Yearbook 2015

With the E.coli|360-HCP assay, a second host-cell protein (HCP) assay based on the novel 360-HCP ELISA concept enters the market. 360-HCP ELISA integrates four different assay types. So a scientist can evaluate in no time which kit type performs best for a specific process. Read the full text of this application note in the PDF (Login required).

Development of a single drug, whether it is a new chemical entity, biotherapeutic, or genetic/cellular therapy, requires significant investment of resources. Care must be taken to choose analytical methods that are fit for the purpose of monitoring product and contaminants in the process. With expertise in labeling and detection, Enzo offers solutions to help rapidly analyze protein stability and integrity for all your bioprocessing needs. Read the full text of this application note in the PDF (Login required).

High productivity in bioprocess development demands efficient bioanalytical procedures to measure clone expression, product titer, and process impurities. Commonly used methods such as enzyme-linked immunosorbent assay (ELISA) or high-performance liquid chromatography (HPLC) can create bottlenecks in critical workflows due to limitations in throughput, performance, and time to results. Read the full text of this application note in the PDF (Login required).

Nova Biomedical is a technology company based in Waltham, MA, that provides state-of-the-art, automated cell-culture analyzers for the biopharmaceutical market. In 1998, Nova introduced the first line of chemistry analyzers for the biotechnology industry: the BioProfile® series. Nearly a decade later, Nova added the BioProfile Flex series featuring an expanded menu and real-time analysis of key metabolites, nutrients, and gases in cell culture media. In 2011, we announced the BioProfile CDV automated cell density/viability analyzer, which measures up to 80 million cells/mL and provides results in less than three minutes. Read the full text of this application note in the PDF (Login required).

Microbial quality control (QC) testing is a critical aspect of pharmaceutical, medical device, and personal‑care products manufacturing. Such tests typically include the following: Read the full text of this application note in the PDF (Login required).

Historically, single-use connections involved a male and a female half. These were two distinctly different parts that mated with each other. Genderless connections — those in which the connector halves are identical in design — bring multiple benefits to modular single-use systems. Read the full text of this application note in the PDF (Login required).

This application note describes a monoclonal antibody (MAb) purification process using the expanded MAb purification toolbox of GE Healthcare’s Life Sciences business, covering modern chromatography media (resins) for standard and challenging purification tasks. The most established approach for purifying MAbs is a three-step process, where the initial capture step using a protein A medium is followed by two polishing steps using cation- exchange (CIEX) and anion-exchange (AIEX) media (Figure 1a). However, for more challenging MAb purifications, an expanded MAb purification toolbox is beneficial. Here, a multimodal AIEX medium was used as an alternative in final polishing of a MAb with low monomer stability (Figure 1b). Using the described approach, the set criteria for the polishing steps were achieved, with a recovery of >90% over each step and an aggregate content <1% in the final product. Read the full text of this application note in the PDF (Login required).

Pall’s patented single-pass tangential-flow filtration (TFF) technology simplifies current TFF processes ( 1 ). It eliminates the conventional TFF recirculation, allowing an efficient single-pass operation without mixing or foaming issues and exposes the product to low shear, which optimizes the processing of fragile and shear-sensitive molecules. The single-pass feed flow rates are lower than those of conventional TFF, minimizing the hold-up volume and maximizing product recovery. It allows for higher final concentrations because processing limitations due to minimum working volumes are optimized ( 2 – 4 ). Read the full text of this application note in the PDF (Login required).

The new LEWA EcoPrime® LPLC chromatography platform combines proprietary fluid design and LEWA Intellidrive® technology to deliver unrivaled batch-to-batch reproducibility and accuracy. The new EcoPrime system features our open-architecture automation software and is built on a quality control of the industry’s most vertical supply chain. A single LEWA system has the range of up to three conventional LPLC units while providing higher accuracy. That gives users great flexibility, more floor space, and plant-friendly integration with simple software customization and updating. Read the full text of this application note in the PDF (Login required).

Strong anion-exchange (Q) chromatography is an industry standard for polishing purification steps of monoclonal antibody (MAb) production. It is a proven technology that removes viruses and host-cell proteins (HCP) from process feed streams in flow-through mode. NatriFlo HD-Q device adsorbers feature a hydrogel membrane, which combines high dynamic binding capacity and salt tolerance to deliver best-in-class performance. This makes it possible to rapidly process-large sample volumes using a small disposable device. This article examines the ability of NatriFlo HD-Q adsorbers to clear virus and HCP from partially purified (post–protein A) MAb solutions. Read the full text of this application note in the PDF (Login required).

In batch-mode chromatography, operating conditions do not allow full use of a media’s total capacity, leading to a subutilization of the media ( 1 , 2 ). Sequential multicolumn chromatography (SMCC) is an open-loop process for the separation of multicomponent mixture buffers ( 3 , 4 ). The concept behind SMCC is to perform different steps in smaller columns (from two to eight columns, compared with batch chromatography) connected in series, to maximize media use without product loss. BioSC® Lab is an automated system based on the SMCC process, designed and provided by Novasep. Read the full text of this application note in the PDF (Login required).

Single-use technologies can be applied to tangential-flow filtration (TFF) applications within bioprocessing. In such applications, they can reduce the need for utilities, reduce capital expenditure during early phases of drug development, increase processing flexibility during process design and operation, and limit product cross-contamination risks. Read the full text of this application note in the PDF (Login required).

