Manufacturing

Single-Use Bioreactors: Performance and Usability Considerations Part 1: Performance for Process Control

by , , and

There is ever increasing pressure for the biopharmaceutical industry to drive toward higher efficiency and lower costs. Compared to the past, target markets for many drugs typically are becoming smaller, and so-called blockbuster drugs are becoming more the exception than the rule. Regulatory agencies have continued to increase the pressure on drug makers to meet increasing quality standards and accept higher levels of responsibility. Furthermore, customer pricing, healthcare markets, and recent biopharmaceutical pricing scandals all add incentives toward more efficient…

June 23, 2018

Accelerating Vaccine Production Using a Nonviral Enabling Technology for Cell Engineering

by

At the recent World Vaccine Conference, Victor Ayala, PhD, an early stage investigator with Advanced BioScience Laboratories, Inc. (ABL), discussed how to accelerate vaccine production using a nonviral enabling technology for cell engineering. ABL is a contract research/manufacturing organization (CRO/CMO) providing manufacturing and laboratory research services to advance leading vaccines and therapies from clinical development to the commercial market. The company has been conducting R&D research for over 55 years and performing CMO manufacturing for over 25 years. With more…

June 22, 2018

Cultivating Better Working Relationships with Contract Manufacturing Organizations: A Panel Discussion

by

On 21 March 2018, a panel discussion during BPI West in San Francisco addressed ways to improve working relationships between sponsors and contract manufacturing organizations (CMOs). Our goal as organizers was to avoid retreading overfamiliar ground: Many outsourcing articles stress the importance of good communication without delving into actual strategies for improvement. So I asked the panelists to focus on the word better and what that actually means in this context. The most productive way to approach such a discussion…

June 20, 2018

Dual Sourcing of Protein A Resin to Mitigate Supply Chain Risk: A Comparative Study to Determine Equivalence

by , and

Protein A affinity chromatography is a well-established technology that is used extensively for large-scale purification of monoclonal antibodies (MAbs). With this mode of chromatography, very high product purity can be achieved in a single, relatively simple unit operation. A solution containing the target protein of interest is applied to a liquid-chromatography column at near-neutral pH, and one or more wash steps follow to lower product- and process-related impurities (1). Product is eluted through application of a low-pH buffer. Finally, the…

June 20, 2018

Innovators and Biosimilar Companies: Experts Predict Intense Conflicts Ahead

by

CPhI Worldwide (organized by UBM) announced last fall the final section findings of the fifth edition of the CPhI Annual Report. Presented live at the meeting in Frankfurt, Germany, the report is now available online. It highlights immediate and long-term trends in pharmaceutical data, regulation, generics, and biosimilars. Four experts gave their views. They warned that the US Food and Drug Administration’s (FDA) approach to achieving six-sigma (nearly perfect or 99.9997% defect-free) quality is failing in respect to the pharmaceutical…

June 20, 2018

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

by and

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…

June 7, 2018

A Product–Packaging Interaction Study to Support Drug Product Development

by

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,…

June 1, 2018

Development of a Freeze-Dried Ebola-Expressing Adenoviral Vector: Unexpected Findings and Problems Solved

by and

In December 2013, a two-year-old child in Guinea became the first person to be killed by Ebola in the most recent outbreak. In March of the following year, that outbreak was declared in West Africa. By mid-2014, the World Health Organization (WHO) had declared it to be a public health emergency of international concern and urged pharmaceutical companies to accelerate their development of candidate vaccines. At the peak of the outbreak in 2014, more than 1,200 new cases of Ebola…

June 1, 2018

Rational Design of Liquid Protein Formulations: Application of Biophysical Stability Predictors and Descriptors to Reformulate Biotherapeutics

by , , , and

Successful development of liquid biopharmaceutical formulations requires careful assessment of the biophysical properties of the protein in solution, primarily focused on achieving optimal conformational and colloidal stability of the drug-substance molecule (1–11). It also involves extensive stability studies under stressed conditions. Using state-of-the-art biophysical tools for characterization of developed products, those studies are based on key biophysical descriptors and extended particulate characterization methods (subvisible particles in micro- and nano-size range) to deliver a stable product for market with a shelf…

June 1, 2018

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

by

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…

June 1, 2018