Low-Volume Aseptic Filling Using a Linear Peristaltic Pump

Tim Dreckmann; Imke-Sonja Ludwig; JOERG LUEMKEMANN; JOERG Huwyler

doi:10.5731/pdajpst.2020.011858

References

1.↵
1. Greb E.
Turn Down the Fill Volume. Pharm. Technol. 2010.
2.↵
U.S. Pharmacopeial Convention, General Chapter <151> Pharmaceutical Dosage Forms. In USP 28—NF 33, USP: Rockville, MD, 2015.
3.↵
Council of Europe, Test for Extractable Volume of Parenteral Preparations, Chapter 2.9.17. In European Pharmacopoeia (Ph. Eur.), 10th edition, Council of Europe: Strasbourg, France, 2019.
4.↵
U.S. Food and Drug Administration, Guidance for Industry: Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2015.
5.↵
1. Liu L.,
2. Ammar D. A.,
3. Ross L. A.,
4. Mandava N.,
5. Kahook M. Y.,
6. Carpenter J. F.
Silicone Oil Microdroplets and Protein Aggregates in Repackaged Bevacizumab and Ranibizumab: Effects of Long-Term Storage and Product Mishandling. Invest. Ophthalmol. Visual Sci. 2011, 52 (2), 1023–1034.
OpenUrl Abstract/FREE Full Text
6.↵
1. Storey P. P.,
2. Tauqeer Z.,
3. Yonekawa Y.,
4. Todorich B.,
5. Wolfe J. D.,
6. Shah S. P.,
7. Shah A. R.,
8. Koto T.,
9. Abbey A. M.,
10. Morizane Y.,
11. Sharma P.,
12. Wood E. H.,
13. Morizane-Hosokawa M.,
14. Pendri P.,
15. Pancholy M.,
16. Harkey S.,
17. Jeng-Miller K. W.,
18. Obeid A.,
19. Borkar D. S.,
20. Chen E.,
21. Williams P.,
22. Okada A. A.,
23. Inoue M.,
24. Shiraga F.,
25. Hirakata A.,
26. Shah C. P.,
27. Prenner J.,
28. Garg S.
The Impact of Prefilled Syringes on Endophthalmitis Following Intravitreal Injection of Ranibizumab. Am. J. Ophthalmol. 2019, 199, 200–208.
OpenUrl
7.↵
1. Shetty G.,
2. Zeiss B.
Microlitre Dosing with Prefillable Syringes—When Does a Device Make Sense? ONdrugDelivery 2019, (97), 28–31.
8.↵
1. Erstad A. J.,
2. Erstad B. L.,
3. Nix D. E.
Accuracy and Reproducibility of Small-Volume Injections from Various-Sized Syringes. Am. J. Health-Syst. Pharm. 2006, 63 (8), 748–750.
OpenUrl FREE Full Text
9.↵
1. Gerding H.,
2. Timmermann M.
Accuracy and Precision of Intravitreally Injected Ranibizumab Doses: An Experimental Study. Klin. Monatsbl. Augenheilkd. 2010, 227 (4), 269–272.
OpenUrl PubMed
10.↵
1. Gnanalingham M. G.,
2. Newland P.,
3. Smith C. P.
Accuracy and Reproducibility of Low Dose Insulin Administration Using Pen-Injectors and Syringes. Arch. Dis. Child. 1998, 79 (1), 59–62.
OpenUrl Abstract/FREE Full Text
11.↵
1. Peterson A.,
2. Isberg E.,
3. Schlicht A.
Capability of Filling Systems to Dispense Micro-Doses of Liquid Pharmaceutical Product. Pharm. Eng. 2007, 27 (4).
12.↵
1. Thomas C. R.,
2. Geer D.
Effects of Shear on Proteins in Solution. Biotechnol. Lett. 2011, 33 (3), 443–456.
OpenUrl PubMed
13.↵
1. Maa Y.-F.,
2. Hsu C. C.
Effect of High Shear on Proteins. Biotechnol. Bioeng. 2000, 51 (4), 458–465.
OpenUrl
14.↵
1. Dreckmann T.,
2. Boeuf J.,
3. Ludwig I.-S.,
4. Lümkemann J.,
5. Huwyler J.
Low Volume Aseptic Filling: Impact of Pump Systems on Shear Stress. Eur. J. Pharm. Biopharm. 2020, 147, 10–18.
OpenUrl
15.↵
1. Cromwell M. E. M.,
2. Hilario E.,
3. Jacobson F.
Protein Aggregation and Bioprocessing. AAPS J. 2006, 8 (3), E572–E579.
OpenUrl CrossRef PubMed Web of Science
16.↵
1. Carpenter J. F.
1. Tyagi A. K.,
2. Randolph T. W.,
3. Dong A.,
4. Maloney K. M.,
5. Hitscherich C.
, Jr.; Carpenter J. F. IgG Particle Formation during Filling Pump Operation: A Case Study of Heterogeneous Nucleation on Stainless Steel Nanoparticles. J. Pharm. Sci. 2009, 98 (1), 94–104.