Purolite is using new technologies to produce homogeneous beaded agarose for protein purification at large scale. Particle sizes range from 40 to 90 μm. The resins cover applications from capture to polishing and demonstrate improved pressure–flow properties (Figure 1). The porosity structure is optimized for medium-sized proteins such as monoclonal antibodies (MAbs). Read the full text of this application note in the PDF (Login required).

Specifically engineered to meet the requirements of large-scale bioreactors, OPUS® 45-cm and 60-cm columns match the performance of traditional self-packed columns while delivering the cost and labor savings expected from ready-to-use prepacked columns. Read the full text of this application note in the PDF (Login required).

POROS™ XQ is a next-generation strong anion- exchange resin with a fully quaternized amine surface chemistry. It was designed to retain all the beneficial performance attributes of POROS HQ resin, such as resolution capability, flow properties, and physical stability, with the added benefits of higher capacity and salt tolerance. Those were realized by optimizing the pore structure, which drives better access of biomolecules to the surface charge, and by optimizing the amount of surface charge (the ligand density) as measured by ionic capacity. Better access to a higher amount of ionic capacity increases dynamic binding capacity (DBC) and improves salt tolerance, because the resin can withstand higher amounts of counterion and still allow effective protein binding. Read the full text of this application note in the PDF (Login required).

Design of Experiments (DoE), also called experimental design, is a statistical approach to process development that has gained wide acceptance in the biopharmaceutical industry. DoE is used to reduce development costs by speeding up the design process and to optimize the parameters of a particular step in the manufacturing process. With its inherent ability to take into account multiple variables at once, a designed experiment is also used to minimize process variation leading to a more robust manufacturing process. Read the full text of this application note in the PDF (Login required).

Boehringer Ingelheim BioXcellence™ is your dedicated biopharmaceutical contract manufacturer. As a leading biopharmaceutical contract manufacturer with more than 35 years of experience, it has brought more than 20 biopharmaceutical products to market. Boehringer Ingelheim BioXcellence™ offers tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to fill and finish under one roof at its facilities in Biberach (Germany), Vienna (Austria), Fremont (USA), and Shanghai (China). Boehringer Ingelheim BioXcellence™ can secure product supply throughout the entire product life cycle transferring customer projects at any stage, delivering to almost any scale. Boehringer Ingelheim BioXcellence™ makes outsourcing easy. Read the full text of this application note in the PDF (Login required).

Advances in cryopreservation techniques have been crucial for the substantial progress achieved in many fields, including cell biology research, drug discovery, bio-banking, and assisted reproduction. While cryopreservation techniques have markedly improved, downstream cell thawing techniques have thus far been neglected, even though proper thawing of cryopreserved materials is essential for optimal cell viability. The success of high-promise fields such as cellular therapy and regenerative medicine require reproducible and standardized handling of the therapeutic cells, which includes thawing both during manufacturing and prior to patient administration, to ensure effective patient response. BioCision recognized cell thawing as a process that has been historically overlooked but is critical to the success of the overall process. Consequently, the company developed the ThawSTAR™ Automated Cell Thawing System – an instrument that senses the contents of each cryogenic vial and customizes a rapid thaw of the...

Expertise Cobra Biologics is a rapidly expanding international contract manufacturing organization (CMO) of biologics and pharmaceuticals for clinical and commercial supply. Cobra has three good manufacturing practice (GMP) approved facilities, each with expertise tailored to serving our customers across the world. We offer a broad range of integrated and stand- alone contract services, stretching from cell line and process development through to fill and finish for the supply of investigational medicinal products and commercial production. Read the full text of this application note in the PDF (Login required).

FUJIFILM Diosynth Biotechnologies is implementing the newest evolution of UV-vis spectroscopy. The simple- to-use SoloVPE system provides accurate concentration measurements in under a minute, whereas comparable UV methods may take over an hour. This difference translates into less time spent on cumbersome in-process testing and more time spent confidently making product. It can measure concentration without the need for dilution, which eliminates pipetting and mixing errors associated with sample preparation. Read the full text of this application note in the PDF (Login required).

Ensuring optimal and maximal T-cell production is critical for adoptive immunotherapy and its continued success. The Xuri Cell Expansion System is an important component of the clinical manufacturing process. So we sought to investigate the effect of rocking rate and angle on the expansion of T cells. We used a combination of experimental data and predictive modeling and found that the rocking rate significantly influences the expansion potential of T cells with minimal contribution from the rocking angle. The results indicate that a rocking rate of 15 rocks per minute (rpm) and an angle of 6° are optimal for a 1-L bioreactor to maximize cell growth using a Xuri Cell Expansion System. Read the full text of this application note in the PDF (Login required).

The road from conception to commercialization of a cell therapy is long, complex, and resource-intensive. To be successful, a cell therapy product must be manufactured to high quality standards using a robust, cost-effective process in a manner that will scale to meet demands and be sustainable over the commercial life of the product. Read the full text of this application note in the PDF (Login required).

With over 40 years’ experience, Rentschler is one of the industry leaders for contract development and manufacturing (CDMO) of biopharmaceuticals based on mammalian cell culture. Delivering successful projects allows us to make an essential contribution to the global availability of biopharmaceuticals. Rentschler is an owner-managed company headquartered in Germany and acts independently on a long-term basis. Performing at the highest standard, we lead our clients’ projects to success according to their needs and timelines, which helps enhance their competitiveness in the markets. Read the full text of this application note in the PDF (Login required).

Sandoz is one of the leading specialists in biotech development and manufacturing. Comprehensive know-how is based on more than two decades in microbial and mammalian cell culture production at commercial scale. Today Sandoz offers 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. Read the full text of this application note in the PDF (Login required).