Consortium formed to offer tailored CMC packages
Drawing on the respective strengths of the specialised companies allows the consortium to offer a portfolio of services generally associated with larger businesses and, according to the partners, offers advantages over bigger rivals.
Kim Black-Washington, director, marketing and strategic at Xcelience, told Outsourcing-Pharma that virtual and emerging pharmaceutical companies developing atypical compounds are underserved by current providers.
Fixed timelines and costs are unrealistic for these compounds, according to the consortium. Black-Washington believes they are better served by the Chemistry Playbook consortium’s bespoke developmental programmes that focus on client needs and programme execution.
The potential flaw in the consortium strategy is integration and communication. Larger, all-in-one chemistry, manufacturing and control (CMC) service providers often highlight how a single outsourcing partner can shorten timelines through close cooperation of in-house departments.
Chemistry Playbook has clearly considered this and Washington-Black believes systems are in place to ensure close cooperation between companies. For each client the consortium collectively creates a Gantt chart to define timelines, responsibilities and functional hand off.
This is accompanied by close communication between consortium project managers at each company. These individuals are already in contact with each other and communication will be maintained throughout a project using conference calls.
Washington-Black added that a client’s initial point of contact will depend of the service package they need. For companies without in-house CMC regulatory oversight Beckloff Associates would be the initial point of contact. In contrast, larger companies might not require Beckloff at all.
The consortium claims to cover drug development ‘from carbon to commercialisation’. Each partner has a different strength: Beckloff’s is CMC regulatory oversight; CML’s is API production; Avantium’s is solid state characterisation; and Xcelience’s is formulation development.
