An increase in requirements from regulatory agencies around the world, combined with a growing demand for drugs in prefilled injections systems – a trend that industry experts have projected will continue – has led pharmaceutical and biotech supply chains to gain in significance.
Well established and optimized processes are crucial for offering uninterrupted market supply. To satisfy its customers a CDMO must foster flexibility, efficiency and safety throughout the entire supply chain. The most important goal for all parties involved in the bio-pharma business is maximization of product quality where even small decisions can make a big difference. Future-oriented pharma processes can add value to any compound.
Being successful means being flexible
Pharma and biotech companies demand reliable partners that can meet their needs quickly while reacting swiftly to changing demands. Future oriented CDMOs offer a continuous optimization of all processes by combining innovative and well-established technologies with intelligent solutions. Their customized innovative processes fit perfectly with individual requirements of customers while meeting the demands of regulatory agencies.
Efficiency is key
A service provider who can enable a high level of efficiency does more than simply manufacture a product faster. Efficiency of process means helping companies meet regulatory requirements while assuring a reliable, worldwide market supply. Such processes might include the creation of an optimized spatial concept with short paths for material flows within a site or streamlined and carefully coordinated work processes. For example, optimizing the entire process between several manufacturing sites might include the building of an autonomous site that acts as a central hub for all logistical processes of a company. The smoother the processes interlock, the more efficient the handling of projects.
Safety is important for pharma and biotech companies, especially when dealing with regulatory authorities and high-value compounds. Reliable CDMOs will make every effort to offer secure processes that are as flexible as possible. What are some examples of how specific security measures might appear?
An elaborate cold chain from arrival to delivery of the product is essential for safe manufacturing and is one example of a security measure that a state-of-the-art CDMO can offer. Yet another is the strict segregation of material flow according to temperature, i.e. room temperature and cold storage products. An additional comprehensive material tracking system that registers all products following their arrival at a CDMO helps secure supply chain processes and allows for rigorous tracking throughout the entire supply chain.
Furthermore, extensive automation streamlines processing and reduces manual work while decreasing human error. A trusted partner offers an elaborate concept based on the idea that a secure supply chain with optimized product flow supports high safety levels and harmonized processes. Finally, an appropriate back-up system protects this meticulously planned supply chain, for example, multiple redundancies within the power supply of a production site.
Key priority: High Quality
One area where no pharma or biotech company would ever cut corners is product quality. Therefore, the key priority of a trusted partner is quality conditions that never compromise. This attitude helps a state-of-the-art CDMO support the highest possible quality of a customer’s pharmaceutical and biotechnological products.
The goal of optimized pharma processes is to bundle all supply chain stations within a single innovative structure that stands ready to meet all future requirements. Within a site, promising measures include short transportation, strict segregation of material flow, and extensive automation that reduces risk and sources of error to a minimum. This must be part of a stringent quality management system if the growing needs of both market and partners over the long-term are to be met. Thus, CDMOs can foster extremely efficient, rapid and secure processes in logistics and quality control while remaining highly flexible for customers.
As a reliable partner, Vetter’s process and quality standards are often more stringent than accepted cGMP regulations. With these optimally and continuously harmonized processes, Vetter can implement in-time preparation and rapid processing of the products for each station in the supply chain.