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Comparability Protocols for Biotechnological Products
Mélanie Schlegel, Yves Bobinnec
BioProcess International, Vol. 11, No. 6, June 2013, pp. 30–41
 

Seymour P, Jones SD, Levine HL. Technology Transfer of CMC Activities for MAb Manufacturing. BioProcess Int. 8(6) 2010: S46–S50.

Nixon L, Rudge S. Technology Transfer Challenges for In-Licensed Biopharmaceuticals. BioProcess Int. 8(10) 2010: 10–18.

Wei Z, et al. The Role of Higher-Order Structure in Defining Biopharmaceutical Quality. BioProcess Int. 9(4) 2011: 58–66.

Siemiatkoski J, et al. Glycosylation of Therapeutic Proteins. BioProcess Int. 9(6) 2011: 48–53.

Langer ES. Limited Analytical Technologies Are Inhibiting Industry Growth. BioProcess Int. 9(9) 2011: 18–23.

Mire-Sluis A, et al. Analysis and Immunogenic Potential of Aggregates and Particles. BioProcess Int. 9(10) 2011: 38–47.

Schilling BM, Abu-Absi S, Thompson P. Metabolic Process Engineering. BioProcess Int. 10(1) 2012: 42–49.

Whitford WG. Single-Use Technology Supports Follow-On Biologics. BioProcess Int. 10(5) 2012: S20–S31.

Kozlowski S, et al. QbD for Biologics. BioProcess Int. 10(8) 2012: 18–29.

Klinger C, et al. Enhancing Data Quality with a Partly Controllable System at Shake Flask Scale. BioProcess Int. 10(9) 2012: 68–72.

Mire-Sluis A, Kutza J, Frazier-Jessen M. Rapid Pharmaceutical Product Development. BioProcess Int. 10(11) 2012: 12–21.

Mire-Sluis A, et al. Drug Products for Biological Medicines. BioProcess Int. 11(4) 2013: 48–62.

We believe, however, that a solid rationale for the analytical part of the comparability exercise — based on impact assessment from the process changes — will be a major asset in the overall comparability process. That makes it worth every effort to develop the best comparability protocol.

Author Details
Mélanie Schlegel is regulatory project manager at LFB Biotechnologies in Les Ulis, France. Corresponding author Dr. Yves Bobinnec is senior regulatory affairs manager at DBV Technologies, 80/84 rue des Meuniers, 92 220 Bagneux, France; yves.bobinnec@dbv-technologies.com.

REFERENCES
1.) ICH Q5E 2005. Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. US Fed. Reg. www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q5E/Step4/Q5E_Guideline.pdf 70:37861-37862.

2.) ICH Q8(R2) 2009. Pharmaceutical Development. US Fed. Reg. www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf 71:98.

3.) ICH Q9 2006. Quality Risk Management. US Fed. Reg. www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf 71:32105-32106.

6.) ICH Q6B 1999. Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. US Fed. Reg. www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6B/Step4/Q6B_Guideline.pdf 64:44928.

7.) EMA/CHMP/BWP/534898/2008 2008.Guideline on the Requirements for Quality Documentation Concerning Biological Medicinal Products in Clinical Trials, European Medicines Agency, London.

8.) Bobinnec, Y, and F Rossi. 2011. Review of the New EMA Draft Guideline: Setting the Quality Requirements for Biotechnological IMPDs. Reg. Rapport. 8:25-27.

9.) ICH Q11 2012. Guideline on Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). US Fed. Reg. www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q11/Q11_Step_4.pdf 77:69634-69635.

10.) EMA/CHMP/BWP/30584/2012 2012.Report on the Expert Workshop on Setting Specifications for Biotech Products (EMA, London, 9 September 2011), European Medicines Agency, London.

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