Formulation of Recombinant Therapeutic Proteins

Dear Colleagues,

We are pleased to invite you to contribute to this Special Issue, entitled “Formulation of Recombinant Therapeutic Proteins,” a topic that has not been well reported; research in this area is direly needed in light of the criticality of these formulations in establishing the safety of these drugs and to assist their biosimilars in choosing an appropriate formulation. This choice is made available under the BPCIA.

(1) Introduction: Recombinant therapeutic proteins have emerged as a new category since the first approval of recombinant insulin in 1982; now, more than 100 products are approved, giving a broad understanding of their formulation that is critical to maintaining their immunogenicity. Developers typically do not fully disclose the formulations of injectable products to the public, as they are considered proprietary information or trade secrets. Developers submit detailed formulation data to regulatory authorities like the FDA or EMA during the drug approval process, but this information is not made publicly available in full detail. While summary documents like the FDA’s Drug Approval Packages may include high-level information, they rarely reveal complete formulations. Patents filed by developers to protect their products may disclose specific details about the composition, including excipients and stabilizers, which can be accessed through public patent databases. Additionally, scientific publications and conference proceedings sometimes provide general insights into a product's formulation, such as the role of excipients or stability mechanisms, though exact details are typically excluded. Drug labels and package inserts disclose some formulation components, including active ingredients, preservatives, and buffers, but proprietary details like concentrations or unique stabilizers are not included. For generic and biosimilar products, manufacturers often replicate the reference product's formulation as closely as possible, but regulatory filings rarely provide access to the complete details of the original formulation. In some instances, regulatory agencies may respond to Freedom of Information (FOI) requests, but proprietary information, including detailed formulations, are usually redacted to maintain confidentiality. In this Special Issue, we present articles discussing formulation technologies, their recent shift to buffer-free formulations, the cataloging of the safety of formulation compositions, and the intellectual property issues in developing biosimilar products.

(2) This Special Issue aims to provide deep analyses to assist in selecting appropriate formulations of recombinant therapeutic proteins to enable better safety profiles of new and biosimilar products.

(3) Suggested themes and article types for submissions include a summary of approved formulations, their classification, safety profile, and trends in the changes, such as the buffer-free formulations. The submissions can review articles and research papers that disclose novel formulations and analyze the intellectual property associated with these formulations.

I look forward to receiving your contributions.

Dr. Sarfaraz K. Niazi
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2900 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

• therapeutic proteins
• biosimilars
• formulation
• route of administration
• immunogenicity
• patents
• buffer-free formulations