Skip to main content
  • Main menu
  • User menu
  • Search

Main menu

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore

User menu

  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart

Search

  • Advanced search
PDA Journal of Pharmaceutical Science and Technology
  • .
    • Visit PDA
    • PDA Letter
    • Technical Reports
    • news uPDATe
    • Bookstore
  • Register
  • Subscribe
  • My alerts
  • Log in
  • My Cart
PDA Journal of Pharmaceutical Science and Technology

Advanced Search

  • Home
  • Content
    • Current Issue
    • Past Issues
    • Accepted Articles
    • Email Alerts
    • RSS
    • Terms of Use
  • About PDA JPST
    • JPST Editors and Editorial Board
    • About/Vision/Mission
    • Paper of the Year
  • Author & Reviewer Resources
    • Author Resources / Submit
    • Reviewer Resources
  • JPST Access and Subscriptions
    • PDA Members
    • Institutional Subscriptions
    • Nonmember Access
  • Support
    • Join PDA
    • Contact
    • Feedback
    • Advertising
    • CiteTrack
  • Follow pda on Twitter
  • Visit PDA on LinkedIn
  • Visit pda on Facebook
Research ArticleResearch

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

Alberto Chillon, Arianna Pace and Daniele Zuccato
PDA Journal of Pharmaceutical Science and Technology July 2018, 72 (4) 382-392; DOI: https://doi.org/10.5731/pdajpst.2018.008623
Alberto Chillon
SGLab Advanced Technology, Nuova Ompi s.r.l., Piombino Dese, Italy
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • For correspondence: alberto.chillon@stevanatogroup.com
Arianna Pace
SGLab Advanced Technology, Nuova Ompi s.r.l., Piombino Dese, Italy
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
Daniele Zuccato
SGLab Advanced Technology, Nuova Ompi s.r.l., Piombino Dese, Italy
  • Find this author on Google Scholar
  • Find this author on PubMed
  • Search for this author on this site
  • Article
  • Figures & Data
  • References
  • Info & Metrics
  • PDF
Loading

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.
    OpenUrlGoogle Scholar
  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/.
    Google Scholar
  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 ScienceGoogle Scholar
  4. 4.↵
    1. Randolph T. W.,
    2. Carpenter J. F.
    Engineering Challenges of Protein Formulations. AIChE J. 2007, 53 (8), 1902–1907.
    OpenUrlGoogle Scholar
  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.
    OpenUrlPubMedGoogle Scholar
  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.
    OpenUrlPubMedGoogle Scholar
  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.
    OpenUrlGoogle Scholar
  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.
    OpenUrlPubMedGoogle Scholar
  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.
    OpenUrlCrossRefPubMedGoogle Scholar
  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.
    OpenUrlPubMedGoogle Scholar
  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.
    OpenUrlGoogle Scholar
  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.
    OpenUrlGoogle Scholar
  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.
    Google Scholar
  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.
    OpenUrlGoogle Scholar
  15. 15.↵
    1. Gallo R.
    A Breakthrough Coating Technology for High-Demanding Drugs. 2018 PDA Glass Quality Conference, Washington, DC, January 23, 2018.
    Google Scholar
  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.
    OpenUrlGoogle Scholar
  17. 17.↵
    1. Colas A.,
    2. Aguadisch L.
    Silicones in Pharmaceutical Applications. Chim. Nouv. 1997, 15 (58), 1779.
    OpenUrlGoogle Scholar
  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.
    OpenUrlGoogle Scholar
  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 ScienceGoogle Scholar
  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.
    OpenUrlPubMedGoogle Scholar
  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.
    OpenUrlGoogle Scholar
  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.
    OpenUrlGoogle Scholar
  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.
    OpenUrlGoogle Scholar
  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.
    OpenUrlCrossRefPubMedGoogle Scholar
  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.
    OpenUrlPubMedGoogle Scholar
  26. 26.↵
    Particulate Contamination: Sub-visible Particles (reference 04/2011: 20919). In European Pharmacopoeia, 9th ed. (official on January 2017).
    Google Scholar
  27. 27.↵
    <788> Particulate matters in injection. In United States Pharmacopeia (USP) 40; United States Pharmacopeial Convention: Rockville, MD, 2017.
    Google Scholar
  28. 28.↵
    <789> Particles in ophthalmic solutions. In United States Pharmacopeia (USP) 40; United States Pharmacopeial Convention: Rockville, MD, 2017.
    Google Scholar
  29. 29.↵
    6.07. Insoluble Particulate Matter Test for Injections. In The Japanese Pharmacopoeia, 15th ed.; pp. 111–113.
    Google Scholar
  30. 30.↵
    1. Bureau C.
    Method of Handling a Liquid Drug Formation. U.S. Patent 2016/0251261 A1, 2016.
    Google Scholar
  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.
    OpenUrlPubMedGoogle Scholar
  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.
    Google Scholar
  33. 33.↵
    European Pharmacopoeia, 9th Ed. (official on January 2017) Glass Containers for Pharmaceutical Use (reference 04/2015: 30201).
    Google Scholar
  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.
    Google Scholar
  35. 35.↵
    ICH Guidelines. Available at: http://www.ich.org/products/guidelines.html. Accessed December 22, 2017.
    Google Scholar
  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.
    Google Scholar
  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).
    Google Scholar
  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.
    OpenUrlCrossRefPubMedGoogle Scholar
  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.
    OpenUrlCrossRefPubMedGoogle Scholar
PreviousNext
Back to top

