August 2013

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…

Understanding the Relationship of Bacterial Retention and Growth Media in Biopharmaceutical Processes

Background Tryptic soy broth (TSB) is a general-purpose medium used for cultivating numerous microorganisms including Serratia marcescens, a Gram-negative rod commonly found in water and involved in pharmaceutical contaminations (1, 2). This study examines the growth characteristics and bacterial retention of S. marcescens (ATCC #14756) in five types of TSB: EMD TSB (type 1), EMD Irradiated TSB (type 2), EMD Non-Animal Origin TSB (type 3), EMD Non-Animal Origin Irradiated TSB (type 4), and Competitor A TSB (type 5). Materials and…

Cobra Biologics

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. Experience For over 15 years, we…

Integrity Testing of Flexible 2D/3D Bags and Manifolds Using Helium Integrity Testing Platform (HIT™)

Switching to single-use systems can have financial and performance benefits. However, one critical challenge for complete acceptance of single-use systems is assurance of bag integrity — and in turn, product sterility and operator safety. The main risk with single-use technology is associated with leaks that can be induced by transport and handling (1). The second greatest concern regarding the use of disposables is bag breakage and related loss of production materials (2). Limitations of Pressure-Decay Testing Pressure decay is the…

Presenting Sustainable Fluid Handling

Picture the scene: You head to the boardroom for a meeting with a vendor who promises to optimize your company’s fluid-handling processes. “Sustainability,” he says, enshrined in the spotlight of an overhead projector, “is at the heart of today’s agenda.” You slump into your chair. Sustainability is key to your business, yet efforts to bottle this elusive ideal have so far cost more than they’ve saved. “How can a sustainable bioprocess container solution enhance my business?” you ask. “It’s about…

Enhanced Capture of a Recombinant Human Growth Factor Using Eshmuno® CPX Resin

Eshmuno® CPX resin is a new strong cation exchanger developed using EMD Millipore’s tentacle technology to provide high binding capacity, resolution, and target yield. For process improvement purposes, this resin was applied for capture of rhFGF18, a fibroblast growth factor (expressed in Escherichia coli) in phase 2 clinical development for restoring damaged cartilage surface in osteoarthritis. Early purification work used Resin A at low load (12.3 mg target/mL CV) and moderate flow rate (180 cm/h = 6.7 min residence time,…

Commercial Prefilled Syringe Filling

The commercial prefilled syringe line at Cook Pharmica can process up to 600 syringes per minute, 36,000 syringes per hour, or 70 million syringes per year. The automated, high-speed syringe line is fully enclosed in a barrier isolator to provide the highest level of aseptic processing available by removing the human element from the entire process. With the ability to operate in smaller batches or full-scale campaigning, the prefilled syringe line is capable of bridging clinical programs into commercial production.…