OpenUrl PubMed
17.↵
1. Saller V.,
2. Hediger C.,
3. Matilainen J.,
4. Grauschopf U.,
5. Bechtold-Peters K.,
6. Mahler H.-C.,
7. Friess W.
Influence of Particle Shedding from Silicone Tubing on Antibody Stability. J. Pharm. Pharmacol. 2018, 70 (5), 675–685.
OpenUrl
18.↵
1. Saller V.,
2. Matilainen J.,
3. Grauschopf U.,
4. Bechtold-Peters K.,
5. Mahler H.-C.,
6. Friess W.
Particle Shedding from Peristaltic Pump Tubing in Biopharmaceutical Drug Product Manufacturing. J. Pharm. Sci. 2015, 104 (4), 1440–1450.
OpenUrl
19.↵
1. Adler M.,
2. Bechtold-Peters K.,
3. Boillon A.,
4. Dorn A.,
5. Luemkemann J.,
6. Luthringer D.,
7. Mahler H.-C.,
8. Meyer A.
Dosing a Fluid at a Volume of Less Than One Milliliter. WO 2016012567, 2015.
20.↵
1. Kalonia C. K.,
2. Heinrich F.,
3. Curtis J. E.,
4. Raman S.,
5. Miller M. A.,
6. Hudson S. D.
Protein Adsorption and Layer Formation at the Stainless Steel-Solution Interface Mediates Shear-Induced Particle Formation for an IgG1 Monoclonal Antibody. Mol. Pharmaceutics 2018, 15 (3), 1319–1331.
OpenUrl
21.↵
1. Shieu W.,
2. Lamar D.,
3. Stauch O. B.,
4. Maa Y.-F.
Filling of High-Concentration Monoclonal Antibody Formulations: Investigating Underlying Mechanisms That Affect Precision of Low-Volume Fill by Peristaltic Pump. PDA J. Pharm. Sci. Technol. 2016, 70 (2), 143–156.
OpenUrl Abstract/FREE Full Text
22.↵
1. Dreckmann T.,
2. Aipperspach W.,
3. Pfleghar K.,
4. Tröndle J.,
5. Ernst A.,
6. Huwyler J.,
7. Ludwig I. S.,
8. Luemkemann J.
Assessment of Sensor Concepts for a 100% In-Process Control of Low Volume Aseptic Fill-Finish Processes. PDA J. Pharm. Sci. Technol. 2020, 74 (6), 660–673.
OpenUrl Abstract/FREE Full Text
23.↵
1. Hanslip S.,
2. Desai K. G.,
3. Palmer M.,
4. Bell S.,
5. Schofield P.,
6. Varma P.,
7. Roche F.,
8. Colandene J. D.,
9. Smith T. M.,
10. Nesta D. P.
Syringe Filling of High-Concentration mAb Formulation: Slow Suck-Back Pump Speed Prevented Filling Needle Clogging. J. Pharm. Sci. 2017, 106 (12), 3651–3653.
OpenUrl
24.↵
1. Shieu W.,
2. Stauch O. B.,
3. Maa Y.-F.
Filling of High-Concentration Monoclonal Antibody Formulations into Pre-Filled Syringes: Investigating Formulation-Nozzle Interactions to Minimize Nozzle Clogging. PDA J. Pharm. Sci. Technol. 2015, 69 (3), 417–426.
OpenUrl Abstract/FREE Full Text
25.↵
1. Shieu W.,
2. Torhan S. A.,
3. Chan E.,
4. Hubbard A.,
5. Gikanga B.,
6. Stauch O. B.,
7. Maa Y.-F.
Filling of High-Concentration Monoclonal Antibody Formulations into Pre-Filled Syringes: filling Parameter Investigation and Optimization. PDA J. Pharm. Sci. Technol. 2014, 68 (2), 153–163.
OpenUrl Abstract/FREE Full Text
26.↵
1. Jaspe J.,
2. Hagen S. J.
Do Protein Molecules Unfold in a Simple Shear Flow? Biophys. J. 2006, 91 (9), 3415–3424.
OpenUrl CrossRef PubMed Web of Science
27.↵
1. Lin G. L.,
2. Pathak J. A.,
3. Kim D. H.,
4. Carlson M.,
5. Riguero V.,
6. Kim Y. J.,
7. Buff J. S.,
8. Fuller G. G.
Interfacial Dilatational Deformation Accelerates Particle Formation in Monoclonal Antibody Solutions. Soft Matter 2016, 12 (14), 3293–3302.
OpenUrl

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Mechanistic Study of Drying Phenomena of Highly Concentrated Protein Therapeutics--Drying Kinetics and Protein Aggregation

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Keywords

[1] 1.↵
Greb E.
Turn Down the Fill Volume. Pharm. Technol. 2010.

