Author Archives: Eric S. Langer

Advances in Bioprocessing: Single-Use and Stainless Steel Technologies

The increasing penetration of disposable devices in the biopharmaceutical manufacturing industry has been well documented, and with good reason. These applications represent a new paradigm in the evolution of biomanufacturing technologies and practices, opening the industry up to new possibilities such as flexible and modular facilities. But stainless steel applications and innovations remain vital to this industry. Some stainless devices may be irreplaceable, including large tanks, autoclavable and heat-sterilized fermentors and bioreactors, and storage and filling devices. Other innovations in…

The US Biosimilars Future Is Hard to Predict: Global Health Policy, Innovation, Prices, and Profits Are All at Stake

Enthusiasm in the United States over opportunities for biosimilars has waned since such products were first launched in Europe. The hesitation stems from confusion and uncertainty surrounding regulations. Manufacturers and suppliers are looking for guidance from the US Food and Drug Administration (FDA), which has promised guidelines that are still in process after five years. Even naming protocols for biosimilars are clogging the works. And in the absence of coherent FDA guidelines, many US states are haphazardly implementing laws concerning…

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…

Manufacturers Open Their Wallets for Outsourcing: Accessing Technical Expertise and Cutting Costs

Budgets for outsourcing activities have rebounded in recent years as outsourcing has gradually become a more common and core strategic decision made by bioprocessing companies. Some of the increase in outsourcing activity over the past few years has no doubt been spurred by cost-cutting behavior. But increasing evidence indicates that contract manufacturing organizations (CMOs) are providing specific technical skills that clients may have shed during leaner recession years. In our latest annual industry report (1), we take a close look…

Powders and Bulk Liquids

    The two major bioprocess fluids — culture media for upstream production and buffers for downstream processing — are classic single-use products. They are used once and then disposed of. The two basic options for both differ by physical state: powdered media and buffers (“powders” for in-house preparation of liquids by end users) and bulk liquid culture media and buffers, which are fully prepared by their suppliers (“liquids”). We conducted market research studies comparing the benefits and risks (value…

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.…

Industry Adoption of Membrane Adsorbers

Membrane adsorbers (MAs) are the fastest-growing segment in single-use bioprocessing. But their future is not entirely certain. According to BioPlan Associates’ latest survey of biopharmaceutical manufacturing, the MA market has been growing at ~20% annually since 2006 (1). Paradoxically, however, the segment may not be a true “rising star.” Our study also shows that MAs remain among the least-often adopted devices among biomanufacturers. So the question of how and whether MA technology can revolutionize bioprocessing remains open. Market for Membrane…

Keeping New Technologies Coming

The biomanufacturing industry is heavily invested in improvements in productivity and efficiency, and innovation is a critical component to ensuring gains in these areas. Yet that is not always the case. Suppliers and innovators in this market face greater challenges, and much longer product evaluation cycles than in other segments, for example the information technology or semiconductor industries. In the highly regulated biomanufacturing environment, changing any aspect of a process can potentially necessitate additional regulatory submissions to the US Food…

Sponsors Look to Asia for Potential Contract Partners

As the biopharmaceutical market continues its global expansion, biomanufacturers are becoming increasingly comfortable with the idea of outsourcing activities to international destinations. This year, China expanded its lead as the primary potential destination. This measure of interest shows how the country’s international outsourcing potential and global perception have changed over the past five years. It also suggests a greater international awareness of opportunities opening up in China for local production. Figure 1: () More than a quarter (26.2%) of the…