Monoclonal antibodies have revolutionized medicine, offering tailored treatments with fewer side effects, and continue to drive innovation in healthcare, diagnostics, and research. Their development and application signify a leap toward more personalized and effective medical solutions.
Because monoclonal antibodies are engineered to bind to specific proteins, they precisely interact with the molecules involved in a disease without affecting healthy cells. This makes them ideal for targeted therapies for cancer and autoimmune diseases. Their versatility also means they will continue to drive innovation in healthcare, diagnostics, and research.
At VILS, we understand that the faster your discoveries can be applied, the faster they can start improving – and in some cases saving – people’s lives. We share your passion for your work because it matters to us.
On the other hand, your business needs may lead you to delay investments until more solid scientific data is available, followed by an accelerated path to operational readiness. Either way, VILS is known for delivering solutions quickly to launch when the timing is right.
Streamlined, precise facilities
Manufacturing monoclonal antibodies (mAbs) on a Large-scale, however, is a complex and resource-intensive process with several challenges. For example, supply-chain issues, and production flows must be streamlined.
Facilities must also be designed to deliver precision operation, since monoclonal antibodies are usually produced using living cells that require highly controlled conditions (temperature, nutrients, oxygen levels) to grow and produce mAbs efficiently. Small changes in production conditions can have a major impact. It is also a challenge to prevent contamination and ensure consistency.
That’s especially true of some of the latest therapies such as antibody-drug conjugates (ADCs), which add a layer of complexity. ADCs use a monoclonal antibody as a targeting agent and attach it to a cytotoxic drug via a linker. The ADC binds to the surface of the targeted cancer cell, and the complex is then brought into the cell, where the cytotoxic agent is released, killing the cancer cell, while minimizing impact on healthy tissue.
This sophisticated approach leverages the ability of monoclonal antibodies to precisely deliver the cytotoxic potency of chemotherapeutic drugs directly to cancer cells, while minimizing off-target effects and toxicity to healthy tissues. However, developing stable and efficient ADCs requires precise engineering – and production – of the antibody, linker, and cytotoxic payload.
Bespoke facilities for sophisticated therapies
This kind of emerging, rapidly developing therapy is exactly what the VILS approach to designing facilities is tailor-made for. Our approach is highly pragmatic, based on years of experience working with researchers on the cutting edge who are doing what has never been done before. Our starting point is always an open mind that we focus on your process so that we know it backwards and forwards.
Only then do we start engineering your facility, which will be fully bespoke, not with a preexisting design that is modified to fit. This allows our process architects, project managers, and engineers to focus on the essential to keep your facility lean and operator-friendly, with maximum efficiency and precision.
We also start with a thorough understanding of your business plan to right-size the facility cost-effectively for the step you need to take your business forward. So that you can bring your breakthrough ideas to human lives.
Stringent regulatory environment
Regulatory agencies, such as the FDA or EMA, have strict guidelines to ensure mAbs are safe, effective, and of high quality. There are also regulatory requirements for Good Manufacturing Practices (GMP). Meeting these standards requires extensive testing and documentation. Conducting trials to prove safety and efficacy is expensive, time-consuming, and not always successful. Failure at any stage can mean restarting the process.
After working with a number of companies on the cutting edge of biotechnology, we have experience handling exactly this type of stringent regulatory environment. Our signature focus on the process and on the essential has resulted in lean, efficient facilities that meet all of the requirements for approval.
By acting as innovative, collaborative peers, VILS can play a role in developing scalable, cost-effective monoclonal antibodies that facilitate a leap towards more personalized and effective medical solutions.