Single Use

Disposables for Biomanufacturing: A User’s Perspective

The supply scenario for many biopharmaceutical drugs such as monoclonal antibodies (MAbs) is changing. With the implementation of personalized medicine resulting in drugs for specific, high-responder subsets of patients, market volume per drug will decrease. In addition, increasing fermentation titers of up to 10 g/L for MAbs are leading to smaller fermentation volumes necessary to accommodate individual biopharmaceutical market demands. That results in approaches such as flexible production in campaigns or decentralization of manufacturing using similar facilities with low risk…

BPI Theater at the 2014 BIO Convention

When we launched the BioProcess Theater series at the Biotechnology Industry Organization’s International Convention in 2007, we hoped that our special programming would fill a need within that event’s exhibit hall. We wanted to bring into the hall the type of technical presentations that are not generally part of the main event’s more executive-level, business-focused programming.It has therefore been especially gratifying to see our attendance growing every year — such that standing-room-only is becoming more the rule than the exception.…

Biopharma Unhappy with Suppliers’ Progress on Single-Use Hookups

Single-use equipment vendors are failing to meet their biomanufacturing customers’ expectations in several key areas, according to BioPlan Associates’ 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1). The study — based on a global survey of 238 global biomanufacturers and contract manufacturing organizations, as well as 158 vendors and suppliers in 30 countries — identifies significant gaps between the perceived importance of key vendor attributes and companies’ satisfaction with their vendors regarding those attributes. One area…

Industry Experts Convene in New York to Discuss Latest Innovations: A BPI Special Report

As the biopharmaceutical industry continues to mature and grow, so too does the need to educate a broader audience of biopharmaceutical professionals interested in hearing, understanding, and applying the latest science and technology trends that support and in many cases are transforming today’s bioprocesses. To reach this extended and engaged audience, BioProcess International created the BPI Theater Series: a live, interactive program that provides bioprocessing content to traditional, noncore biopharmaceutical conference programs. It provides attendees with the opportunity to interact…

Development of a Single-Use Filling Needle

Single-use components such as tubing, connectors, and filters have been widely used for many decades in bioprocess unit operations. Users have been able to identify and quantify the specific benefits of single-use over cleanable systems. In more recent years, many other process components have been designed for disposability such as bioreactors, mixers, and chromatography and ultrafiltration systems. Those and other advances have made it possible to incorporate multicomponent, presterilized manifolds into both existing and new processes, realizing benefits such as…

Seeking the Next Generation of Single-Use Technologies

Recent trends in biomanufacturing technology and the biopharmaceutical market are driving the increased adoption of single-use (SU) manufacturing systems. From the demand side, the biopharmaceutical industry’s focus on niche and rare diseases with relatively small patient populations is pushing for smaller, more flexible biomanufacturing capacities than have been needed in the past. The entry of many companies into biosimilars development also is leading to fragmentation and dispersion of manufacturing capacity. Changes on the supply side caused by technological advances have…

Bioprocess Advances Drive Vaccine Manufacturing in Developing Countries

Advances in bioprocessing technology hardware and genetic engineering are expanding the geographic options for biologics manufacturing to include developing and emerging economies. Such advances are beginning to permit biopharmaceutical production in regions that previously lacked the technical expertise or quality processes to permit complex operations, monitoring, record-keeping, and oversight. Global demand by countries for in-country production of biological vaccines is increasing, so those products tend to be leading the way in terms of adoption of modern bioprocessing in developing countries.…

A Sustainable, Single-Use Facility for Monoclonal Antibody Production

Pierre Fabre, the second largest independent pharmaceutical group in France, recently opened a new facility to expand its monoclonal antibody (MAb) production for clinical supply. The Antibody Biotechnology Unit (ABU) facility was designed to provide needed flexibility for adapting to various process and capacity changes, so it includes state-of-the-art single-use technologies. The facility was also built with sustainability in mind to minimize the company’s environmental footprint. The company integrated this plant into an existing antibody research and development (R&D) center,…

Simpler and More Efficient Viral Vaccine Manufacturing

Human and veterinary vaccines are divided into five main categories: conjugate, toxoid, subunit, inactivated (killed), and live (attenuated) vaccines (1). The vast majority of currently licensed human and veterinary vaccines are inactivated or live (2, 3). They are produced mostly using adherent cells: primary cells such as chicken embryo fibroblasts (CEF), human diploid cells such as MRC-5, or continuous cell lines such as Vero and MDCK (4). The pioneering legacy inherited by vaccine manufacturing development has led to strategies for…

Broadening the Baseline

When the editors of BPI asked us at BPSA to put together a content-rich article on single-use issues, we were happy to do so. Our challenge was how to bring in multiple viewpoints about the growing business of single-use that would be a “quick read” for the BPI audience. The answer: an expert colloquy. Represented here are several of the most qualified industry spokespersons in single-use — all are members of BPSA and speak as directors of the alliance. Their…