August 2011

Anticipated Regulatory Changes Affecting Biopharmaceutical Testing

It is important to ensure that testing services meet applicable regulatory standards necessary to support investigational new drug (IND) applications, the clinical development life cycle, and commercialization. However, monitoring and — when possible — anticipating the ever-changing regulatory landscape is a challenge. Yet, the failure to do so can negatively affect both the cost and time needed to move a product from development through to commercialization. This article describes BioReliance’s position concerning anticipated regulatory changes over the next three to…

How Can You Improve Your BioProcess Efficiency by 40%?

          Biopharmaceutical companies generate a vast amount of high-value process data that are typically stored in paper records, data silos, and in the minds of key personnel. This represents valuable corporate knowledge that is often lost or ineffectively used. The manual transcription involved in recording process data necessitates high QA overheads and makes obtaining a holistic view of the processes problematic. It is both time-consuming and costly to support decision-making, root cause analysis, and continuous improvement.…

Sartopore® 2 XLM

Filters rated at 0.1 µm have been increasingly used for cell culture media filtration due to concerns about mycoplasma contamination of cell cultures. Sartorius Stedim Biotech has recently launched a new 0.1-µm, mycoplasma-retentive, sterilizing grade filter: Sartopore® 2 XLM. it is a heterogeneous, double-layer PES membrane filter with a highly asymmetric 0.2-µm prefilter layer in-built with the same 0.1 µm mycoplasma-retentive final membrane as its predecessor, Sartopore® 2 0.2/0.1. Sartopore® 2 0.1-µm. 10″ cartridges have been validated as mycoplasma-retentive by…

Bioprocess Reagents Made Better As cGMP

Both industrial and research scale protein purification require the development of superior procedures for increasing recovery yields. This places an emphasis on maintaining proteins in fully reduced states to solubilize inclusion bodies, while increasing the recovery of active proteins through improved protein-folding technologies. These concerns have a common theme: the ability to maintain the disulfide bonds in the protein in a sufficiently reduced state so as to facilitate correct folding while simultaneously avoiding protein aggregate formation. Dithiothreitol (DTT) is still…

Rational Culture Media Design™

          Irvine Scientific is committed to supporting the biopharmaceutical industry in the successful development and commercialization of biopharmaceutical products. A strong understanding of our media products is not the only basis for our successful supply, but the foundation of the innovation we provide to the market. Knowing innovation can result from the next big idea or an incremental change, we look for the small critical elements in our business that provide substantial process improvements and value…

Protein-Free Culture of Sf9 Cells

The development of insect cell culture production systems has produced opportunities for the expression of recombinant proteins for research and therapeutic applications in a non–mammalian cell culture environment. Various insect cell lines have been developed for the baculovirus expression vector system (BEVS). Development of stable transfected Drosophila and lepidopteran cell lines has offered a nonlytic culture for the production of recombinant proteins from insect cells. Spodoptera frugiperda Sf9 cells have been successfully adapted to suspension culture and have become an…

Protein Crystallization in Downstream Processes

Two decades of intensive development of novel expression systems for mammalian cells and microorganisms have led to a significant increase in fermentation titers in the biopharmaceutical production of proteins (more than 20 g/L in microbials and more than 4 g/L in mammalian cell culture). However, dynamic binding capacity of chromatography resins is often limited, and very large chromatography columns are needed to purify such large amounts of target proteins. New paths for cost-efficient purification are therefore needed, including downstream processing…

EcoPrime

LEWA developed its first pulseless pump for liquid chromatography in the late 1970s and delivered its first chromatography system in the early 1980s. LEWA is the leader in supplying pumps used for pilot and industrial HPlC, SMB, and lPlC chromatography worldwide. A customer came to us several years ago requesting a lowpressure liquid chromatography system with a flow range of 20 − 2,200 L/h. They also wanted the ability to achieve linear gradient from 1 to 99%. We designed and…

Vetter Development Service

          Vetter, a leading provider of aseptically prefilled drug-delivery systems, launched a new state-of-the-art facility at the Illinois Science + Technology Park in suburban Chicago. The site offers a central US location with a domestic and international airline hub. Moreover, it is uniquely situated in a thriving biopharmaceutical region that offers an established infrastructure, prominent research institutions, and a talent pool of 70,000–80,000 professionals. An expansion of Vetter Development Service, the Chicago site supports preclinical through…

Increase Efficiency and Accelerate Protein Workflows with the LabChip GXII

Vaccine engineering, antibody quality screening, and glycosylation profiling processes can generate large quantities of protein samples that must be analyzed in a timely manner. Generation of high-quality data and rapid, quantitative analyses are mandatory to determine next steps. Although still heavily relied upon, sodium dodecyle sulfate polyacrylamide gel electrophoresis (SDS-PAGE) is labor-intensive and only semiquantitative, and its throughput capacity is limited. Quantitative analysis techniques such as capillary electrophoresis (CE) and high-performance liquid chromatography (HPLC) do not provide the throughput necessary…