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Phase Appropriate CGT

At K2bio, the ongoing experience of our clients through each step of their process is always at the top of our priority list. Those that we work with rely on us to utilize our expertise to gauge their best interests, and we do not take this trust lightly. Being a source of information and advisory requires that we not only maintain reliability and consistency in areas already cultivated by the industry but also continue to expand as new faculties emerge and evolve.

Cell & Gene Therapy has been on the leading edge of innovation in the BioScience industry for some time now, and an overwhelming number of ways these therapies can be applied have been and continue to be identified. Originally gaining popularity for their use in oncology services, cell & gene therapies have furthered their momentum into the medical science field as a whole.

Here at K2bio, we have been invested in cell and gene therapy since early on in its development, and have worked diligently to stay up to date consistently as it has progressed. We pride ourselves in offering cutting-edge services for cell and gene therapies for the best possible customer outcome and experience.

Our expertise and ongoing research into what is available in the cell and gene therapy market is only the tip of the iceberg when it comes to the advantages K2bio holds in the cell and gene therapy sector. Location is also an advantageous factor in the work that we do here. Nestled adjacent to the Texas Medical Center in Houston, Texas we have the ability to readily access an immense amount of top-of-the-line technology to optimize outcomes for our clientele. Our primary location in Houston allows us to not only more easily access medical centers, but also a wide array of local talented professionals that specialize even further in the details that can make the difference in your cell and gene therapy services.

Cost is another advantage we hold at K2bio. Price is a factor commonly weighed when analyzing which route to go for cell and gene therapy services. Research and clinical trials can become rapidly expensive, and many companies prioritize their cost efficiency with emphasis, for good reason. Each step of the process incurs a significant cost, and the path of establishing clinical trials or bridging the gap to human trials requires a huge overall investment that whittles quickly. We know well that every dollar matters. At K2bio, we have worked to satisfy this problem by developing a hybrid model to maximize the capital spent on your process. We utilize this model to streamline your process based on what you truly need, avoiding much of what could otherwise be excess under certain circumstances. Advanced equipment, highly attuned professional evaluations, and cutting-edge technology all work simultaneously to save time and expense with this model. Adding to the cost-benefit of this model and the processes within it, K2bio also has access to GMP-compliant equipment that is otherwise difficult to obtain and afford. This technology is almost always more efficient in its transmission of data and information than its more dated alternatives. Some of the equipment we keep available includes but is not limited to LCMS, HPLC, 5 Flow Cytometers, Xenium from 10X Genomics, Chromium, and Visium.

With both experience and efficiency on our side, we have the capability to serve as a bridge for companies who don’t yet have the experience or active personnel to get to the CMP space. We can reduce costs in many cases, helping some companies make the leap to finally establish human trials. We have also taken many companies with open processing complications and helped them navigate the confines of more rigid regulations and finally make it to cell and gene therapy trials. No matter your goal in opposition to where you are currently – we can help you get there.

When we say we have the expertise and a wealth of knowledge to offer our clients, we mean it. We have spent time navigating and understanding the industry and the processes it entails so that you don’t have to. We pride ourselves in being able to take a sometimes confusing and chaotic process and make it more linear from vision to goal. We do this by having professionals on staff that have worked hands-on in the field with scientists and regulators, and also those who have worked with the EMA, the US FDA, and even the Taiwanese FDA. We know the information you need inside out, and we have spent the time ‘reinventing the wheel’ so you don’t have to.

K2bio works with companies of varying sizes and need regimens, but it is important to note our capability for those with an advanced vision for their future. We are not limited here, with experience working with both commercial and GMP products and the systems that encompass them. This gives us the ability to benefit your process and development work no matter where you are. We can help you from where you’re at while simultaneously holding the mindset of what is coming next. Many companies only have preclinical experience, and therefore run into limitations when you escalate your product to a certain point.

We don’t just focus on what you need and where you are, we focus on where you’re going. We keep our eyes on the horizon, helping you through the fundamental steps of your process while keeping in mind what regulatory agencies are going to expect and what documentation will be required of your company and product moving forward into the future. Our goal is not just your current or next step – it’s the development of you, your team, your company, and your product from start to finish.

We know these processes can be looming, technical, and overwhelming. For this reason, we work to make the process as simple and easy to navigate as possible. We have more of an open-door approach, inviting conversation and collaboration regarding what will benefit you most. We want you to understand the steps and stay in the loop throughout the entire process.

Our current docket has availability for immediate projects, and depending on your needs and circumstances we can begin your processes promptly for a turnaround time of as little as 60-90 days. A huge limitation in the industry is capacity – we don’t always have the availability so when we have a window, we want you to know about it so you can take full advantage of the opportunity!

From the preclinical up to pre-developmental stages of your process, we are fully equipped and ready to take your gene and cell therapy services onward and to their full potential. Reach out and let us know how we can utilize our skill sets and expertise to best serve you today!

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