In This Issue

PDA Journal of Pharmaceutical Science and Technology: 72 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 72, Issue 4
July/August 2018
  • Table of Contents
  • Index by Author
Print
Download PDF
Article Alerts
Email Article
Citation Tools
Share
Introducing the Alba® Primary Packaging Platform. Part 1: Particle Release Evaluation
Alberto Chillon, Arianna Pace, Daniele Zuccato
PDA Journal of Pharmaceutical Science and Technology Jul 2018, 72 (4) 382-392; DOI: 10.5731/pdajpst.2018.008623
Twitter logo Facebook logo Mendeley logo
  • Tweet Widget

Jump to section

  • Article
    • Abstract
    • Introduction
    • Materials and Methods
    • Results and Discussion
    • Conclusions
    • Conflict of Interest Declaration
    • Reference
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

Related Articles

  • No related articles found.
  • PubMed
  • Google Scholar

Cited By...

  • Introducing the Alba(R) Primary Packaging Platform. Part 2: Inorganic Extractables Evaluation
  • Google Scholar

More in this TOC Section

  • Quantitative and Qualitative Evaluation of Microorganism Profile Identified in Bioburden Analysis in a Biopharmaceutical Facility in Brazil: Criteria for Classification and Management of Results
  • Evaluation of Extreme Depyrogenation Conditions on the Surface Hydrolytic Resistance of Glass Containers for Pharmaceutical Use
  • A Holistic Approach for Filling Volume Variability Evaluation and Control with Statistical Tool
Show more Research

Similar Articles

Keywords

  • Primary packaging
  • Visible particles
  • protein aggregation
  • Protein formulation
  • Silicone oil
  • Subvisible particles

Readers

  • About
  • Table of Content Alerts/Other Alerts
  • Subscriptions
  • Terms of Use
  • Contact Editors

Author/Reviewer Information

  • Author Resources
  • Submit Manuscript
  • Reviewers
  • Contact Editors

Parenteral Drug Association, Inc.

  • About
  • Advertising/Sponsorships
  • Events
  • PDA Bookstore
  • Press Releases

© 2025 PDA Journal of Pharmaceutical Science and Technology Print ISSN: 1079-7440  Digital ISSN: 1948-2124

Powered by HighWire
Alerts for this Article
Sign In to Email Alerts with your Email Address
Email this Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Enter multiple addresses on separate lines or separate them with commas.
Introducing the Alba® Primary Packaging Platform. Part 1: Particle Release Evaluation
(Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology
(Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
10 + 7 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.
Citation Tools
Introducing the Alba® Primary Packaging Platform. Part 1: Particle Release Evaluation
Alberto Chillon, Arianna Pace, Daniele Zuccato
PDA Journal of Pharmaceutical Science and Technology Jul 2018, 72 (4) 382-392; DOI: 10.5731/pdajpst.2018.008623

Citation Manager Formats

  • BibTeX
  • Bookends
  • EasyBib
  • EndNote (tagged)
  • EndNote 8 (xml)
  • Medlars
  • Mendeley
  • Papers
  • RefWorks Tagged
  • Ref Manager
  • RIS
  • Zotero

We use cookies on this site to enhance your user experience

By clicking any link on this page you are giving your consent for us to set cookies.