INSIGHTS ON CONTRACT PHARMA MANUFACTURING

• Mitigate Risk By Conducting Filling Assessments During Formulation Development

  A small-sized pharmaceutical company had worked with a variety of other CMOs and had no success achieving the necessary product yields to advance the development of their highly cohesive product formulation. Read how they learned the importance of introducing filling studies during formulation development.

• How Extrusion-Spheronization Can Help To Control Delivery And Enhance Performance Of Complex Therapies

  In this blog, we explore why and how the technique of extrusion-spheronization offers pharmaceutical companies a robust, proven way to manufacture today’s most complex therapies. We also discuss the key considerations for drug developers who are looking to select a contract manufacturer as a partner to deliver this technique.

• How To Select An API Partner For Strategic Success

  A strategic partner should always seek ways to innovate and improve your compound or product’s value, and do it with the dedication of a partner, not a supplier. With the growing importance of contract services and plenty of providers, it is more critical than ever to make the right choice. Where do you start? Tom Wilson, Pfizer CentreOne’s Contract Manufacturing Lead shares his tips for picking the perfect API partner.

• The Value Of Expertise In Aseptic Fill Finish Manufacturing Of Biologics

  Aseptic fill finish manufacturing is one of the final but crucial steps between biopharmaceutical development and patient care. This process is especially critical for highly valuable biologic drug substances since, with vast amounts of time and resources invested upstream, any errors resulting in loss of product at such a late stage have the potential to be catastrophic. One way to mitigate the risk associated with aseptic fill finish manufacturing of biologics is to partner with a contract manufacturing organization (CMO) demonstrating proven expertise in all aspects of biologics production.

• Using Quality By Design For Process Development And Scale-Up Of A Novel ALS Drug Product

  Thermo Fisher’s stepwise approach to Quality by Design (QbD), an approach that drives consistent quality into manufacturing, became integral to the success of Amylyx's AMX-0035 campaign. 

• Technical Considerations For Developing Oral Solids (Part 2)

  What technical considerations should be at the forefront for your oral solids project? This two-part series features four oral solids experts from Pfizer CentreOne’s global network and partner organizations discussing the technical considerations to be aware of. In the second installment of the series, our experts consider the effects of equipment design and different tablet strategies.

• Technical Considerations For Developing Oral Solids (Part 1)

  Navigating your oral solids project from development through commercial manufacture can be a challenging path. In a two-part series, four oral solids experts from Pfizer CentreOne’s global network and partner organizations discuss the technical considerations to be aware of. In this first installment, we look at the importance of technical groundwork and understanding excipients in the early stages of your project.

• Small Molecule APIs: Aligning Drug Strategy With Partnering Strategy

  Development of novel small molecule APIs is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. 

• Tech Transfer And Scale-Up For Custom APIs Driven By A Collaborative Culture

  Technical expertise and access to state-of-the-art equipment and facilities are necessary but insufficient for successful completion of small molecule API technology transfer projects. CDMOs must have a collaborative culture that encourages open and transparent communication among internal team members, client representatives and other external partners.