Search results for " reliability"
Article
Breakthrough Drugs Raise Development and Production Challenges
For biologics, breakthrough designation may prompt greater focus on the reliability of the Phase I cell line, process and formulation, as shorter pivotal trials may truncate optimization of the Phase …
Article
Biopharma Advances Demand Specialized Expertise
Jun 15, 2015
By BioPharm International Editors
BioPharm International eBooks
Volume 28, Issue 13
Contract service providers share insights on biopharma market developments and the impl…
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
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
Relationship Building at Top of Mind for Clients
The ideal CMO
Results from the BioPlan study show that clients continue to seek better relationships with CMOs, and that reliability is a key trait they look for in their partners. Technical consid…
Article
Challenges in Analytical Method Development and Validation
Depending on the intended use of the method, typical performance criteria (accuracy, reliability, specificity, sensitivity, range, robustness/maintenance, as well as speed and throughput capacity, but…
Article
ReadyToProcess WAVE 25 Bioreactor System
The single-use ReadyToProcess WAVE 25 bioreactor system is a reliable and intuitive cell culture device for working volumes up to 25 L.
The system is based on a well-known rocking technology tha…
Article
Biosimilars Development and Supply: How Complex Can the Process Be?
The complexity of the manufacturing process can have an impact on the reliability of supply (8). Shortages of prescription medicines are a growing problem around the world. FDA defines “drug shortages…
Article
Reviewing the Importance of Biosimilarity and Interchangeability
Developing a robust and reliable strategy for analytical studies of a biosimilar in development is crucial for a successful regulatory pathway. The importance of biosimilar products is tied to…
Article
Introducing the VH3 ligand ELISA kit
Ensuring the safety and efficacy of antibody-based therapeutics is crucial in biotherapeutic manufacturing. Accurate testing for ligand leakage from affinity resins is a key part of this proce…