A significant paradigm shift is underway in the regulatory environment for impurities in pharmaceutical products. Recent incidents involving genotoxic impurities (GTIs) are driving tighter restrictions and guidelines, as well as…
Soluble drug APIs are now the exception, not the rule. An article at PharmTech by Felicity Thomas (Looking Beyond the Solubility Horizon) caught my eye recently as it discussed a…
With the global population continuing to both increase and age, pharma industry growth is likely to continue. While facing pricing hurdles in well-established mature markets, the emerging drug markets (China,…
In our PE Lab, a team of 27 highly specialized engineers integrates the key attributes of QbD process understanding, process control, and continuous improvement with advanced equipment, Design of Experiments…
Properties which can affect an API’s yield, delivery date and purity include: Type of Synthesis Propinquity Complexity of Structure Cost Efficient Synthesis Carryover of impurities into drug substance Minimum isolation…
In a PharmTech webcast, the Neuland team linked up with Dr. San Kiang – Research Professor from the Department of Chemical Engineering at Rutgers University. The objective was a discussion…
Synthetic route selection is a crucial element in API manufacturing. While the requirements of the synthetic process of a drug will naturally evolve during its life cycle, scouting alternate routes…
While linear drug scale-up sounds great on paper, the reality is usually much different. In fact, scaling up an API can be challenging even under the best circumstances. In fact,…
A couple of years ago, I published a post on 5 API Regulatory Challenges to Avoid, and it was interesting to look over the list and contemplate what updates I’d…
With technology racing onward, drugs are becoming more complex than ever before – along with their active ingredients and the processes that produce them. Different Challenges, Different Scales – The…
