Introducing the Alba^® Primary Packaging Platform. Part 1: Particle Release Evaluation

Reference

1. 1.↵
   1. Ciociola A. A.,
   2. Cohen L. B.,
   3. Kulkarni P.,
   4. Kefalas C.,
   5. Buchman A.,
   6. Burke C.

   ; FDA-Related Matters Committee of the American College of Gastroenterology. How Drugs are Developed and Approved by the FDA: Current Process and Future Directions. Am. J. Gastroenterol. 2014, 109 (5), 620–623.

   OpenUrl
2. 2.↵
   1. Sittampalam G. S.,
   2. Coussens N. P.,
   3. Brimacombe K.,
   4. Grossman A.,
   5. Arkin M.,
   6. Auld D.,
   7. et al

   1. Strovel J.,
   2. Sittampalam S.,
   3. Coussens N. P.,
   4. Hughes M.,
   5. Inglese J.,
   6. Kurtz A.,
   7. et al

   . Early Drug Discovery and Development Guidelines: For Academic Researchers, Collaborators, and Start-up Companies. In Assay Guidance Manual [Internet], Sittampalam G. S., Coussens N. P., Brimacombe K., Grossman A., Arkin M., Auld D., et al., Eds.; Eli Lilly & Company and the National Center for Advancing Translational Sciences: Bethesda, MD, 2004. Accessed Nov. 13, 2017; available from: http://www.ncbi.nlm.nih.gov/books/NBK92015/.
3. 3.↵
   1. DiMasi J.

   New Drug Development in the United States from 1963 to 1999. Clin. Pharmacol. Ther. 2001, 69 (5), 286–296.

   OpenUrlCrossRefPubMedWeb of Science
4. 4.↵
   1. Randolph T. W.,
   2. Carpenter J. F.

   Engineering Challenges of Protein Formulations. AIChE J. 2007, 53 (8), 1902–1907.

   OpenUrl
5. 5.↵
   1. Lubiniecki A.,
   2. Volkin D. B.,
   3. Federici M.,
   4. Bond M. D.,
   5. Nedved M. L.,
   6. Hendricks L.,
   7. Mehndiratta P.,
   8. Bruner M.,
   9. Burman S.,
   10. Dalmonte P.,
   11. Kline J.,
   12. Ni A.,
   13. Panek M. E.,
   14. Pikounis B.,
   15. Powers G.,
   16. Vafa O.,
   17. Siegel R.

   Comparability Assessments of Process and Product Changes Made during Development of Two Different Monoclonal Antibodies. Biologicals 2011, 39 (1), 9–22.

   OpenUrlPubMed
6. 6.↵
   1. Sacha G. A.,
   2. Saffell-Clemmer W.,
   3. Abram K.,
   4. Akers M. J.

   Practical Fundamentals of Glass, Rubber, and Plastic Sterile Packaging Systems. Pharm. Dev. Technol. 2010, 15 (1), 6–34.

   OpenUrlPubMed
7. 7.↵
   1. Gerhardt A.,
   2. Nguyen B. H.,
   3. Lewus R.,
   4. Carpenter J. F.,
   5. Randolph T. W.

   Effect of the Siliconization Method on Particle Generation in a Monoclonal Antibody Formulation in Pre-filled Syringes. J. Pharm. Sci. 2015, 104 (5), 1601–1609.

   OpenUrl
8. 8.↵
   1. Ennis R. D.,
   2. Pritchard R.,
   3. Nakamura C.,
   4. Coulon M.,
   5. Yang T.,
   6. Visor G. C.,
   7. Lee W. A.

   Glass Vials for Small Volume Parenterals: Influence of Drug and Manufacturing Processes on Glass Delamination. Pharm. Dev. Technol. 2001, 6 (3), 393–405.

   OpenUrlPubMed
9. 9.↵
   1. Jiang Y.,
   2. Nashed-Samuel Y.,
   3. Li C.,
   4. Liu W.,
   5. Pollastrini J.,
   6. Mallard D.,
   7. Wen Z. Q.,
   8. Fujimori K.,
   9. Pallitto M.,
   10. Donahue L.,
   11. Chu G.,
   12. Torraca G.,
   13. Vance A.,
   14. Mire-Sluis T.,
   15. Freund E.,
   16. Davis J.,
   17. Narhi L.

   Tungsten-Induced Protein Aggregation: Solution Behavior. J. Pharm. Sci. 2009, 98 (12), 4695–4710.

