Akron Biotech’ Innovative Products and Services at ISCT

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Our recent expansion to a new state-of-the-art facility has allowed us to further expand our R&D efforts as well as provide improved support services to clients seeking validated cell therapy development processes – from bioassay development through product development, validated raw materials and scale up.

With new innovative products and solutions, we will be attending the ISCT Annual Meeting in Las vegas this week presenting the latest developments and offerings from Akron.

Highlights include:

  • Human Plasma Fibronectin: On the heels of one of the most-trusted fibronectin products on the market – our research grade fibronectin – we will be announcing the launch of our GMP-grade fibronectin, including the industry-first virus-inactivated GMP fibronectin. We will be presenting the various formulation options as well as custom delivery solutions including coating services and well as bioassay services with a variety of cell lines.
  • DMSO-Free Cyropreservation: Akron’s line of DMSO-free cryopreservation media, CryoNovo, is an ever-expanding line of cryopreservation media that is being developed under the mantra “one size doesn’t fit all.” In the spirit of this, we will be on hand to discuss options for cryopreserving traditionally hard-to-preserve cells as well as new developments in DMSO-free crypreservaton that address known difficulties encountered with various cell lines.
  • AB Serum: Akron’s AB serum is true off-the clot: visit us at our booth to learn how our superior AB serum product can help you in your cell culture projects where other AB sera have failed.
  • Custom Development Services: Bioassay development, cell therapy projuct validation, raw materials: innovations at Akron are constantly ongoing. Come to booth 412 to learn much more about how Akron is leading the way.

 

ISCT Agenda

Here is a breakdown of opportunities to meet us and hear from us:

  • Booth 412: We will be there throughout the conference, so make sure to come and speak with us
  • Poster 259: Come learn about the latest in DMSO-free cryopreservation media. The poster session is Friday, May 29th from 5:30 – 7 pm
  • Panel: Strategies for Commercialization Track 2 – Ancillary Materials. Dr. Claudia Zylberberg will chair, alongside Lynn Csontos, a panel discussion on ancillary materials on Thursday, May 28th from 11:15 – 12:30 in the Pompeian Ballroom I/II.
  • Talk: Critical Considerations for the Development of Cell Therapy Potency Assays. Case study: Angiogenesis. Dr. Claudia Zylberberg will speak on Thursday, May 28 during the Strategies for Commercialization Track from 4 –  5:30 pm in the Pompeian Ballroom I/II.

If you would like to set up a private meeting, please contact us at info@akronbiotech.com.

Akron Participates in NIST Standardization Workshop + Visit Us At ISCT

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Akron Moderates Potency Assay Standardization Workshop Akron last week participated in the workshop “Measurement Assurance for Cell Therapy Products,” held at and organized by the National Institute of Standards and Technology. The workshop brought together some of the leading representatives from industry and academia to discuss the best strategies for the standardization of various measurements critical in the development of cell therapy products: cell counting, cell viability and potency assays. A series of seminars gave way to the workshop sessions, which saw the participants split into three groups, each tackling one of the three critical measurement areas. Discussions ranged from challenges currently experienced when dealing with various assays (such as cell clumping during cell counting), to best cross-labroatory solutions how to address and solve these problems. Akron’s Dr. Sandro Matosevic was a moderator at the session on Potency Assay development, alongside Dr. Juliana Woda (Juventas), Dr. Yael Porat (Biogencell), Dr. Eytan Abraham (Lonza) and Dr. Carl Simon (NIST), which was also organized by Akron’s Dr. Claudia Zylberberg. The session focused on two angiogenesis potency assays: endothelial cell proliferation and the tube formation assay, both of which were identified as suffering form significant drawbacks stemming from the multiple factors involved in their setup, particularly the tube formation assay. Some of these include variability in cell source, tube-inducing growth factor as well as detection which is very subjective and relies on processing of microscope-collected images. Potential solutions for standardization were proposed, as well as strategies to achieve harmonization across the various elements of the assays. The two-day workshop highlighted the critical need for industry and academia to work together on identifying best practices – as well as bottlenecks – during the cell therapy product development process, as well as industry-wide organizations’ role in bridging such gaps. Further follow-ups from the workshop will outline some of the proposed solutions. Akron at ISCT in Las Vegas This year, Akron will again participate at the International Society of Cell Therapy Annual Meeting. In the interest of efficiency, here is a breakdown of opportunities to meet us and hear from us:

