181 related articles for article (PubMed ID: 35081407)
1. Stress Factors in Primary Packaging, Transportation and Handling of Protein Drug Products and Their Impact on Product Quality.
Narhi LO; Chou DK; Christian TR; Gibson S; Jagannathan B; Jiskoot W; Jordan S; Sreedhara A; Waxman L; Das TK
J Pharm Sci; 2022 Apr; 111(4):887-902. PubMed ID: 35081407
[TBL] [Abstract][Full Text] [Related]
2. Stress Factors in Protein Drug Product Manufacturing and Their Impact on Product Quality.
Das TK; Sreedhara A; Colandene JD; Chou DK; Filipe V; Grapentin C; Searles J; Christian TR; Narhi LO; Jiskoot W
J Pharm Sci; 2022 Apr; 111(4):868-886. PubMed ID: 34563537
[TBL] [Abstract][Full Text] [Related]
3. Introducing the Alba® Primary Packaging Platform. Part 2: Inorganic Extractables Evaluation.
Chillon A; Zuccato D
PDA J Pharm Sci Technol; 2019; 73(3):235-246. PubMed ID: 30651335
[TBL] [Abstract][Full Text] [Related]
4. Low Leachable Container System Consisting of a Polymer-Based Syringe with Chlorinated Isoprene Isobutene Rubber Plunger Stopper.
Kiminami H; Takeuchi K; Nakamura K; Abe Y; Lauwers P; Dierick W; Yoshino K; Suzuki S
PDA J Pharm Sci Technol; 2015; 69(6):713-24. PubMed ID: 26659102
[TBL] [Abstract][Full Text] [Related]
5. Introducing the Alba
Chillon A; Pace A; Zuccato D
PDA J Pharm Sci Technol; 2018; 72(4):382-392. PubMed ID: 29853611
[TBL] [Abstract][Full Text] [Related]
6. Non-destructive vacuum decay method for pre-filled syringe closure integrity testing compared with dye ingress testing and high-voltage leak detection.
Simonetti A; Amari F
PDA J Pharm Sci Technol; 2015; 69(1):108-22. PubMed ID: 25691719
[TBL] [Abstract][Full Text] [Related]
7. Recommendation of Single Time Point Leachables Testing for Lyophilized Biotechnology Products Stored in Rubber Stoppered Glass Vial Systems.
Gallegos A; Liu J; Ronk M; Qi L; Li K; Semin D; Nashed-Samuel Y
J Pharm Sci; 2022 Jun; 111(6):1599-1604. PubMed ID: 35257694
[TBL] [Abstract][Full Text] [Related]
8. Balancing Container Closure Integrity and Aesthetics for a Robust Aseptic or Sterile Vial Packaging System.
Oni Y; Song X; Schrader M; Kulshrestha A; Franck J; Asselta R; Flores-Crespo C; Mantri RV
PDA J Pharm Sci Technol; 2019; 73(6):572-587. PubMed ID: 31101708
[TBL] [Abstract][Full Text] [Related]
9. Evaluation of Container Closure System Integrity for Storage of Frozen Drug Products: Impact of Capping Force and Transportation.
Nieto A; Roehl H; Adler M; Mohl S
PDA J Pharm Sci Technol; 2018; 72(6):544-552. PubMed ID: 29853608
[TBL] [Abstract][Full Text] [Related]
10. Vapor-Phase Hydrogen Peroxide Uptake by Silicone Tubing and Primary Packaging Components during Protein Drug Product Aseptic Filling: Impact of Pretreatment and Sterilization Process.
Eisner DR; Hubbard A; Eppler K; Tegoulia V; Maa YF
PDA J Pharm Sci Technol; 2019; 73(5):443-458. PubMed ID: 31004039
[TBL] [Abstract][Full Text] [Related]
11. Novel Mechanism of Glass Delamination in Type 1A Borosilicate Vials Containing Frozen Protein Formulations.
Jiang G; Goss M; Li G; Jing W; Shen H; Fujimori K; Le L; Wong L; Wen ZQ; Nashed-Samuel Y; Riker K; Germansderfer A; Tsang P; Ricci M
PDA J Pharm Sci Technol; 2013; 67(4):323-35. PubMed ID: 23872443
[TBL] [Abstract][Full Text] [Related]
12. A strategy for the prevention of protein oxidation by drug product in polymer-based syringes.
Nakamura K; Abe Y; Kiminami H; Yamashita A; Iwasaki K; Suzuki S; Yoshino K; Dierick W; Constable K
PDA J Pharm Sci Technol; 2015; 69(1):88-95. PubMed ID: 25691717
[TBL] [Abstract][Full Text] [Related]
13. Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at -80 {degrees}C.
Zuleger B; Werner U; Kort A; Glowienka R; Wehnes E; Duncan D
PDA J Pharm Sci Technol; 2012; 66(5):453-65. PubMed ID: 23035029
[TBL] [Abstract][Full Text] [Related]
14. A Small-scale Model to Assess the Risk of Leachables from Single-use Bioprocess Containers through Protein Quality Characterization.
Xiao NJ; Medley CD; Shieh IC; Downing G; Pizarro S; Liu J; Patel AR
PDA J Pharm Sci Technol; 2016 11/12; 70(6):533-546. PubMed ID: 27325598
[TBL] [Abstract][Full Text] [Related]
15. A Holistic Approach of Extractables and Leachables Assessment of Rubber Stoppered Glass Vial Systems for Biotechnology Products.
Qi L; Liu J; Ronk M; Gallegos A; Fujimori K; Luo Y; Li K; Lee H; Nashed-Samuel Y
J Pharm Sci; 2021 Nov; 110(11):3580-3593. PubMed ID: 34324943
[TBL] [Abstract][Full Text] [Related]
16. Identification of an Oxidizing Leachable from a Clinical Syringe Rubber Stopper.
Schröter A; Peter S; Mahler HC; Zerr A; Danton O; Chalus P; Koulov AV; Huwyler J; Jahn M
J Pharm Sci; 2021 Oct; 110(10):3410-3417. PubMed ID: 34089713
[TBL] [Abstract][Full Text] [Related]
17. Impact of Ethylene Oxide Sterilization of Polymer-Based Prefilled Syringes on Chemical Degradation of a Model Therapeutic Protein During Storage.
Funatsu K; Kiminami H; Abe Y; Carpenter JF
J Pharm Sci; 2019 Jan; 108(1):770-774. PubMed ID: 30296419
[TBL] [Abstract][Full Text] [Related]
18. Development of an inductively coupled plasma mass spectrometry method for quantification of extracted tungsten from glass prefilled syringes used as a primary packaging for pharmaceutical and therapeutic protein products.
Fujimori K; Lee H; Phillips J; Nashed-Samuel Y
PDA J Pharm Sci Technol; 2013; 67(6):670-9. PubMed ID: 24265307
[TBL] [Abstract][Full Text] [Related]
19. Observation and Mitigation of Lamellar Silica Particles Formed in Pharmaceutical Products Packaged in Glass Vials.
Nashed-Samuel Y; Gastwirt J; Kotia RB; Moore S; Masatani P; Torraca G; Goss M; Dolan DG; Akers M; Padala C; Wypych J; Semin DJ
J Pharm Sci; 2022 Dec; 111(12):3275-3286. PubMed ID: 36116524
[TBL] [Abstract][Full Text] [Related]
20. Quality evaluation of radiographic contrast media in large-volume prefilled syringes and vials.
Sendo T; Hirakawa M; Yaginuma M; Aoyama T; Oishi R
Acad Radiol; 1998 Jun; 5(6):444-7. PubMed ID: 9615155
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]