Update-Cell Based Assay Solutions

We continue to expand our cell centric strategy. With the addition of Cancer Associated Fibroblasts (CAFs), we are now positioned to develop highly engineered customer specific co-cultures. These engineered cells will inculde our hMSCs, Osteoblasts, Chondrocytes and Fibroblasts. Our goal is to develop in vivo like cell based assays to lower the costs of discovery and increase your “hit” rate.

New Products
Cancer Associated Fibroblasts
Image: Culture of Adeno-Carcinoma CAFs at Day 2.
 

We will keep you posted as we add capability to our cell based assay solutions.

Musculoskeletal Disorders-Stem Cell Based Drug Discovery

A common Neuromics’ theme is harnessing the power of cellsTM. The raw cost of the cells are often the biggest consideration. We encourage our customers to focus on true costs. These include the # of cells (how many times can they be passaged?), culture viability (how long do the cells live) and bioactivity (how closely do cultures mimic in vivo behavior?). I would like to present a presentation and publication confirming our competitive advantage when analyzing true costs.

Setting a higher bar for Neuron-Glial Based Assays!

Dr. Randen Patterson and his team at UC Davis have developed new culturing techniques using our e18 Rat Primary Hippocampal Neurons. They have developed a protocol that allows for culturing of E18 hippocampal neurons at high densities for more than 120 days. These cultured hippocampal neurons are (i) well differentiated with high numbers of synapses, (ii) anchored securely to their substrate, (iii) have high levels of functional connectivity, and (iv) form dense multi-layered cellular networks. We propose that our culture methodology is likely to be effective for multiple neuronal subtypes–particularly those that can be grown in Neurobasal/B27 media. This methodology presents new avenues for long-term functional studies in neurons. This is good news indeed: Todd GK, Boosalis CA, Burzycki AA, Steinman MQ, Hester LD, et al. (2013) Towards Neuronal Organoids: A Method for Long-Term Culturing of High-Density Hippocampal Neurons. PLoS ONE 8(4): e58996. doi:10.1371/journal.pone.0058996.

We will continue to raise the bar. Better cultures=lower costs and better outcomes!

New Osteoblasts

In conjuction with our manuacturing partner, Vitro Biopharma” , we are pleased to announce we now have commercially available unlabeled and FITC-labeled Osteoblasts. These are differentiated from our Umbilical Cord Blood derived Human Mesenchymal Stem Cells.

They are designed for:

  • Osteogenesis/Bone Formation Studies
  • Compound/Small Molecule Testing
  • Gene Expression Analysis
 

Images: (A) Human cord-blood MSCs were expanded in low-serum MSC-GroTM to confluence as shown here. (B) were differentiated in osteogenic MSC-GroTM. Early stage osteoblasts are shown here; the arrow shows early formation of mineralized matrix. (C)&(D) Mature osteoblasts stained positive for Alizarin red. Phase contrast image at 200 x, scale bar is 50 mmeters.

I will continue to update you on new Cell Based Assay Solutions.

Claudia Zylberberg-Cell Culturing Innovator

Taking You Cultures to New Dimensions

I am pleased to feature Dr. Claudia Zylberberg, President and CEO of Akron Biotech, in this edition of “News Behind the News”.  She is an expert and innovator in providing tools and methods for the discovery and development of cell based therapies.  This starts with potent cell based assays and culminates with the ability to provide GMP produced reagents to support animal testing and other pre-clinical trial drug discovery processes.

Scientist and Entrepreneur a Synopsis

Claudia has a background that uniquely positions her to understand and address the growing needs and requirements of the basic and drug discovery research community. This includes researchers using stem cells as for discovery and potential therapies. Here’s an overview.

With a PhD in Biotechnology from the University of British Columbia and University of Buenos Aires, Claudia has over 25 years of experience in the international biopharmaceutical industry.  At NABI Biopharmaceuticals, she and her team developed and scaled plasma-derived products and recombinant vaccines. This included harmonizing products between EMEA and FDA. She has authored and co-authored many scientific articles and developed several commercial products for use in the field of cellular biology. She has also authored a children’s book on genetics and has several patent pending products in the area of cryopreservation and QC of stem cells.

