2014

Stopping Biological Clocks

The only method of stable and long-term — practically infinite — preservation and storage of perishable biological materials (biostabilization) is to keep them in a glassy (vitreous) state. This was understood by Father Luyet when he titled his pioneering works in the 1930s, “The Vitrification of Organic Colloids and of Protoplasm” and “Revival of Frog's Spermatozoa Vitrified in Liquid Air” (1,2). He and other pioneers of the cryobiological frontiers clearly understood that only a glassy state would ensure stable and…

How Plastics Are Made

The term plastics includes materials composed of various elements such as carbon, hydrogen, oxygen, nitrogen, chlorine, and sulfur. Plastics typically have high molecular weight, meaning that each molecule can have thousands of atoms bound together. Naturally occurring materials, such as wood, horn, and rosin, are also composed of molecules of high molecular weight. Manufactured or synthetic plastics are often designed to mimic the properties of natural materials. In fact, some of the earliest plastics were developed to replace scarce natural…

Microbial Strain Development Using BioLayer Interferometry

At the core of every drug development program is the challenge to successfully express active and high-quality proteins. Drug developers often are faced with protein-expression issues, struggling to express a specific protein for months (and sometimes years) with varying degrees of success. Low or no expression, insoluble expression, and proteolytic clipping of an expressed protein or a combination thereof are examples of the hurdles encountered in product development efforts. With protein expression being vital to the success of every stage…

Single-Use and Sustainability

What is sustainability? For some people, the special meaning of the word in an environmental context is how biological systems remain diverse and productive over time. Thus, sustainability is not just about saving resources or preventing pollution within a narrow context; it's more a long-term holistic approach to ecologically relevant activities. For other people, the term includes all environmental concerns, including those of immediate and/or nonbiological nature. Examples of such issues might involve a town's solid-waste disposal system or a…

Begin By Thinking of Your Goal

The biopharmaceutical industry is experiencing a surge of collaborations among large and small companies seeking to develop new drug candidates. Often, such efforts have been a result of a merger or acquisition. But other factors also are pushing the rise in collaborations, including dwindling drug pipelines, increasing generics and biosimilars, rising costs of drug development, and changing regulations that are already complex. High costs of drug development in particular have created greater risks. That is especially true for small biotechnology…

Analytics for Modern Bioprocess Development

Twelve years ago, about the same time the US Food and Drug Administration was putting the finishing touches on its quality by design (QbD) and process analytical technology (PAT) guidelines, I wrote an article about breakthrough pharmaceutical educational programs. That article included the perspectives from a few members in academia of the future essential skills for pharmaceutical students. At the time, bioinformatics and computerized industrial process modeling were relatively new disciplines, but their importance in future manufacturing was clear. Several…

Advocating for Advanced Therapies

My sense is that we’ve come a long way and that 2013 was actually a very good year — perhaps maybe even the best year ever for regenerative medicines and advanced therapies. Clearly the financial markets have allowed us to do more in terms of raising capital to fund projects in this space, and we are seeing a growing interest in the sector in the investor community. We’ve seen a number of major financing events over the course of the…

Cell Therapy Will Transform the Future of Medicine

The third annual IBC Cell Therapy Bioprocessing conference was held in Bethesda, MD, on 21–22 October 2013. It brought pioneers in the development of cell-based therapies together with companies that have enabling technologies, such as bioreactors, cell culture media, and advanced monitoring software. After the conference, I discussed the highlights and key themes coming out of the event with Dr. Phil Vanek, general manager of cell bioprocessing at GE Healthcare Life Sciences in Westborough, MA. Also an instructor for advanced…