Search results for " specification" in Articles / App Notes
Article
Optimization of Protein Expression in Escherichia Coli
May 01, 2015
By Siavash Bashiri, David Vikström, Nurzian Ismail
BioPharm International
Volume 28, Issue 5
Production of proteins for manufacturing therapeutics and pharmaceuticals is a c…
Article
Ensuring the Quality of Biologicals
The monographs are based on licensed specifications (for the drug substance or finished product) backed up by batch data.
Additionally, the Ph. Eur. monographs are supported by a large number of g…
Article
Tackling Analytical Method Development for ADCs
ICH, Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, (1999).
About the Author
Cynthia A. Challener, PhD, is a contributing editor to BioPh…
Article
Securing the Single-Use Supply Chain
Both methods may be acceptable depending on the end-user’s specifications.
The challenges of complexity and cost
There are numerous challenges when considering true dual sourcing, and many rel…
Article
Trends in Single-use Bioreactors
Establishing full traceability of raw materials, robust process controls, and meaningful specifications from the polymer resin to the finished bag is crucial. Another issue is related to high cell den…
Article
Challenges and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design.
Sep 1, 2014
By: Susan Haigney
BioPharm International
Volu…
Article
Applying GMPs to the BioPharma Supply Chain
Fit-for-purpose specifications
Suppliers must be open to working with end users to align material specifications. They need to help end users maximize the use of standard specifications and to min…
Article
Monoclonal Antibodies Key to Unlocking the Biosimilars Market
The biosimilars market, many analysts believe, is on the cusp of significant growth. This growth in large part is due to the fact that numerous monoclonal antibody (mAb) biosimilars are expect…
Article
Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
…s and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control (4).
…
Article
Implementing QbD in Sterile Manufacturing
Becoming familiar with a drug product´s frame and its limits through conducting numerous tech runs of varying versions allows one to define the product´s specification in which the process is running …