Pharmaceutical Technology May 2017

May 2017 | Volume 2017 eBook, Issue 1
Pharmaceutical Technology’s 2017 Biologics and Sterile Drug Manufacturing eBook
Effective cleanroom disinfection programs require extensive testing and evaluation processes. A three-step process can help ensure that the cleanroom environment will satisfy regulatory requirements and be safe for biopharmaceutical manufacturing.
Samsung BioLogics’ aggressive growth strategy begs the question: Are there lessons that US and European pharma might still learn from the electronics industry?
The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.
The existing, obsolete highpurity water generation system and water-forinjection generation system were replaced with new, reliable technologies.
Prefilled dual-chamber cartridges offer several advantages. Several steps should be taken to determine if a dual-chamber system is viable for a lyophilized injectable drug product.
Good project management, budgeting, planning, and clear documentation are the only ways to prevent overruns and project failure.
A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.
The complex packaging and logistics required for personalized medicine pose significant challenges, but proactive planning can help ensure success.
Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.
Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.
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