April 2012

Videos Can Help Ensure Reproducibility of Scientific Results

Biological experiments must be performed correctly. A textual method description doesn’t always capture the myriad techniques involved in even a fairly simple study. So the inability of researchers to reproduce published results is becoming a problem. And it is being addressed by video methods that show exactly how scientific results are achieved, helping future researchers learn new techniques and replicate scientific results. The ability to reproduce and confirm a study’s results and conclusions is a foundation of scientific research. And…

From The Editor

Quality control isn’t only a scientific priority; editorial QC, proofreading, and knowing when and what to question is becoming more and more complicated, even as (ironically) the Internet facilitates research and information sharing. Plagiarism can be entirely unintentional. Most accomplished editors notice when a paper seems pieced together and styles clash — one reason that we copyedit fairly rigorously in BPI. But you have to work harder to infringe a copyright. Editors worry whether authors have acquired proper permissions to…

Ten Years of Microbial Fermentation

Microorganisms play a vital role in modern life — with applications ranging from wine fermentation to biofuel production to solutions for complex mathematical problems (1). During the past decade, microbial fermentation for protein production reached a higher level of sophistication and wider adoption. When BPI was first published in 2003, the physical and biological characteristics of many microbial cells and the attributes of their fermentation processes were well known. Nonetheless, the economic environment at that time created immense pressure on…

Biopharmaceutical and Medical Device Compliance

Off-label marketing occurs when doctors prescribe a drug or device for a use that has not received FDA approval (1). Physicians have the unfettered right to prescribe the best drugs or devices for their patients, including approved drugs and devices for unapproved uses. Pharmaceutical and medical device manufacturers, however, cannot promote their products for such uses — even if those are supported in medical literature. Companies cross the line when their sales representatives sell physicians on the idea of using…

Standards Can Help Bring Cell Therapy Products to Market

Companies trying to market cell therapy products face a number of challenges in communicating highly technical knowledge, understanding the nature and complexity of their products, and trying to understand the global regulatory environment within which they must operate. The role standards development organizations (SDOs) play is key to overcoming some of those challenges through a standardization process. The British Standards Institution (BSI) sits at the forefront, developing a number of documents that will increase the chances of cell therapies for…

Key Downstream Problems Decline While Industry Continues to Demand New Technologies

Downstream problems for biomanufacturers finally appear to be lessening. Over the past six years, demand for better purification has topped the list of biomanufacturing areas in need of improvement. This year, however, it appears that purification woes — though still a hot topic — are cooling off. After seven years of measuring the impact on capacity of specific biomanufacturing operations, preliminary data from BioPlan Associates’ ninth annual survey shows that activities associated with both optimizing internal downstream processes (DSPs) and…

Strategies for Rapid Production of Therapeutic Proteins in Mammalian Cells

It is estimated that hundreds of new recombinant proteins and monoclonal antibodies (MAbs) enter preclinical and clinical development each year (1, 2). Concomitant global competition in biologics manufacturing has put immense pressure to shorten the time to market. Over the years, cells from various origins have been used for therapeutic protein production (2, 3,–5). One of the most economical choices is Escherichia coli, used to make proteins such as human insulin and growth hormone. But the bacteria have some serious…

Method for Preserving Cell Density and Viability in Two-Phase Fed-Batch CHO Culture

Risk of cell-culture contamination is a common concern whenever materials are added to or removed from a bioreactor. It is essential to maintain a sterile barrier and provide containment against intruding organisms during such operations. Many R&D and pilot-scale manufacturing tasks involve flexible, single-use processes with presterilized containment systems in nonclassified laboratory areas. Here, we examine a process that requires substantial manipulation of a culture — first completely removing and later returning the culture to a bioreactor during media exchange…

Balancing the Statistical Tightrope

During one development meeting early in my industrial career, a process development group member asked me whether the value my group had reported in one result was okay to use. I confidently replied “Yes, it’s fine. It’s about 40, somewhere between 38 and 42. The other person raised his eyebrows. “About 40?” In response, I somewhat awkwardly mumbled “Yes, probably…about that” — an answer not met with full understanding, but rather concern. My answer hadn’t been incorrect. The result was…

Improve Process Uniformity and Cell Viability in Cryopreservation

Cell therapies and related cell-based technologies constitute an emerging, fast-growing market with a total value expected to exceed US$100 billion by 2019 (1). Cell therapy is defined as the process of introducing cells to a patient’s tissue for disease treatment. These therapies generally require cryopreservation to maintain sufficient product quality and shelf life. As a common practice, cell therapy manufacturers use controlled-rate freezers to optimize cooling profiles. The goal is to preserve final products in cryopreservation media with the highest…