From research to market, in cell therapy the right partner is key

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Remarkable discoveries in regenerative medicine happen almost on a daily basis.  Just last week, for instance, scientists at the University of Edinburgh reported that they were able to regenerate the thymus in an aging mouse.  If you’re a regular follower of this blog, you will notice that every week we attempt to report on some of the more interesting discoveries in the field, both in the clinical as well as the research arena. Yet, we manage to barely scrape the surface. While some of these discoveries eventually make it to market, many stall long before.

The complexity of developing regenerative medicine products requires expertise beyond the lab bench. To meet the needs and requirements of the novel therapeutic models that regenerative medicine develops, partnerships across all aspects of product and process development are of paramount importance. Akron’s application-specific skills and functionality, combined with manufacturing capabilities that are among the industry’s most advanced, enable us to deliver complete packaged solutions. To advance the rapidly growing cell therapy industry, Akron has in place systems to provide our clients support with product development, raw materials qualification, logistics and packaging optimization, bioassay design, validation and regulatory services.

Akron is an active member of the Alliance for Regenerative Medicine, a non-profit organization whose mission is to promote public policies, initiatives and programs—funding, legislative,  regulatory, technical, reimbursement and other—to facilitate the development and advancement of regenerative medicine technologies.

Our expertise across product development and qualification enables us to fully understands the nuances of the many that operational challenges and offer tailored solutions to improve operational efficiencies of our partners’ development programs.

From research and development through to clinical trials, we pride ourselves of being a one-stop solutions provider with the know-how to improve the market potential of our partner’s development products.

If you would like to talk more about your application and how Akron can help, visit us at the International Society for Cellular Therapy, Booth #47, in Paris, France from April 23-26, 2014. Click here to set up an appointment or just stop by.

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This week in cell therapy news: From stem cell renewal to differentiation in one step; Meet Akron at ISCT

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This week, we highlight a new study that has the potential to significantly simplify stem cell manufacturing for therapy, and the upcoming ISCT conference which Akron will take part in.

Stem Cells: From expansion to differentiation in a single step

The production of stem cells for use in cell therapy is a two stage process: Cells are first expanded in culture, and then differentiated into functional cells or tissues. Traditionally, each of these steps requires a separate microenvironments and has been, as a result, done in separate media conditions. This has also been one of the major bottlenecks in the large scale production of cells for therapy due to need forof separate microenvironments for both processes. This may, however, change if a new study is to go by. A team of researchers at The University of Nottingham School of Pharmacy has created a novel biomaterial with a dual role: to allow for both the self-renewal of stem cells and their differentiation into cardiomyocytes from the same material.

The breakthrough scaffold biomaterial is based on a mixture of collagen and alginate: the alginate-rich part allows for the proliferation of cells. By then chelating calcium ions when the cells have expanded sufficiently, the environment becomes collagen-rich. This change triggers the cells to begin differentiating into tissue. The authors triggered induced pluripotent stem cells to differentiate into cardiomyocytes (heart cells). By modifying the medium, it will be possible to alter the efficiency of differentiation.

The study is of note because it introduces a brand new biomaterial concept that has the potential to truly simplify the way stem cells are obtained for therapy. The study has been published in the Proceedings of the National Academy of Sciences.

Akron to attend ISCT

Here is an opportunity to meet Akron, interact with us and learn about our new products: Akron will attend the 20th International Society for Cell Therapy Annual Meeting to be held in Paris April 23rd to April 26th, 2014. Together with presenting some of our recent research, Akron will host a booth where we will feature all of our products and highlight some new additions to our cell therapy and research lineup. Make sure to look for us and stop by to chat (we may have chocolates). More details to come in the coming weeks. If you would like to schedule an appointment in advance, contact us here.

The Past, Present and Future of Cell Therapies: Podcast with Akron’s Claudia Zylberberg

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At the ISCT 2014 meeting in Paris at the end of next month, Akron Biotech CEO Dr. Claudia Zylberberg will co-host a plenary session panel on the past, present and future of cell therapies. In advance of the meeting, the International Society of Cell Therapy interviewed Dr. Zylberberg for their Pre-Event Podcast series, in which Dr. Zylberberg discusses the current regulatory and clinical state of cell therapies, including raw materials quality, in process controls, logistics, business modelsas well as the current regulatory climate including funding.

Listen to the informative podcast here.

For more information and to listen to Dr. Zylberberg speak at ISCT, she will participate in the panel “Ancillary Materials for Cellular Therapies” on Thursday April 24th.

The International Society of Cellular Therapy 20th Annual Meeting takes place in Paris from April 23 – 26, 2014. Register to attend here.

Scaffolds and robots? The exciting potential of regenerative medicine

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Catherine Mohr, director of medical research at Intuitive Surgical, recently spoke to Wired about her company’s technology: surgeon-controlled robots for operating rooms. The telemanipulators, as she calls them, are robotic surgical hands that assist surgeons in performing surgery, particularly helpful during very precise and complex procedures.

Dr. Mohr envisaged the technology going beyond traditional surgeries and developing synergystically with new advances in regenerative medicine, particularly new biomaterials and scaffolds. Whether this is means robots will be implanting collagen scaffolds into patients soon is another story, but it may be a reality that’s slightly less science fiction than it sounds.

