1. IMARC. Biologics market: global industry trends, share, size, growth, opportunity and forecast 2023-2028. 2022.
2. Formulation and process development strategies for manufacturing biopharmaceuticals;Laird,2013
3. FDA. Code of federal regulations Title 21 3.2(e). Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-3/subpart-A/section-3.2#p-3.2(e). Accessed April 7,2023.
4. Design control considerations for biologic-device combination products;Anderson;Adv Drug Deliv Rev,2017
5. Development of prefilled syringe combination products for biologics;Dimitrova;Challenges Protein Product Dev,2018