In the years since CHO based biopharmaceutical manufacturing began in the 1980’s, the technology has come a long way. Despite continual improvements over the years, including advances in equipment, cell line development practices, and media formulation, gains can still be made in CHO based manufacturing. CHO remains, by far, the most popular cell line for best selling biologics on the market today and as such it is imperative that we continue to find ways to improve on product yield, product quality, cost, and a myriad of other manufacturing challenges. If you are looking for ways to improve your CHO cell line or have a challenge to share, please review our Ask the Expert session on everything CHO.
Paul A. Offit, MD is the Chief of the Division of Infectious Diseases and the Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. In addition, Dr. Offit is the Maurice R. Hilleman Professor of Vaccinology and a Professor of Pediatrics at the University of Pennsylvania School of Medicine. He is also the author of five medical narratives: The Cutter Incident: How America’s First Polio Vaccine Led to Today’s Growing Vaccine Crisis (Yale University Press, 2005), Vaccinated: One Man’s Quest to Defeat the World’s Deadliest Diseases (HarperCollins, 2007), for which he won an award from the American Medical Writers Association, Autism’s False Prophets: Bad Science, Risky Medicine, and the Search for a Cure (Columbia University Press, 2008), Deadly Choices: How the Anti-Vaccine Movement Threatens Us All (Basic Books, 2011), and Do You Believe in Magic?: The Sense and Nonsense of Alternative Medicine (HarperCollins, 2013).
With Dr. Offit’s breath of knowledge see what people asked him about his vaccine work, his vaccine related medical narratives, or his recent medical narrative on the sense and nonsense of alternative medicine.
The classical cell culture medium consists of amino acids, vitamins and a source of energy, such as glucose, in a buffered salt solution. These formulations require further supplementation with a protein source such as serum. The classical media formulations were designed using cancer-derived cell lines and can be very sub-optimal for the growth of specialized cells, such as stem cell, recombinant cells and differentiated cells. In the absence of serum and serum proteins it becomes essential that you control for the osmolality, ammonia and the production of free radicals. As important as using the right medium is the proper handling of the both the media and the cells and together can be the difference between a successful or failed experiment. If you have had a problem with an experiment or cells, take this opportunity to prevent either from crashing. Dr. Price has over 50 years of experience in cell culture and media design and has had the opportunity to make all of the mistakes and find ways to correct them. Paul J. Price, Ph.D., Media Design Consultant. Dr. Price has been a research scientist for over 50 years. Positions he has held include Branch Chief in the Center for Infectious Diseases at the CDC, and founder and Executive Vice-President of Hycor Biomedical.
An early pioneer in the area of disposable bioreactors, the WAVE Bioreactor was the first single-use bioreactor system when it was presented to the bioprocessing community in 1996. Since then, the range of products has expanded to include larger scale systems and advanced optical sensor and control technologies. WAVE Bioreactor systems are today widely used in both research and manufacturing operations. The latest WAVE bioreactor, ReadyToProcess WAVE 25, combines the ease-of use that comes with the rocking technology as such, with intelligent control and advanced sensor technology. Come and see what others asked about WAVE bioreactor technology.
There are an increasing number of promising new stem Cell Therapy candidates in development and many are showing promising results in clinical studies. As more stem cell therapies move from the lab to the clinical setting, there is increased interest in identifying best practices for stem cell manufacturing. Many researchers have specific questions about scaling up stem cell production, optimizing culture media, selecting the right manufacturing equipment, and the regulatory requirements for clinical production. If you have questions regarding stem cell manufacturing, then please review our Ask the Expert session “Clinical Stem Cell Manufacturing.”
Single-use systems have many clear advantages, however, one challenge is ensuring the integrity of these plastic bags and components. Microscopic breaches of integrity, even those that cannot be seen, can allow microbial ingress. Possible breaches extend beyond just the bags, so the entire single-use assembly including tubing, connectors, seals, etc. must be tested for integrity to ensure against potential contamination problems.
To address integrity concerns, companies that manufacture single-use components will typically conduct a visual inspection and perform pressure decay testing. Pressure decay testing is the industry standard for validating single-use bag integrity, however there are limitations to the level of assurance this testing can provide. Please see how others have addressed this issue.
We’ve all attended conferences and some of us have arrived wondering – where do I start? Conferences are an investment and whether you are attending, speaking, or exhibiting, we all want to get the most out of our investment. So if you have ever wondered about how to choose the right conference, how to prepare for a conference, or how to get a speaking slot, then this is the perfect session for you. Please review our Ask the Expert session about conference attendance.
