Biotech quality

MEHTA R A, CASSOL T, LI N, HANDA A K and MATTOO A K (2002) Engineered polyamine accmnnlation in tomato enhances phytonutrient content, juice quality and vine life . Nature Biotech, 20, 613-18. 

Taylor CR. Quality assurance and standardization in immunohistochemistry. A proposal for the annual meeting of the Biological Stain Commission. Biotech. Histochem. 1992 67 110-117. 

After years of struggling to raise money for biotech companies, I have concluded that every private deal must have a lead investor. The "lead" is the individual (and his firm) whose commitment persuades other investors to participate. Some combination of two qualities designate the lead investor (1) recognized expertise and success in the field which makes the deal credible and (2) sufficient financial commitment to the deal to get it done without most of the other investors. 

Over the past 40 years, capillary electrophoresis (CE) has advanced significantly as a technique for biomolecular characterization. It has not only passed the transition from a laboratory curiosity to a mature instrumental-based method for micro-scale separation, but also emerged as an indispensable tool in the biotech and pharmaceutical industries. CE has become a method of choice in research and development (R D) for molecular characterization, and in quality control (QC) for the release of the therapeutic biomolecules.In the biopharmaceutical industry, more and more CE methods have been validated to meet International Conference on Harmonization (ICH) requirements. In this chapter, we present real industrial examples to demonstrate the role of CE in R D of pharmaceutical products. The focus in this chapter is on method development analytical control for manufacturing and release of therapeutic proteins and antibodies. 

The following points describe lessons learned from over a decade of experience with CE method development, qualification, and transfer to quality labs in the biotech and pharmaceutical industries. These lessons may be beneficial to other companies on their journey to implement CE methods for characterization and release of therapeutic products. 

Nicholson, S., Patricia M. Danzon, and Geoffrey McCullough. 2002. Biotech-Pharmaceutical Alliances as a Signal of Asset and Firm Quality. National Bureau of Economic Research Working Paper 9007. 

Peppi MC, Fidelibus MW, Dokoozlian NK. 2007. Application timing and concentration of abscisic acid affect the quality of Redglobe grapes. J Hort Sci Biotech 82 304-310. 

In this new era, three basic strategies can be pursued the introduction of new and more efficient products, innovation in crop seeds with new biotech traits, or commoditization. Only the leading companies will be able to pursue more than one option. Whichever strategic model they adopt, successful agribusiness players will continue to deploy their strengths to increase plant yield through plant protection applications, improved seed quality, and approaches to targeting consumer value. 

The traditional audit may still be useful in that it leads one in the direction of identifying a faulty system or process, and if one chooses one can go further. Using the innovative approach offered by the quality assessment has some limitations in that it is not the current approach used during pharmaceutical and biotech inspections. Mock FDA audits should be used on a routine basis to ensure employees communication skills are sharpened and that the facility is inspection-ready. Preparation for an FDA inspection should begin during product development. It is a continuous process of the QAP, which the company should implement as early as phase I. No amount of resources in the last weeks before an inspection can make up for lack of adequate planning and preparation. 

Use the executive management review aspect of the quality system regulation as a quality guidepost within the pharmaceutical and biotech industries. 

By integrating information and developing tools for the use of European food allergy scientists, health professionals, food and biotech industries, and consumers it is Europrevall s hope that causes of food allergy can become better understood, diagnosis of food allergy can become swifter and the quality of life of food allergy sufferers improved. 

Eckart MR, Bussineau CM. Quality and authenticity of heterologous proteins synthesized in yeast. Curr Opin Biotech 1996 7 525-30. 

US FDA. ICH Q5C Quality of Biotechnological Products Stability Testing of Biotech nological/Biological Products. 1996. 

Q4 Q5A Pharmacopoeial Harmonisation Quality of Biotechnological Products Viral safety Evaluation of Biotech- CPMP/ICH/295/95 Step 5... 

Frank Wicks, Pres., Research Specialties Essentials David Smoller, Pres., Research Biotech Steve Walton, VP-Quality Safety Jai Nagarkatti, Chmn. 

It is not unreasonable to extend this analysis and conclude that the quality of research is not significantly different within the top 20 companies. An important observation from this is that Biotechs, if you look at... 

As a result, electronic document and records management systems (ERMS) are becoming more and more essential in this environment in order to handle the volume of data and related documents as well as to verify the quality and the integrity of the data for FDA auditors. ERMS have become critical for research and development in the biotech and pharmaceutical industry to the extent that the FDA created... 

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