The term ‘mRNA’ entered the public lexicon in a massive way with the impact of mRNA vaccines during the COVID-19 pandemic. But did you know that the technological advancement of mRNA vaccines had a much-acclaimed predecessor, known as mRNA reprogramming? While mRNA vaccines apply mRNA technology to making vaccines, mRNA reprogramming employs it in the domains of cell biology and cell therapy development.
Allele Biotech is both fortunate and proud to have been one of the two pioneering groups in the realm of mRNA reprogramming, initiating our development back in 2010 and subsequently publishing our method in 2012 (https://www.nature.com/articles/srep00657). We have played a crucial role in enhancing the efficiency and consistency of this technology, ultimately paving the way for its seamless transition into cGMP production. In fact, we are the world’s first to establish a cGMP reprogramming and iPSC expansion facility, since 2018.
Some additional information about Allele Biotech’s cGMP mRNA reprogramming:
- Efficiency translates to the fact that reprogramming can be completed in as fast as a week
- Consistency signifies an impeccable track record over the past 12 years since the establishment of the technology at Allele Biotech.
- Speaking of cGMP at Allele Biotech, it encompasses an end-to-end approach. This spans from donor recruitment to cGMP banking and shipping, all underpinned by a commitment to quality-by-design and validation.
- One needs to be cautious about how ‘cGMP’ is defined by a facility. Be wary of those that merely advertise cGMP but lack a validation process or the underpinning quality management system.
For more information, feel free to reach out to us via email at firstname.lastname@example.org, and we will be delighted to initiate the conversation from there.
For those who have worked with Allele Biotech and experienced the remarkable success of our mRNA-based reprogramming, wouldn’t your next ambitious development plan naturally gravitate toward mRNA-Based Differentiation? We share that scientific curiosity and enthusiasm and have wasted no time initiating its development.
By leveraging the power of mRNA technology, we have effectively developed numerous iPSC differentiation protocols. To name a few: for in vitro functionally mature cells (without need to wait for post-implantation maturation), we can produce pancreatic β cells, lung epithelial cells, and hepatic cells; for highly proliferative lineage-committed precursors, we can produce myogenic precursor cells, neural progenitor cells, and oligodendrocyte precursors. These are just a few examples in addition to over two dozen differentiation protocols that have been developed.
We firmly believe that each validated differentiation protocol serves as a desirable starting point for cell therapy product development. Additionally, the development is more than just the differentiation protocol; it entails years of dedication to proof-of-concept and mechanism research following the establishment of the differentiation protocol.
However, if you encounter challenges related to the efficiency or consistency of your differentiation protocol, or if you are contemplating the launch of an iPSC-based cell therapy program, we encourage you to get in touch with us via email at email@example.com. We may have a ready-to-implement solution that fully suits your needs.
mRNA Genome Editing
At Allele, we have established and validated a reliable iPSC genome editing platform utilizing advanced Mad7 CRISPR technology. What sets us apart from the conventional Mad7 CRISPR methods is the integration of the Allele mRNA technology, which is also a cornerstone of our patented, mRNA-based reprogramming and a suite of iPSC differentiation technologies.
This unique combination of “Mad7” and “mRNA” enhances efficiency and consistency, forming the bedrock of our cGMP genome editing platform. Whether your goal is to knock-out, knock-in, or insert an expression cassette into a safe-harbor locus, our platform can support you to initiate cGMP operations promptly with minimal protocol customization.
Given the diverse range of objectives, genome editing may involve a combination of knock-out, knock-in, safe-harbor insertion, or multiplex gene editing. The complexity of these projects makes it imperative to discuss your specific project details and customization needs. Please feel free to contact us via email at firstname.lastname@example.org.
cGMP iPSC Single Cell Cloning
In an era where an increasing number of cell therapy development projects involve genome editing, the significance of cGMP single cell cloning cannot be overstated.
At Allele, we have established robust cGMP processes for iPSC single cell cloning. Leveraging the exceptional stability of Allele’s iPSC lines, we have achieved remarkable results, with up to 60~70% of the single cell wells successfully establishing single iPSC clones. While non-Allele iPSC lines also work well enough in our cGMP single cell cloning process, the success rate is typically lower.
While the manual approach remains effective, we further implemented an instrument-based method for higher throughput and enhanced workflow. This innovative method captures images as single cells pass through the microfluidic tube before and after depositing. These stringent measures ensure the true single-cell status of each clone. Our process design also effectively mitigates the risk of cross-contamination during subsequent maintenance and passaging procedures.
Our comprehensive approach generates highly stringent data, minimizing downstream technical risks and providing support for any regulatory filing.
eQMS Tailored for Cellular Product Manufacturing
Quality Management System (QMS) serves as the foundation for cGMP operations, providing a comprehensive framework of standardized operating procedures (SOPs) that cover all facets of cGMP processes. We have meticulously developed a QMS that aligns with the stringent requirements of both the US FDA and ISO. To enhance performance, we integrate our established QMS into the Laboratory Information Management System (LIMS). This integration also incorporates years of insights gained from our extensive cGMP operations. The result is a customized and validated electronic Quality Management System (eQMS) that has demonstrated exceptional effectiveness in supporting cGMP operations for cellular product manufacturing.
Any clients contracting Allele for cGMP production can leverage the efficiency of our validated eQMS. As part of our cGMP consulting services, Allele is committed to sharing our knowledge and insights to help your team develop your own eQMS if you intend to do so.