August 2013

Optimizing Conditions for Using Sartobind® STIC Pico and Sartobind® STIC Nano on Liquid Chromatography Systems

Table 1:&#8 Sartobind® STIC Pico and Sartobind® STIC Nano are the smallest scalable representatives of the Sartobind® STIC membrane adsorber family. STIC is a salt-tolerant anion-exchange membrane effective at removing contaminants in buffers containing up to 200 mM NaCl, saving time and reducing costs by avoiding buffer changes. The small size and high throughput of these capsules make them perfect for use on automated chromatography systems such as the popular ÄKTA® series offered by GE Biosciences. Although both Pico and…

Rapidly Translating Novel Vaccine Concepts into the Clinic

CRM197 is a nontoxic mutant of diphtheria toxin containing a single amino-acid substitution of glutamic acid for glycine. CRM197 is a well-characterized carrier protein used in a number of approved and highly successful conjugate vaccines including Pfizer’s Prevnar® pneumococcal vaccine, a multibillion-dollar franchise; HibTiter® (Haemophilus influenzae b) vaccine, and Novartis’ Menveo® meningococcal vaccine. Traditionally, CRM197 is produced by fermentation of a Corynebacterium diphtheriae C7 (β197) tox (–) strain, which secretes it into the culture supernatant. It is then recovered after…

Fujifilm Diosynth Biotechnologies

One of the major bottlenecks in the production of biopharmaceuticals is the efficient expression of therapeutic proteins in microbial or mammalian cells. The Escherichia coli pAVEway™ expression system described here has been developed to ensure high product titers and efficient scale up to GMP manufacture while minimizing many common issues seen in other expression systems, such as “leaky” expression (expression of recombinant protein in the absence of inducer). How It Works The use of a number of powerful E. coli…

Purification of Oligonucleotides on TOYOPEARL GigaCap® Q-650S

TOYOPEARL GigaCap Q-650S high capacity, high resolution anion-exchange resin for process scale applications was recently introduced by Tosoh Corporation. This resin, with dynamic binding capacities (DBCs) approaching 190 g/L for bovine serum albumin (BSA), is the newest member of the TOYOPEARL® product line. TOYOPEARL GigaCap Q-650S maintains the high capacity of our popular TOYOPEARL GigaCap Q-650M, and the 35 µm particle size provides high resolution for improved separation of process impurities and aggregates. Introduction The purification of oligonucleotides using anion…

High-Performance Biopharmaceuticals Manufacturing

Identifying the most appropriate contract manufacturer that is most likely the best match for your lead pharmaceutical candidate is a true challenge. Rentschler is a biopharmaceutical manufacturer with over 35 years proven track record. Focused on mammalian cell lines, our experience covers the development, production, and aseptic filling of recombinant proteins such as cytokines, enzymes, monoclonal antibodies, and fusion proteins in compliance with international GMP standards (EMA/FDA). We don’t just claim to be reliable and experienced; our many successful projects…

More Functionality, Lower Costs, Better Usability with the Arc System

Figure 1:  Figure 1:  When planning a modern 750-L fermentation plant including a cross-flow unit, the GEA Diessel company was looking for the best available measurement technology suited for its customer requirements. Attention turned to the new intelligent Arc sensors from Hamilton. After testing the Arc system, the plant engineer and GEA’s customer were convinced of the advantages of the new technology, deciding to use the Arc system in the fermentation plant. GEA Diessel and Hamilton were able to supply…

Separation of Monoclonal IgG and Its Aggregates Using TOYOPEARL MX-Trp-650M

The importance of proper aggregate removal during polishing of a monoclonal antibody (MAb) for therapeutic use is beyond controversy. Severe anaphylactic reactions have been described in the literature for the application of aggregated proteins as a drug byproduct. Traditionally, ion-exchange chromatography (IEX) or hydrophobic-interaction chromatography (HIC) are used to purify a structurally homogeneous product. In case those platforms do not satisfy the requirements for MAb polishing, advanced chromatography resins need to be considered. For instance, mixed-mode stationary phases such as…

Biopharmaceutical Development and GMP Manufacturing

Richter-Helm has more than 25 years of experience in the development and good manufacturing practice (GMP)-compliant production of a wide range of biopharmaceuticals, including recombinant proteins (e.g., cytokines, growth factors, antibody fragments, surface antigens) plasmid DNA microbial vaccines (e.g., attenuated whole cell vaccines). Customized Solutions Richter-Helm offers customized solutions for all steps in biopharmaceutical projects through contract development and manufacturing services featuring Development of production strains (Escherichia coli, Pichia) Establishment of MCB/WCB Development of fermentation (1 to 1,500 L) and…

Labfors 5 with LabCIP

Table 1:&#8 The need for a rapid turn-around in quantity (and the loss of technicians in many laboratories) has created a trend toward single-use vessels. Their advantages include no time lost in cleaning or sterilization (especially for bench-scale, autoclavable systems), no chance of inhibition or cross-contamination due to poor cleaning, and no need for cleaning and sterilisation facilities in a crowded laboratory. For production-scale steel bioreactors, fully automated clean-in-place (CIP) and sterilization-in-place (SIP) has been possible for decades. By contrast,…

Large-Scale Expansion of Hepatic Progenitor Cells

Cell therapy is offering a promising future in medical advances. Although multilayer trays are suitable for R&D and preclinical cell amplification, they cannot support large-scale industrial production. A successful transition from laboratory scale to an efficient and robust process based on good manufacturing practice (GMP) is key. The Integrity® Xpansion™ multiplate bioreactors have been specifically designed to enable an easy transfer from existing multiple-tray stacks processes by offering the same cell growth environment on two-dimensional (2D) hydrophylized polystyrene (PS) plates…