August 2013

E. coli Cultivation in a 12L and 120L CELL-tainer™ Single-Use Bioreactor

Although single-use bioreactors are widely applied in the biopharmaceutical industry, microbial cultivation in them is restricted due to limitations in oxygen mass transfer, mixing, and heat transfer. The CELL-tainer™ single-use bioreactor makes use of an innovative principle applying a two-dimensional (2D) rocking motion, thus providing excellent mass transfer, making this single-use reactor very suitable for microbial cultivation at different scales. With a simple pillow-shaped bag without moving parts, the technology is robust and leads to cost savings compared with other…

Affinity Chromatography Applications with Single-Domain Antibodies

Figure 1:  Current downstream processing strategies for recombinant proteins often require multiple chromatographic steps, which may lead to poor overall product yields. Product purification can be especially difficult when a target protein displays reduced stability, has isoforms or misprocessed variants, or needs to be purified from a complex mixture containing a high level of impurities. Through highly specific antibody–antigen based interactions, affinity chromatography brings significant technical advantage to these protein purification challenges. Developed to tackle such challenges, CaptureSelect™ technology is…

Bio on Demand

NNE Pharmaplan has developed a new facility concept called Bio on demand™, which enable facilities to be established in one to two years. The result is a flexible facility that is fully operational and locally compliant, with functioning quality systems. Bio on demand™ involves a high degree of single-use technology to ensure cost-effective production and fast establishment. Facilities based on our Bio on demand™ concept can be delivered globally, but they are primarily intended for growth markets where time to…

Bioprocess Specialists All Under One Roof

Setting its sights on the benefits to the customer, Eppendorf has steadily expanded its proven bioprocess technology portfolio since 2007. With the integration of New Brunswick™ and DASGIP®, Eppendorf combines its own expertise with the know-how of these renowned suppliers of bioreactors to set new benchmarks. For industrial and research users, this translates into sophisticated bioprocess software and hardware solutions from a single source that covers the full range from miniature bioreactor systems for R&D to production-scale, sterilize-in-place systems. The…

KANEKA KanCapA™

Protein A chromatography is still the preferred capture step in monoclonal antibody (MAb) production because of its high selectivity and robustness, although cation-exchange (CEX) or multimode chromatography techniques are claimed as alternatives. KANEKA KanCapA increases the value of protein A affinity chromatography for MAb production. Kaneka’s unique combination of a proprietary-designed alkaline stable protein A ligand and a highly cross-linked cellulose base matrix meets customer requirements for improved performance, high binding capacity, alkaline and chemical stability for cleaning in place…

Technology Transfer to a Contract Development and Manufacturing Organization (CDMO)

Technology transfer (TT), the transfer of technical know-how from a product sponsor company to a contract development and manufacturing organization (CDMO), is the cornerstone of a fruitful working relationship between the parties. It is critical for successful advancement of the sponsor’s product development and commercialization efforts. Having worked with more than 100 clients over 14 years, PCT has performed nearly as many TT programs, underscored by the key success factors listed below. Communication: Upon establishing a collaborative sponsor– CDMO staff…

Cultivation of CHO Suspension Cells and SEAP Expression in the Finesse Glass Bioreactor

This application note describes the cultivation of Chinese hamster ovary (CHO) suspension cells in the Finesse SmartGlass vessel bioreactor with a maximum working volume of 2.0 L. Using chemically defined minimal media, cell densities of up to 7.44 × 106 cells/mL were achieved. Recombinant secreted embryonic alkaline phosphatase (SEAP) expression was induced by medium exchange and temperature shift. Maximum SEAP activities of up to 63 U/mL were reached. A novel stirred glass bioreactor suitable for cell culture applications at benchtop…

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…