Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing and Controls
Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis.
Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls covers efficient manufacturing of peptide drug substances, a review of the process for submitting applications to the regulatory authority for drug approval, a holistic approach for quality attributes and quality control from a regulatory perspective, emerging analytical tools for the characterisation of impurities, and the assessment of stability.
This book is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about CMC, and facilitating development and manufacture of peptide-based drugs.
Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing and Controls, The Royal Society of Chemistry, 2019.
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Table of contents
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Chapter 1: Regulatory Considerations for Peptide Therapeuticsp1-30ByLarisa WuLarisa WuOffice of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug AdministrationSilver SpringMD 20993USA[email protected]Search for other works by this author on:
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Chapter 2: Regulatory Perspective on Synthetic Peptides in Europep31-68ByRené ThürmerRené ThürmerBfArM, Federal Institute for Drugs and Medical DevicesKurt-Georg-Kiesinger-Allee 353175 BonnGermany[email protected]Search for other works by this author on:
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Chapter 3: Biological and Immunogenicity Evaluation Strategy for Therapeutic Peptides: Chemistry, Manufacturing and Controls Perspectivep69-96ByArunan KaliyaperumalArunan KaliyaperumalLilly Biotechnology Center, Eli Lilly and Company, 10290 Campus Point DriveSan DiegoCA 92121USA[email protected]Search for other works by this author on:
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Chapter 4: Chemistry, Manufacturing and Controls: Active Pharmaceutical Ingredient and Drug Productp97-110ByPrem RamiyaPrem RamiyaSearch for other works by this author on:
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Chapter 5: Peptide Manufacturing Methods and Challengesp111-150BySatyanarayana KotaSatyanarayana KotaPeptides Laboratory, Natco Research Centre, Natco Pharma LimitedB-13, Industrial Estate, SanathnagarHyderabad 500018India[email protected]Search for other works by this author on:
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Chapter 6: Economic and Environmental Factors Affecting the Sustainability of Peptide Therapeutic Manufacturingp151-193ByTrishul ShahTrishul ShahPolyPeptide Laboratories Inc.365 Maple AvenueTorranceCA 90503USASearch for other works by this author on:
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Chapter 7: A Holistic Quality Control Strategy for Peptide Active Pharmaceutical Ingredients (APIs)p194-273ByAleksander Swietlow;Aleksander SwietlowPolyPeptide Laboratories Inc.TorranceCA 90503USASearch for other works by this author on:Asher LowerAsher LowerSearch for other works by this author on:
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Chapter 8: Higher-order Structure Characterization and Comparability Assessments for Peptidesp274-312ByRenata Varga;Renata VargaTeva Pharmaceuticals Inc., Analytical Sciences and Operations, Biologics CMC, Brandywine ParkwayWest ChesterPA 19380USA[email protected]Search for other works by this author on:Anuja RaneAnuja RaneTeva Pharmaceuticals Inc., Analytical Sciences and Operations, Biologics CMC, Brandywine ParkwayWest ChesterPA 19380USA[email protected]Search for other works by this author on:
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Chapter 9: Impurity Characterization and Quantification by Liquid Chromatography–High-resolution Mass Spectrometryp313-342ByKui Zeng;Kui ZengDivision of Pharmaceutical Analysis, US Food and Drug Administration645 South Newstead AvenueSt LouisMO 63110USASearch for other works by this author on:Connie RuzickaConnie RuzickaDivision of Pharmaceutical Analysis, US Food and Drug Administration645 South Newstead AvenueSt LouisMO 63110USASearch for other works by this author on:
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Chapter 10: Mass Spectrometric Analysis for the Quality Control of Peptide Conjugate Therapeuticsp343-380ByOsama Chahrour;Osama ChahrourSpectroscopy Group, Almac House, 20 Seagoe Industrial Estate, Craigavon BT63 5QDNorthern IrelandUK[email protected]Search for other works by this author on:Anna Meljon;Anna MeljonSchool of Biological Sciences, Institute for Global Food SecurityQueen's University, University Road, Belfast BT7 1NNNorthern IrelandUKSearch for other works by this author on:Diego F. CobiceDiego F. CobiceBiomedical Sciences Research Institute (BMSRI)Ulster University, Cromore Road, Coleraine BT52 1SANorthern IrelandUKSearch for other works by this author on:
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Chapter 11: Determination of the Identity, Content and Purity of Therapeutic Peptides by NMR Spectroscopyp381-420ByTorgny RundlöfTorgny RundlöfSearch for other works by this author on:
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Chapter 12: Transport, Stability and Delivery Considerations for the Design of Peptide Drugsp421-471ByTomi Sawyer;Tomi SawyerMRL, Merck & Co., Inc.33 Avenue Louis PasteurBoston, MA 02115USASearch for other works by this author on:Suzanne M. D'Addio;Suzanne M. D'AddioMRL, Merck & Co., Inc.33 Avenue Louis PasteurBoston, MA 02115USASearch for other works by this author on:Brad Sherborne;Brad SherborneMRL, Merck & Co., Inc.33 Avenue Louis PasteurBoston, MA 02115USASearch for other works by this author on:Marian E. GindyMarian E. GindySearch for other works by this author on:
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Chapter 13: Assessing the Impact of Functional Excipients on Peptide Drug Product Attributes During Pharmaceutical Developmentp472-502ByJameson R. Bothe;Jameson R. BotheMRL, Merck & Co, Inc.126 East Lincoln AvenueRahwayNJ 07065USASearch for other works by this author on:Marian E. GindyMarian E. GindyMRL, Merck & Co, Inc.770 Sumneytown PikeWest PointPA 19486USASearch for other works by this author on:
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Chapter 14: Formulations of Microspheres and Nanoparticles for Peptide Deliveryp503-530ByJyothi ThundimadathilJyothi ThundimadathilSearch for other works by this author on:
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