Business

Advocating for Advanced Therapies

My sense is that we’ve come a long way and that 2013 was actually a very good year — perhaps maybe even the best year ever for regenerative medicines and advanced therapies. Clearly the financial markets have allowed us to do more in terms of raising capital to fund projects in this space, and we are seeing a growing interest in the sector in the investor community. We’ve seen a number of major financing events over the course of the…

Cell Therapy Will Transform the Future of Medicine

The third annual IBC Cell Therapy Bioprocessing conference was held in Bethesda, MD, on 21–22 October 2013. It brought pioneers in the development of cell-based therapies together with companies that have enabling technologies, such as bioreactors, cell culture media, and advanced monitoring software. After the conference, I discussed the highlights and key themes coming out of the event with Dr. Phil Vanek, general manager of cell bioprocessing at GE Healthcare Life Sciences in Westborough, MA. Also an instructor for advanced…

Thinking Strategically

At the recent Phacilitate Gene and Cell Therapy Conference (27–29 January 2014 in Washington, DC), BPI’s editor in chief Anne Montgomery and publisher Brian Caine spoke with Richard Grant, executive vice president, life sciences, at Invetech (www.invetech.com.au); and Brian Hanrahan, program manager at Invetech. They and their colleagues were instrumental in advising us how to bring ongoing discussions of regenerative medicines into BPI four years ago for the first Cell Therapy Supplement issue. We asked them to comment generally on…

Essentials in Quality By Design

Quality by design (QbD) is a systematic approach to drug development. It begins with predefined objectives and emphasizes product and process understanding and process control, all based on sound science, data-based decision making, and quality risk management (QRM). As introduced by the US Food and Drug Administration (FDA), QbD brings modern drug development methodologies to chemistry, manufacturing, and control (CMC) teams working on biologics, pharmaceuticals, and vaccines. The innovations associated with QbD are not so much the development concepts (which…

Activatable Immunoconjugates for Target Cancer-Cell–Specific Diagnosis and Therapy

In cancer treatment, early diagnosis and targeted therapies are assumed to yield the highest cure rates. However, most current methods are limited by their low sensitivity to early disease and a lack of specificity for targeted cell killing. Newly developed, activatable immunoconjugates assist in the accurate detection of cancer through in vivo imaging with high target-to-background contrast (1,2). They also provide for the possibility of highly specific, light-mediated treatment with minimal effects on healthy cells surrounding tumors (3). In fact,…

Bioprocess Advances Drive Vaccine Manufacturing in Developing Countries

Advances in bioprocessing technology hardware and genetic engineering are expanding the geographic options for biologics manufacturing to include developing and emerging economies. Such advances are beginning to permit biopharmaceutical production in regions that previously lacked the technical expertise or quality processes to permit complex operations, monitoring, record-keeping, and oversight. Global demand by countries for in-country production of biological vaccines is increasing, so those products tend to be leading the way in terms of adoption of modern bioprocessing in developing countries.…

Evolving Biologics Demand Spurs New Facility Needs

In the era of biologics manufacturing, chemical medicine production facilities are becoming the dinosaurs of the life sciences sector. Traditional chemical facility development and management systems are simply unequipped to support the highly sensitive — and highly regulated — process of developing and producing biological and biosimilar medicines. Renovating or building such facilities anew is a mammoth undertaking by any measure. All signs point to the value of evolving facility design and management to house more sophisticated biologic laboratory services.…

Innovation in Biopharmaceutical Manufacture

The following is a report from a workshop on innovation in biopharmaceutical manufacturing held at the Annual bioProcessUK Conference in Bristol on 29 November 2012. The aim of the workshop was to access the experience of practitioners in the United Kingdom so as to understand better the challenges and opportunities for innovation in this sector. The workshop addressed the drivers that influence the implementation of process improvements and novel technologies in biopharmaceutical manufacture from the perspective of both manufacturers and…

Optimizing for the Future

The 2013 biennial meeting of the European Society for Animal Cell Technology (ESACT) was in Lille, France this past June. While there, BPI editorial advisor Miriam Monge (vice president of Biopharm Services Ltd.) interviewed ESACT executive committee member Hitto Kaufmann, PhD (vice president of biopharmaceutical process sciences for Boehringer Ingelheim). They talked about some scientific developments being discussed at this year’s ESACT conference as well as Boehringer Ingelheim’s recent announcement about setting up in China and Kaufmann’s own thoughts on…

Outsourcing Facility Safety for Biomanufacturing

As the life-science industry increasingly outsources noncore functions, some companies are finding that managing the expanding web of safety and environmental requirements associated with various functions is, in turn, growing vastly more complex. As multiple third parties handle numerous noncore activities, the risk — and headaches — of monitoring them effectively is a growing challenge by any standard. At first glance, the lowest-risk solution for many organizations may seem to be managing associated safety programs with in-house personnel and programs.…