Thursday, July 1, 2010 Daily Archives

Development and GMP Manufacturing of Biopharmaceuticals

With Richter-Helm BioLogics and Richter-Helm BioTec, over 20 years of experience in development and manufacturing of biopharmaceuticals and the innovative strength of high-performance teams are coupled with the solid foundation of the owner companies Gedeon Richter Plc. (Hungary) and HELM AG (Germany). Preclinical to Commercial Supply Richter-Helm BioLogics offers services for development and manufacturing of biopharmaceutical products from customers in the pharmaceutical and biotechnology industries. Richter-Helm BioLogics develops and produces recombinant proteins, plasmid DNA, and vaccines in microbial systems. Richter-Helm…

Biological Manufacturing

RecipharmCobra Biologics is the specialist biologics division of the Recipharm AB group, one of the leading contract development and manufacturing organisations in Europe. We provide a comprehensive range of services, from early-stage development to the supply of GMP material for Phase I, II, and III clinical trials. We are with you every step of the way. The Market Is Growing — So Are We We have provided contract development and manufacturing services to customers worldwide for more than a decade,…

Lancaster Labs Develops Extractables Database for LC/MS Analysis

The FDA has been focusing effort into evaluation of potential adulteration of drug products due to contact with packaging and closure systems, sample delivery devices, and components used in product manufacturing. Packaging includes components such as vials, caps, and stoppers. Drug delivery devices include nebulizers and inhalers. Components used during product manufacturing include filters, tubing, fittings, connectors, bioprocess bags, and bioreactors. Lancaster laboratories provides support by performing extractables and leachables testing. Extractables are compounds that can be extracted from a…

pDNA Production and Purification

In recent years, there has been a growing demand for DNA-based therapeutics, commonly known as gene therapy, to combat genetically-based pathologies. Because plasmid DNA have significantly different biophysical characteristics than proteins, their production can have a drastic impact on downstream purification unit operations. Join Dr. Stephen Palmieri and Dr. Jesse McCool of Lonza Biologics and Dr. Fred Blattner of Scarab Genomics as they take a detailed look at the challenges faced by pDNA manufacturers and how Lonza’s pDNA Production Platform addresses those challenges.