July 2008

Rapid Profiling of Reduced and Intact Monoclonal Antibodies By LC/ESI-TOF MS

Figure 1. As the pharmaceutical industry focuses on developing biotechnology-derived drugs, bioanalytical groups must produce generic methodologies for antibody characterization with higher throughput and faster sample turnaround times. Although antibody selectivity varies, overall antibody structures are highly conserved. Intact antibody LC/MS analysis is useful for profiling glycovariants and C-terminal Lys processing, and even more information can be gleaned from analysis of a reduced antibody. UltraPerformance LC® (UPLC®) technology permits efficient desalting and rapid LC/MS mass profiling of an intact (4…

Accurate, Reproducible, and Standardized Cell Counting and Viability Analysis

Cell counting and viability assessment are routine but essential parts of bioprocessing procedures, and accuracy, reproducibility, and standardization are essential to successful outcomes. Traditional methods produce variable results because they rely on subjective discrimination of dye-stained cells using a hemacytometer and microscope. Substantial operator-to-operator variability in the cell counts is common, even when one researcher examines the same sample twice. Guava technologies offers a solution: a simple, accurate, and reproducible absolute cell counting and viability assay that overcomes many of…

A Platform for Purifying Pharmaceutical-Grade Plasmid DNA Using CIM® Monolithic Columns

Figure 1. CIM Convective interaction Media® are monolithic chromatographic supports used for purification of plasmid DNA, viruses, and other large biomolecules on a laboratory and industrial scale. CIM® monoliths are characterized by large flow-through channels (average diameter of 1,500 nm), which enhance the mass transfer between the mobile and stationary phase. This results in a high and flow-independent dynamic binding capacity and resolution. For plasmid DNA purification on an industrial level, these characteristics increase productivity, making CIM® monolithic columns attractive…

Boehringer Ingelheim: From Mind to Market Our Services in Biopharmaceutical Contract Development and Manufacturing

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 135 affiliates in 47 countries and nearly 39,800 employees. Since its foundation in 1885, the family-owned company has been committed to researching, developing, manufacturing, and marketing innovative products of high therapeutic value for human and veterinary medicine. Our therapeutic areas are respiratory, cardiovascular, central nervous system, urology, virology, rheumatology, metabolism, immunology, and oncology. Boehringer ingelheim is one of the…

Take the Laboratory to the Sample: Implementing PAT with Miniature Modular Technology

Figure 1. The pharmaceutical industry has relied on laboratory testing for all of the past century. Typically, biopharmaceuticals are manufactured in batches and tested for quality using off-line laboratory test methods of samples extracted from the process line. However, taking the laboratory to the sample changes the way analyses are conducted. The FDA Guidance for industry, PAT: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, promulgated in final form in September 2004, encourages the use of available process…

Optimization for Biopharmaceutical Manufacturing

innovatis has established a technology portfolio to assist with the implementation of process analytical technology (PAT) at pharmaceutical companies focused on manufacturing biologics. PAT is a critical component in FDA’s initiative entitled, “Pharmaceutical CGMPs for the 21st Century: A Risk-Based approach,” which was announced in August 2002. This initiative is intended to support innovation and efficiency in pharmaceutical development, manufacturing and quality assurance. PAT is a system of building into processes “quality by design” (QbD), an idea that product quality…

Robust Small Virus Removal with Planova® Virus-Removal Filters: No Effect from Varying Virus-Spike Quality and Concentration in a Validation Model

Figure 1. A virus validation study is required for virus-removal filters prior to employing them in a biopharmaceutical purification process. Validation conditions are determined on a case-by-case basis by each filter user. Optimizing conditions for removal of parvovirus is important to achieve LRV = 4. However, the optimal conditions are often unclear for validation studies, because each product may behave differently. We attempt to establish optimal conditions for human IgG and show the effects of varying IgG concentration, purity of the virus…

Biopharmaceutical Product Development

Catalent Pharma Solutions offers a total solution for the development and manufacture of biopharmaceutical and sterile products. Our proprietary technology — and expertise in working with proteins, peptides and other biotechnology-derived active materials and small molecules — helps to maximize the potential of your API and accelerate your product’s speed to market. From cell line engineering to manufacture of API and Drug Product for clinical trials, our team of highly experienced protein chemists, biochemists, pharmacists and pharmaceutical scientists provide the…

Microfluidics Offers M-110P Microfluidizer® Processor

Microfluidics offers its M-110P Microfluidizer® processor, a benchtop laboratory machine that requires no compressed air or cooling water for hydraulics. Designed to operate reliably, quietly, and efficiently at up to 30,000 psi process pressures, the portable M-110P requires only a standard 20-amp, single-phase “household” electrical outlet and can easily be incorporated into any laboratory setting. Using Microfluidics’ fixed geometry diamond interaction chamber technology and ceramic plunger, the M-110P easily enables the production of nanosuspensions and nanoemulsions, as well as liposomal…

Team Up for Today’s Cell Culture Challenge: PD-Direct® BioProcess Services

Invitrogen has 45 years of experience in the cell culture business. Over this time, the Invitrogen name and reputation has made us the recognized leader in cell culture systems. In 2003, Invitrogen expanded on this tradition in innovative cell culture products through the creation of a team focused on process development, PD-Direct® BioProcess services. The PD-Direct team responds to core customer needs by offering customers comprehensive service from cell line and media development, to process optimization. Upstream Optimization Services The…