Manufacturing Organizations (CDMOs) and Contract Manufacturing Organizations (CMOs) produce nearly one-third of all biopharmaceutical products. Because these companies produce products for various customers in a dynamic industry, they encounter many different production processes, rapidly changing demand and short-term requests. These challenges make it essential for CDMOs and CMOs to be provided with flexible, single-use solutions that can be delivered quickly, with last-minute changes possible.
At Hitma, we understand the unique challenges of CDMOs and CMOs. We offer single-use solutions for every step of the (bio)pharmaceutical process: upstream process (USP), downstream process (DSP) and Final Fill. In addition to tailor-made solutions and fast delivery times, we offer the necessary service and knowledge to determine the best solution for each unique process and we look at possibilities for standardization.
Flexible and fast delivery
CDMOs and CMOs often need to respond quickly to changes in customer needs and the market. The biopharmaceutical market can change rapidly, with sudden increases in demand for certain drugs, often in response to health crises or breakthrough therapies. By holding dedicated stock – keeping a certain amount of products and materials specific to a customer in our warehouse – Hitma can help CDMOs and CMOs to respond efficiently to these sudden changes. Keeping dedicated stock ensures that ready-to-use single-use assemblies can be delivered within six weeks. Specific components in processes or assemblies can also be easily replaced or adjusted if it is discovered in the development phase that, for example, a different filter is needed or a tubing needs to be longer.
Expert knowledge and fast service
Because CDMOs and CMOs often work with many different customers, they also deal with many different processes. These processes are often very complex and therefore require tailor-made solutions. The single-use specialists therefore support you at every step of the process and help you to find the best solutions that can be used as widely as possible. Additionally, they are experts in the field of regulations and quality, which allows them to determine the right solution for each process that meets all standards and regulations.
In addition, the Hitma customer service is ready to assist in solving issues and technical problems. As a result, malfunctions are resolved as quickly as possible and downtime is minimized. Due to the quick response time of customer service, it is also possible to respond quickly to (last-minute) changes in processes or customer demand.
Standardization and upscaling
With standardization of processes, variability of the process is minimized, so that as few adjustments as possible are required per project in both the design of the assembly and the components that are used. The final solution is built modularly, breaking it up into smaller standardized parts. For example, a C(D)MO can duplicate a process from one end customer to another end customer, with minimal to no changes to the design. The necessary components are then kept in stock in order to achieve even faster delivery times. In addition to efficiency in the area of process design and delivery, standardization also contributes to compliance with regulations. Implementing a process that is already compliant and proven to be of quality saves the time normally required for demonstrating regulatory compliance and performing quality checks. Moreover, a CMO or CDMO can significantly reduce the time and costs required by not designing and ordering new single-use materials for each new project, but by choosing from an existing library.
The (standardized) single-use technology is easier to adapt to changing production volumes, making it suitable for the different phases of the production process and meeting fluctuating customer demand. By using single-use products, you can easily switch from laboratory testing to small-scale production and eventually scale up to large-scale production. Single-use technology also complies with Good Manufacturing Practice (GMP).
Hitma's specialists are happy to support you in deciding which solutions best suit your unique process and how standardization can improve overall efficiency. Are you curious about the best solution for your process? Feel free to contact me.
