Press Release: Allele Biotechnology & Pharmaceuticals Closes Purchase of cGMP Facility for Production of Clinical-Grade Cells for Cell Therapy Applications

SAN DIEGO–(BUSINESS WIRE)–Allele Biotechnology & Pharmaceuticals, Inc. (“Allele”), a leader in the development of specialized cells for pharmaceutical drug discovery and regenerative medicine, today announced that it has closed the purchase of a new facility intended for its cGMP (current good manufacturing practices) production of clinical-grade cells for cell therapy applications.

The 18,000 square-foot facility, located near the main headquarters of Allele in San Diego, California, will be the center of production of human induced pluripotent stem cells (hiPSCs) using Allele’s proprietary synthetic mRNA platform, a technology that generates hiPSCs with neither the random integration of foreign DNA nor the use of whole virus or virus-based elements, drawbacks that are common to other technologies for making hiPSCs. Such “footprint-free” cells will be produced by Allele for industrial and academic partnerships, as well as Allele’s own efforts in the area of cellular therapeutics.

hiPSCs, as cells that have the potential to become any cell in the human body, hold great promise for therapies that can alleviate or cure human disease. Towards this end, Allele has recently made a number of advances regarding the differentiation of hiPSCs towards cells of specific lineages, such as neural progenitor cells, neurons, astrocytes, mesenchymal stem cells, cardiomyocytes, skeletal muscle cells, hepatocytes, and adipocytes, including brown fat cells. These cells would also be produced in the cGMP facility when intended for specific therapies.

“This dedicated facility will help us to realize a number of our visions in bringing the benefits of pluripotent stem cells to society,” said Jiwu Wang, Ph.D., President and CEO of Allele. “The first step in helping people in need with all the stem cell technologies developed in labs is to clear a path to move them from bench to bedside, which requires high-quality, controlled production that can be monitored by the FDA. Together with our licensees, drug development partners, investors, and individuals who would like to participate in banking hiPSCs for research and therapy, we anticipate even faster pace in our business development in this area.”

Contacts

Allele Biotechnology & Pharmaceuticals, Inc.
Jiwu Wang, 858-587-6645
info@allelebiotech.com

Tags: GMP iPSCs, GMP Stem Cells

The NIH is one step closer to be short of $260 million from its 2011 budget

The National Institutes of Health (NIH) 2011 budget will be cut by $260 million in the budget that the House has just passed based on the last minute pact reached last Friday to avoid federal government shut down.

The NIH’s 2011 budget will be $30.7 billion, down 0.8% from its 2010 budget of $30.9 billion, according to news releases that can be found from various sources. Previously, the President proposed a $32.1 billion budget for the NIH and the House of Representatives allocated $29.4 billion to the agency. President Obama asked for a $1 billion increase for the NIH in 2012, which will be in new debate to start immediately. Chances are the 2012 budget for the agency will be less than what the administration wanted.

Combined with “the cliff effect” from the ending of the stimulus money the NIH has epically managed since 2009 to fund extra research projects, the negative growth of the NIH budget could mean less academic positions and tighter lab budgets ahead. Cutting-edge technology and cost effectiveness will be the key for survival of the fittest in the biomedical research jungle.

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Tags: 2011 budget, budget, congressional republicans, federal budget, NIH, President Obama, research budget

State of the Biomedical Research–Not So Good for Pharma R&D

Exerpt from From Science News

Pfizer’s R&D budget, $9.3 billion in 2010, will drop to less than $8.5 billion this year and to between $6.5 billion and $7 billion in 2012, and the company will stop funding research in internal medicine, allergy and respiratory diseases, urology, and tissue repair.

In fact, the pharmaceutical industry as a whole faces financial pressures, as companies are producing fewer new drugs than in the past. In these conditions, even highly promising research has gotten the ax; in November, Roche cut its RNA interference research unit after spending $400 million over 3 years.

Drug companies also seem less wary nowadays about outsourcing. Among other examples, Eli Lilly began outsourcing animal toxicology studies in 2008, and Wyeth (purchased by Pfizer in 2009) began out sourcing data management for its clinical trials in 2003. In 2007, AstraZeneca even decided to move the production of many active pharmaceutical ingredients—perhaps the core activity of a drug company—to China.

These downsizing events are not particularly caused by still depressed economy, they have more to do with industry-specific patent expiration and productivity issues with large pharmas. What does it all mean to current graduate students and postdocs? Perhaps an even tighter job market than now for starting researchers for some years to come until the next round of sea change comes around. Be aware of what’s going on in smaller, more productive, and focused biotech companies.

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Tags: budget, drug market, patent expiration, Pfizer, R&D, RNAi, Roche

Integration of Orbigen Products

Allele Biotech has been marketing products previously offered by Orbigen since July of 2008. In the process, Allele Biotech has transferred the majority of the Orbigen products to its own product lines, and left out a few that were no longer in demand, under proper license, or in some cases replaced with newer and better versions.

