Search results for " sterile"
Article
Modern Manufacturing Systems Key to FDA Quality Initiative
Such situations often result in critical drug shortages, particularly for low-cost sterile injectable products made by a limited number of generic-drug companies. FDA has been able to prevent and miti…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Mar 01, 2015
By Randi Hernandez
BioPharm International
Volume 3, Issue 28
Aggregation in biopharmaceuticals remains a major concern and threatens the stability of a product. Protein …
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
Pharma Investments Reflect Key Industry Trends
In October 2013, however, Teva opened a $100 million plant in Croatia that produces tablets, capsules, and sterile formulations for the European and US markets.
About the Author
Cynthia Challe…
Article
Gowning Practices Provide Clues to cGMP Compliance
Review gowning practices as a tool to evaluate cGMP compliance in a facility.
The foundation of any successful quality-assurance system is strict adherence to good manufacturing practices (GMP…
Article
Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Furthermore, the use of bioreactors ensures a closed, sterile, controlled environment, and thus the risk of potential impurities is reduced. As a result, Novartis’ Flucelvax vaccine does not contain a…
Article
Bioprocessing Advances in Vaccine Manufacture
Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.
The vaccine industry, particularly, in major Western markets, continues to be dominated by a few majo…
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical change management processes extend to the materials and services employed to manufacture and test drug products, necessitating the need for an effective supplier-initiated change …
Article
Operational Excellence: More Than Just Process Improvement
By embracing efficiency and quality, biopharmaceutical organizations can work better and achieve better work.
Life-sciences companies face more pressure than ever to reduce costs and increase eff…
Article
Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Report from the Lanzarote meeting May 13th – 17th, 2013
Yet another well-attended and successful Plasma Product Biotechnology (PPB) meeting has been held. The meeting focu…