Search results for " scale up" in Articles / App Notes

Article Technologies and Practices Must Evolve to Meet Demand
Purification, stability, scale up, and achieving adequate expression levels of product were the top challenges identified by manufacturers of nucleic-acid based drugs in the 2015 survey, similar to th…

Article Securing the Single-Use Supply Chain
Dual sourcing is one of many possible solutions to securing the supply chain. Single-use systems (SUS) have become established in biopharmaceutical drug development. As confidence in the technol…

Article Improving PAT for Biologics
The complexity of biopharma processes requires innovative solutions. Dec 01, 2014 By Cynthia Challener, PhD BioPharm International A key component of the quality-by-design (QbD) ap…

Article Continued Process Verification for Biopharma Manufacturing
The authors discuss complications of implementing continued process verification and provide recommended approaches. Oct 1, 2014 By: Jeff Fleming, Robin Payne BioPharm International …

Article Q&As with Industry Leaders
Discovering the unknown: How does in silico process development change PD scientists’ work? Jeanne Linke Northrop, BioPharm International Nora Ketterer, Manager, Modeling Services…

Article Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…

Article Brazil Emerges as Global Biopharm Collaborator
Brazil is the first Latin American country to emerge as a global biopharmaceutical collaborator. The pharmaceutical market in Brazil has been growing steadily and strongly in the past five ye…

Article 2014 Manufacturing Trends and Outlook
Single-use systems and other technologies drive process efficiencies, but there is room for improvement. In a recent survey of current trends and practices in biopharmaceutical manufacturing…

Article Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
A practical roadmap in three parts that applies scientific knowledge, risk analysis, experimental data, and process monitoring throughout the three phases of the process validation lifecycle. A…

Article Comparing Protein A Resins for Monoclonal Antibody Purification
A prototype Protein A resin is evaluated for purification performance, reusability, and cost performance. With greater economic pressure on monoclonal antibody (mAb) production for therapeutic …

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