   OpenUrlCrossRefPubMed
10. 10.↵
    1. Felsovalyi F.,
    2. Janvier S.,
    3. Jouffray S.,
    4. Soukiassian H.,
    5. Mangiagalli P.

    Silicone-Oil-Based Subvisible Particles: Their Detection, Interactions, and Regulation in Prefilled Container Closure Systems for Biopharmaceuticals. J. Pharm. Sci. 2012, 101 (12), 4569–4583.

    OpenUrlPubMed
11. 11.↵
    1. Bee J. S.,
    2. Randolph T. W.,
    3. Carpenter J. F.,
    4. Bishop S. M.,
    5. Dimitrova M. N.

    Effects of Surfaces and Leachables on the Stability of Biopharmaceuticals. J. Pharm. Sci. 2011, 100 (10), 4158–4170.

    OpenUrl
12. 12.↵
    1. Rauk A. P.,
    2. Griffiths K. L.,
    3. Gossage M. D.,
    4. Weiss W. F.

    Variability in Flow-Imaging Microscopy Measurements and Considerations for Biopharmaceutical Development. J. Pharm. Sci. 2016, 105 (11), 3296–3303.

    OpenUrl
13. 13.↵
    Research and Markets. Global Prefilled Syringes Market, Analysis & Forecast, 2017–2021 (Focus on Type, Design, Material both (Value & Volume) and Patent Landscape). https://www.researchandmarkets.com/research/43j73w/global_prefilled (accessed Nov 13, 2017), 2017; Available from: https://www.researchandmarkets.com/research/43j73w/global_prefilled.
14. 14.↵
    1. Zadbuke N.,
    2. Shahi S.,
    3. Gulecha B.,
    4. Padalkar A.,
    5. Thube M.

    Recent Trends and Future of Pharmaceutical Packaging Technology. J. Pharm. Bioallied Sci. 2013, 5 (2), 98.

    OpenUrl
15. 15.↵
    1. Gallo R.

    A Breakthrough Coating Technology for High-Demanding Drugs. 2018 PDA Glass Quality Conference, Washington, DC, January 23, 2018.
16. 16.↵
    1. Adler M.

    Challenges in the Development of Pre-filled Syringes for Biologics from a Formulation Scientist's Point of View. Am. Pharm. Rev. 2012, 15 (1), 96.

    OpenUrl
17. 17.↵
    1. Colas A.,
    2. Aguadisch L.

    Silicones in Pharmaceutical Applications. Chim. Nouv. 1997, 15 (58), 1779.

    OpenUrl
18. 18.↵
    1. Shi G. H.,
    2. Shinkle S. L.,
    3. Gopalrathnam G.,
    4. Dong X.,
    5. Hofer J. D.,
    6. Jensen E. C.,
    7. Rajagopalan N.

    Impact of Formulation Variables on Silicone Oil Distribution and Functionality of Prefilled Syringe System. PDA J. Pharm. Sci. Technol. 2017, 72 (1), 50–61.

    OpenUrl
19. 19.↵
    1. Thirumangalathu R.,
    2. Krishnan S.,
    3. Ricci M. S.,
    4. Brems D. N.,
    5. Randolph T. W.,
    6. Carpenter J. F.

    Silicone Oil- and Agitation-Induced Aggregation of a Monoclonal Antibody in Aqueous Solution. J. Pharm. Sci. 2009, 98 (9), 3167–3181.

    OpenUrlCrossRefPubMedWeb of Science
20. 20.↵
    1. Krayukhina E.,
    2. Tsumoto K.,
    3. Uchiyama S.,
    4. Fukui K.

    Effects of Syringe Material and Silicone Oil Lubrication on the Stability of Pharmaceutical Proteins. J. Pharm. Sci. 2015, 104 (2), 527–535.

    OpenUrlPubMed
21. 21.↵
    1. Teska B. M.,
    2. Brake J. M.,
    3. Tronto G. S.,
    4. Carpenter J. F.

    Aggregation and Particle Formation of Therapeutic Proteins in Contact with a Novel Fluoropolymer Surface versus Siliconized Surfaces: Effects of Agitation in Vials and in Prefilled Syringes. J. Pharm. Sci. 2016, 105 (7), 2053–2065.

    OpenUrl
22. 22.↵
    1. Funke S.,
    2. Matilainen J.,
    3. Nalenz H.,
    4. Bechtold-Peters K.,
    5. Mahler H.-C.,
    6. Friess W.

