You have to hand it to Tengion, they are trying to tackle one of the largest challenges I can think of: producing tissue engineered organs and tissues from a patients own cells in unrelated indications (bladder, blood vessel, and kidney). While moving through clinical trials Tengion will surely be transforming patients lives with these technologies. They have already had early-stage clinical success with their tissue engineered bladder (highlighted at CNN), but there are several challenges to overcome in creating a business from autologous tissue engineered products. However, the cards are stacked in their favor. Their management team is chock full of seasoned big pharma veterans. Their technology team consists of at least a few Advanced Tissue Sciences alumni (bringing familiarity to the challenges) and they have a stacked scientific advisory board (SAB) and a close collaboration with the Wake Forest Institute for Regenerative Medicine. And lastly, Tengion has funding from JNJ and VCs coming out of their ears. If personalized engineered tissue products are going to be successful somewhere, odds are it will happen at Tengion.
Their technology platform (watch a 4 minute video here) is dependent on successfully harvesting and growing cells from a patient needing a therapy. This step requires expertise not just on the cell isolation, culture and analysis side, but also in logistics, informatics (holding chain of custody between the sample and the patient), and cell preservation after the cells are grown. Once there are sufficient cells, these cells need to be harvested and transferred to three dimensional biomaterial scaffolds where they will be cultured to tissue-like densities prior to implantation. This step in manufacturing requires a strong background in the previous disciplines translated to 3D culture (not straightforward), as well as bioreactor design, bioprocess development, biomaterials science and engineering, and imaging or assay technologies to know when your product is ‘done cooking’. Proof of concept is a huge challenge that Tengion has already overcome, but scale up will only create larger (but not insurmountable) hurdles for them (this is where the former ATS people come in as they have done it before). The next step in manufacturing is harvesting the 3D tissue, sterile packaging and delivering/distributing the tissue, and then having a surgical team successfully implant the product back in the patient- all with different challenges. Due to the expensive and delicate nature to the work, it almost makes sense to have patients travel to centralized institutions to have this work done. This could remove the tissue packaging, shipping, and storage issues, and Tengion would have more control over the end-user handling of these fragile, living implants. The last thing you want is a poorly trained surgical team injuring the living tissue during surgery after you spent 30-90 days tenderly assembling the neo-organ. It will be interesting to see how Tengion charges into this uncharted territory.
Tengion has technology platforms in three major tissue/organ systems covering a variety of indications (see the product pipeline graphic by clicking the thumbnail at the left). Tengion has a great outline on their website of their products, which I quote below:
Tengion is taking on some of the most challenging aspects of personalized medicine and tissue engineering. They have built a strong management team, including a seasoned manufacturing operations executive that will help them navigate both scale up and scale out as they progress through clinical development. They also have a pipeline of products at various stages of development to keep their R&D busy as the bladder project enters late-stage development. Importantly, Tengion has excellent funding and a resource in JNJ, who should help guide them in the process of building a business from their discontinuous technological innovations. If successful, Tengion will certainly change the way that medicine will be practiced.