Cell therapy using embryonic or adult stem cells for regenerative medicine is generating high interest in the global medical community and in the general population.Physicians and patients are looking to cell therapies as potentially curative treatments for diseases such as diabetes, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, Graft versus Host disease (GvHD), and cancer. Cell-based therapeutic products have been administered in clinics for nearly 90 years in the form of blood transfusions and for 50 years in the…
Search Results for: regenerative medicine
I’m Losing Cell Viability and Function at Different Points in My Process, and I Don’t Know Why!
Development of cell and tissue therapies presents bottlenecks in manufacturing process development and scale-up as commercial and academic groups move from small-scale research and development (R&D) to more complex logistics. Often, the simplicity of maintaining cell yield, viability, and function in a laboratory setting cannot be replicated when source tissue and final therapeutic products are subjected to the extended distances and times of actual clinical delivery. These bottleneck issues have a number of causes. One specific and common…
Managing the Product Pipeline
In 2007, the biopharmaceutical market represented ~$71 billion: 10% of the entire pharmaceutical market. Therapeutic proteins and monoclonal antibodies (MAbs) account for 98% of all biotherapeutics in development, the rest being blood proteins and enzymes — all the products of recombinant DNA technology. Before the recession hit full on, growth of this market was estimated by some at ~15%. (Now it’s hard to predict at all.) Making biotech drugs consumes huge amounts of time and money, but they…
Interest in Hollow-Fiber Perfusion Bioreactors Is Growing
People who regularly culture animal cells become so comfortable with standard techniques that novel approaches can seem contrived or even unnatural. However, the typical cycle of seeding cells at very low density in an excess of medium and harvesting (often quite aggressively) just before the point of medium exhaustion is quite an unphysiologic process. Popular culture systems often take cells that originally grew attached to a porous matrix at high densities, with little variability in nutrient and oxygen supply, and…
A World of Possibilities
Biotechnology truly is global, with some form of the industry in progress on every continent but Antarctica. Countries such as Brazil are even outpacing Europe and North America in the advancement of biofuels technology. But as in the developed world where this industry began, we see other countries looking first and foremost to the medical applications of biotech — because historically that’s where the money has been. Some countries are building their own fully integrated bioindustrial sectors.…
Biologics New and Improving
By far the most successful applications of biotechnology have been in the medical field. The vaccine industry is undergoing a complete transformation thanks to biotechnology. And cutting-edge research is giving us whole new ideas about disease therapy using nucleic acids and regenerative medicine. Proteins and Other Therapeutics Cancer has been a primary target for many MAb “magic bullets” and a major research area for life scientists over the past quarter-century. Oncologists have identified ∼200 cancers that affect human beings, some…
Poster Presentations
Production and Economics Friedrich Nachtmann, head of biotech cooperations in biopharmaceuticals at Sandoz GmbH NAFT: Npro Autoprotease Fusion Technology Microbial expression systems play an important role in the biopharmaceutical industry. A robust, scalable, and well-understood process, reduced development times, and competitive costs are requirements for successful manufacturing. In cooperation with the Austrian Center of Biopharmaceutical Technology, Sandoz has developed a platform Escherichia coli expression technology that provides high expression levels and rapid process development for a broad range of peptides…
Reviewing the Real Costs of GMP Compliance
Readers of our February 2008 article “Construction and Start-Up Costs for Biomanufacturing Plants: Canadian Case Studies in the Cost of Regulatory Compliance” may have noticed something missing (1). Two somethings, in fact: First, biographical information for coauthor Agnès Coquet was not listed at the end of the article. She is manager of analytical development for Debiovision Inc. of Montreal, Quebec, in Canada; 1-514-842-9976, ext. 104; acoquet@debiopharm. ca. Second, “Table 1” was called out on the fourth page of the article…
In the Drug Delivery Zone
A rule of thumb in drug development states that the larger a therapeutic molecule is, the more trouble it will be to make, ship/store, and administer to patients. Biotherapeutics include proteins (such as antibodies), vaccines, some smaller peptides (such as hormones), DNA for gene-transfer therapies, cells and tissues, and to a lesser extent blood-fractionation products, allergenics, and RNA/oligonucleotides. Biomolecules are big and unwieldy, they’re produced in complex mixtures by biological processes, and they face numerous challenges in storage and within…
In the Therapeutics Zone
Small molecules are still not providing cures for many diseases, and this is why biological therapies continue to be developed. They often offer greater convenience to patients, as well as longer lasting therapies,” says William Prather, MD, senior vice president of corporate development at the Israeli stem cell company, Pluristem. The therapeutics area at this year’s BIO International Convention will play host to many interesting technologies for producing and improving protein therapeutics, vaccines, and stem cells. Protein Therapies Remain Top…