Industry Yearbook 2015-2016

Single-Use Tangential-Flow Filtration Can Save Five Hours of Facility Time

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).

Modern Resins for a MAb Platform Process

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).

POROS XQ: The Next Generation of Anion-Exchange Resin

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…

CaPure-HA™: DoE Optimization of Elution Conditions

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…

MAb Aggregate Removal Through Ion-Exchange Chromatography: In Bind/Elute and Flow-Through Mode with TOYOPEARL NH2-750F

A polishing step for the purification of a monoclonal antibody (MAb) using TOYOPEARL NH2-750F was developed. In general, anion-exchange resins can be used in bind and elute (B/E) mode as well as in flow- through (FT) mode. Both options were evaluated. To increase the amount of aggregates of the test sample, a MAb was aggregated by acidic incubation and subsequently diluted to 1 g/L in loading buffer. Read the full text of this application note in the PDF (Login required).

Avid Bioservices Adds a New State-of-the-Art Biomanufacturing Facility

In July 2015, Avid Bioservices debuted its new state-of-the-art biomanufacturing facility in Tustin, CA. Designed to be one of the first US late phase 3 and commercial production facilities for the exclusive operation of single- use equipment to produce biologics, the 40,000-ft2 build-out of an industrial 110,000-ft2 warehouse provides the perfect setting to install state-of-the-art modular cleanroom bioproduction suites. This new facility incorporates the relatively recent concept of converting an existing building in to a new bioproduction facility, known as…

ThawSTAR™ Automated Cell-Thawing System: Breakthrough Adaptive Sensing Technology for Reproducible, Standardized Cell Thawing

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…

Producing Value with Boehringer Ingelheim BioXcellence™

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…

Cobra Biologics Expertise, Experience, and Excellence

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…