Using a case study, the author demonstrates how comparative statistical analysis enabled his team to improve the yield of a component used in API synthesis by more than 2.5 x 108 U/batch.
Understand the strategies which can be employed at the different stages of development when choosing parenteral dosage forms.
To take advantage of the growing HPAPI market, a company must have the proper controls in place to safely handle these potent compounds and successfully bring its drug to market.
Follow the paths of two companies as they learn how a science-led, risk-based development approach yields a more successful outcome in the long run.
Small and emerging companies face significant challenges in today’s market. This calls for an alternative solution to help them achieve success. One option is a single-source solution, which can eliminate the silos that can often exist in today’s outsourcing paradigm, increasing both communication and speed.
As pharma continues to evolve, the drive to pursue new cutting-edge drugs will become even greater. For those companies competing to push the boundaries of innovation, a fear of implementing QbD might end up being the biggest threat in its race to the finish.
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.
With Patheon OneSource™ you can combine your drug substance and drug product development and manufacturing into a single customized solution to simplify your supply chain and accelerate your discovery to proof of concept.
Access a remarkable range of conventional and specialized oral solid dosage form capabilities and scale. Further expand your options with innovative combinations of these forms and a variety of controlled-release technologies.
To be successful, new treatments require superior real world outcomes providing market differentiation and delivering the best outcomes to you, your stakeholders, and most importantly the patients who depend on your therapy.