August 2011

Experience Makes the Difference

BioPharma Solutions, a business unit of Baxter, partners with pharmaceutical companies to support your commercialization objectives by providing scientific expertise, sterile manufacturing solutions, parenteral delivery systems, and customized support services needed to meet the unique challenges that parenteral products face. Experience Makes the Difference: With 80 years of parenteral expertise, we can help to navigate the pathway of success for your molecule. As a dedicated CMO with over 20 years of experience devoted to our customers’ clinical and commercial success,…

Improved Capture with Better Productivity in MAb Bioprocessing

Growing commercial demand for therapeutic monoclonal antibodies (MAbs) has increased the need for efficient and cost-effective manufacturing processes. The development of cell cultures with very high expression levels is one clear example. over recent years, the antibody titers of mammalian cell culture have risen dramatically, and today we often see titers of 5–10 g/L. Expression levels as high as 15 g/L or greater have even been reported. Chromatography media (resins) that can capture these high-titer antibodies are therefore essential for…

OPUS™ Prepacked Chromatography Columns with CaptivA™ PriMab™ Protein A Resin Speed Time-to-Market

Repligen™ OPUS (open Platform User Specified) prepacked columns packed with CaptivA™ PriMab™ Protein A resin offer high performance and all the advantages of single-use technology (reduced validation effort, reduced risk, faster time-to market). What makes this solution truly unique, however, is that oPUS prepacked columns provide lower total cost of ownership in many applications compared with conventional stainless steel or glass columns. Single-Use Chromatography Study BioPharm Services ltd (Chesham, UK) conducted a study to assess the impact on total cost…

BD Recharge™

Peptones have a long history of use in cell culture media. However, increasing emphasis has been placed on growing cells in animal-free and chemically defined systems for the production of biopharmaceuticals. This has created a demand for cell culture media supplements that equal the performance of peptones but have greater certainty of composition. This demand prompted BD’s efforts to identify the functional components of yeast extract to develop a chemically defined supplement, BD recharge. Formulation The keys to making a…

Optimization of Conditions for Producing Influenza Virus in Cell Culture Using Single-Use Products

          Traditional influenza vaccine production uses fertilized hen eggs. This method is labor-intensive and requires large facilities with limited scalability. A switch to cellculture–based vaccine production methods and use of disposable products would provide flexibility to substantially reduce the time to vaccine clinical trials and approval, effectively decreasing the time-to-market. The aim of this work was to establish a process to propagate influenza virus in Vero cell culture using animal-component–free conditions for cell growth and disposable…

Sandoz: Provider of Customized Solutions in Biotech Manufacturing

Sandoz is one of the leading specialists in biotech development and manufacturing. Comprehensive know-how is based on more than wo decades in microbial and mammalian cell culture production at commercial scale. Today Sandoz offer a broad variety of integrated services including innovative expression systems, process development, scale-up, and production of recombinant products derived from microbial systems and mammalian cell culture in state-of-the-art facilities. Our expertise is based on numerous projects successfully erformed in collaboration with our customers. Currently, Sandoz is…

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…