Author Archives: S. Anne Montgomery

May 2017 – From the Editor

The first half of 2017 has been leading us to next issue’s focus on the state of the industry. Although we are not officially calling it our “15th anniversary issue,” that of course is what prompts our focus on progress and future projections. By the time you read this, that issue will be on its way to the printer. So here are my thanks, in advance, to those of you who took time with our related survey. We editors look…

Current Thinking in Viral Safety: Risk Management Protects Patients

BPI’s editor in chief S. Anne Montgomery recently caught up with long-time editorial advisor Hazel Aranha (purification technologies technology expert for Sartorius Stedim Biotech, North America). They discussed a number of topics related to viral safety. Montgomery: What is the current thinking regarding virus-safety assurance in biopharmaceutical manufacturing? How is the industry preventing viral contamination? Aranha: The “holy grail” of viral safety — absolute freedom from extraneous agents or residual pathogenicity — is a myth. That said, biopharmaceutical products have…

April From the Editor

The BPI West conference is always a “candy store” of timely presentations and key networking opportunities for an editor who cannot be in all places at once. This year’s event in San Francisco (27 February – 2 March) was no exception. Nearly 900 delegates were joined by 86 exhibitors and 48 poster presentations. I’m inviting a number of speakers to convert their talks into manuscripts for BPI. In focusing on late-stage processes and commercial trends at this year’s event, I…

Strategies for Successful Sample Transfer

Nadine Ritter is president and senior analytical advisor of Global Biotech Experts, LLC and a long-time member of BioProcess International’s editorial advisory board. At a recent CASSS North American CMC Strategy Forum called “Methods on the Move: Addressing Method Transfer Challenges,” she discussed the biopharmaceutical industry’s logistical challenges of analytical test samples for drug substances and products. At the conference, BPI’s editor in chief Anne Montgomery met with her to discuss some key points of this topic. Logistics Challenges 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…