She is as an advisor for the US Pharmacopoeia in standards setting for biologics and ancillary materials critical for the production of cellular therapies.  She is a member of the BioFlorida Board of Directors, Board member of Business Development Board of Palm Beach County, Scientific Advisor for ISCT (International Society for Cell Therapy), Executive Committee Member for the Alliance of Regenerative Medicine and the Chair of the Business Advisory Board for the Banner Center of the State of Florida and is part of the organizing committee for the World Stem Cell Summit coming up in Palm Beach December 2012.

Excellence in Cell Based Assays

Excellent in cell based assays means lower research and development costs. There are two sides of the “cost coin”. On one side, if any of the raw materials (plates, cells, media, growth factors, markers, probes or detection, etc. are a weak link), the whole chain is destroyed and all time and material cost are wasted. On the other side, if culture conditions do not promote an environment enables in vivo like conditions, the data may prove to be unsupported in pre-clinical testing. This results in big costs in both opportunity and related expenses.

This is why Akron Biotech’s product and expertise are so important.  This is also why they could become important partners for Neuromics.  They have the ability to deliver a large cross section of the capabilities required for excellence in cell based assays. 

These capabilities include:

  • Best manufacturing practices (GMP) guarantee products will work as expected.
  • Delivery of tools and methods that support research from the bench to pre-clinical studies.
  • Product strategies that insure current and future fill known gaps in driving cell based assay excellence.

These includes:  media, growth factors, 2D/3-D culturing ECMS and Polyfibers, recombinant proteins and cryopreservatives.  Many fit hand in glove with my strategic offerings. I plan on continue to publishing update on new developments from Akron Biotech.

Neuromics and Vitro Biopharma Partner to offer Human Chondrocytes

More good news from our partnership!

Vitro Biopharma Launches Products for Drug Development & Advancement of Joint Regeneration Technology-GOLDEN, Colo., Oct. 9, 2012 (GLOBE NEWSWIRE) — Vitro Diagnostics, Inc. (OTCQB: VODG), dba Vitro Biopharma, announced the launch of a series of products for use in the development of advanced treatment of injury and diseases of joints. The new products are chondrocytes derived from human adult stem cells, mesenchymal stem cells (MSCs). These cells produce collagen and are critical to proper joint function. Joint disease and injury often involve defects in collagen production and/or damage to chondrocytes due to inflammation, disease or injury. The new products include native and fluorescent labeled MSC-derived human chondrocytes together with SPIO-labeled chondrocytes. The later cells are labeled with super paramagnetic iron oxide (SPIO) and may be used for in-vivo imaging of chondrocytes using MRI (magnetic resonance imaging) a common clinical imaging procedure. The availability of native and multiply-labeled chondrocytes provides customers with numerous options to conduct in-vitro high throughput screening cell assays and to coordinate these studies with in-vivo studies.

Images: Chondrocyte Cultures

Our plans call for the addition of more types of primary cells as well as cells that can be tracked in vivo by MRI. I will keep you posted on these developments. 

Vitro Biopharma and Neuromics Announcement

I recently featured Dr. Musick, CEO of Vitro Biopharma. I am pleased to post our joint announcement on our partnership aimed at Harnessing the Power of CellsTM . Together, we provide researchers potent UCB derived human mesenchymal stem cells and MSGroTM media.

Vitro Biopharma Strengthens and Expands Its Distribution Agreement With Neuromics
Published: July 24, 2012
GOLDEN, Colo., July 24, 2012 (GLOBE NEWSWIRE) — Vitro Diagnostics, Inc. (OTCQB:VODG), dba Vitro Biopharma, announced an expanded relationship with a key distributor of its stem cell-based products, privately-held Neuromics, Inc (www.neuromics.com). Vitro Biopharma officials recently met Neuromics principals at their corporate headquarters in Minneapolis, MN. Neuromics was formed in 2005 by Pete Shuster, a marketing and sales professional with extensive experience in the computer industry who is now focused on providing integral products to the life science industry. Neuromics competitive advantage is based on providing products that lower costs and raise the probability of successful outcomes and include bio-markers, growth factors, transfection reagents, apoptosis detection kits, primary cells and related media. They are designed to serve basic and drug discovery researchers focusing on finding root causes and therapies for neuro-degenerative, autoimmune, inflammatory response diseases and certain forms of cancer.

