Supply Chain

Building Regulatory Compliance for Personalized Medicine

    Regulatory compliance is the means by which biopharmaceutical companies bring new medicines to market. But as we embark on developing and bringing to market more complex, more personalized medicines in the 21st century, we are about to find that our most experienced sources of compliance know-how and intelligence are getting ready to leave for the comforts of retirement. Demographics are working against the biopharmaceutical industry.   Survey Results   A 2006–2007 survey by the University of Southern California…

Minimizing the Environmental Footprint of Bioprocesses

    Biomanufacturers must take active measures to minimize their environmental footprints and promote environmental sustainability. The collateral benefit of reducing environmental footprint often is viewed as only a secondary consideration after cost of goods and product quality. Biopharmaceutical processes are 80% defined by the time of proof-of-concept studies (clinical trial stage 2b). This milestone is before the official technical transfer to commercialization or manufacturing organizations and almost always before the environmental evaluation of a production process. This step is…

Navigating the Logistics of Local Biomanufacturing

    As much as one-third of the world’s population lacks access to essential medicines, and in the poorest regions of Africa and Asia, this figure rises to one-half (1). Along with other organizations, Medicins sans Frontieres (MSF, Doctors Without Borders) advocate for a combination of global and regional policies to lower drug prices sustainably, including local drug manufacturing. At this year’s annual meeting of the Biotechnology Industry Organization (BIO), during a session on building vaccine capacity in developing countries,…

Single-Use Technology

Single-use technology began on the downstream side of bioprocessing, primarily in presterilized filter capsules and plastic biocontainers for buffers and media. Since then, it has expanded to upstream operations, including disposable bioreactors and mixers. The newest trend is to move further downstream into sterile formulation and filling. With the increasing popularity of disposable systems, some users are wondering what is being done to standardize the various components from different manufacturers and what BPSA (the Bio-Process Systems Alliance) is doing to…

Using Innovation to Drive Competitive Advantage

    Figure 1: () STOCKXPERT (WWW.STOCKXPERT.COM) After spending decades as the “sleepy” segment of the biopharmaceutical industry, vaccines are now seen as one of its highest growth segments. Major pharmaceutical companies — Novartis AG (www.novartis.com) and Pfizer, Inc. (www.pfizer.com), for example — are aggressively entering this area. Those already in it are expanding capacity and increasing business development activity. Indeed, access to the vaccines business was a major driver of Pfizer’s acquisition of Wyeth Pharmaceuticals (www.wyeth.com) (1). Several factors…

Environmental Life-Cycle Assessment of Disposable Bioreactors

    Disposable technology for bioprocessing is efficient and cost effective in many product development scenarios. For an industry dedicated to improving human health, however, the environmental contributions of a product must also influence its bottom line. Product transitions evaluated within a people/planet/profit framework require assessment regarding shifts in human and environmental impact. Life-cycle assessment (LCA) offers one perspective by evaluating the environmental loading of inputs and outputs to a product or process. The contribution of individual product life-cycle stages…

A Prescriptive Approach to Management of Solid Waste from Single-Use Systems

    In biopharmaceutical manufacturing, the disposal of solid waste from single-use systems is becoming an increasingly important issue. The new focus is driven by several major factors including a broadening range of disposable technologies enabling, in some cases, the installation of completely disposable multistage systems; improved scalability of single-use components offering production capacities to thousands of liters; and the environmental impact of waste disposal. The latter concern includes not only regulatory and cost constraints, but also the need for…

Environmental Impact of Single-Use and Reusable Bioprocess Systems

    Bioprocess manufacturing systems have incorporated single-use/disposable components for more than 50 years and have demonstrated well-defined process benefits from their use (1,2,3,4,5,6). The environmental impact of single-use technologies, however, has been a major focus of attention only in recent years. This evolving interest has been driven by many factors including concerns over environmental change, emissions, and energy supplies; rapidly increasing costs and restrictions on waste disposal; greater recognition of the role of disposables in bioprocessing; and availability of…

Single-Use Technologies and Other Key Drivers in Biomanufacturing

      The biomanufacturing industry has issues. From key drivers and hurdles, to the spectre of leachables legislation and the need for greater harmonization between suppliers, the biotech sector is experiencing a period of growing competition and increasing pressure. But, it is also a market with a future; the commercial success of more than 350 approved biologics has prompted the biotechnology industry to accelerate discoveries in further protein-based therapeutics, placing greater emphasis upon the importance of biomanufacturing. In addition,…

Supplier Innovation is an Imperative

    As organizations begin their annual budgeting meetings, the question will inevitably arise: How can we reduce costs and still retain or improve our quality? For some, the answer to the first part may seem easy, but to have a packaged improvement plan that includes both aspects appears to be more indefinable. So what can the biopharm industry do to counter these daily pressures? The answer may not be as elusive as you think. Companies need to drive innovation…