In the past cultureware has mostly been focused on culturing standard cell lines that have historically been easy to culture. However, with the explosion of stem cell culture and the now common practice of culturing many different cell types, cultureware has needed to evolve as well. Over the years, improvements have been developed to increase the success of cultureware and to provide a more hospitable cell-growing environment, including innovations like gas-plasma treatment and biological extracellular matrices. Yet there is still opportunity to improve cultureware and address some of the most common challenges cell culture scientists face. Please review our discussion about cultureware, challenges and latest products in this area.
According to the dictionary there are many definitions for the word matrix. From my point of view the following three pertain to cell culture; 1) a substance in which something is embedded or enclosed; 2) a situation or set of circumstances that allows or encourages the origin, development, or growth of something and; 3) the substance that exists between cells and from which tissue., for example, cartilage and bone, develops.
Many of the common cell types we use are robust and grow on cell culture treated plastic. However there are many cell types that have difficulty attaching and/or spreading on cell culture treated plastic. In other cases, cells may attach but not differentiate unless the attachment surface correct. To learn more about matrices or if you are using them and have questions, this Ask The Expert topic is a good place to learn more about attachment surfaces and the rationale for using them.
Probably the most common and annoying problem encountered in a cell culture laboratory is biological contamination. Contamination can be a minor nuisance or a major catastrophe depending on the type of contamination present and the culture method and volume utilized. Today reputable media and sera providers do a very good job of filtering their products using specialized filtration systems and therefore most if not all contamination is due to problems with technique, incomplete sterilization of equipment or some other failure. Prevention from biological contamination cannot be absolute, biological contamination does sometimes happen especially given that it is recommended that culturists do not use antibiotics. It is possible to reduce the severity and frequency of biological contamination by following procedures such aseptic technique. Please review these suggestions about biological contamination and how to overcome contamination problems in your lab.
The production and maintenance of a hybridoma cell begins with the fusion of a specific antibody producing B cell, to a cancer B cell called a myeloma, which does not produce an antibody by itself. Fusion results in an immortalized line called a hybridoma that will faithfully produce a specific antibody against a single epitope called a monoclonal antibody. Once produced, proper maintenance and culturing is required to maximize the performance and continued production of the antibody in question. Have you ever wondered how this is done? Are you fusing cells to produce your own monoclonal antibodies or wondering about your culturing options. This is your opportunity to review our discussion on monoclonal antibody production and the culturing of mouse hybridoma cells.
There are an increasing number of promising new stem Cell Therapy applications in research and development. When these potential therapies show promise, the challenge of moving these therapies from concept to commercialization can be a daunting and confusing task. Important steps need to be followed for success including finding funding, creating effective partnerships with organizations and fostering a positive regulatory process, including IND submission. If you have questions about the best way to move your product idea forward, then please see our Ask the Expert session “Moving your Cell Therapy from Concept to Product.
Hosting the session is Neil Littman, the Business Development Officer at the California Institute for Regenerative Medicine (CIRM): Mr. Littman is responsible for facilitating opportunities for outside investment in Stem Cell Research in California for both CIRM-funded and non CIRM-funded programs by biopharmaceutical strategic partners, equity investors, and disease foundations.
Inadvertent cell line contamination is a serious concern for many researchers. Failure to monitor cell lines for contamination may result in compromised data. Current estimates are that 18% to 36% of all active cell lines are either cross-contaminated or misidentified.This level of concern has led a number of journals to actively encourage cell line authentication prior to submission for publication. Cell line authentication testing is a good quality control step for any laboratory utilizing human cell lines and/or stem cell lines. If you want to set your research on a strong foundation, please review our Ask the Expert – “The Role of Cell Line Authentication in Today’s Biomedical Research World,” about Cell Line Authentication.
Most of us want to be serum-free or move in this direction, but transitioning to a serum-free media can be a daunting task. Some are struggling with how to plan their transition to serum-free conditions. Some have already transitioned to serum-free but are not getting the results that they want or that they achieved with serum containing media. Still others are stuck in the process of transitioning with cells that just won’t cooperate in serum-free conditions. If this describes your current cell culture situation, you are not alone. Please review our Ask the Expert session on cell culture in serum-free conditions.
Xcellerex XDR single-use, stirred-tank bioreactors are well-characterized systems that deliver a performance comparable with that of conventional bioreactors from process development to manufacturing scale. The technology has been successfully used in a variety of different applications including mammalian suspension cell culture, microbial fermentation and cultivation of adherent cells using microcarriers. Please review our session on these systems.
Hosted by Patrick Guertin, Senior Manager, Upstream Process Development and Pilot Plant, Xcellerex, now part of GE Healthcare Life Sciences. Mr. Guertin has 25 years of experience and significant expertise in upstream process development, pilot plant operations and cGMP manufacturing for recombinant therapeutics, monoclonal antibodies and vaccines. His skill set also includes process optimization and scale-up and down procedures in microcarrier, fed-batch and perfusion modes.