Vitro Biopharma and Neuromics recently entered a distribution agreement whereby Vitro provides its stem cell-based products to Neuromics’ customers. Stem cell research continues to grow, based on positive results from several studies showing potential clinical benefit of stem cell-based cellular therapy. There is a growing demand for adult stem cells known as mesenchymal stem cells (MSCs). Vitro Biopharma manufactures and sells several fundamental tools needed to advance adult stem cell research and clinical studies, including human MSCs and derivatives, the MSC-Gro™ Brand of media optimized for growth and differentiation of MSCs as well as assay kits for determination of MSC quality, potency and response to toxic agents.

Based on the growing demand for MSC products provided by Vitro Biopharma for both research and clinical studies, Neuromics officials have committed increased resources to promote these products. Furthermore, both Vitro Biopharma and Neuromics are evaluating additional products that are perceived to enhance the competitive advantage of Vitro Biopharma’s existing MSC product line through strategic combination. A strategic goal moving forward, is an additional partner to supply devices needed for FDA-compliant manufacture of clinical materials for use in pre-clinical and clinical studies. These devices are known as bio-reactors that allow for highly controlled and reproducible production of large numbers of stem cells needed to provide therapeutic benefit. Several characteristics of these bioreactors are essential in reaching the demanding goals needed to achieve regulatory compliant manufacturing to support stem cell therapy that maintains rigorous standards of safety and efficacy. We are presently evaluating suitable devices for this application that appear to be well-suited to the required needs, specifications and characteristics.

Dr. Jim Musick, Vitro’s President & CEO, said, “We are very pleased to expand our relationship with Neuromics, Inc and look forward to a long-term mutually beneficial business relationship. While we focus on product development, manufacturing and advancement of our product pipeline, our sales partnerships are important alliances in the expansion of revenue generation. Neuromics is an ideally suited sales partner due to their broad experience and success in distribution of critical life science products. We also see the importance of a complete manufacturing system to support stem cell-based cellular therapy. It is through the highly complex interactions of cells, cell culture media, extracellular matrices and other environmental conditions that together determine the characteristics of the stem cells intended for clinical use. We also anticipate additional expansion of our relationship with Neuromics as Vitro Biopharma’s product pipeline advances through the commercialization process.”

“Neuromics’ strategic direction aligns tightly with Vitro’s goal of ‘Harnessing the Power of Cells™’”, said Shuster, “expanding capabilities enable us to serve an increasing segment of the Biotech and Pharma research community. This is especially true of the stem cell and regenerative medicine research community. Our relationship with Vitro Biopharma adds horsepower to these capabilities. Mesenchymal Stem Cells and Media are raw materials for high throughput and high content cell-based assays. Better materials help insure only the best targets, biologicals and compounds are passed on to downstream processes.”

About Vitro Diagnostics, Inc.

Vitro Diagnostics, Inc. dba Vitro Biopharma (OTCQB:VODG);(http://www.vitrobiopharma.com), owns U.S. patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. Vitro also owns a pending international patent for generation of pluripotent stem cells. Vitro’s mission is “Harnessing the Power of Cells™” for the advancement of regenerative medicine to its full potential. Vitro operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro manufactures and sells “Tools for Stem Cell and Drug Development™”, including human mesenchymal stem cells and derivatives, MSC-Gro™ optimized media for stem cell self-renewal and lineage-specific differentiation. Vitro recently formed a strategic alliance with HemoGenix®, Inc. (http://www.hemogenix.com/) to jointly manufacture and distribute LUMENESC™ and LumiSTEM™ quantitative assays for determination of stem cell quality, potency and response to toxic agents.

About Neuromics, Inc.

Neuromics (http://www.neuromics.com), located in Minneapolis, MN, is a profitable and growing bio-regents company. The company was initially built by supplying bio-markers to Neuroscience Researchers. Today, Neuromics provides a range of solutions that include markers, growth factors, gene expression analysis tools, apoptosis detection kits, primary cells and related media. These solutions are increasingly being used in combinations by customers to help accelerate or improve the process of drug discovery.

Safe Harbor Statement

Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward looking statements are identified by words such as “intends,” “anticipates,” “believes,” “expects” and “hopes” and include, without limitation, statements regarding the Company’s plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company’s products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company’s filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company.

Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward looking statements, whether as a result of new information, future events or otherwise.

CONTACT:
Dr. James Musick
Chief Executive Officer
Vitro Biopharma
(303) 999-2130 Ext. 3
E-mail: jim@vitrobiopharma.com

Source: Vitro Diagnostics, Inc.

