Monoclonal Antibodies, from science to manufacturing production with TECNIC's Biotech Solutions
In 1986, the United States Food and Drug Administration (US FDA) approved the first monoclonal antibody therapy, and since then, the field of antibody engineering has undergone a significant evolution, as monoclonal antibodies (mAbs) represent a significant advancement in biotechnology and play a pivotal role in modern medical therapeutics. The current generation of antibody drugs exhibits high specificity, leading to a substantial reduction in adverse effects. Consequently, therapeutic antibodies have emerged as the predominant category among newly developed drugs for treating various human health conditions, including cancer, autoimmune disease, metabolic conditions and infections.
Given the critical applications of mAb biotech, it is paramount to optimize both the quality and quantity of its production. TECNIC solutions, with a commitment to evolve together, offers equipment designed to assist you in achieving your monoclonal antibody development. Our upstream bioreactors ⇀ are designed to elevate and optimize monoclonal antibody production, ensuring enhanced yields. Furthermore, our Tangential Flow Filtration systems ⇀, designed for downstream purification, provide an easy and automatic step for purifying the desired mAb.
Explore TECNIC and let our innovative solutions catalyze your next monoclonal mAb breakthrough.
What are monoclonal antibodies?
Monoclonal antibodies (mAbs) are laboratory-produced proteins that act identically to immune system antibodies and, therefore, are designed to identify, bind and induce a neutralizing immune response when they are faced with certain bacteria, viruses, fungi, tumour cells, allergens, venom or other toxins. These laboratory-engineered antibodies are designed to be highly specific, and their specificity makes them invaluable in disease diagnosis and treatment.
This monoclonal antibody treatment is a prime example of modern-day medicine, designed to be personalized and based on specific disease characteristics. Being at the forefront of personalized therapeutics in areas such as hematology, immunology, oncology and infectious disease while limiting the adverse systemic effects associated with traditional treatment options.
Monoclonal antibody treatment offers high specificity and improved sensibility while minimizing side effects when compared to conventional therapeutics. The evolution of monoclonal antibody production, from hybridoma techniques to recombinant DNA technologies, has not only enhanced their therapeutic potential but also broadened their application in research and diagnostics applications.
Use of monoclonal antibodies
Monoclonal antibodies are immunoglobulins routinely used in several fields, as they have a number of promising potential therapeutic applications in the treatment of asthma, autoimmune diseases, cancer, poisoning, septicemia, substance abuse, viral infections, and other diseases. Moreover, they have become indispensable not only for health diagnosis and research, but also to prevent food poisoning and investigate environmental pollution.
Some examples of applications include:
Challenges in monoclonal antibodies production
Since the first monoclonal antibody was approved in 1986, antibody engineering has dramatically evolved. As our understanding of diseases deepens, the potential for monoclonal antibody treatments expands. We have seen an evolution from murine to human antibodies in what has been a largely successful effort to duplicate more precisely the characteristics of naturally occurring antibodies. Due to these advances, current antibody drugs have increasingly fewer adverse effects owing to their high specificity, which has made them in recent years the predominant class of new drugs developed.
However, despite these notable achievements, the production of monoclonal antibodies (mAbs) still faces certain challenges and complexities that require continuous research and technological innovation:
Advanced Bioreactors
For an effective bioprocess development, maintaining cost-effectiveness, maintaining desired quality attributes while reducing production time, and providing manufacturing flexibility are key issues in today's competitive mAbs market. Moreover, in order to produce large doses of antibody over extended periods of time, it is required to optimize various factors, including cell lines, culture media, culture conditions, and a thorough understanding of the culture performance at different scales, to facilitate a smooth scale-up and purification step.
TECNIC Bioreactors are the premier solution for the efficient and robust production of monoclonal antibodies. Our upstream bioreactors eLAB®, ePILOT® and ePROD® are meticulously designed to provide precise control over environmental parameters, optimizing cellular conditions for maximal yield while minimizing resource and time utilization. This exact control and accurate measurements with real-time data from our automatic control unit PLC enable you to fine-tune the culture conditions needed to achieve reproducible and consistent results. Choose the desired parameters – temperature, pH, agitation speed, gas flow rate, dissolved O2 and CO2, redox potential, viable cell concentration and viability – and develop a smooth bioprocess performance.
Additionally, even though mammalian cells are generally considered difficult to scale up due to their sensitivity to physico-chemical conditions, TECNIC's inherent scalability and adaptability of our equipment ensure the successful scale-up process with an automatic control system and proper aeration and agitation systems. Whether you are engaged in pioneering research or driving industrial-scale production, enable us to meet your end demand for high-quality monoclonal antibodies.
Tangential Flow Filtration equipment for monoclonal antibodies
Upon reaching the final stage of the bioreactor culture, it is primordial to obtain a good mAb end-product. The advanced downstream Tangential Flow Filtration equipment of TECNIC effectively separates the target antibody from impurities and contaminants, ensuring a high level of purity with high flow rates. Moreover, thanks to its fully automatic system and its variety of operational options, eLAB® TFF ⇀, ePILOT® TFF ⇀ and ePROD® TFF ⇀ contribute to the final purity of your overall bioprocess with an easy step.
