2018

Accelerating Intensified Bioprocesses with High-Throughput Small-Scale Tools

While many biopharmaceutical companies are exploring paths toward continuous processing, many tools already exist for implementing process intensification. As the authors of this special report illustrate, hybrid continuous processes that benefit from single-use technologies along with continuing improvements in perfusion cell culture already now are enabling improvements in cost reduction and accelerating time to market. And novel high-throughput and automated small-scale systems are helping development scientists gather more information in less time than before, reduce their development footprints, and make…

Oxygen Mass Transfer Correlation for a Rocking-Motion Bioreactor System

Disposable bioreactor systems are technologies commonly used in bioprocessing. They provide cost-effective contamination control and allow more flexible facility layouts than do stainless steel alternatives. One of the most popular types of single-use bioreactors uses a rocking platform in place of a traditional shaft and agitator assembly to aerate and mix cell culture material within a presterilized, single-use plastic bag (1). The system studied here is the ReadyToProcess WAVE 25 bioreactor (GE Healthcare Life Sciences). In contrast to conventional stirred…

Demonstrating Scalable T-Cell Expansion in Stirred-Tank Bioreactors

Emerging cell therapies have excited the pharmaceutical industry because they indicate potential new pathways to treat some of the most life-threatening diseases. T-cell therapies currently are the flagship technology in cell therapy with recent US FDA approvals of Novartis’ Kymriah (tisagenlecleucel) and Gilead’s Yescarta (axicabtagene ciloleucel) treatments. Those therapies and others still in development use peripheral blood isolated lymphocytes (PBLs) modified with chimeric antigen receptors (CARs) or modified T-cell receptors (TCRs) to trigger the innate cytotoxic response of these immune…

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

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…

PDB-Dimer Payloads for Antibody Drug Conjugates: A Robust Approach to cGMP Production

From the 1960s when monomeric pyrrolobenzodiazepines (PBDs) such as anthramycin were isolated and characterized, to the dramatic increase of potency induced by dimerization in the 2000s, PBD dimers have evolved as one of the leading classes of antibody drug conjugate (ADC) payloads. Currently, 17 ADCs are in clinical trials involving PBD-dimers — second only to auristatins (23 ADCs), and more than those with maytansines (16 ADCs). Four different PBD-dimer ADC payloads are in clinical trials: Talirine (SGD-1910) from Seattle Genetics;…

Accelerating Vaccine Production Using a Nonviral Enabling Technology for Cell Engineering

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…

eBook: Quality By Design for Monoclonal Antibodies — Establishing the Foundations for Process Development, Design Space, and Process Control Strategies

The quality by design (QbD) modernized approach to pharmaceutical development is intended to provide regulatory flexibility, increased development and manufacturing efficiency, and greater room to innovate as well as improve manufacturing processes within defined ranges without obtaining regulatory approval first. QbD is a systematic developmental approach that starts with a clear goal in mind and emphasizes understanding of how variability in both process and materials affects a final product (1). Historically, product quality has been assured either with end-product testing…

June From the Editor

It surprises some folks in the BPI community to learn that I’m a journalist by training, boasting a mere bachelor of arts degree in journalism despite my high-fallutin’ technical editor title. I was originally trained in Associated Press (AP) style by a veteran newsman who spent many years working for AP’s main competitor, United Press International (UPI). When I first started on BioPharm back in 1996, I had to get up to speed quickly on the stylebooks of Chicago and…

June Spotlight

Holding True to the Price-Cap Pledge As in previous years, 2018 started with more than 30 drugs increasing in price on the US market. However, data and analysis firm GlobalData observes that criticism from politicians and the public seems to be keeping the industry to a 10% self-imposed price-hike limit. It began with Allergan CEO Brent Saunders pledging to police pricing in 2016, when he stated that his company would limit itself to one price increase per year and only…

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

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…