Nanofiber 3-D Cell Based Assays

This “News behind the News” is a historic event.  It demonstrates how nanofiber scaffolds can be used to engineer organs for human transplants. Good news for researchers looking solutions are in vivo like environments for cell based assays.

Nanofibers Solutions work in transplants-imagine how well they will work in your 3-D based cell based assays.

3-D Cell Based Assays for Drug Discovery are the future. Like any new model, adoption rates are a function of how well the new solutions works. “The proof is in the pudding”.

Here’re highlights of a historic event based on transplants using nanofiber engineered laryngotrachea : Collaboration between Nanofiber Solutions and the Karolinska Institutet produces first synthetic laryngotracheal implants seeded with the patient’s stem cells to be successfully transplanted into human patients in Russia.

COLUMBUS, Ohio, June 26, 2012 – Nanofiber Solutions, LLC, an Ohio-based developer, manufacturer and marketer of 3-D synthetic scaffolds to advance basic research, tissue engineering and regenerative medicine announced today the first and second successful transplants of its tissue engineered laryngotracheal implants seeded with cells from the patients’ bone marrow.

The surgeries were performed June 19th and 21st at the Krasnodar Regional Hospital (Russia) by Dr. Paolo Macchiarini, Professor of Regenerative Surgery at the Karolinska Institutet (Stockholm, Sweden), and colleagues. Dr. Macchiarini led an international team that included Dr. Vladimir Porhanov, head of Oncological and Thoracic Surgery at Kuban State Medical University (Russia), Dr. Jed Johnson, Nanofiber Solution’s Chief Technology Officer who created the synthetic organs, Harvard Bioscience (Boston, USA) who produced the bioreactor, and Dr. Alessandra Bianco at University of Rome, Tor Vergata, who performed mechanical testing during scaffold development.

Both patients, a 33 year-old mother from St. Petersburg and a 28 year-old man from Rostov-on-Don, were in au to accidents and suffered from a narrowing of the laryngotracheal junction for which they already had failed previous surgeries. Transplantation was the last option for the patients to have normal quality of life. Immediately following transplantation, both patients were able to speak and breathe normally.

Nanofiber Solutions, lead by Dr. Johnson, designed and built the nanofiber laryngotracheal scaffolds specifically to match the dimensions of each patient’s natural larynx and trachea, while Harvard Bioscience provided a bioreactor used to seed the scaffold with the patients’ own stem cells.  Although this procedure represents the world’s first and second successful use of synthetic synthetic laryngotracheal implants, it is Nanofiber Solution’s second and third successful organ implants using their synthetic scaffolds within the last year.

Nanofiber Solutions’ scaffolds mimic the body’s physical structure and allow for a more successful seeding, growth and differentiation of stem cells. Because the cells used to regenerate the larynx and trachea were the patients’ own, doctors report there has been no rejection of the transplants and the patients are not taking immunosuppressive drugs. (more).

Capabilities of 3-D nanofiber scaffolds for cell based assays:

Human brain tumor biopsy showing migrating tumor cells along the alligned nanofiber.
  • Nanofibers are optically transparent to allow for live-cell imaging and real time quantification of cell mobility using an inverted microscope
  • Nanofibers mimic the 3D topography found in vivo which produces a more realistic cellular response to therapeutics.
  • More realistic cellular behavior means you can use fewer animals and decrease time-to-market for drug discovery and development.
  • Nanofibers can easily be coated with ECM proteins using existing protocols for standard lab ware.
  • Cells can be easily removed for protein or gene analysis using trypsin, EDTA, etc.
  • We will continue posting relevant press releases, pubs and data that prove the capabilities of these important solutions.

    Dr. Jim Musick-Making MSCs Work

    Harnessing the Power of CellsTM

    Dr. Jim Musick

    Dr. Jim Musick

    Dr. Jim Musick and his company, Vitro Biopharma, give Basic and Drug Discovery Researchers the ability to harness the power of Human Mesenchymal Stem Cells (hMSCs). This power is essential for blazing new trails in the stem cell research and regenerative medicine frontier.

    I am pleased to welcome Jim as a partner in providing my company the expertise and knowledge highlighted in this profile. Together, we give our customers, colleagues and friends the ability to easily culture, grow, differentiate and maintain large stocks on hMSCs.

    Background

    Jim received his PhD from Northwestern University in 1975 and then joined the staff of University of Utah where he specialized in the study of Neuroscience and synaptic transmission. He joined UltraPure Laboratories in 1983.

