In the rush to market, be aware of these critical missteps that can occur during the early development phases, in order to avoid major challenges later during commercial API scale-up.
Over the life of a drug, changes in raw materials are almost inevitable. But even a small modification can throw your drug out of compliance. Using case studies, the author explains how to safeguard drug integrity when raw materials change.
Whether biopharmaceutical companies have one candidate or 100, the directive is clear: moving quickly into FIH testing is essential. But, how?
By checking the pulse of your organization, you can identify gaps and develop a plan for how to address them, so you can make the right decisions at the right time.
Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing.
To address the ongoing public health crisis related to opioid abuse, Xtampza ER, an oral ER abuse-deterrent formulation of oxycodone, has been developed to resist the ability of abusers to tamper with the product and alter the route of administration.
Joe Principe, Vice President of Strategic Partnerships, Patheon, discusses the new set of “must-haves” that are emerging from the increased need for flexibility in outsourced manufacturing partnerships.
Single-use technologies are being seen as the solution to flexibly and cost-effectively address many of the challenges around creating biologics manufacturing capacity.
Pharmaceutical manufacturer and developer, Penn Pharma, has confirmed that its new contained manufacturing facility for producing highly potent products is on track for opening Q1 2013 at an exclusive event held at the British Embassy, Madrid during ICSE.
Piramal Pharma Solutions is the contract development and manufacturing (CDMO) arm of Piramal Enterprises Ltd. with a vast network of development and manufacturing facilities in North America,Europe and Asia. We offer a vast array of services, which include Drug Discovery & Development, Clinical Supply of API & Dosage Forms, Commercial Manufacturing & Supply of API, KSMs, RSMs, Intermediates and Finished Dosage Forms. At Piramal, we are committed to fulfil our clients’ API development & manufacturing requirements, across all phases of the drug life cycle.
Piramal Pharma Solutions is the contract development and manufacturing (CDMO) arm of Piramal Enterprises Ltd with a vast network of development and manufacturing facilities located in North America, Europe and Asia.
Piramal Pharma Solutions is the contract development and manufacturing (CDMO) arm of Piramal Enterprises Ltd., having a vast network of development and manufacturing facilities located in North America, Europe and Asia.