For most biotechnology and biopharmaceutical organizations, “business as usual†means a perpetual race to the finish line: Conceive a new invention, reduce it to practice, attain patent protection, repeat ad infinitum. But sometimes, the very technologies scientists use to expedite that chain of events (e.g., electronic laboratory notebooks and cloud-based laboratory data sharing) create security and authenticity holes. In essence, the more agile and sophisticated our work flow systems become, the more difficult it becomes to guarantee the…
Business
The Role of Higher-Order Structure in Defining Biopharmaceutical Quality
Cosponsored by CASSS (an International Separation Science Society) and the US FDA, the 17th CMC Strategy Forum was designed to explore the relationships between higher-order molecular structure and quality of therapeutic proteins and peptides, vaccines, and blood-derived products. Understanding those relationships is important to defining and controlling the critical quality attributes (CQAs) of biopharmaceutical products. The forum program highlighted the current state of the art for analytical tools used to monitor higher-order structure. Case studies demonstrating the effects…
Opportunities in Regenerative Medicine
Capitol Hill fly-in days (see the last page of this issue) … A focus of Google Ventures (www.google.com/ventures) … A favored new investment arena for GE’s CEO Jeffrey Immelt, the recently named head of President Obama’s economic recovery advisory panel, and Life Technologies’ Greg Lucier … Hardly a day skipped without a major news publication covering some exciting aspect of the science … The provocative cover of Wired magazine’s (www.wired.com/magazine) November 2010 issue … It all sounds like the stuff…
A 483 Primer
The words of George Santayana — “Those who do not remember the past are condemned to repeat it†— ring especially true for companies regulated under good manufacturing practices (GMPs). Learning from and reacting to lessons from past inspections (both your own and those of other companies) is one of the best ways to prepare for future inspections. Regular review and close study of 483 notices issued during inspections can be an efficient and accessible means of identifying and absorbing…
Addressing Business Models, Reimbursement, and Cost of Goods
The early ISCT organization provided a powerful forum for sharing solutions, developing standards, and moving the emerging concepts in cell therapy forward as the field grew up and out of academia. Currently, the ISCT organization is uniquely positioned to facilitate sharing of best practices, standards, and strategies across the for- profit cell therapy industry through its Commercialization committee. The Business Models, Reimbursement and CoGS (cost of goods sold) subcommittee of the ISCT Commercialization committee was formed to address several key…
Working Together for the Future
Most individuals who choose to pursue a career in healthcare would say they do so because they are driven by a fundamental desire to help people. If you ask people why they decided to work in the field of regenerative medicine, many will tell you it’s because they believe it is the most exciting area of medical research and that it holds the greatest potential to transform medicine as we know it. The transformational potential of stem cells and regenerative…
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…
Questions to Consider When Thinking About Companion Tests
Personalized medicine is a catch phrase of the 21st century — and with good reason. Advances in genetics and biochemistry promise to tease apart factors that explain why some patients benefit dramatically from a therapy whereas others receive no benefit at all. They also help explain side-effect profiles. To accomplish such lofty goals, drug makers are increasingly partnering with diagnostics companies to develop companion biomarkers. But these companies operate in very different business and regulatory environments, so partnerships can be…
Extractables and Leachables
The 13th WCBP CMC Strategy Forum on extractables and leachables was held in Bethesda, MD, in January 2008. The purpose of this forum, cosponsored by CASSS (an international separations society) and the FDA, was to discuss questions related to extractables and leachables in the context of biopharmaceutical manufacturing and find consensus on some of those topics. Morning sessions began with “Extractables and Leachables: Challenges and Strategies in Biopharmaceutical Development†with program cochairs Stacey Ma of Genentech, Inc., Ingrid…
Combination Products for Biotherapeutics
Combination products (see the “Definition†box) are experiencing steady growth in the pharmaceutical industry. According to one report, about 30% of products currently in development are combination products (1). Expanding interest in such products can be attributed to manufacturers’ need to generate new market value for current products that will soon lose patent, requirements for long-term patient care, pressure to reduce healthcare costs, and consumer interest in localized drug delivery with improved therapeutic effectiveness (2). During the 2008…