August 2013

Optimizing Your Media

Figure 1:  For more than 65 years, Kerry’s Sheffield brand has earned its reputation for reliability and excellence in serving the biotech, pharmaceutical, and nutrition markets. We deliver innovative, animal-component– free supplements to help customers increase cell proliferation, extend cell viability, and increase target protein production. Every day we expand our capabilities to meet the changing needs of the biotech market by providing the industry’s most innovative and extensive biotechnologies, including complete supplement systems, hydrolyzed proteins, recombinant proteins, and yeast…

From Bench Scale to Industrial Scale

Adherent cell processes for production of adenoviruses often involve 2D vessels that require many manual operations and large areas of cleanroom space, or microcarrier cultures that require complex cell transfer steps and a very high level of expertise. To maximize surface area within a compact space, Integrity® iCELLis® bioreactors contain macrocarriers trapped in a fixed-bed, providing ≤500 m2 of 3D growth surface area in only 25 L of fixed-bed. The iCELLis technology can be used at small scales (iCELLis nano…

Scale Up on Efficiency in Biologics Contract Manufacturing

Wacker Biotech is a dedicated contract manufacturer of biopharmaceuticals with over 20 years of experience in microbial systems. Our customers benefit from a comprehensive service for the development of robust and highly efficient production processes and GMP-compliant manufacturing for clinical trials and commercial supply. Service Wacker Biotech’s services cover the whole process chain: from construction and optimization of host/vector systems to delivery of the bulk API. A well-equipped quality control department supports characterization of master and working cell banks and…

Development, Qualification, and Application of Single-Use Technologies for Bioprocessing

In the manufacture of biopharmaceuticals, single-use technologies are now employed throughout the workflow — from buffer and media preparation to bioreactor cultures for vaccines and biotherapeutics production as well as in the storage of those intermediates and bulk biologics. This diversity of applications adds to the difficulty in establishing appropriate testing and requirement specifications, as well as qualification and validation approaches. The integrity and performance of single-use systems depends primarily on the characteristics of the film, the largest component (and…

Avid Bioservices

Avid Bioservices is your CMO partner offering a suite of fully integrated, comprehensive biomanufacturing services that support the development and cGMP production of clinical and commercial-stage monoclonal antibodies, recombinant proteins, and enzymes. Our client’s success is our main focus. With over 15 years of experience, Avid provides services that support every phase of development: cell line optimization, process development, analytical methods development, clinical and commercial cGMP manufacturing, and regulatory support. As the wholly owned subsidiary of Peregrine Pharmaceuticals, a clinical-stage…

Enhancing Efficiency and Economics in Process Development and Manufacturing of Biotherapeutics

Analytical techniques that measure protein quantity and quality are used in nearly all stages of research, process development and manufacturing of biotherapeutics. Biopharmaceutical companies have enthusiastically adopted Pall ForteBio’s Octet systems due to their broad utility in protein quantitation and functional characterization combined with no need for labels, real-time monitoring, enhanced throughput, decreased sample preparation requirements, and low cost of operation. Concentration Measurement The Octet platform uses ForteBio’s proprietary Biolayer Interferometry (BLI) technology to measure concentration in 96-well and 384-well…

An Integrated Filtration System for Harvest of Small-Scale Bioreactors

Parker domnick hunter’s HarvestClear™ Filtration System is a complete, out-of-the-box filtration system that provides automated clarification of small-scale bioreactor outputs while maximizing filtration performance. The HarvestClear™ System allows for walk-away cell-culture harvest, reducing hands-on time and increasing operator safety without filter blockage. Summary The clarification of batch and fed-batch bioreactor systems can pose a practical challenge to biopharmaceutical manufacturers because of high cell densities in cell culture process streams. The HarvestClear™ Filtration System provides an easy solution for clarifying 1–20…

A Profile of Bosch Packaging Technology

Bosch Packaging Technology has been supplying the pharmaceutical industry with final fill solutions for over 30 years. During that time, Bosch has continued to focus on quality and industry-leading customer-focused solutions that provide the best return on investment over time. Filling Systems Bosch is the premier supplier of final fill–finish solutions to the pharmaceutical industry. As a single-source supplier with the industry’s widest portfolio of solutions, Bosch can supply the type and scale of equipment you require. We offer systems…

Supporting Biopharmaceutical Development and Manufacturing

As the pharmaceutical industry continues to accelerate its focus on developing biological drugs derived using cell culture processes, the ability to accurately monitor osmolality throughout each phase of development, production, and finished product quality control (QC) becomes increasingly important. Osmolality is arguably one of the most important physical parameters to monitor in mammalian cell cultures because of its fundamental implications to the growth, viability, yield, and the close relationship between cells and media. Freezing point osmometers are considered the gold-standard…

Scale-Up of Adherent Vero Cells Grown on Cytodex™ Microcarriers Using WAVE Bioreactor™ Systems

Traditionally, cell-based vaccine production is performed using stainless steel bioreactors that require extensive cleaning procedures. Because disposable bioreactor systems have no need for cleaning and validation, they can significantly reduce start-up times for good manufacturing practice (GMP) manufacturing of cell-based vaccines (1). Although they are susceptible to a broad range of viruses, Vero cells were recently successfully used for industrial-scale influenza vaccine production (2,3,4). However, these adherent cells can proliferate only when provided with a suitable surface on which to…