Author Archives: S. Anne Montgomery

Outsourcing Manufacturing and Analytical Needs in the Biopharmaceutical Industry

Expanding biopharmaceutical pipelines and therapeutic modalities are feeding a boom in outsourcing key elements of development and manufacturing projects. The rapid growth of the industry as well as of emerging therapeutic areas (e.g., antibody–drug conjugates, biosimilars) challenge sponsors and contractors alike to meet industry needs. The authors in this featured report explore increasing complexities of devising long-term business strategies, the importance of choosing between long-term partnerships or one-time/transaction-based projects; the assurance that adequate business support and technical capabilities exist on…

February From the Editor

The real word twitterpated (meaning infatuated or obsessed, in a state of nervous excitement) apparently was coined in Disney’s Bambi movie. Use of the word has increased over the past five or six years, achieving a new relevance. Now it can mean Twitter-headed, and I am finally beginning to catch on to the role that tweeting plays, for good and ill. As expected from a Hollywood word, it focuses our attention on the ephemeral, the superficial glitz of a person…

Driving Therapeutic Innovations: Academic Institutions Can Help Lessen Development Risks

During the Biotech Week in Boston this past October, I had a chance to talk with David DiGiusto (Stanford University) about his work toward advancing bioprocessing and cell therapy development. I asked him to comment on points from his keynote presentation about how academic research groups can sustainably cycle assets into the biopharmaceutical pipeline. University research departments have long made innovative technologies available for commercial licensing. But in the excerpt below, he details ways in which such groups are further…

From the Editor for January

Happy New Year from all of us at BPI. As you can see on the cover, 2017 is the start of our 15th year of publication. Launching a magazine is an uncertain prospect in any era, especially within the trade press format, and our addition of peer-review gives us a split personality. But we are not immune to the print-versus-digital conundrums facing publishers these days, and an anniversary year provides a logical platform on which to update editorial approaches. I…

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…

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…

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…

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…

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…

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…