The production and use of antibodies are ubiquitous in biomedical sciences, but determining the best research and production practices is still in progress. Most commercially available antibodies have been characterized poorly and lacked a proper validation form. Such uncritical application of valuable tools like those has led to a crisis in reproduction in biomedical research.
Custom antibody production has also faced many issues that need some solutions. Finding solutions to antibody production is crucial because antibodies are useful tools in the sector of biomedical research in the characterization and study of protein-protein, proteins, or the interactions of protein-DNA. This article examines five effective ways of avoiding custom antibody production mistakes.
Ensure that you maintain sample Integrity
The production of antibodies is ordinarily prone to contamination issues and the proper temperatures of cell storage. Temperature fluctuations can occur with some loopholes in the efficiency of storage of samples during shipping from one facility.
The fluctuations of temperature will then stress the cells a great deal. That will be detrimental given that stressed cells can negatively affect the production of antibodies, which will need intensive efforts to get back the cell lines to the optimal production level as a remedy.
Therefore, the solution will be to ensure that you strictly control your samples at the point of shipment, which could maintain optimal temperature from one facility to another and within the process. You must also be careful about contamination with mycoplasma and other adventitious agents. To minimize such contaminations, ensure that you document the laboratory procedures, including partner laboratories, purchase the supplements and tested media from reputable sources, and adequately segregate cells and equipment to reduce the chances of contamination.
Document and verify for higher returns
More often than not, clones are often inherited, sold, or passed on with ongoing buyouts and mergers of companies which may be lacking in a complete chain of custody. Therefore, a viable cell line may thus have significant commercial potential and promise.
However, not much is known concerning its history and development. Because biological systems might not always perform as expected and could possess unpredictable manufacturing behavior, companies must continually capture necessary documentation and verify that their clones have met what is expected.
It is always a worthy idea to keep and maintain complete records because it will help avoid downstream issues in the production process and help maintain timelines.
Exercise Patience while promoting downstream production
Sometimes you may want to develop some cell lines quickly to provide an answer to a research question for a project that is short-term. Then with time, the cell line will become valuable, prompting you to evaluate it for commercial potential. However, if you created the cells rapidly or chose them improperly for optimal production, your yield could be compromised. In that case, the cell line will need a lot of extra effort and time for its optimal performance. Additionally, the client will also be left with a cell line increasing their production costs.
Assess a potential development partner
In selecting a partner to develop your antibodies, you should consider their capacity, flexibility, and history. Your company should possess proper quality assurance controls and SOPs. It is also vital to request documentation showing their ability to reproduce processes, ensuring consistency. Another factor that could influence your decision-making is flexibility. Some development partners need their clients to adhere to some strict internal protocols. On the other hand, others can offer a custom flexible process adjusting to the specific needs of their customers.
On the in vivo side, capacity is also crucial to ensure that a project can scale up quickly. You could easily handle a few small or one-time projects, but the labor-intensive projects requiring access to specific models of animals could be a challenge without a partner.
Develop a Strong Ongoing Communication
Once you have selected a development partner, you need to share much information upfront. Your partner should have extensive knowledge of your product’s ultimate goal. For instance, you need to put out if your product represents piloting for feasibility or not and if it will be a licensed product that requires cGMP or other regulatory requirements. The details will help develop partner design for scalability and prepare for gathering crucial data as are necessary for downstream submissions.
Also needed is proactive communication for developing a partner for keeping their clients informed about issues and progress. Custom antibody production always has challenges. However, an aggressive strategy is needed to avoid some common pitfalls to increase success chances. It would help if you started with an open mind while considering whether monoclonal or polyclonal antibodies best fit your application, depending on your antibody application.
There is an urgent need for proper identification and production of antibodies to avoid many issues, including irreproducibility of the research results and the confusion of product similarities through the rebranding of single antibodies.
Therefore, to reiterate the need for sanity in the production of antibodies, players will need to; maintain sample integrity, create or develop strong ongoing communication, assess a potential development partner, and carry out verification and documentation for higher returns.