Dr. Helen Baker, Director of Formulation Design, and Dr. Richard Castledine, Head of Drug Substance Operations, contribute to Pharmaceutical Technology's issue, 'Poor API Quality Threatens a Healthy Supply'.
The API is, one might say, the most important element in a pharmaceutical product. Poor API quality may often lead to delays in production and a shortage of supply.
Dr. Castledine emphasizes that poor quality API presents several risks to the drug product, supply chain, and ultimately patients, ranging from a lack of efficacy to the possibility of toxicity.
Dr. Baker explains how more drugs than ever are now classed as highly potent, discussing how HPAPIs present additional CMC challenges due to the containment requirements to protect both the operators and manufacturing facilities.
Read the full article on Pharmaceutical Technology's website here.