TECNIC's TFF systems are meticulously designed to meet demanding bioprocessing product recovery requirements, providing superior purification across diverse biotech applications. Our filtration equipment can complement and enhance the efficiency of your overall bioprocesses. Offering reliable filtration solutions, coupled with high flow rates and high solute retention, our advanced features are engineered for optimal downstream processing of mAbs. Additionally, our advanced automatic systems deliver a user-friendly experience across various operational scales, ensuring a seamless and consistent outcome.
Less efforts in sterility and cleaning bioprocesses
TECNIC equipment is crafted from stainless steel AISI 304 and 316L, so all our solutions are manufactured with the best high-quality materials, delivering unparalleled productivity at both the laboratory and industrial scales. Additionally, understanding that each industry has unique cleaning requirements, we also manufacture an optional fully automatic and Easy-to-use ePLUS® CIP system ⇀, which is an innovative compact solution that features preestablished recipes and a large range of customizable options to meet specific needs in bioprocessing facilities. Capable of handling cleaning operations for equipment volumes up to 2000 liters, the ePLUS® CIP ensures consistent, high-quality outcomes with an intuitive configuration experience, increasing efficiency and minimizing the downtime of large-scale bioprocessing facilities.
However, some clients prefer the use of Single-Use bioreactors, as they allow for easy bioprocess validation and require fewer efforts regarding sterility and cleaning. For this reason, in the rapidly evolving landscape of Biotech, the innovative Single-Use eBAG® of TECNIC ⇀ elevates your bioprocess endeavours with redefined functionality, style, durability and convenience. Developed and manufactured in TECNIC ISO7 Clean Room (End-to-End methodology) and built with tough, high-quality materials, these products undergo gamma irradiation, which makes them ready-to-use according to the strictest pharmaceutical industry standards.
Available in various sizes, they can be introduced rapidly into laboratory and manufacturing facilities since installation, qualification and personnel training requirements are minimal. In addition, SU eBAG® can increase plant capacity and flexibility by reducing turnaround time, especially in the event of contaminations, and decreasing set-up time. Implementing design changes is also more rapid with disposable SU eBAG®, allowing for continuous improvement and the integration of new technologies such as on-line monitoring systems. Overall, these advantages lead to significantly lower capital costs and lower resource requirements, which are key considerations for both large and small companies alike.
Success stories and applications
While we cannot provide specific details due to confidentiality, there have been numerous instances where TECNIC's equipment has significantly enhanced the production of monoclonal antibodies. Our clients placed their trust in us, and the success of TECNIC solutions underscores our excellence and commitment to evolve together.
For example, in the realm of new advancements in patient-specialized diagnostics, one of our clients aimed to allow hospitals to process patient blood samples with the combination of flow cytometry analysis and monoclonal antibodies. For their in vitro diagnostics, they needed to Scale Up the production of one of their research successes (using eLAB® Advanced ⇀ as a bioreactor). As they aspired to manufacture larger quantities of the needed recombinant IgM, they bought one ePILOT® BR ⇀ and one ePILOT® TFF ⇀, trusting TECNIC validated standards of quality and robustness for the bioprocess.
Leveraging TECNIC biotech solutions, they were able to optimize the expression system of their cells, leading to a high yield of mAbs. Afterwards, using ePILOT® TFF, this client was able to purify the needed mAbs for their diagnostic product. As a result, their production goals were achived with enhanced efficiency and an optimal quality end-product. Moreover, our commitment to our clients’ projects ensures that we stay updated on any developments or additional assistance that may be required, and for now, we are still providing ongoing support and staying actively engaged with this client project.
In the pharmaceutical sector, TECNIC is used to collaborate with companies that are focused on large-scale production of biotech pharma products such as monoclonal antibodies, anticancer drugs, cell therapies, and more. These cutting-edge pharmaceutical and biotechnology products often require the use of bioreactors for upstream processes and downstream tangential filtration systems to ensure optimal yield, purity, and scalability.
For instance, TECNIC is currently deeply involved in a veterinarian large-scale manufacturing project of a Chlamydia for infection diagnostic. In this biotech endeavour, our ePROD® equipment plays a pivotal role, providing the precision and the perfect control of the bioprocess to ensure the high yields of mAbs expected for this project. Subsequently, our ePROD® TFF effectively separates the target monoclonal antibody from the media culture and other impurities. This ends with an overall high level of purity coupled with impressive yield rates, which is a testament to our commitment to client success.
Explore our complete range of equipment
Our bioreactors are designed for diverse applications, ensuring efficiency and quality. Discover our full range of biotechnology solutions, including Bioreactors, Tangential Flow Filtration systems, and more. Visit our pages for Bioreactors ⇀, Tangential Flow Filtration ⇀, and Contact ⇀ for further information and inquiries.