Just like Dr. Terry Riss, senior product specialist, Cell Health at Promega Corp, explained in a recent webinar, Overview of 3D Cell Culture Model Systems & Validating Cell-based Assays for Use with 3D Cultures, there are still a lot of challenges that we are facing when developing functional biological scaffold systems, primarily stemming from the complex technical nature of the tissues created through 3D cultures, which are often either biologically incomplete or not sufficiently robust. Such considerations, when dealing with 3D scaffolds, often involve the material used (for example, alginate vs collagen) and how this will translate into functional, implantable systems.

Such considerations are familiar to scientists working on developing 3D scaffolds systems. A step closer to full biocompatibility and uniformity came a few weeks ago, when Feng Zhao of Michigan Technological University developed a fully natural, uniform and highly aligned 3D matrix made entirely of – and by – fibroblasts. The study was published in the journal Advanced Functional Materials. The scientists made highly aligned nano­fibrous ECM scaffolds by directing human dermal fibroblasts to grow on synthetic nanogratings. In doing so, they obtained a uniform fibroblast cell sheet with highly aligned cells and ECM nanofibers. They further showed that these scaffolds are fully functional by successfully expanding human mesenchymal stem cells. You can download the study here.

So will robots be implanting 3D scaffolds into patients during transplant surgery? It’s unlikely we will be seeing this in the foreseeable future. However, what a decade ago was but a potential script of a science fiction film is slowly shifting to being a reality that, though distant, is not so impossible to imagine anymore.

There is no doubt that regenerative medicine is in an exciting place right now. If you’re curious about scaffolds, the extracellular matrix, or how any of this works, you can talk to us. Akron has been developing and researching a range of 3D scaffolds, including electrospun polymeric nanofibers, for a long time, and we are excited to be part of this rapidly growing field. Contact us to talk.

From cell to bone: In osteogenesis, vitronectin matters

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We have, in the past, introduced fibronectin’s less known extracellular matrix sibling, vitronectin. While vitronectin traditionally doesn’t get as much press, its function warrants just as much attention. New studies – and new work from our labs – prompted us to highlight some of vitronectin’s important roles in cell adhesion, migration and differentiation and highlight its critical role in tissue regeneration.

We are not the only ones to tout its important cellular functions: Not only is vitronectin important in differentiation of human pluripotent stem cells into large-scale motor neurons (Qu et al., Nature Comm, 5(3349), 2014), but it has significant implications in tissue engineered products, particularly regenerative orthopedics.

Case in point: Mesenchymal stem cells, owing to their good differentiation potential towards cartilage, tendon and bone cells, are critical cellular components in orthopedic implants. Indeed, interactions between mesenchymal stem cells and implants are critically important for successful osteointegration. At the heart of this process is successful cell adhesion to the implant, which includes binding of ligands from the extracellular matrix, one of them being vitronectin. Vitronectin is one of the important ECM biomimetic signals, together with fibronectin and osteocalcin, that is thought to promote cell survival during the osteogenesis process.

That is why vitronectin is often found as a critical component of osteogenesis differentiation media.  Yet not all vitronectins are created equal: optimal activity is achieved with pure vitronectin in its fully active form.

So where do you start? At Akron, we are constantly improving our vitronectin manufacturing process to deliver the best possible product. From supplying human vitronectin to developing biological assays, we provide support and know-how across the entire development process. Contact us and let’s talk.

Are we there yet? Printing the human body, one piece at a time

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3D printing technology is taking a big medical step forward. About a year ago, a team at Cornell University developed a so-called ear printer that prints just that – perfectly modeled living ears. Just like regular 3D printing, the process starts with a 3D model of the ear, which is then printed with “ink” made up of living cells. The 3D ears were indeed living: they grew cartilage over three months to replace the collagen they were molded with.

Around the same time, a team at Heriot-Watt University in Edinburgh, UK developed a 3D printing method for the creation of spherical aggregates of human embryonic stem cells, all of which maintained their pluripotency after the printing process.

These two examples are hardly rare. Bioprinting, the medical application of 3D printing to produce living tissue and organs is booming, thanks to rapid developments in 3D printing technology. Examples such as the two mentioned above are joined by a growing number of examples of successfully 3D printed constructs, which includes tissues and, increasingly, organs.

The ultimate goal of tissue engineering is to generate organs for transplants. Increasingly, scientists are speculating that bioprinting is poised to make a huge impact on tissue engineering and organ replacement, particularly as bioprinted applications enter the commercialization arena, aided in no small part by the general public’s familiarity with it. Credit the media for that – recent articles in the Economist and the Telegraph join a slew of other mainstream publications which have, over the past year, helped popularize concepts of 3D printing and, now, bioprinting. Bioprinting companies are also emerging, bringing the reality of commercialization closer.

San Diego-based Organovo is leading the pack. The company bioprinted the first blood vessel without scaffolds in 2010, and currently bioprints 3D liver, bone and blood vessel tissues for research and therapeutic use. They are currently conducting animal tests.

Is this the beginning of a 3D revolution? Time will tell, but the beginning is exciting.

Heads up: Meet Akron at biotech commercialization roundtable

Heads up: Akron Biotech CEO Claudia Zylberberg will participate in a roundtable titled “Clinical and Commercial: Successes and Cross Region Collaborations” at the upcoming BioFlorida Latin America & Caribbean Life Sciences Conference in Miami on March 27 and 28 at Florida International University. She will be joined by Rolando Brewer (ThermoFisher), Michelle Cuccia (Teva Latam) and Eduardo Emrich (Biominas).For more information, visit this link. We will be covering the event in the coming weeks, so watch this space and if you are in the area, register to attend.

To get in touch with us, we are always available at info@akronbiotech.com.