The biggest class of Orbigen products now under the Allele Biotech brand name are the polyclonal antibodies such as anti-EDG1 EDG2… EDG8 (catalogue numbers: PABs 10626, 10619, 10628, 10630, 10496, 1063), anti-BMRPs (catalogue numbers: PABs 10536, 10537, 10538). Other popular polyclonal antibodies from Orbigen include PAB-10983, PAB-10216, PAB-10683, PAB-11651, PAB-11141, PAB-10241, PAB-10469, PAB-10778, PAB-11248, PAB-11665, PAB-10563, PAB-10774. Orbigen antibodies have been tested in hundreds to thousands of labs over more than ten years.

One key product group developed by Orbigen is the baculovirus system, which includes the viral Sapphire genomic DNA and pOrb transfer vector plasmid for efficient packaging. We have further developed the pOrb vector into a bicistronic vector for dual expression or mammalian infections.

Retrovirus packaging cells, on the other hand, have been obtained from non-Orbigen sources and are now called Phoenix 2 as products under a new product line, the Gryphon retrovirus system. These cells have similar functions but were built by different researchers and further selected at Allele Biotech. Like all packaging cells we have experience with, these cells do not attach well after a freeze/thaw cycle. It is absolutely essential to wash away DMSO and better seed them in high quality, attachment enhancing dishes such as our EcoCulture plates.

Products previously under the Orbigen brand name are now included in Allele Biotech’s brand new shopcart (now beta-testing at shop.allelebiotech.com). We hope the new functionalities at the new site combined with the relevant knowledge and information you used to enjoy at our current allelebiotech.com site will provide you with an improved shopping experience.

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Tags: Allele Biotech Orbigen merge, anti-BMRP, anti-EDG, biocarta antibodies, Orbigen, Orbigen antibodies, PAB-10, PAB-11, polyclonal antibodies

How I started my company and why–Inaugural Event by San Diego Entrepreneurs Exchange (SDEE)

For current graduate students, postdocs, and holders of other “in-transient” positions in bioscience-related fields today, a persistently resounding question on our minds is “What path should I follow at the end of a long and ragged journey of training?” Interestingly in our industry, like downhill skiing you see in the Winter Olympics, once you start one path it is not an easy switch to get on another.

Many of the Ph.D.s in biomed share the general view that an independent research position typically at an academic institute or non-profit organization such as San Diego’s local Salk, Scripps, or Sanford—Burnham, is the goal of the many years of training. Others soon realize that there are numerous research jobs at biotechnology and pharmaceutical companies that will make good use of their expertise, experience, and unique background knowledge in a particular field. And of course there are those who “defect” to different industries that may or may not directly relate to their extensive experience in wet labs, such as working in intellectual property laws, clinical trial management, biomedical sales, business development and management.

Research in major pharmaceutical companies (big pharma) normally focuses on a project with set goals, milestones, and layers of monitoring and management. That is how a large team can function together and get the tasks done in a timely manner. Working in smaller biotech companies can be much more flexible, researcher-initiated, and in many ways fun. On the other hand, you will be required to do much more than reading papers, designing experiments, obtaining and interpreting results. Starting a small biotech company is by no means an easy path to take, but if done correctly with some luck and a lot of determination, it can be a very rewarding career. You will get to utilize to the maximum extent of all your intelligence, knowledge, vision, and personal relations. You also have the opportunity to do real cutting-edge research in various areas, and see the fruits in journal publications, grant awards, as well as in the wild wide market.

The San Diego Entrepreneurs Exchange (SDEE) was founded by local San Diego entrepreneurs in order to provide a voice for the early stage technology startup, to encourage new entrepreneurs, and to sponsor networking and educational events that help develop the skills necessary to bring funding and business to the San Diego area.

The inaugural SDEE event to be held Wednesday March 10th at 5pm. It will help answer some of the questions you may have been thinking about regarding starting or working in a startup biotech company. Allele Biotech’s founder and CEO Dr. Jiwu Wang will be among the speakers. Ten years ago Dr, Wang was a postdoc at UCSD with an NIH fellowship, right before he started Allele with a number of NIH small business innovative research grants. He will talk about the ultimate “academic freedom”–doing any research you want but completely at your own risk– as the reason to start a technology-focused company, and the lessons he learned the hard way about running a lab vs organizing a business. Other speakers include CEOs from a number of San Diego biotech companies with great stories to share with postdocs and others. The talks will be brief yet informative, and on-site interactions are encouraged. The Sanford-Burnham building 12 is outside the main campus, with plenty of free parking. Click here for more details about the event. http://www.allelebiotech.com/allele3/SDEE-First-Event-Announcement.pdf (at AlleleNews). Let us know if you are coming by emailing to events@sdentrepreneurs.org

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Tags: biotech, biotech careers, biotech jobs, biotech startup, pharmaceutical companies, postdoc jobs, research positions., San Diego Entrepreneurs Exchange, SDEE