Monoclonal antibodies, or mAbs play a crucial role in medicine, diagnostics and research particularly when it comes to treating cancer and autoimmune diseases. Even though their production is moving forward purification is still a really important and tricky step that has a direct impact on quality, safety and function.
Host cell proteins (HCPs), DNA, endotoxins and aggregates can compromise the safety and effectiveness of mAbs. Regulatory compliance requires high purity with HCPs under 100 ppm and DNA below 10 ppb. Different antibody types such as full length, fragments or recombinant have varying purification needs, influenced by production scale for lab or commercial use.
Choosing the right partner for antibody purification is crucial due to various challenges. Techniques like Protein A affinity chromatography and mixed mode methods enhance purity and yield. Since purification significantly impacts production costs, innovations like membrane based systems can improve efficiency and reduce expenses.
This blog provides a checklist for biotech teams choosing a purifying partner based on the latest advances and industry best practices. Read on to learn the important purification partner checklist biotech teams should use the appropriate partnership can improve quality, compliance and speed to market.
Biotechnology relies on antibody purification to isolate high specificity, pure antibodies for numerous uses. Maintaining antibody integrity and functionality requires the right purification process.
Concisely antibody purification is essential to producing high-quality antibodies which affects research findings and therapeutic applications. Biotechnology and medicine require continuous purifying technique advances.
The following is an exhaustive list of the essential considerations that biotechnology teams need to take into account while evaluating potential business partners. In this case the selection of a provider is less important than the identification of a strategic ally.
To make sure your antibodies are pure and effective, it all starts with picking a purification partner who really knows their stuff. A knowledgeable partner will understand various purification methods and the nuances associated with different antibody types.
It’s really important to check if the purification service provider focuses on monoclonal antibodies (mAbs), polyclonal antibodies (pAbs) or if they handle both types. Every type of antibody comes with its own unique traits and needs for purification:
It is possible for a partner who is skilled in both mAb and pAb purification to provide flexibility and individualized solutions in order to fulfill a wide range of research and manufacturing requirements.
Getting high purity and yield is super important for making sure antibody applications work well and are safe particularly when it comes to therapeutic and diagnostic uses. Impurities might cause some non specific binding, lower activity and could even trigger immunogenic responses.
To improve purity and yield, they must use affinity, ion-exchange and size-exclusion chromatography using Protein A or G. Inotiv offers Protein A/G affinity and ion-exchange chromatography to balance yield, purity, and cost.
Ask about quality assurance before hiring a purifying partner. Check for Certificates of Analysis (CoA) that list purity, concentration and endotoxin levels. Your antibody based initiatives can benefit from a partner who prioritizes purity and yield.
In the world of antibody development, having quick purification processes is really important to speed up research and development timelines. Advanced purification technologies have really cut down processing times, making things more productive and efficient.
Innovations like integrated disposable assemblies have really changed the game for traditional purification workflows. For example, swapping out the usual concentration and dialysis steps for ultrafiltration/diafiltration has cut down process times from two weeks to about 25 hours, while also hitting 100% purity and a 96.64% yield.
Automation really helps speed up the purification process. Using systems like Bio-Rad’s NGC™ Chromatography System, labs have managed to purify 84 monoclonal antibody samples in just two days. It only takes about 30 to 45 minutes for each purification cycle and you end up with proteins that are 95% pure.
When you’re looking for a purification partner, it’s really important to check if they can provide quick results while still maintaining high quality. This way, you can be sure that your project timelines are handled smoothly.
As antibody projects move from preclinical studies to clinical trials it’s super important to have purification processes that can scale and adapt as needed. A purification partner should be ready to manage different production scales while keeping things consistent and compliant.
Getting scalable processes right from the start is really important for smoothly moving forward with monoclonal antibody projects. Putting in place platform processes and carrying out solid risk assessments can really help tackle the time and cost hurdles that come with scaling up.
Plus using single use technologies and modular systems makes it easier to adapt operations, letting you quickly adjust capacity and tailor process flows to your needs. These advancements really help connect facilities that have to handle both small scale and pilot-scale production needs.
Choosing a purification partner is really important. You want to make sure they have the right infrastructure and know-how to help you move smoothly from preclinical development to clinical manufacturing keeping up with the changing needs of your project.
When it comes to ensuring that antibody manufacturing is both effective and of the highest quality selecting a purifying partner that possesses robust skills within the company is of great assistance.
Ensuring that antibodies remain intact and continue to function appropriately during the purification process it is of the utmost importance to have comprehensive quality control methods in place.
An effective quality control protocol will often include:
To ensure that the purified antibodies are up to the requisite requirements for usage in research or therapeutic applications these quality control measures are very necessary.
As you transition from the research phase to the clinical phase it’s really crucial for a purifying partner to have a good grasp of regulatory standards. If antibody products are made following Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) you can be sure they’re safe, effective and consistently high quality.
GLP is all about how organisations handle the planning, execution, monitoring, recording, and reporting of non-clinical studies. cGMP is all about the manufacturing processes. It makes sure that products are made consistently and controlled to meet quality standards. A partner who knows these regulations inside and out will have:
Working with a partner who knows their way around GLP and cGMP standards is really important for successfully developing and bringing antibody-based products to market.
Working well with a purification partner really depends on clear communication and strong technical support. Having an open conversation helps make sure everyone is on the same page with project goals any potential issues get tackled quickly and processes are fine tuned for success.
Here are some key things to think about:
A partner who focuses on clear communication and top-notch technical skills can really boost the efficiency and success of antibody purification projects.
When it comes to your research or therapeutic development, precision, quality, and reliability are everything. You’re not looking for just another vendor; you want a strategic partner who really gets the science, the stakes and the standards involved. Precision Antibody really delivers on that front.
Precision Antibody combines cutting-edge in-house capabilities, a dedication to regulatory excellence and demonstrated scientific knowledge with more than 20 years of experience in custom antibody production and purification. Their team offers services ranging from early discovery to GLP-compliant and even cGMP-compatible, regardless of whether you’re working on monoclonal or polyclonal antibody development, research, or clinical-grade product advancement.
What makes them different?
Working with Precision Antibody is all about feeling confident, clear and consistent at every turn.
Purifying antibodies is super important for making sure therapies work, keeping research top-notch and meeting regulatory standards. Every step, whether it’s about purity or yield, really affects how confidently and quickly you can move ahead.
A great partner does more than provide tools; they come with valuable expertise, readiness for GLP/cGMP, quick turnaround times, scalability, and open communication. Precision Antibody really has it all covered, boasting over 20 years of reliable experience, thorough quality control and smooth support from research and development right through to the clinic.
Are you ready to elevate your antibody development process? Explore what Precision Antibody has to offer or partner with us today! Let’s work together to advance science and achieve excellence. Don’t settle for mediocrity. Join forces with Precision Antibody to enhance your scientific endeavours efficiently, securely and effectively.
Got any questions or thoughts on antibody purification? We’d really like to hear your thoughts so feel free to drop a comment below!
Led by innovative minds in immunology and the antibody development field, Precision Antibody has been an industry leader for over 20 years. We not only implement a cutting-edge technique in antigen design, antibody development, production, and other analyses, but we are also constantly working on ways to improve and advance technology to match the ever-changing world of science. If you are interested in learning more about Precision Antibody’s Custom Antibody development.
Precision Antibody™ is the forefront of the global Custom Antibody industry & it is led by the innovative minds in immunology and antibody development field.