    At UltraPure, he learned the art and science of commercializing biologicals. There he helped develop procedures for the commercial production of purified human pituitary hormones including, prolactin, growth hormone and TSH. This included developing QA/QC procedures to support commercial distribution of these products.

    He joined Vitro Diagnostics in 1988 and directed all operations involved in the establishment of a diagnostic product line that included about 30 different purified antigen products.  His direct responsibilities included research & development, manufacturing, intellectual property development and maintenance, marketing and sales.  He was also responsible for the development & initial commercialization of the fertility drug VITROPIN™ as well as the cell immortalization program of the Company.  He is an inventor or co-inventor of all issued and pending patents owned by the Company.

    In 1998 he also completed an Executive Program at JJ Kellogg Graduate School of Management, Northwestern University in Managing New Product Development.

    In 2000, he orchestrated the sale of the antigen manufacturing division to Aspen Biopharma (Nasdaq, APPY) while retaining IP related to use of FSH as a fertility drug and to cell line generation technology.

    He has the spirit of a polished scientist/entrepreneur with strong operational and process expertise.

    Harnessing the Power of hMSCs

    As President and CEO of Vito Biopharma, Jim leverages his expertise and experience to manufacture Cord Blood Derived hMSCs. The stem cell revolution demands large stocks of cells of the highest quality. Meeting the demand is the key to the development of stem cell related therapies. Vitro Biopharma has the capabilities to delivery.

    It is all about starting with vials of potent and pure hMSCs. From there, the customer can grow and differentiate large stocks and be confident in the quality because Jim’s company has the processes in place to insure this. The cell lines are well-characterized with regard to species authentication using sensitive PCR methods to quantify non-conserved genes including COX1, Cytochrome B and actin.  Vitro Biopharma also utilizes karyotyping to authenticate its  cell lines.  Adventitious agents are also tested negative by sensitive PCR methods including known viral contaminants and mycoplasma.  Performance is assured by rigorous testing of viability, growth rate and differentiation capacity for formation of chondrocytes, adipocytes and osteoblasts.  Finally these cells are characterized with regard to phenotypic cluster designation antigens.

    Current Products

    Native and fluorescent-labeled human MSCs including native and fluorescein/rhodamine-labeled MSC-derived chondrocytes and osteocytes along with MSC-GroTM  growth and differentiation media. MSC-Gro™ media is provided in low-serum, humanized and serum-free formulations for both growth and differentiation.  Humanized serum-free media may be supplemented with allogeneic or autologous serum for direct comparisons of growth and differentiation under these conditions.  Powdered MSC-Gro™ formulations are also provided.  Vitro Biopharma’s human MSCss have the capabilities to be expanded through at least 10 passages at rapid growth rates and can be further expanded to 16 passages (~50 population doublings) at slower growth rates.

    Human MSC-derived Osteoblasts stained with Alizarin red at 100 x.

    Image: Human MSC-derived Osteoblasts stained with Alizarin red at 100 x.

    Vitro Biopharma has recently launched a new and revised website complete with convenient online ordering and detailed product technical information (www.vitrobiopharma.com).

    Futures

    In our interview, Jim gave blinding glimpses of the future especially with regard to new products to extend Vitro Biopharma’s offering of clinical tools to fully explore the ever-expanding therapeutic applications of MSCs. I am excited about the potential. I will keep you posted as new products are commercialized.

    Mesenchymal Differentiation Pathways

    I will soon be profiling Dr. Jim Musick of Vitro Biopharma.  He manufacturers and provides us a wealth of expertise on our Human Mesenchymal Stem Cells (hMSCs) and MSCGro™ Mesenchymal Stem Cell Media.  As the demand for these grow, we are receiving a variety of questions on differentiation. Specifically, researchers desire to drive these cells to specific progenitor and cell phenotypes like Osteocytes, Adipocytes and Chondroytes.

    I would like to share a pathway map that gives a snapshot of these pathways:

    Regenerative Biology of the Spine and Spinal Cord. Edited by: Rahul Jandial, Mike Y. Chen, Bihong T. Chen and Joseph Ciacci. ISBN: 978-1-4614-4089-5. Publication date: May 25, 2012. Series: Special Books

    I will continue to post information that will enable the researchers to harness the power of Mesenchymal Stem Cells.