July 2008

Take the Laboratory to the Sample: Implementing PAT with Miniature Modular Technology

Figure 1. The pharmaceutical industry has relied on laboratory testing for all of the past century. Typically, biopharmaceuticals are manufactured in batches and tested for quality using off-line laboratory test methods of samples extracted from the process line. However, taking the laboratory to the sample changes the way analyses are conducted. The FDA Guidance for industry, PAT: A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance, promulgated in final form in September 2004, encourages the use of available process…

Optimization for Biopharmaceutical Manufacturing

innovatis has established a technology portfolio to assist with the implementation of process analytical technology (PAT) at pharmaceutical companies focused on manufacturing biologics. PAT is a critical component in FDA’s initiative entitled, “Pharmaceutical CGMPs for the 21st Century: A Risk-Based approach,” which was announced in August 2002. This initiative is intended to support innovation and efficiency in pharmaceutical development, manufacturing and quality assurance. PAT is a system of building into processes “quality by design” (QbD), an idea that product quality…

Robust Small Virus Removal with Planova® Virus-Removal Filters: No Effect from Varying Virus-Spike Quality and Concentration in a Validation Model

Figure 1. A virus validation study is required for virus-removal filters prior to employing them in a biopharmaceutical purification process. Validation conditions are determined on a case-by-case basis by each filter user. Optimizing conditions for removal of parvovirus is important to achieve LRV = 4. However, the optimal conditions are often unclear for validation studies, because each product may behave differently. We attempt to establish optimal conditions for human IgG and show the effects of varying IgG concentration, purity of the virus…

Biopharmaceutical Product Development

Catalent Pharma Solutions offers a total solution for the development and manufacture of biopharmaceutical and sterile products. Our proprietary technology — and expertise in working with proteins, peptides and other biotechnology-derived active materials and small molecules — helps to maximize the potential of your API and accelerate your product’s speed to market. From cell line engineering to manufacture of API and Drug Product for clinical trials, our team of highly experienced protein chemists, biochemists, pharmacists and pharmaceutical scientists provide the…

Microfluidics Offers M-110P Microfluidizer® Processor

Microfluidics offers its M-110P Microfluidizer® processor, a benchtop laboratory machine that requires no compressed air or cooling water for hydraulics. Designed to operate reliably, quietly, and efficiently at up to 30,000 psi process pressures, the portable M-110P requires only a standard 20-amp, single-phase “household” electrical outlet and can easily be incorporated into any laboratory setting. Using Microfluidics’ fixed geometry diamond interaction chamber technology and ceramic plunger, the M-110P easily enables the production of nanosuspensions and nanoemulsions, as well as liposomal…

Team Up for Today’s Cell Culture Challenge: PD-Direct® BioProcess Services

Invitrogen has 45 years of experience in the cell culture business. Over this time, the Invitrogen name and reputation has made us the recognized leader in cell culture systems. In 2003, Invitrogen expanded on this tradition in innovative cell culture products through the creation of a team focused on process development, PD-Direct® BioProcess services. The PD-Direct team responds to core customer needs by offering customers comprehensive service from cell line and media development, to process optimization. Upstream Optimization Services The…

Specialists in Purification and Analysis

Figure 1. As a leading provider of process and analytical solutions for the biotechnology and pharmaceutical industries, Applied Biosystems offers an extensive portfolio of tools to help optimize every stage of biopharmaceutical production — from characterization to purification to pharmaceutical manufacturing. These solutions provide pharmaceutical manufacturers with the tools they require to maximize throughput and yield and ensure product quality. Purification High Performance on a Large Scale: Applied Biosystems POROS Perfusion Chromatography products are today’s best-performing chromatographic media for process-scale…

Providing Process Solutions for the Biopharmaceutical Industry Worldwide

Figure 1. Integrating production processes within a complete facility does not always lead to a costly execution and long time to market for end users. This is what a specialist company such as Boccard can offer thanks to its expertise in process design and construction of pharmaceutical GMP systems, and thanks to a different project implementation strategy that focuses on the client’s core business, production needs, and operating methodologies. Case Study: Alpha Biologics Facility Project in Malaysia Present in 20…

Advanced Scientifics’ Single Use Systems

Who Is Advanced Scientifics? Advanced Scientifics is an ISO 13485:2003, FDA registered global leader in the design and manufacture of single use systems for the Pharmaceutical and Biotech industries. Our vast array of manufacturing capabilities allows us to provide a custom disposable system in some of the industry’s shortest lead times. From system design, to the highest standard in quality production and assembly, to final packaging and sterilization, advanced Scientifics is your complete single use systems provider. Facilities Advanced Scientifics…

Genomic Innovation for Metabolic Engineering

Figure 1. Established in 1997, integrated Genomics (IG) provides a full range of products and services to support research in microbial genomics, metabolic analysis, and engineering. Our flagship genome analysis system, ERGO™, provides a bioinformatics toolkit enabling better and faster identification of gene function and pathways across organisms, which is evident within more than 100 scientific publications in top peer-reviewed journals (www.integratedgenomics.com/igpubs.html). The ERGO in silico metabolic discovery and analysis tool set is the world’s largest commercially available database of…