Contract Pharma: What led to PCS’ decision to enter development-stage outsourcing?
Michael Kosko: That decision was really driven by our customers. They are seeking vendors who can enter strategic partnerships across the entire product life cycle. The extensive platform within Pfizer Global Supply (PGS) and Pfizer’s Product and Process Development (PPD) organization makes it a great fit.
CP: How does that business model differ from PCS’ commercial-stage focus?
MK: The expansion into services allows Pfizer CentreSource (PCS) to support a partner early on during the development process and minimizes the need for multiple partners and potential technical transfer between companies and sites. This model will rely heavily on establishing stronger working relationships with customers as activities will progress over a much longer timeline, and success will be dependent on stronger communication and coordination between both parties across multiple disciplines.
CP: What’s the client base look like? Are you seeing more interest from other large pharmas/biopharmas or smaller, specialty companies and virtual/emerging companies?
MK: The existing customer base for PCS covers all segments: major pharmas, secondary tier, specialty, generic and virtual companies. Extending our service offering has been well received across both our existing and potential customer base. While my initial assumption was that we would have more interest from smaller and virtual companies, the interest from larger companies who understand our value proposition has been strong.
CP: How do you assure clients that internal work for Pfizer won’t disrupt their projects?
MK: Once an agreement is in place, the customer’s product is considered on an equivalent basis to a Pfizer product. In the development stages, the volume of work ebbs and flows. Having multiple products on-going provides for efficiencies in our utilization of Resources .
CP: Are there other services that PCS is expanding into?
MK: PCS is expanding in service offerings to support earlier stage development work as well as commercial supply. Services include High Potent API Development and Manufacturing, Separation Sciences, Excipients Studies, Formulation Development, Product Enhancement as well as Cold Chain Distribution.
CP: Are there other opportunities that have opened up in the post-Wyeth integration?
MK: After the integration, one of the areas we are most excited about is the ability to offer Contract Manufacturing services in the microbially expressed therapeutic proteins out of Pfizer’s Strängnäs (Sweden) facility. The site happens to be one of the pioneering “biotech” manufacturing sites, having been active in this space for over 30 years. The new “Bio 7” facility at Strängnäs is one of the most modern, well engineered, and operationally efficient in the industry, demonstrated by their being awarded a Facility-of-the-Year Award from ISPE. We continue to analyze other capabilities that are consistent with the PCS Business Model.