Business

Back to Basics for Biotech: Driving a Culture of Quality and Compliance with Practical Communication Techniques

The robust regulatory environment surrounding biotechnology and bioprocessing demands a comprehensive current good manufacturing practice (CGMP) culture of quality, compliance, and absolute adherence to policy. Employees need to be engaged in their work, with a laser focus on meeting stringent specifications and operating under tight controls. A misstep in quality or compliance can lead to hefty fines, legal concerns, regulatory retaliation, and reputational damage. Communication and stakeholder engagement are critical to aligning organizations and driving the right culture in highly…

Reverse Translational Medicine: The Promising Future of Failure

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…

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…

Beyond Compliance: Serialization Has More to Offer

As the global pharmaceutical industry implements serialization (track and trace from manufacturing to dispensing) to meet governmental regulatory requirements, other opportunities arise for drug companies. The main driver here is to improve the integrity of the overall drug supply chain, but other meaningful business benefits can come from serialization. Generally accomplished through automated, electronic means, it involves such practices as recording, authenticating, maintaining, and sharing accurate records of products. Outside-the-Box Benefits In addition to tightening up the supply chain and…

Postapproval CMC Changes: Increasingly a Fact of Biopharmaceutical Life

The manufacture of vaccines and therapeutic proteins has suffered from a reputation of being part art and part science, with heavy doses of regulatory uncertainty thrown in. Postapproval changes (PACs) to chemistry, manufacturing, and controls (CMC) were initiated reluctantly and carefully in the era of “the process is the product.” Today, CMC PACs are a normal part of the biopharmaceutical industry business. Emma Ramnarine (head of global biologics quality control at Hoffmann-La Roche in South San Francisco, CA) notes that…

Serialization: Background, Justification, Requirements, Timelines, and Readiness Across the Supply Chain

Drug manufacturers are facing unprecedented serialization challenges. Serialization requires weighty consideration and focused strategy for successful commercialization, even for those companies that have yet to bring a product to market. The World Health Organization estimates that 10% of medicines worldwide and up to 50% of drugs consumed in developing nations are counterfeit. In response to increasing drug integrity concerns, more than 40 countries have introduced laws mandating serialization and tracing of pharmaceutical products as they pass through the supply chain.…

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,…

Building Competency in Basic Science: The Secret Weapon of Tomorrow’s Bioprocessing Technician

Today’s bioprocessing technicians are highly skilled professionals who can operate large automated equipment, juggle numerous support activities, and document manufacturing deviations. In coming years, their jobs will become even more rigorous as companies push more decision-making to the production floor to save time and resources. With the trend toward smaller batches made in bench-scale and/or single-use equipment, this strategy becomes easier to implement. One way to foster improved decision-making on the production floor is to hire or promote employees who…

Addressing Knowledge Gaps and Skills Development: Modular Training Keeps the Bioindustry at the Leading Edge

One major challenge facing the global bioindustry today is finding talented individuals to work in the type of highly skilled interdisciplinary environments necessary for effective bioprocess development. Ideally, such individuals require a combination of technical knowledge and expertise spanning biological sciences, physical sciences, mathematics, and engineering. Numerous industry surveys have repeatedly stressed the lack of suitably trained individuals equipped with necessary skills to work at the biology−engineering interface to meet the growing and changing demands of industry. The challenge is…