Author Archives: S Anne Montgomery

From The Editor

      Not long ago I assembled a few current and former coworkers to meet with a young woman who is contemplating a career in journalism. Part of that visit involved comparing experiences of those who had been in the field for many years with those who had finished their formal education only a few years ago. We wondered whether the field still welcomes newcomers with degrees other than in journalism; or whether publishers now insist on that specific…

From the Editor

      Conference themes and approaches can be looked at as sort of a crazy quilt representing the state of the industry: with pieces of all different shapes and colors that come together to form a cohesive whole. They fit together in many ways, depending on the organizers (quilters?); many pieces are omitted and saved for the next quilt. But how to find the most successful combinations requires technique as well as imagination. Here are some topics I’ve been…

Fill and Finish for Biologics

    As most novelists will tell you, if you make substantial changes to the beginning of a story, you may well need to revise your preestablished conclusion. Similarly, as approaches to process design and development change, new tools, technologies, and various shifting “paradigms” also affect the way companies approach final formulation, filling, and finish steps. As yet another ref lection of increased process understanding and quality-by-design’s (QbD’s) holistic approach to biopharmaceutical development, those final steps — traditionally outsourced by…

From The Editor

          Early on in the life of BPI we offered a few “closer” pages that we called “Defining Moments.” It was to be a forum for distinguishing between terms that are misused and for proposing new definitions for new approaches. In fact, because one particular topic came up again in a conference I attended this past January regarding the terms analytical and bioanalytical, we decided to revisit one of these entries from 2005 (with a few…

Building from the Ground Up

    New treatment modalities — as transformative as they may be of our approaches to human healthcare — still need to be profitable for their developers, provide the sorts of returns desired by investors, and be accessible to patients financially. As many industry experts have told us, the venture capital climate these days is much different from that of the early, giddier days of monoclonal antibodies. And with criteria still-emerging around the world for how regenerative medicines are and…

From The Editor

          From the beginning, BPI has developed creative, collaborative relationships with industry groups and associations as well as our own Informa colleagues at IBC. We have continuing relationships with Interphex, BIO, and ESACT. Through an upcoming supplement on cell therapies, we are enjoying contacts with ISCT, ARM, CTG, and the Phacilitate conference organizers. The list goes on. Such collaborations take many forms. Some people develop webcasts for www.bpiseminars.com. Others describe technical experiences and insights through manuscript…

From The Editor

          Welcome to 2011 — and our ninth year of publication. This milestone is both rewarding and a bit daunting. We want to drive discussions rather than just reveal their results. Venturing into new territories can require more than a simple roadmap. Think of bioengineers as experienced “cooks” who have reached a confidence level allowing them to combine recipes and create new “menus” from existing processes. Same ingredients, different combinations — with tasty new chemistries. But…

Product Lifecycle Management

    Biopharmaceutical manufacturers have often explored the idea of real-time process control and monitoring — but until relatively recently, few case studies were available to help put all the information together in a coherent plan for true product lifecycle management. Shifting from previous BPI Conference programs that included a “scale-up” track, this year’s lifecycle track will reflect how companies are being encouraged to view development, design, and manufacturing as a continuum rather than (more “traditionally”) as a set of…

Manufacture Locally, Market Globally?

    One response to a survey we sent out last year kept coming back to me as we prepared this issue. In answer to what a company does if a product in development doesn’t fit into the company’s platform technology, one answer was, “We innovate a solution.” Whether meant seriously or not, it rings true to the history of the industry’s ability to invent and reinvent solutions as necessitated by economic realities. When we began working on the topic…

Road Map to Implementation of Single-Use Systems

        The Bio-Process Systems Alliance (BPSA) is an organization of equipment suppliers, service providers, and users in the biopharmaceutical industry whose shared mission is to facilitate implementation of single-use technologies in biomanufacturing processes. A key focus of BPSA’s core activities is to educate users and develop guides that help safeguard the quality of drugs and therapies produced with single-use process technologies. As an extension of its technical guides and white papers, BPSA realized the importance of developing…