Alejandra Gallegos
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Research Subjects
Alejandra Gallegos has a total of 12 co-authors. Here are the top co-authors by number of shared publications:
- Yasser Nashed-Samuel
Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA
2 shared publications David Semin
Amgen Inc, Attribute Sci, One Amgen Ctr Dr, Thousand Oaks, CA 91320 USA
1 shared publication- Hans Lee
Los Angeles Trade-Technical College
1 shared publication Jian Liu
Amgen Inc, Attribute Sci, One Amgen Ctr Dr, Thousand Oaks, CA 91320 USA
1 shared publication- Jian Liu
Attribute Sciences, Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320, USA
1 shared publication Kim Li
Amgen Inc, Environm Hlth Safety & Sustainabil, One Amgen Ctr Dr, Thousand Oaks, CA 91320 USA
1 shared publication
Latest Publications
- 5 March 2022
- Published by Elsevier in Journal of Pharmaceutical Sciences
- Vol. 111 (6) , 1599-1604
Recommendation of Single Time Point Leachables Testing for Lyophilized Biotechnology Products Stored in Rubber Stoppered Glass Vial Systems
- 5 March 2022
- Published by Elsevier in Journal of Pharmaceutical Sciences
- Vol. 111 (6) , 1599-1604
Recommendation of Single Time Point Leachables Testing for Lyophilized Biotechnology Products Stored in Rubber Stoppered Glass Vial Systems
- 16 July 2020
- Published by Parenteral Drug Association, Inc. in PDA Journal of Pharmaceutical Science and Technology
- Vol. 74 (6) , 627-643
Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
Glass prefilled syringes (PFS) are a container and delivery device of choice for storing and administering therapeutic protein products to patients. Addressing concerns and regulatory expectations related to the risk to biologic drug product quality and patient safety from PFS requires implementation of an extractable and leachable program based on understanding of materials, risk assessment, review of existing literature and testing based on a sound scientific foundation. Extractables and leachables data generated as part of thorough and holistic program are presented for 5 PFS systems, including glass and plastic syringes, and 12 biologic drug products encompassing the implementation of traditional and single-use biotechnology manufacturing processes. The comprehensive extractables and leachables data presented demonstrate and substantiate a holistic extractable and leachable program designed to ensure product quality and patient safety.
- 16 July 2020
- Published by Parenteral Drug Association, Inc. in PDA Journal of Pharmaceutical Science and Technology
- Vol. 74 (6) , 627-643
Holistic Extractables and Leachables Program: Evaluations of Prefilled Syringe Systems for Biotechnology Products
Glass prefilled syringes (PFS) are a container and delivery device of choice for storing and administering therapeutic protein products to patients. Addressing concerns and regulatory expectations related to the risk to biologic drug product quality and patient safety from PFS requires implementation of an extractable and leachable program based on understanding of materials, risk assessment, review of existing literature and testing based on a sound scientific foundation. Extractables and leachables data generated as part of thorough and holistic program are presented for 5 PFS systems, including glass and plastic syringes, and 12 biologic drug products encompassing the implementation of traditional and single-use biotechnology manufacturing processes. The comprehensive extractables and leachables data presented demonstrate and substantiate a holistic extractable and leachable program designed to ensure product quality and patient safety.