Formulation and Drug Product (DP) Development
This workstream shares cutting-edge science to enable immediate changes to formulation and drug product strategies. We are building understanding of formulation challenges across the industry.
Delayed submissions, approvals and development timelines
This workstream focuses late-stage / commercial development strategies to ensure the robust delivery of safe and efficacious drug product. Industry may not always be consistent or up to date with draft guidance, regulatory expectations or emerging trends. If data addressing these areas is not provided it can delay submissions. Similarly, development timelines may be delayed if requirements are not built in as new guidance is published. Differences in approach may expose companies to greater regulatory scrutiny.
Providing industry alignment
This workstream provides industry alignment based on a shared understanding of requirements for formulation strategies through benchmarking and knowledge sharing. It aims to identify and mitigate any risks (including regulatory), identify studies to support in-use compatibility, understand the type of data required to support Biologics Licensing Agreements (BLA); and apply Quality by Design (QbD) principles.
Members are addressing gaps around new technologies and reducing approval or development delays. The workstream is establishing industry alignment for recent regulatory questions/feedback and takes a proactive position, providing advanced warning of shifting requirements in this area.
Formulation and Drug Product (DP) Development deliverables
More related workstreams
Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.
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