The key issue when transferring a bead coating process from the Research and Development department to the manufacturing department is scalability. It is essential to ensure that the system being utilized for a particular protocol is adaptable to larger volumes. Ideally, any scale-up would be carried out with the use of a homogeneous biomagnetic separator, as this would ensure that the conditions of the protocol are well-defined and able to be reproduced for a larger volume.
This post is about scaling up the coating process for magnetic beads. If you want detailed information about this topic, download our free ebook The Advanced Guide for the use of Magnetic Beads in Chemiluminescent Immunoassays:
What are the advantages of scaling the process in a homogeneous separator?
Beads that undergo a separation process in a homogeneous separator experience a constant force regardless of the distance from the magnet. In contrast, scaling up a process in a non-homogeneous separator volume results in the beads located at a greater distance from the magnet experiencing a decreased magnetic force. This necessitates a disproportionately large increase in separation time. Problems that arise as a result include non-reversible bead agglutination, consequently leading to decreased and inconsistent yields.
It is crucial that departments involved in scaling up a process remain in constant communication in order to ensure a successful transfer of a coating protocol. The research and development department charged with establishing a procedure should play a hand in the manufacturing process, and vice versa. If the equipment used to develop a protocol can also be used to scale it up, then any problems associated with applying a procedure to a larger volume can be minimized. Similarly, if the conditions of the initial protocol can be clearly defined, as they are when utilizing a homogeneous magnetic separator, then the transition of the process to an increased batch volume will be relatively straightforward and the quality of the final product will be maintained.
Don't forget to check these posts from our blog in order to get a deeper insight into magnetic particles and immunoassays:
- Using streptavidin magnetic beads in Chemiluminescent Immunoassays
- Pros and Cons of Classical Biolinks (Streptavidin, Biotin, Protein A, Protein G)
- Scaling up magnetic bead coating protocols