The drug development landscape is awash with candidates that have shown enormous promise and efficacy in preclinical models but failed when administered to clinical trial subjects. Although such failures occur for different reasons, one of the most pervasive causes is the inability of preclinical models to recapitulate human physiology accurately. Despite advances with both in vitro and in vivo models, improving those toward a more accurate avatar of the human physiological process remains a challenge. Central to that effort will…
Economics
Market Research and Life Sciences: From Laboratory to Market
Start-ups in life sciences are constantly reshaping and redefining markets. As such, these companies must understand their unique markets because potential partners and investors seek out companies with such understanding. In my experience, it is not unusual for entrepreneurs to believe that they already know their market. They might have been active in their market for a long time, or they might have operated in similar industries and are making parallel assumptions. But markets are fluid environments, and they change…
Extend the Life of Your Facility: Flexibility Allows for Biopharmaceutical Process Innovation
For an industry built on constant change, there’s a surprising disconnect between the continuous drive for innovation and the inflexible facilities that house biopharmaceutical operations. Some of today’s facilities are built for today’s use with little thought about tomorrow’s. The typical approach for a new process or drug coming to market is to start with a brand-new building and permanently embedded equipment designed around that specific process. That approach is expensive and unsustainable. New bioproduction facilities can cost US$500 million…
eBook: Of Microbrews and Medicines — Understanding Their Similarities and Differences in Bioprocessing Can Help Improve Yields and Quality While Reducing Cost
Meeting a biopharmaceutical scientist or engineer who proclaims a love for brewing is not surprising. Perhaps it’s because of the challenge of mixing raw ingredients together and waiting patiently for the final product, maybe it’s the hands-on nature of the equipment or the data analytics entertainment, or it just might be the simple joy of creating something. Whatever attracts a scientist or engineer to making medicines and/or craft brews, a surprising number of principles hold true for both bioprocesses despite…
eBook: Challenges Facing Biosimilar Entries into US Markets
Since the 2009 enactment of the Biologics Price Competition and Innovation Act (BPCIA) (1), the US Food and Drug Administration (FDA) has licensed six biosimilar products under PHS 351(k) and approved one product under FD&C 505 (b)(2). It also provided complete response letters (CRLs) to four biologics license application (BLA) filings (Table 1) (2). By comparison, the European Medicines Agency (EMA) has approved 31 biosimilar products (3) and refused or withdrawn about five. There is no doubt that US market…
Data Analysis and Visualization to Improve Biopharmaceutical Operations Part 1: What Are You Trying To Measure?
This begins a five-article series of “how-to†guides for tackling the most common obstacles in assessing, measuring, analyzing, and improving the performance of global biopharmaceutical manufacturing operations. Each installment covers a component of proper collection, analysis, and use of data for the best possible performance outcomes. When taken as a whole, the series should provide imperative best practices for handling business-performance data. First, consider what you want to know about your bioprocesses. How can you more appropriately measure those data…
Better Solutions Needed As Cancer Drug Costs Escalate
The out-of-pocket price of many life-saving cancer medications continues to rise while insurance companies continue to raise deductibles and copays. Patients are paying more for their prescriptions than ever before, and they need solutions that offer cost-effective treatment. The Oncological Problem Cancer is the second leading cause of death in the United States. More often than ever before, patients obtaining potentially life-saving cancer drugs face a severe financial burden (1). Newer cancer medications can cost patients over US$100,000 each year,…
Developments in Antibody–Drug Conjugates: A Discussion with Thomas Ryll of ImmunoGen
As a major class of emerging therapies, antibody-drug conjugates (ADCs) already have gained the attention of biopharmaceutical researchers and manufacturers because they combine both the precision of monoclonal antibodies and the potency of highly potent drug compounds. A few ADCs already have entered the market, but many more candidates are progressing through industry pipelines. Platform processes are not yet universal (and it remains to be seen whether they ever will be), but major ADC developers are establishing their own with…
The Unican Concept: Engineering Dual Capability into Single-Use Vessels
Use of disposable bioreactors in the biopharmaceutical industry has increased gradually over the past several years in pilot, clinical, and production scale facilities (1–4). Reduced time to market in today’s drug industry has created a need for cost-effective development and production strategies as well as manufacturing flexibility. When compared with traditional stainless steel equipment, disposable bioreactor and mixing systems have smaller space requirements, are portable, and come presterilized to eliminate the need for preuse sterilization procedures such as steam-in-place (SIP).…
Emerging Markets: Current Insights into the State of Global Biopharmaceutical Manufacturing
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…