New product introduction

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How to introduce new materials – one gate at a time

There are many challenges during drug substance supply in a biopharmaceutical new product introduction (NPI) process. Clinical supply programs are frequently subject to change and therefore supporting drug substance (active pharmaceutical ingredient, API) supply requirements can be extremely variable. Given this unpredictability, key supply issues can arise. In a worst-case scenario, the inability to deliver from any part of a new supply chain...

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Guidelines for materials introduction supporting drug substance delivery

A standard process map providing industry with a set of simple tools containing a structured approach for materials introduction across the supply chain. This paper summarizes a stepwise process that can be used as a guideline for introducing a material to support new drug substance manufacture and can be used in conjunction with detailed, company-specific NPI procedures. In addition it is relevant best practice for cell and gene therapy manufacturers.

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CGT considerations when assigning responsibilities during a product transfer between a sponsor and a contract development manufacturing organization

With over 1000 CGT developers worldwide, the FDA expects to approve 10-20 CGT products per year annually from the year 2025. Based on this information, there is an industry emphasis on streamlining the technology transfer process for new products into CDMOs. There are many considerations that are unique to CGT and if discussed early in the NPI process, could help reduce the risk of unplanned disruptions and align expectations in the early stages. This paper presents a common understanding and proposed ownership of these unique aspects, developed via a consensus of CGT sponsor (client) and CDMO participants in the Validation workstream of BioPhorum Cell and Gene Therapy. These recommendations could serve well as pre-established expectations or as an agenda for an NPI–kickoff meeting upon the initiation of a CGT sponsor CDMO relationship.They could also be used to support master supply agreement and quality agreement discussions.

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