[2] Greb E.

[3] 2.↵
U.S. Pharmacopeial Convention, General Chapter <151> Pharmaceutical Dosage Forms. In USP 28—NF 33, USP: Rockville, MD, 2015.

[4] 3.↵
Council of Europe, Test for Extractable Volume of Parenteral Preparations, Chapter 2.9.17. In European Pharmacopoeia (Ph. Eur.), 10th edition, Council of Europe: Strasbourg, France, 2019.

[5] 4.↵
U.S. Food and Drug Administration, Guidance for Industry: Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products. Center for Biologics Evaluation and Research. U.S. Department of Health and Human Services: Rockville, MD, 2015.

[6] 5.↵
Liu L.,
Ammar D. A.,
Ross L. A.,
Mandava N.,
Kahook M. Y.,
Carpenter J. F.
Silicone Oil Microdroplets and Protein Aggregates in Repackaged Bevacizumab and Ranibizumab: Effects of Long-Term Storage and Product Mishandling. Invest. Ophthalmol. Visual Sci. 2011, 52 (2), 1023–1034.
OpenUrl Abstract/FREE Full Text

[7] Liu L.,

[8] Ammar D. A.,

[9] Ross L. A.,

[10] Mandava N.,

[11] Kahook M. Y.,

[12] Carpenter J. F.

[13] 6.↵
Storey P. P.,
Tauqeer Z.,
Yonekawa Y.,
Todorich B.,
Wolfe J. D.,
Shah S. P.,
Shah A. R.,
Koto T.,
Abbey A. M.,
Morizane Y.,
Sharma P.,
Wood E. H.,
Morizane-Hosokawa M.,
Pendri P.,
Pancholy M.,
Harkey S.,
Jeng-Miller K. W.,
Obeid A.,
Borkar D. S.,
Chen E.,
Williams P.,
Okada A. A.,
Inoue M.,
Shiraga F.,
Hirakata A.,
Shah C. P.,
Prenner J.,
Garg S.
The Impact of Prefilled Syringes on Endophthalmitis Following Intravitreal Injection of Ranibizumab. Am. J. Ophthalmol. 2019, 199, 200–208.
OpenUrl

[14] Storey P. P.,

[15] Tauqeer Z.,

[16] Yonekawa Y.,

[17] Todorich B.,

[18] Wolfe J. D.,

[19] Shah S. P.,

[20] Shah A. R.,

[21] Koto T.,

[22] Abbey A. M.,

[23] Morizane Y.,

[24] Sharma P.,

[25] Wood E. H.,

[26] Morizane-Hosokawa M.,

[27] Pendri P.,

[28] Pancholy M.,

[29] Harkey S.,

[30] Jeng-Miller K. W.,

[31] Obeid A.,

[32] Borkar D. S.,

[33] Chen E.,

[34] Williams P.,

[35] Okada A. A.,

[36] Inoue M.,

[37] Shiraga F.,

[38] Hirakata A.,

[39] Shah C. P.,

[40] Prenner J.,

[41] Garg S.

[42] 7.↵
Shetty G.,
Zeiss B.
Microlitre Dosing with Prefillable Syringes—When Does a Device Make Sense? ONdrugDelivery 2019, (97), 28–31.

[43] Shetty G.,

[44] Zeiss B.

[45] 8.↵
Erstad A. J.,
Erstad B. L.,
Nix D. E.
Accuracy and Reproducibility of Small-Volume Injections from Various-Sized Syringes. Am. J. Health-Syst. Pharm. 2006, 63 (8), 748–750.
OpenUrl FREE Full Text

[46] Erstad A. J.,

[47] Erstad B. L.,

[48] Nix D. E.

[49] 9.↵
Gerding H.,
Timmermann M.
Accuracy and Precision of Intravitreally Injected Ranibizumab Doses: An Experimental Study. Klin. Monatsbl. Augenheilkd. 2010, 227 (4), 269–272.
OpenUrl PubMed

[50] Gerding H.,

[51] Timmermann M.

