Supply Chain

Recommendations for Cell Banks Used in GXP Assays

Cells and cell-derived reagents form the basis of an operationally challenging class of test methods used in execution of product potency testing (stability and lot release), assessments of pharmacokinetic/ pharmacodynamic (PK/PD) profiles, detection of antidrug antibodies (ADAs) or neutralizing antibodies (NAB), and characterization and comparability testing of biopharmaceutical products. Frequently, cell-based assays provide the only measurement of the tertiary/quaternary structure of each batch of product at the time of lot release and during stability testing to assist in determining product…

Make Innovation Sourcing a Business Strategy

A recent study published by CAPS Research (the research arm of the Institute of Supply Management), underscores the importance of organizations adopting external innovation rather than relying solely on their internal research and development (R&D) efforts. Some companies set goals to increase revenues by adopting external innovation. Procter & Gamble, for instance, wanted to attain 50% of its revenues through external innovations — that is, licensing technologies — over five years (1). A joint project from CAPS Research with Western…

Glass Delamination and Breakage

    Although glass is widely considered to be the most traditional and cost-effective option for a parenteral drug container or delivery system, it may not always be the most economical or the best choice for certain products. With knowledge emerging about the suitability of materials in contact with drug products, it is time to look at alternatives that may offer a more appropriate choice and mitigate the risks associated with glass. As single-use technology finds its way into upstream…

Sustainability in Bioprocessing

    The concept of sustainability has evolved over the past few decades to describe conditions for harmonious coexistence of industry and nature while meeting socioeconomic requirements of present and future generations. For this environmentally focused report, I like the simple definition offered by Armstrong International, a provider of steam, air, and hot water systems that improve utility performance, lower energy consumption, and reduce environmental emissions. According to a brochure that in part describes its work with Pfizer, Armstrong defines…

A Framework for Selecting and Working with a Normal-Flow Filtration Supplier

The biopharmaceutical market accounts for about 20% of the total market for pharmaceuticals, but its share continues to increase because of double-digit compound annual growth rates leading to projections that by 2014 eight of the top 10 best-selling drugs will be biologics (1). The industry faces many challenges and opportunities, as Jim Davies of Lonza Biologics explained to me: “Biomanufacturers have to contend with what is at present a dynamic technical and commercial landscape. Industry consolidation continues to occur as…

NIR Spectroscopy Analysis of Phosphate Salts

Confirmation of raw material quality is a vital part of biopharmaceutical manufacturing processing. Incorrect or poor-quality vendor materials account for a considerable portion of failed and recalled product. To prevent these expensive problems, strict quality control (QC) procedures are often implemented and used to screen for inappropriate incoming materials. QC procedures commonly used are chemical tests that involve removing samples to a laboratory and performing, which can at times be complex, time-consuming, and laborious protocols. A common test procedure that…

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…

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…

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…