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Demands on a drug’s synthetic processes naturally evolve during its lifecycle. Scouting alternative methods for synthesizing active pharmaceutical ingredients (APIs) early in process development — before they are needed by changing…
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…
Rise of the Peptide Era Peptide synthesis has a long pharmaceutical history, stretching back to the early 1900s – and then followed by a lengthy period of dormancy….
The first in the class of drugs known as selective relaxant binding agents (SRBA), Sugammadex sodium is used to reverse anesthesia. Via 1:1 binding of rocuronium or vecuronium, it rapidly…
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…
Since generic drugs are – on average – 20 to 90% cheaper than innovator drugs (or NCEs), the market for generics has grown considerably in recent years as a means…
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…
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…
