The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use (ICH) was founded in 1990 as a way to standardize the introduction of new drug substances to the worldwide market. The council wrote and maintains guidelines for how new pharmaceutical products must be tested for stability and quality before they can be approved for worldwide distribution. The guidelines protect consumers and allow new therapeutic drugs to reach patients across international borders more quickly. The ICH has written guidelines for the stability testing of new drug substances and products. There is a general document known as Q1A(R2) that outlines the details of every stability test that a new drug substance must undergo before being registered. These tests examine how the drug degrades in high temperature or high humidity over time. It outlines methods for defining the mechanism of degradation for the new drug, and how to test proposed protective packaging for efficacy. A supplementary document (Q1B) contains additional details specifically about photostability testing.
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.
Once a protocol for coating beads is developed and put in place, it will need to be scaled up in order to meet demand. Scaling up a process, however, requires careful attention to ensure that the details of the protocol are replicated for larger volumes.
This is the last of a series of posts on pros and cons of classical covalent links, which we have been publishing during the last few weeks. This one is about 3 well-known classical covalent links: streptavidin beads, biotin, protein A and protein G.
This is the second of a series of posts on pros and cons of classical covalent links, which we will publish during the next few weeks. This one is about 3 well-known classical covalent links: tosyl, epoxy and chloromethyl groups. In the next posts we are going to review other examples, such biotin or streptavidin beads.
This is the first of a series of posts on pros and cons of classical covalent links, which we will publish during the next few weeks. The very first one is about 3 well-known classical covalent links: carboxyl, hydroxyl and amino groups. In the next posts we are going to review other examples, such as tosyl or streptavidin beads.
Attaching a protein to a bead can be a detailed process that requires forethought and careful planning. Generally, a molecule is attached to a particle through a surface group available on the coating of that particle, for example in the case of streptavidin beads. In cases where the attachment is covalent, it is essential to choose a binding site on the molecule that will allow for proper orientation, maximally presenting the desired site to the sample while still retaining a strong attachment between the molecule and the bead.
Preparing magnetic beads for a particular assay, such as streptavidin beads, requires the beads to be functionalized. The beads need to be attached to the biological material that will serve as a capture molecule in the application. The particular type of attachment by which a molecule is linked to the bead will depend primarily on two things: the molecule being bound and the aim of the process.
Should I use streptavidin beads or gold particles when developing my IVD kits? In order to ensure the success of a protocol, it is essential to have a clear and unbiased knowledge base and a reliable source of reference material. When trying to decide the best platform or application to use for a process, it is critical to ensure that the information on which the decision will be based is generic and factual, and not propagated as promotional data.
The main reason for changing from latex to magnetic latex particles is the need for a change from an homogeneous to an heterogeneous immunoassay. The latter allows washing steps, which potentially help to improve analytical sensitivity and to reduce interference from sample components. The main consideration in shifting from a process that utilizes latex beads to one that uses magnetic latex beads will be the physical separation process itself. Applications that utilize latex beads traditionally make use of a centrifuge or, alternatively, tangential filtration. In contrast, processes that use magnetic latex beads are carried out in a biomagnetic separator. As such, it is necessary to acquire an adequate separator for the process. Ideally, this would be a homogeneous separator.