Biologic master file

The expression platform comprises a portfolio of glyco-optimized human suspension cell lines for tailor made glycosylation of recombinant proteins. The cells highly efficiently produce a broad range of difficult to express glycoproteins and provide authentic human post-translational modifications. More information: www. The proprietary information may only be cross-referenced, not accessed, by a partner.

The DMF has been around for a long time as a tool to support licensure of products. Recently, while researching DMF requirements for a client who manufactures cell culture media for biologic processes, I reviewed guidance documents and templates on the FDA website.

In response to my inquiries as to why and when the process changed, I learned that the process for MFs supporting biologics changed effective March 23, Before proceeding further, it is important for the reader to distinguish between historical requirements for the earliest biologic products e. For a new small molecule product being proposed for testing in the clinic or for marketing authorization under an NDA, it is absolutely appropriate to utilize the DMF for raw materials, starting materials, drug substance, drug substance intermediate, drug product, or packaging materials.

For a new biologic product being proposed for testing in the clinic, the FDA may allow the use of DMFs for drug substance, drug substance intermediate, or drug product.

For a new biologic product applying for marketing authorization under a BLA, the DMF may be utilized for raw materials, starting materials, and packaging materials, but not for drug substance, drug substance intermediate, or drug product, for reasons that will be discussed further below.

CDER still maintains oversight of these products and has worked hard to minimize the burden to sponsors of these products, including allowing the continued use of DMFs. A reader with more expertise in this area could certainly write an interesting and informative article on this aspect of the BPCIA alone. MFs and updates to MFs that are larger than 10 GB, as well as any submission that is not required to be submitted in eCTD format, can be submitted using the ESG or should be mailed on electronic media to the address below.

What Are Master Files? What Are Master Files for Devices?