Author Archives: S. Anne Montgomery

BTEC produced this meeting of ISPE’s NCSU student chapter, in which many of  Biogen Idec’s professionals participated. (www.btec.ncsu.edu)

Measuring the Impact of Investments in Professional Development: A Virtual Roundtable

Well-designed education, training, and professional development programs and partnerships add considerable return on investment to stakeholders across the biopharmaceutical manufacturing industry. As biomanufacturers, suppliers, and regulatory bodies share similar workforce needs, focused education and training efforts can lead to increases in productivity, yield, and employee engagement and retention. In addition, education and training programs can decrease the incidence of deviations, which are costly to investigate and remediate. Yet when compared with other business needs, training, development, and human performance initiatives…

Students in the Master of Microbial Biotechnology (MMB) program at NCSU.

Exploring Academic Models for Biomanufacturing Education

Undergraduate and/or graduate programs in physical and life sciences can provide a solid background for science and engineering students who are interested in careers in biotechnology research and development. Yet many such programs have not adequately prepared students for careers within and related to the biopharmaceutical industry. In today’s globally competitive job market, developing a workforce pipeline for the bioprocess industry requires academic programs that equip students with knowledge, skills, and theory surrounding the equipment, methodologies, processes, and regulatory requirements…

SAM-thoughtful

December From the Editor

It is no big revelation that publishing is changing. How people prefer to read and access information is in some ways a demographic conundrum and in other ways an expected technology-driven evolution. Recognizing those changing attitudes and in honor of our 15th anniversary year as a publication, for 2017 BPI is planning to both adapt to and further drive business and publishing trends in ways that truly meet the information needs of our readers around the world. We simply didn’t…

SAM-thoughtful

November: From the Editor

In 2012, to mark BPI’s 10th year of publication, we launched our biennial BioProcess International Awards program. Our publication has from the start aimed to help drive advancements in this industry, not simply to report on them. We have to date (in 2012, 2014, and now 2016) recognized more than 50 people and companies that represent excellence in leadership, corporate citizenship, collaborations and partnerships, and innovative technologies and applications. This year, our 16-member judging panel evaluated each nomination within assigned…

SAM-straighton

October Supplement From the Editor

Good things come in small packages — like this issue, for example. Each author brings a critical aspect of regenerative medicine development into perspective, highlighting progress and remaining challenges. I am especially pleased to highlight the current stage of gene therapies. At cell therapy conferences a few years ago, some people insisted to me that quality by design (QbD) would have little to no relevance for these advanced therapies. Speakers were academic and medical researchers or commercial manufacturers of traditional…

SAM-straighton

October 2016 From the Editor

Every September, we editors step onto a virtual slide that takes us into the new year with increasing steepness and velocity. Here come the fall supplements and special projects! And as the new year approaches, our momentum is often halted abruptly by the November and December holiday schedules, during which many of our contacts seem to vanish. The highlight of our fall season is always the BioProcess International Conference and Exposition in Boston, this year occurring the very week that…

SAM-straighton-featured

September Supplement From the Editor

When it comes to outsourcing, I sometimes worry that most of what can be said already has been. How many times do we need to focus on communication issues, which are still an essential element behind successful contract services relationships? As with so many subjects we cover, familiar outsourcing terminology can lead to the false assumption that an industry segment or technical process is pretty much the same as always. After all, speed and efficiency and cost-effectiveness have been goals…

Left to right, Gil Roth, Cory Lewis, Andrew Sandford, David Powell, and Rajan Puri   (PHOTO BY LEAH ROSIN)

Making the Correct Outsourcing Decisions: BPI Theater Panelists at BIO 2016 Discuss Current and Future Needs for Contract Services

Outsourcing has become a critical part of the industry in general and will play a larger role as companies continue to seek faster and more cost-effective routes to market. On Wednesday 8 June 2016, Gil Roth (president of the Pharma and Biopharma Outsourcing Association, PBOA) chaired a lunchtime roundtable titled “Making the Correct Outsourcing Decisions.” Roth’s association is a nonprofit trade group that represents CMOs and CDMOs through work with Congress and the FDA, with a focus on intra-industry issues.…

SAM-thoughtful

September From the Editor

Some issues of BPI more than others emphasize to me the interdisciplinary nature of our audience. One example: I am happy to bring you the latest consensus paper from the CMC Forum series. In its discussion of host-cell protein control strategies, the authors write of their goal to “bring industry, academics, and regulators together for generating integrated perspectives on HCPs and their control.” Those three groups — industry, academics, and regulators (government) — constitute three major categories of our readership…

SAM-thoughtful

From the Editor

Our second annual BPI Theaters supplement once again brings you summaries from presentations at our BioProcess Theaters during Interphex and the BIO Convention.As a summer companion piece to our annual Yearbook’s company profiles and application notes, this serves as a midyear overview of the biopharmaceutical landscape. These summaries are the highlights.To hear the full presentations (and see their PowerPoint slides) please go to www.bioprocessintl.com/Interphex2016 www.bioprocessintl.com/BIO2016 This special summer issue comes to you through the efforts of many people.Our publisher, Brian…