The use of gamma sterilized, pre-filled syringe plungers for Ready-to-Use primary packaging components
Historically, injectable drugs havemostly been packaged aseptically, with pharmaceutical laboratoriescarrying out the sterilization of the primary packaging components internally.
The conventional solution is for pharmaceutical laboratories to sterilize components before use, generally using steam.Yet, the...
High quality ophthalmic consumables at affordable prices to developing countries: An Aurolabs Case Study
Aurolab, the manufacturing division of Aravind Eye Hospital, at Madurai, Tamil Nadu that supplies high quality ophthalmic consumables at affordable prices to developing countries.
Though its primary focus is on ophthalmic industry, Aurolab is also...
Natural History of Diabetes
This editorial is a response to many and many requests to submit a paper on diabetes although I never treated diabetes except for a few subjects.
I treated many reversible pathological conditions by teaching a...
Innovative solutions to improve supply chain efficiency
Do you providecompanies with innovative solutions to improve supply chain efficiency?
In addition to our primary packaging for solid doses, unit dose packaging and secondary packaging services, we also provide integrated supply chain services, such...
FDA enforcement discretion: why delaying serialization implementation is a risky strategy
In June 2017, the FDA announced that it will delay the active enforcement of the Drug Supply Chain Security Act (DSCSA) for pharmaceutical manufacturers to November 2018 due to industry-wide concerns that many members...
Influenza Is Nothing to Sneeze At
The Zika virus is considered a major global health risk, as infection during pregnancy is associated with babies born with microcephaly. The 2014 Ebola outbreak in West Africa killed over 11,300...
Auditory Therapy, Ototoxicity and GLP Compliance Will the promising market for ear disorder treatments...
The numbers are daunting – 15% of the global population suffers from hearing loss, including a significant number of children, teenagers, and the elderly. Hearing loss presents a growing public health problem, due to...
Direct-to-Patient Solutions Assuring Patient Participation and Retention in Clinical Trials
The average cost of bringing a new drug to market is $2.6 billion, according to a 2014 report published by Tufts Center for the Study of Drug Development. This is a rise of 145%, adjusted...
Asia’s increasing levels of clinical trial industry competition are to your benefit
Biotechnology and pharmaceutical companies within the United States and Europe face an increasing number of hurdles when undertaking clinical trials within their own country or region; problems such as over saturated patient pools, difficulties meeting and maintaining enrollment numbers, increasing costs and...
Time for a Different Approach to Quality Systems in Biopharmaceutical Manufacturing
Despite the wide array of information systems available for biopharmaceutical manufacturing, we need to adopt a “follow-the-workflow” approach to overcome the process inefficiencies generated by quality and production silos.
For the better part of thirty...