  • Booth 412: We will be there throughout the conference, so make sure to come and speak with us
  • Poster 259: Come learn about the latest in DMSO-free cryopreservation media. The poster session is Friday, May 29th from 5:30 – 7 pm
  • Talk: Critical Considerations for the Development of Cell Therapy Potency Assays. Case study: Angiogenesis. Dr. Claudia Zylberberg will speak on Thursday, May 28 during the Strategies for Commercialization Track from 4 –  5:30 pm in the Pompeian Ballroom I/II.
  • Panel: Strategies for Commercialization Track 2 – Ancillary Materials. Dr. Claudia Zylberberg will chair, alongside Lynn Csontos, a panel discussion on ancillary materials on Thursday, May 28th from 11:15 – 12:30 in the Pompeian Ballroom I/II.

If you would like to set up a private meeting, please contact us at info@akronbiotech.com.

Expanding Fibronectin Function in 3D Environments

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The extracellular matrix (ECM) is a complex network of biological material – such as proteins and polysaccharides – that is secreted by cells and which regulates many critical processes critical for cell survival, such as cell-to-cell communication and migration. The many individual ECM components are implicated in numerous processes that cells rely on, and they are increasingly being seen as as therapeutic targets.

Fibronectin, a key ECM protein that is close to our hearts – and one that we wrote about extensively in the past – regulates cell migration, differentiation, organization and has been implicated, recently, in T cell immunotherapy to treat cancer.

Alongside other key components of the ECM such as collagen, laminin and vitronectin, fibronectin was recently shown to be able to be formed into implantable ECM scaffolds that are suitable as first-generation synthetic tissue. Preliminary results of a new ECM collection and assembly technique from skeletal muscle cells were recently published in the journal Biomaterials by Jeffrey Molchok’s lab at the University of Arkansas.

Elsewhere, the use of fibronectin is being extended, owing to its high cellular function, to novel tissue engineered assemblies: A recent study in the journal International Journal of Hematology-Oncology and Stem Cell Research described the expansion of hematopoietic stem cells in 3D nano-scale scaffolds coated with fibronectin. The authors studied the expansion of CD34+ cells fibronectin-coated polycaprolactone (PCL) scaffolds, and observed a 1.5-fold increase in cell expansion compared to that observed in regular, 2D cell culture scaffolds. A higher expression of CXCR4 in 3D confirmed that the cells were better homed in the fibronectin-coated scaffold.

This study relates to recent ongoing work by Rutgers University which investigates whether fibronectin in 3D culture plays a role in the healing process of breast cancer patients after radiation therapy and how such an effect is dependent on the nature and environment of the 3D culture/tissue. The authors recently presented their preliminary results, and more studies are underway.

We are keeping a close eye on such studies, and are actively supporting further advancements in cell therapy involving fibronectin and complex 3D scaffolds as next-generation constructs for tissue regeneration. Our expertise in fibronectin development as well as construction of 3D nano-scale scaffolds is enabling such discoveries.

Akron Participates in NIST Workshop on Standardization Strategies for Cell Therapies

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We have highlighted, in a recent blog entry, industry efforts at harmonizing various standards established by leading industry bodies for the development of cell therapies. While these efforts are aimed at globally addressing issues of standardization, it is individual labs who are faced with day-to-day decisions as potential cell therapies are taken through the development stages.

in order to address such issues, the National Institute of Standards and Technology is organizing a two-day workshop, titled “Strategies to Achieve Measurement Assurance for Cell Therapy Products”, the aim of which is to provide scientists and researchers with concrete feedback on the best practices to achieve measurement consistency and reliability.

The workshop has been designed to address three focus areas: Cell counting, cell viability and potency assays.

Akron will participate in the session on Potency Assays, which will focus on best strategies and methods to achieve standardization of cellular assays such as the endothelial cell tube formation assay.

The session is built around the recent paper “Critical elements in the development of cell therapy potency assays for ischemic conditions” which Akron’s Dr. Claudia Zylberberg co-authored with Dr. Yael Porat (BioGenCell), Dr. Eytan Abraham (Lonza), Dr. Ohad Karnieli (Pluristem), Dr. Sagi Nahum (Pluristem) and Dr. Juliana Woda (Juventas) and which was published in Cytotherapy earlier this year.

