According to the Merriam-Webster Dictionary, the English noun “solution” refers to:
i) an action or process of solving a problem,
ii) a bringing or coming to an end or into a state of discontinuity,
iii) an act or the process by which a solid, liquid, or gaseous substance is homogeneously mixed with a liquid or sometimes a gas or solid.
This blog post introduces Biovian’s in-house Solution preparation team that primarily focuses on the latter definition, although the other two are present in their daily work as well.
Many biopharmaceutical processes start with solution preparation
Biovian’s in-house Solution preparation team is a key part for the smooth operation of our Development and Manufacturing Organization. It acts as a starting point and a waypoint for various kinds of processes implemented by other teams in our organization. Bioprocess technicians working in the Solution preparation are therefore familiarized with a wide spectrum of tasks related to solution preparation. To avoid bottlenecks, every team member has the readiness to prepare and provide whichever solution is needed at a particular time. It is also worth noticing that all these processes and preparations must comply with strict quality requirements and GMP guidelines to ensure patient safety. Hence, working in a solution preparation team requires attention to detail and a cautious working style. Knowledge of chemical safety is also important for operators own safety.
In-house solution preparation is essential for swift process flow
The in-house Solution preparation team at Biovian mostly provides GMP-grade solutions for production, but it also prepares solutions for engineering batches and developmental processes across the departments. The broad repertoire of solutions includes stock solutions, wash solutions, growth media, formulation buffers, specified solutions used for analytical purposes and so on. Having one team dedicated to the solution preparation enables consistency and continuity in production, ensures high quality of the manufactured products, creates flexibility in project schedules, and allows better control over raw materials and material releases. Moreover, solutions can be tailored according to the client project needs without the intervention of any intermediary service operators. It would take a lot more time if the solutions were prepared and delivered by an external service provider.
Routines and variation in the same package
Bioprocess technicians Miikka Puranen and Jonna Nurmi from Biovian’s Solution preparation team clarify that solution preparation offers a great combination of routine tasks and daily variation. The GMP guidelines, regulations, and standards set up the requirements which they need to follow persistently. Miikka and Jonna consider GMP guidelines and procedures a necessity to achieve high quality and consistency in biopharmaceutical manufacturing. “Having clear guidelines makes my work easier and leaves no margin for interpretation” clarifies Jonna. Moreover, detailed documentation and aseptic work in a controlled cleanroom environment require a systematic and precise approach at each process step.
Even though the GMP guidelines set the requirements for Bioprocess technicians’ work tasks, every day at solution preparation is still a bit different. “Variation in the solution types, purity, and volumes make our work interesting and versatile”, says Miikka. For instance, solution volumes can vary from 10 mL up to 800 L, and preparing a solution on a milliliter scale requires different methods, tools, and scheduling than preparing a solution batch with volumes of hundreds of liters. Oftentimes, problem-solving skills are needed to accomplish these tasks smoothly, even under tight schedules, which is why good time management skills come out useful. Similarly, flexibility and dynamic teamwork are needed in the solution preparation as plans might change under a short notification time and tasks need to be re-coordinated. Fortunately, Biovian’s solution preparation team implements our key values in their daily work, especially Responsibility, as the team members are committed to carry out their tasks precisely and always ready to help each other.