    Silicone Migration from Baked-on Silicone Layers. Particle Characterization in Placebo and Protein Solutions. J. Pharm. Sci. 2016, 105 (12), 3520–3531.

    OpenUrl
23. 23.↵
    1. Gerhardt A.,
    2. Mcgraw N. R.,
    3. Schwartz D. K.,
    4. Bee J. S.,
    5. Carpenter J. F.,
    6. Randolph T. W.

    Protein Aggregation and Particle Formation in Prefilled Glass Syringes. J. Pharm. Sci. 2014, 103 (6), 1601–1612.

    OpenUrl
24. 24.↵
    1. Jones L. S.,
    2. Kaufmann A.,
    3. Middaugh C. R.

    Silicone oil induced aggregation of proteins. J. Pharm. Sci. 2005, 94 (4), 918–927.

    OpenUrlCrossRefPubMed
25. 25.↵
    1. Depaz R. A.,
    2. Chevolleau T.,
    3. Jouffray S.,
    4. Narwal R.,
    5. Dimitrova M. N.

    Cross-Linked Silicone Coating: A Novel Prefilled Syringe Technology That Reduces Subvisible Particles and Maintains Compatibility with Biologics. J. Pharm. Sci. 2014, 103 (5), 1384–1393.

    OpenUrlPubMed
26. 26.↵
    Particulate Contamination: Sub-visible Particles (reference 04/2011: 20919). In European Pharmacopoeia, 9th ed. (official on January 2017).
27. 27.↵
    <788> Particulate matters in injection. In United States Pharmacopeia (USP) 40; United States Pharmacopeial Convention: Rockville, MD, 2017.
28. 28.↵
    <789> Particles in ophthalmic solutions. In United States Pharmacopeia (USP) 40; United States Pharmacopeial Convention: Rockville, MD, 2017.
29. 29.↵
    6.07. Insoluble Particulate Matter Test for Injections. In The Japanese Pharmacopoeia, 15th ed.; pp. 111–113.
30. 30.↵
    1. Bureau C.

    Method of Handling a Liquid Drug Formation. U.S. Patent 2016/0251261 A1, 2016.
31. 31.↵
    1. Sharma D. K.,
    2. King D.,
    3. Oma P.,
    4. Merchant C.

    Micro-Flow Imaging: Flow Microscopy Applied to Sub-visible Particulate Analysis in Protein Formulations. AAPS J. 2010, 12 (3), 455–464.

    OpenUrlPubMed
32. 32.↵
    ISO 4802-2:2010 Glassware—Hydrolytic resistance of the interior surfaces of glass containers— Part 2: Determination by flame spectrometry and classification, 2010–04; International Organization for Standardization: Geneva, Switzerland. https://www.iso.org/standard/50308.html.
33. 33.↵
    European Pharmacopoeia, 9^th Ed. (official on January 2017) Glass Containers for Pharmaceutical Use (reference 04/2015: 30201).
34. 34.↵
    ISO 2859-1:1999(E) Sampling procedures for inspection by attributes, 1999-11-15, International Organization for Standardization: Geneva, Switzerland. https://www.iso.org/standard/1141.html.
35. 35.↵
    ICH Guidelines. Available at: http://www.ich.org/products/guidelines.html. Accessed December 22, 2017.
36. 36.↵
    SADC guideline for stability testing. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ABOUT_ICH/Organisation/SADC/Guideline_for_Stability_Studies.pdf. Accessed December 22, 2017.
37. 37.↵
    ASTM F1980-07 (2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, 2011, ASTM International: West Conshohocken, PA. http://www.astm.org/cgi-bin/resolver.cgi?F1980-07 (2011).
38. 38.↵
    1. Carpenter J. F.,
    2. Randolph T. W.,
    3. Jiskoot W.,
    4. Crommelin D. J. A.,
    5. Russell Middaugh C.,
    6. Winter G.,
    7. Fan Y. X.,
    8. Kirshner S.,
    9. Verthelyi D.,
    10. Kozlowski S.,
    11. Clouse K. A.,
    12. Swann P. G.,
    13. Rosenberg A.,
    14. Cherney B.

    Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality. J. Pharm. Sci. 2009, 98 (4), 1201–1205.

    OpenUrlCrossRefPubMed
39. 39.↵
    1. Narhi L. O.,
    2. Schmit J.,
    3. Bechtold-Peters K.,
    4. Sharma D.

    Classification of Protein Aggregates. J. Pharm Sci. 2012, 101 (2), 493–498.

    OpenUrlCrossRefPubMed