Alongside Akron, all authors of the paper will participate in the session.

The workshop runs on May 11 and May 12 on NIST’s campus in Gaithersburg. For more information, click here.

Smarter Scaffolds for Improved Cell/Tissue Interactions: New Research

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There is a growing need for improvements in synthetic assembly techniques aimed at constructing artificial tissue constructs both for therapy and further research. In recent months, we highlighted recent work on combinatorial assembly approaches for vascular tissue scaffold assembly, as well as 3D scaffolds for iPSC differentition – a drop in the bucket of the ever-increasing body of work in a field that is, despite significant medical impetus, still for many of its applications, in the development stage.

Since our entry last year, “Towards ‘Smarter’ 3D Scaffolds,” which highlighted improvements in biomaterial design that are introducing innovative combination and hybrid materials coated with biomaterials such as growth factors or cells for improved in vivo behavior, the field has seen some remarkable progress in the form of innovative research surface thereby expanding the existing capabilities for tissue regeneration using such combinatorial techniques.

Just a few months ago, work by David Mooney’s lab at Harvard University, published in Nature Biotechnology, disclosed an innovative, injectable scaffold/drug hybrid that self-assembles in the body into macroporous structures that, once delivered to the target tissue, alongside delivery of the drug, recruit host cells to provide a substrate for adhesion and tissue regeneration. The structures, based on mesoporous silica rods, were tested in mice and shown to be able to recruit dendritic cells in the host whose behavior can be further modulated by sustained release of inflammatory signals from the scaffold. The authors tested the delivery of vaccines from the scaffold with promising results based on the effect on systemic helper T cells and cytotoxic T cell levels evaluated after injection.

Elsewhere, further evidence was presented that particular tissues require very specific and tailored three-dimensional surfaces for optimal behavior. Work by Laura Ballerini’s lab at the University of Trieste, published in Nature Scientific Reports, highlighted a hybrid scaffold system which was based on porous scaffolds made of PDMS (polydimethylsiloxane) mixed with carbon nanotubes for enhanced growth and function of primary neurons. The scaffolds were fabricated with multi-walled carbon nanotubes, which are thought to improve interaction with dendrites owing to their high electrical conductivity and large surface area. Their results showed that such scaffolds allowed improved interfacing of neuronal cells with the nanomaterial structure and thereby enhanced the activity and function of cellular network dynamics.

Amidst the growing body of work, some of which was highlighted here, is the reality that the field is steadily moving in the direction of tailor-made scaffold constructs that reflect the specificities of the particular tissue that the construct is aimed at. This is hardly a surprise, but a realization that researchers are increasingly embracing.

Akron’s capabilities include extensive expertise in the development and manufacturing of custom scaffolds for a variety of regenerative medicine applications: from single polymer scaffolds to more complex constructs which include blends as well as combination scaffolds with the incorporation of biomaterials. Custom shapes, sized and tissue targets are part of our know-how: contact us to discuss your applications, or if you just have questions.

Cell Therapy Product Development: Main Hurdles to Regulatory Approval

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As of today, there are over 8,600 ongoing trials related to cell therapy listed on clinicaltrials.gov, most of which are in phase 2 (~4,000) or phase 1 (~2,500), with more than 1,000 in phase 3, although only a handful of products have reached the clinical approval stage.

The primary reasons why the maturation of cell therapy trials to commercial stage is slow, and why only a very small fraction of trials reach clinical approval, are thought to be, broadly, the following:

  • Product development and characterization. Cell therapies are complex: different cell types, various tissue sources and treatment type (allogeneic vs autologous) introduce significant levels of complexity to the development of CT products. This also includes raw material sourcing.
  • Manufacturing and scale up. Manufacturing and scale-up to clinical stages is marred with difficulties for reasons which include the need to tightly ensure reproducibility, consistent potency, a control of manufacturing costs, process and environmental controls (e.g. closed systems, batch-to-batch variations etc.)
  • Regulatory landscape. Not fully defined regulatory guidelines.

Regulatory landscapes are, moreover, set up differently in different markets: the Japanese regulatory landscape follows different regulations than doesthe FDA in the USA. For that reason, some US companies are engaged in trials in foreign markets (for example, Japan), due to more favorable approval hurdles than those in the USA.

