Author Archives: S. Anne Montgomery

Emerging Markets: Current Insights into the State of Global Biopharmaceutical Manufacturing

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Opportunities for establishing strong biopharmaceutical capabilities are expanding across the globe. This e-book seeks to encapsulate the current state of emerging markets/countries, tracing key elements above and offering examples to show where (in the world) the biopharmaceutical industry is expanding and securing its footholds. Generally, to succeed in these markets, foreign companies must exercise efficient resource management and control, show creativity and receptiveness to cultural differences, develop new strategies, and manage expectations. Working with local partners can provide access to…

August 31, 2017

From the Editor: BioProcess International Theater

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This special insert summarizes our well-attended BioProcess Theater at the BIO International Convention in San Diego this past June. Focusing on emerging therapies and technologies enabled us to touch upon interconnected topics of interest to both BPI readers and the BIO exhibit-hall attendees. Speakers highlighted approaches ranging from analytical development to evolving business and commercial models. On behalf of our publisher, Brian Caine (who creates these programs every year) and our marketing and editorial teams, I thank the speakers and…

August 8, 2017

May 2017 – From the Editor

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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…

May 18, 2017

Current Thinking in Viral Safety: Risk Management Protects Patients

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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…

May 18, 2017

April From the Editor

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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…

April 17, 2017

Strategies for Successful Sample Transfer

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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:…

April 17, 2017

Outsourcing Manufacturing and Analytical Needs in the Biopharmaceutical Industry

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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…

March 9, 2017

February From the Editor

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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…

February 13, 2017

Driving Therapeutic Innovations: Academic Institutions Can Help Lessen Development Risks

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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…

February 13, 2017

From the Editor for January

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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…

January 20, 2017