[52] 10.↵
Gnanalingham M. G.,
Newland P.,
Smith C. P.
Accuracy and Reproducibility of Low Dose Insulin Administration Using Pen-Injectors and Syringes. Arch. Dis. Child. 1998, 79 (1), 59–62.
OpenUrl Abstract/FREE Full Text

[53] Gnanalingham M. G.,

[54] Newland P.,

[55] Smith C. P.

[56] 11.↵
Peterson A.,
Isberg E.,
Schlicht A.
Capability of Filling Systems to Dispense Micro-Doses of Liquid Pharmaceutical Product. Pharm. Eng. 2007, 27 (4).

[57] Peterson A.,

[58] Isberg E.,

[59] Schlicht A.

[60] 12.↵
Thomas C. R.,
Geer D.
Effects of Shear on Proteins in Solution. Biotechnol. Lett. 2011, 33 (3), 443–456.
OpenUrl PubMed

[61] Thomas C. R.,

[62] Geer D.

[63] 13.↵
Maa Y.-F.,
Hsu C. C.
Effect of High Shear on Proteins. Biotechnol. Bioeng. 2000, 51 (4), 458–465.
OpenUrl

[64] Maa Y.-F.,

[65] Hsu C. C.

[66] 14.↵
Dreckmann T.,
Boeuf J.,
Ludwig I.-S.,
Lümkemann J.,
Huwyler J.
Low Volume Aseptic Filling: Impact of Pump Systems on Shear Stress. Eur. J. Pharm. Biopharm. 2020, 147, 10–18.
OpenUrl

[67] Dreckmann T.,

[68] Boeuf J.,

[69] Ludwig I.-S.,

[70] Lümkemann J.,

[71] Huwyler J.

[72] 15.↵
Cromwell M. E. M.,
Hilario E.,
Jacobson F.
Protein Aggregation and Bioprocessing. AAPS J. 2006, 8 (3), E572–E579.
OpenUrl CrossRef PubMed Web of Science

[73] Cromwell M. E. M.,

[74] Hilario E.,

[75] Jacobson F.

[76] 16.↵
Carpenter J. F.
Tyagi A. K.,
Randolph T. W.,
Dong A.,
Maloney K. M.,
Hitscherich C.
, Jr.; Carpenter J. F. IgG Particle Formation during Filling Pump Operation: A Case Study of Heterogeneous Nucleation on Stainless Steel Nanoparticles. J. Pharm. Sci. 2009, 98 (1), 94–104.
OpenUrl PubMed

[77] Carpenter J. F.

[78] Tyagi A. K.,

[79] Randolph T. W.,

[80] Dong A.,

[81] Maloney K. M.,

[82] Hitscherich C.

[83] 17.↵
Saller V.,
Hediger C.,
Matilainen J.,
Grauschopf U.,
Bechtold-Peters K.,
Mahler H.-C.,
Friess W.
Influence of Particle Shedding from Silicone Tubing on Antibody Stability. J. Pharm. Pharmacol. 2018, 70 (5), 675–685.
OpenUrl

[84] Saller V.,

[85] Hediger C.,

[86] Matilainen J.,

[87] Grauschopf U.,

[88] Bechtold-Peters K.,

[89] Mahler H.-C.,

[90] Friess W.

[91] 18.↵
Saller V.,
Matilainen J.,
Grauschopf U.,
Bechtold-Peters K.,
Mahler H.-C.,
Friess W.
Particle Shedding from Peristaltic Pump Tubing in Biopharmaceutical Drug Product Manufacturing. J. Pharm. Sci. 2015, 104 (4), 1440–1450.
OpenUrl

[92] Saller V.,

[93] Matilainen J.,

[94] Grauschopf U.,

[95] Bechtold-Peters K.,

[96] Mahler H.-C.,

[97] Friess W.

[98] 19.↵
Adler M.,
Bechtold-Peters K.,
Boillon A.,
Dorn A.,
Luemkemann J.,
Luthringer D.,
Mahler H.-C.,
Meyer A.
Dosing a Fluid at a Volume of Less Than One Milliliter. WO 2016012567, 2015.

[99] Adler M.,

[100] Bechtold-Peters K.,

[101] Boillon A.,

[102] Dorn A.,

[103] Luemkemann J.,

[104] Luthringer D.,

[105] Mahler H.-C.,

[106] Meyer A.

