Manufacturing

eBook: SUStainability — Concerning Single-Use Systems and the Environment

Disposable materials have been used in many aspects of biomanufacturing since muromonab was first launched in 1986. Single-use stirred-tank bioreactors first became commercially available from HyClone in 2004 (1). Despite their demonstrated value to bioprocessing, disposable materials remain the subject of wide-ranging differences of opinion. Discussions of any technology are healthy and important for identifying areas for improvement, but some hearsay and bold propositions made regarding single-use components and the environment are not always helpful. Sustainability is an important and…

A Product–Packaging Interaction Study to Support Drug Product Development

Drug packaging is subject to a number of regulatory requirements, including those for product containers and packaging. For example, according to the federal Food, Drug, and Cosmetic Act (FD&C) section 501(a)(3), a drug is considered adulterated “if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health.” And 21 CFR states that drug packaging “shall not be reactive, additive, or absorptive so as to alter the safety,…

Large-Volume Wearable Injectors: A New Delivery Approach Could Change the Game

Biologic drugs are a driving force in the pharmaceutical industry. More than 2,700 were in pharmaceutical pipelines as of June 2017 to treat cancers (836), rare diseases (566), neurologic conditions (420), autoimmune disorders (311), and other ailments (567) — triple the number in 2013 overall (1). Biopharmaceuticals make up more than half of all drugs in development and are nudging out traditional small-molecule drugs rapidly while already bringing in billions of dollars in sales. The success of such drugs is…

eBook: The Future of Monoclonal Antibody Manufacturing — Incremental Improvement or Industrial Revolution?

Monoclonal antibody manufacturing is at a crossroads. Biomanufacturers could continue exploring new technologies and fine-tuning proven systems such as mammalian cell expression systems in stirred-tank bioreactor fed-batch cultures. But some experts say an opportunity is arising to turn the industry on its head by taking lessons from other branches of bioprocessing, such as the industrial enzyme sector. Drug makers are criticized often these days for the high prices of their products. The lay media, governments, payers, and patients themselves all…

Facilities of the Future: Intelligent Design and Control Enable Quality, Efficiency, and Good Citizenship

Today’s biomanufacturers need to be able to add capacity and capability quickly; provide increased supply service to customers on demand; and streamline the flows of personnel, traffic, utilities, and materials throughout bioprocess facilities. And companies need to be flexible enough to subtract capacity and retool quickly to produce new or different products. Many future facilities will be automated to some extent and use robotics in manufacturing. With personalized medicine on the rise, bioprocessors can benefit from colocation with academic research…

Flexibility, Automation, and Leadership: Drug-Sponsor Perspectives on Modern Biomanufacturing Facility Design

The title of this featured report — Smart(er) Facilities — came about in conversations with our KNect365 colleagues as they worked to plan this year’s BPI West conference, which took place 19–22 March 2018 in San Francisco, CA. For decades, biopharmaceutical facilities have incorporated cutting-edge designs for supporting processes, products, and human development. Each year, design innovations are rewarded for creating workspaces that facilitate both worker comfort and essential movement of promising drug candidates toward commercialization. In that context, biomanufacturing…

Partnerships for Progress: Supplier Perspectives on Facilities of the Future

Biomanufacturers are constantly tasked with making their products ever more efficiently with ever increasing quality. As major advancements come in biomanufacturing technology, companies find themselves in need of “smarter,” more flexible facilities than ever before. Recently, I asked several industry leaders for their thoughts on some criteria for smarter designs, including why there is such a demand: Cristina Amorim (vice president of facilities, EHS, and sustainability in the life sciences group of Thermo Fisher Scientific) Scott Battist (vice president, general…

Ensuring the Integrity of Single-Use Containers: Providing Robustness, Science, and Helium-Based Technology with a Detection Limit of 2 μm

Identifying the greatest defect size, both for liquid leaks and microbial ingress, is a fundamental step toward protecting the integrity of single-use systems (SUS) under real process conditions. Integrity testing of such systems may become a prerequisite in the future because they are used in the most critical process steps, with detection limits correlating to liquid leaks and microbial ingress. Such testing guarantees the sterility of drug substances and drug products packaged in single-use systems and, therefore, enhance patient safety.…

eBook: Innovations in CRISPR Technology — A Perspective on Research and Bioprocess Applications

One of the fastest growing areas in genome engineering is research using the powerful editing tool of clustered regularly interspaced short palindromic repeats (CRISPR). When paired with the Cas9 (CRISPR-associated protein 9), an RNA-guided DNA endonuclease enzyme from Streptococcus pyogenes, the site-specific prokaryotic immune system can be used to cut and manipulate DNA strands in cells of patients with genetic diseases to treat, or in some cases, prevent such diseases. Within the past couple of years, CRISPR has been shown…

Driving Cell Therapy Innovation: Applying Key Lessons from the Evolution and Commercialization of Protein-Based Therapies

After many trials and errors — and milestones — regenerative medicine has become a mainstream part of the biopharmaceutical industry, supported by at least 670 companies and clinics of all sizes. But many experiences in the protein-based industry segment can be leveraged to further improve successful commercialization of advanced therapies. At the 2017 Biotech Week Boston conference, BioProcess International editor in chief Anne Montgomery hosted a panel of industry cell therapy experts to discuss key lessons that can be gleaned…