Thursday, September 1, 2011 Daily Archives

Localized Surface Plasmon Resonance for Bioprocess Development, Manufacturing, and Validation

Vendor Voice in this preprint from our September 2011 issue, authors from Lamdagen describe a new label-free sensor platform for bioprocess development, monitoring, and validation during therapeutic antibody manufacture. The technology, referred to as localized surface plasmon resonance (LSPR), is made possible through the creation and use of nanostructured metallic films. The two areas most likely to benefit from this new technology are process development and monitoring and Quality Control. More effective process development efforts can lower costs of therapeutic…

Implementation of the ASTM Standard for Manufacturing Systems Verification

Example Documents Many companies use risk assessments, yet their test protocols remain bloated and cumbersome, with a focus on protocol adherence rather than verification of system functionality. In the September 2011 issue, Peter Watler introduces the ASTM E 2500-07 international industry consensus standard for conducting risk-based design and qualification of GMP manufacturing systems.It uses risk- and science-based practices to focus on critical aspects affecting equipment systems throughout their design-qualification-operation lifecycle.This moves the process from a rigid, protocol-enforced accumulation of documentation…

New Technologies to Meet the Challenge of Pandemic Influenza

    In the early spring of 2009, a new strain of H1N1 influenza emerged and swept across the globe more rapidly than vaccine producers could keep pace. By the time the pandemic abated in February 2010, the US Centers for Disease Control (CDC) estimated that between 8,500 and 17,600 Americans had died from H1N1 infection, with a disproportionate number of deaths occurring among healthy children and young adults. An estimated 15–25% of the nation’s population was exposed to the…

Implementation of the ASTM Standard for Manufacturing Systems Verification

In 2007, ASTM International (ASTM), formerly known as the American Society for Testing and Materials, published its “E2500-07” international industry consensus standard for conducting a risk-based design and qualification of good manufacturing practice (GMP) manufacturing systems (1). This guide incorporates risk- and science-based practices to focus on critical aspects affecting equipment systems throughout their design–qualification–operation lifecycle. Presentations at recent PDA and ISPE annual meetings indicate that the bioprocess industry is embracing E2500 to improve system designs and reduce costly validations.…

Pseudomonas fluorescens Expression Technology for Subunit Vaccine Production and Development

New methods and platforms for rapid development and production of effective subunit vaccines have become a 21st-century imperative. Not only is it important to rapidly express and produce a large number of antigens, but those antigens must be expressed and folded such that their effectiveness in preclinical studies is predictive of their potential effectiveness as vaccines. This task has created a bottleneck in vaccine development because recombinant protein expression is difficult and time-consuming, involving a large number of variables. Highly…

Uniting Small Molecule and Biologic Drug Perspectives

    Cosponsored by CASSS (an international separation science society) and the US Food and Drug Administration (FDA), the January 2010 CMC Strategy Forum explored antibody–drug conjugates (ADCs), which are monoclonal antibodies (MAbs) coupled to cytotoxic agents. The ADC platform of products is being used more and more for clinical evaluation in oncology. More than a dozen companies are developing several types, including products conjugated with calicheamicin, auristatins, and maytansinoids. Such products use the specificity of a MAb to deliver…

Trends and New Technology in Vaccine Manufacturing

Significant changes are sweeping the vaccine manufacturing industry. Demand for human vaccines is predicted to grow significantly — in part driven by needs in emerging countries, where only small fractions of their large and growing populations has access to vaccines. Sustained growth is expected to yield a vaccine market of US$25 billion by the year 2015 (1). Relatively low immunization rates in the Asia–Pacific regions represent significant untapped potential for vaccine manufacturers. Growing populations, increased government funding, and increasing personal…

Considerations in Scale-Up of Viral Vaccine Production

    On 28 June 2011, the Food and Agriculture Organization of the United Nations declared the Rinderpest cattle plague virus to be the second troublesome virus (after smallpox) that humans have eradicated from the Earth (1). Such achievements herald exciting times both for classical vaccinology and for many new and developing technologies. Here we consider scaling up of vaccines and related hybrid, targeted, and conjugated viral therapeutics that are made through animal cell culture. The vaccine industry is now…

Electroporation-Enhanced Delivery of DNA Vaccines

    Vaccines represent one of the most important medical developments in human history. As recently as a century ago, infectious diseases were the main cause of death worldwide, even in the most developed countries. For instance, the Spanish flu pandemic of 1918 killed more people than all the bullets and bombs did during World War I (1). Today, a vast range of vaccines are available to protect against more than two dozen infectious diseases, especially in pediatrics. Our society…

DNA Vaccine Technology

    Picture rows and rows of chicken eggs incubating not to hatch chickens, but to produce vaccines. With the exception of a few products on the market now, most vaccines are still made using this 50-year-old technology. Using chicken eggs to produce vaccines takes about half a year to complete and requires on average one to two eggs to make a single vaccine dose. It is inefficient, labor intensive, time consuming, and subject to contamination. The latter may be…