Business

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…

Hands-On Training for Biopharmaceutical Careers: Trainees Gain Practical Experience in Realistic Production Environments

At the April meeting of the BPI International Summit (25−26 April 2017) delegates were treated to a tour of a new training facility. The Biotech Training Facility is about a 20-minute drive from the Amsterdam airport and located in the Leiden Bioscience Park. The park houses companies that employ ~18,000 life science workers. In addition, the Leiden University and the Leiden Academic Medical Center complement the dynamic high-tech environment that facilitates establishment of such a knowledge and experience center as…

Introducing NIIMBL: Accelerating Innovation in Biopharmaceutical Manufacturing

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) was launched in March 2017 as a cooperative agreement with the National Institute for Standards and Technology (NIST), part of the US Department of Commerce. NIIMBL is one of the newest members of Manufacturing USA, a network of manufacturing innovation institutes through which industry, academia, and government work together to accelerate implementation of advanced manufacturing and develop a trained workforce in several key sectors of ththe US economy. NIIMBL’s mission is…

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…

Transforming Deviation Management

All biopharmaceutical companies espouse a belief in scientific, risk-based approaches. However, with respect to deviation management systems (DMSs), the industry is falling short of that promise. By and large, companies still use a small-molecule pharmaceutical compliance model that dates back to the 1980s, based on the strategy that all deviations are created equal and require 30-day closure. Most bioprocessors still hold to a default 30-day rule, even though there is no specific regulatory requirement for that time frame. Major or…

China’s Biopharmaceutical Companies Target Global Markets

Global perspectives of China as a major biopharmaceutical supplier have changed over the past decade. In 2008, BioPlan Associates completed its first analysis and directory of the top 60 biopharmaceutical facilities in China (1). Based on findings from our study titled Advances in Biopharmaceutical Technology in China (2), we found that China clearly held the image of a low quality manufacturer of biogeneric products almost exclusively for its domestic market. Further, concerns over intellectual property protection, contracting problems, and management…

Change Happens: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (CMC Forum)

In the current global regulatory environment, management and implementation of postapproval CMC changes often can be unpredictable and inefficient. Timelines for change approval can vary from months to years, depending on regional regulatory procedures. Therefore, the challenge in postapproval lifecycle management is to maintain a constant supply of high-quality product while supporting innovation and continual improvement. This was the premise of the CASSS Chemistry, Manufacturing, and Controls (CMC) Strategy Forum held in Gaithersburg, MD, on 20–21 July 2016. The forum…