[107] 20.↵
Kalonia C. K.,
Heinrich F.,
Curtis J. E.,
Raman S.,
Miller M. A.,
Hudson S. D.
Protein Adsorption and Layer Formation at the Stainless Steel-Solution Interface Mediates Shear-Induced Particle Formation for an IgG1 Monoclonal Antibody. Mol. Pharmaceutics 2018, 15 (3), 1319–1331.
OpenUrl

[108] Kalonia C. K.,

[109] Heinrich F.,

[110] Curtis J. E.,

[111] Raman S.,

[112] Miller M. A.,

[113] Hudson S. D.

[114] 21.↵
Shieu W.,
Lamar D.,
Stauch O. B.,
Maa Y.-F.
Filling of High-Concentration Monoclonal Antibody Formulations: Investigating Underlying Mechanisms That Affect Precision of Low-Volume Fill by Peristaltic Pump. PDA J. Pharm. Sci. Technol. 2016, 70 (2), 143–156.
OpenUrl Abstract/FREE Full Text

[115] Shieu W.,

[116] Lamar D.,

[117] Stauch O. B.,

[118] Maa Y.-F.

[119] 22.↵
Dreckmann T.,
Aipperspach W.,
Pfleghar K.,
Tröndle J.,
Ernst A.,
Huwyler J.,
Ludwig I. S.,
Luemkemann J.
Assessment of Sensor Concepts for a 100% In-Process Control of Low Volume Aseptic Fill-Finish Processes. PDA J. Pharm. Sci. Technol. 2020, 74 (6), 660–673.
OpenUrl Abstract/FREE Full Text

[120] Dreckmann T.,

[121] Aipperspach W.,

[122] Pfleghar K.,

[123] Tröndle J.,

[124] Ernst A.,

[125] Huwyler J.,

[126] Ludwig I. S.,

[127] Luemkemann J.

[128] 23.↵
Hanslip S.,
Desai K. G.,
Palmer M.,
Bell S.,
Schofield P.,
Varma P.,
Roche F.,
Colandene J. D.,
Smith T. M.,
Nesta D. P.
Syringe Filling of High-Concentration mAb Formulation: Slow Suck-Back Pump Speed Prevented Filling Needle Clogging. J. Pharm. Sci. 2017, 106 (12), 3651–3653.
OpenUrl

[129] Hanslip S.,

[130] Desai K. G.,

[131] Palmer M.,

[132] Bell S.,

[133] Schofield P.,

[134] Varma P.,

[135] Roche F.,

[136] Colandene J. D.,

[137] Smith T. M.,

[138] Nesta D. P.

[139] 24.↵
Shieu W.,
Stauch O. B.,
Maa Y.-F.
Filling of High-Concentration Monoclonal Antibody Formulations into Pre-Filled Syringes: Investigating Formulation-Nozzle Interactions to Minimize Nozzle Clogging. PDA J. Pharm. Sci. Technol. 2015, 69 (3), 417–426.
OpenUrl Abstract/FREE Full Text

[140] Shieu W.,

[141] Stauch O. B.,

[142] Maa Y.-F.

[143] 25.↵
Shieu W.,
Torhan S. A.,
Chan E.,
Hubbard A.,
Gikanga B.,
Stauch O. B.,
Maa Y.-F.
Filling of High-Concentration Monoclonal Antibody Formulations into Pre-Filled Syringes: filling Parameter Investigation and Optimization. PDA J. Pharm. Sci. Technol. 2014, 68 (2), 153–163.
OpenUrl Abstract/FREE Full Text

[144] Shieu W.,

[145] Torhan S. A.,

[146] Chan E.,

[147] Hubbard A.,

[148] Gikanga B.,

[149] Stauch O. B.,

[150] Maa Y.-F.

[151] 26.↵
Jaspe J.,
Hagen S. J.
Do Protein Molecules Unfold in a Simple Shear Flow? Biophys. J. 2006, 91 (9), 3415–3424.
OpenUrl CrossRef PubMed Web of Science

[152] Jaspe J.,

[153] Hagen S. J.

[154] 27.↵
Lin G. L.,
Pathak J. A.,
Kim D. H.,
Carlson M.,
Riguero V.,
Kim Y. J.,
Buff J. S.,
Fuller G. G.
Interfacial Dilatational Deformation Accelerates Particle Formation in Monoclonal Antibody Solutions. Soft Matter 2016, 12 (14), 3293–3302.
OpenUrl

[155] Lin G. L.,

[156] Pathak J. A.,

[157] Kim D. H.,

[158] Carlson M.,

[159] Riguero V.,

[160] Kim Y. J.,

[161] Buff J. S.,

[162] Fuller G. G.

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Low-Volume Aseptic Filling Using a Linear Peristaltic Pump

References

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Author/Reviewer Information

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