As far as product development is concerned, process controls start with raw material sourcing. The cellular starting material is an integral part of the living, functional cells that constitute the active drug substance of cell therapy products. It is for that reason that tight controls must be in place to ensure traceability and quality control of raw material for cell therapy products. Moreover, special considerations in starting material qualification for patient-specific products (autologous or allogeneic) vs. off-the-shelf allogeneic products (multipotent or pluripotent stem cell-derived) are of significant importance too.

Manufacturing considerations also relate to closed systems (cell therapy products cannot be manipulated after manufacturing and must thus ensure aseptic processing during the manufacturing and formulation stages), environmental controls and scaleability.

Finally, logistics in relation to transport, shipping and storage during these steps is critical in ensuring integrity of the product is maintained by the time the cell therapy product reaches the end user facility (usually the hospital). Cryopreservation strategies must not only ensure the product is fully potent by the time of administration (usually stored in the frozen state), but the time from thawing to administration must also be accounted for (during which the product is stored at temperatures far above freezing).

All of this must be done while ensuring cGMP compliance, which is related to the maintenance of tightly controlled production, process and personnel flow documentation.

We have previously discussed efforts aimed at improving standardization for cell therapy product development across various markets, and the gaps that currently exist in harmonizing various guidelines, including the key organizations operating in that space.

If you have particular comments/thoughts in relation to what you consider the most important considerations to be with regards to cell therapy product development, we would love to hear them. This is part of a concerted effort to understand the developer and market sentiments that align with bringing more clarity to issues that will ultimately help cell therapy products find more favorable paths to market.

Feel free to share them in the comments or email us at info@akronbiotech.com.

 

 

Akron Biotech In the Community: Events Locally and Beyond

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A recent article in the Sun Sentinel highlighted the fast pace of growth that the cell therapy field in South Florida is currently enjoying: over 40% of the 5,500 biotech companies operating in the State are located in South Florida, the article states—and they have contributed to a staggering 75% growth of the biotech industry in the pasty six years.

This fast pace of growth is not expected to slow down soon. Companies such as Akron Biotech—which was recently profiled in a separate Sun Sentinel article—are heavily investing in new technologies, new laboratory space, new personnel and new partnerships to seize this momentum and maximize the potential of new research and medical needs.

Academic institutions such as Palm Beach State College, The Scripps Research Institute and Florida Atlantic University have been critical in providing educated and trained workforce professionals to fill the growing needs of the biotechnology and cell therapy industry employers in the area.

Akron has been a strong supporter of the local biotech community’s efforts since our inception, by partnering with academic institutions and other companies.

Palm Beach State College’s Biotechnology program has been a long-term partner of Akron Biotech, collaborating on not only professional development, but technology transfer and various strategic partnerships as well.

This year, Akron Biotech will participate in PBSC’s 4th Annual Biotech Networking Event and Career Panel which brings together professionals that cover a variety of roles in the local biotech community, including academic leaders (Dr. Ken Dawson-Scully of FAU and Dr. Joseph Kissil of Scripps Florida), management professionals (Dr. Liton Roy, Manager of Laboratory Operations at Sancilio & Company and Mrs. Julie Wilkinson, COO at ImmunoSite) as well as industry professionals (which includes Mrs. Shannon Pasley, laboratory technician at Akron Biotech) to discuss careers in manufacturing, academic research and corporate biotechnology.

The event takes place on April 14th at PBSC’s Palm Beach Gardens campus, from 5:30 – 7:30 PM. For more details, go here.

For those not in the vicinity, Akron Biotech is gearing up to participate at the International Society of Cellular Therapy‘s annual meeting in Las Vegas, Nevada, which takes place from May 27-30 at Caesars Palace.

The meeting will highlight Akron’s products, research and development and exciting news, and we will be showcase a number of research presentations. Mark your calendards in advance, and we will be sharing more details closer to the event. Contact us if you would like to set up individual meetings.

Akron will also participate at a number of other meetings throughout the year, which will include the 4th Annual Tissue Engineering and Regenerative Medicine World Congress, which takes place from September 8-11 in Boston, MA and Stem Cell Meeting on the Mesa, from October 7-9 in La Jolla, CA.

We will be posting more details about these meetings as the time comes.