Langer E.S.,BioPlan Associates Inc
Pharmaceutical Outsourcing | Year: 2014
Outsourcing of non-core activities continues to be a value-driven calculus, as the biopharmaceutical manufacturing industry remains very much focused on productivity gains. However, there are signs that the outsourcing landscape has moved beyond its traditional concentration on non-core activities. The outsourcing decision has become a more strategic one that takes into account key CMO capabilities that are sometimes not available in-house.
Langer E.S.,BioPlan Associates Inc.
EBR - European Biopharmaceutical Review | Year: 2010
Most biopharmaceutical companies have turned to outsourcing in an attempt to control costs and manage their internal staff and resources, so that in-house activities are performed cost-efficiently. Economic conditions today are causing organisations to re-evaluate their core competencies and decide how they will direct their R&D and manufacturing resources. In an annual report on the industry, it has been found that many companies are starting to use outsourcing proactively rather than on a tactical basis (1). Outsourced projects now cover all areas of R&D, manufacturing, testing and services. They are being used to not only fill temporary gaps in capacity, but also to focus a company's skill base on core competencies, in addition to controlling costs.
Langer E.,BioPlan Associates Inc.
BioPharm International | Year: 2010
The industry is demanding more flexibility across all unit operations and vendors have responded by developing technologies to improve downstream processes. Our annual study also continues to show downstream processing as the primary bottleneck today, and although no fully commercialized downstream alternative to current chromatography processes exist, a number of products are in development. Once such products are available, more companies will likely increase their overall use of single-use systems. This will make it possible to begin to realize the advantages expected from fully disposable production processes. In addition, as new regions such as China and India begin to produce biologics and biogener-ics intended for Western markets, the need for consistent quality will likely dictate a greater use of disposables, because they can be implemented more efficiently and with fewer risks of quality problems. As new biomanufacturers enter the industry and new products enter the pipeline, the disposables option will become part of the decision process from the very start. This may help start-up organizations and those in less developed regions become more effective and competitive.
Langer E.S.,BioPlan Associates Inc. |
Rader R.A.,BioPlan Associates Inc.
Engineering in Life Sciences | Year: 2014
Single-use bioprocessing equipment has made considerable progress in the past 10 years. These devices now dominate small- and mid-scale bioprocessing and are starting to graduate to larger scale manufacturing. We now have nearly a decade of combined industry experience covering the benefits of single-use vs. fixed stainless steel. Single-use systems are generally recognized as enabling rapid setup of bioprocessing at multiple scales in the same manufacturing area. A decade ago there were significant unknowns and concerns about single-use equipment. Today, these plastics and equipments have much improved, and include advanced design, multilayer laminated plastic bags, and other integrated technologies. This article reviews bioprocessing single-use systems market characteristics and trends over the past decade and forecasts future developments. Much of this grounded and based on data from the annual survey of bioprocessing professionals conducted by BioPlan Associates, Inc., now in its 11th year. In addition to quantitative survey data, this annual report includes extensive discussion and external analysis of bioprocessing and related trends. This article also includes data from other primary research resources. Single-use and modular systems are making capacity crunches increasingly unlikely; in fact, estimating current and projected industry capacity may become subjective and possibly irrelevant. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
PubMed | BioPlan Associates Inc
Type: Journal Article | Journal: mAbs | Year: 2010
The administration of high doses of therapeutic antibodies requires large-scale, efficient, cost effective manufacturing processes. An understanding of how the industry is using its available production capacity is important for production planning, and facility expansion analysis. Inaccurate production planning for therapeutic antibodies can have serious financial ramifications. In the recent 5(th) Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, 434 qualified respondents from 39 countries were asked to indicate, among other manufacturing issues, their current trends and future predictions with respect to the production capacity utilization of monoclonal antibodies in mammalian cell culture systems. While overall production of monoclonals has expanded dramatically since 2003, the average capacity utilization for mammalian cell culture systems, has decreased each year since 2003. Biomanufacturers aggressively attempt to avoid unanticipated high production demands that can create a capacity crunch. We summarize trends associated with capacity utilization and capacity constraints which indicate that biopharmaceutical manufacturers are doing a better job planning for capacity. The results have been a smoothing of capacity use shifts and an improved ability to forecast capacity and outsourcing needs. Despite these data, today, the instability and financial constraints caused by the current global economic crisis are likely to create unforeseen shifts in our capacity utilization and capacity expansion trends. These shifts will need to be measured in subsequent studies.