Pharmaceutical development of biopharmaceuticals and particulars of the CMC dossier

• Sources and main characteristics of biopharmaceuticals
• European CMC data requirements for the marketing authorization (Module 3) and for the IMP
• Comparability
• Formulation development
• Isoform characterization and glycosylation of biopharmaceuticals
• Virus and TSE safety
• Stability of biopharmaceuticals
• Bioassay establishment and data presentation
• New approaches in the manufacture - platform technologies and QbD
• CMC Data requirements in the USA and Japan
• The special characteristics of the International Nonproprietary Name system (INN) for biopharmaceuticals

Learning Objectives

• Understand the key quality (CMC) issues specific to biopharmaceuticals such as the manufacturing process definition, consistency, stability, definition of specifications, infectious agents' safety, comparability, bioassay use and apply them in the regulatory strategy
• Understand and adapt the implications of the introduction of changes in the manufacturing process on the quality of the product, i.e. apply the comparability concept
• Allows to conduct and steer the relevant regulatory strategy for CTA and MAA submissions for biopharmaceuticals due to knowing the rules and required data for Module 3
• Understand the CMC essentials of an IMPD/CTA, CTD and MAA submission
• Understand the regional differences in the scientific requirements for regulatory submissions for biopharmaceuticals and to utilize this in global submissions

Content

Biopharmaceuticals are special since they stem from a biological source, or the protein structure is transcribed from genetic information and is expressed by a living cell. They are usually complex and large and the quality is determined by the manufacturing process, where consistency and stability need particular attention. This has implications on the way biopharmaceuticals are developed and regulated and particular guidelines are available which are covered in this seminar. The manufacturing process determines the quality of these products and the requirements for the key quality (CMC) issues are complex accordingly. Issues specific to biopharmaceuticals such as the manufacturing process definition, consistency, stability, definition of specifications, infectious agents' safety, comparability, bioassay are covered in this seminar as well as specific topics such as how changes of the process can impact the quality of these products. In addition to the European requirements on biopharmaceuticals the specific requirements of other global regions are dealt with in detail. Furthermore, the specific requirements for IMPs, investigational medicinal products are covered.

Agenda

DAY 1: TUESDAY, 24 JANUARY 2012 (10.30-18.30)

Welcome and introduction

Introduction: Sources and main characteristics of biopharmaceuticals
• Recombinant development of biopharmaceuticals
• Mammalian, bacterial, yeast, plant expression systems
• Typical parenteral application
• Typical characteristics

International Nonpropriatory Name (INN) of biopharmaceuticals

Safety of starting material and auxiliary material of animal and /or human origin used in the process or formulation of the medicinal product

DAY 2: WEDNESDAY, 25 JANUARY 2012 (09.00-18.30)

Stability of biopharmaceuticals

Formulation and drug product manufacturing of biopharmaceuticals
• Formulation development
• Process development
• Routes of administration
• PEGylation technologies

Bioassay

Quality Module 3 of the CTD for recombinant and classical biopharmaceuticals
• Overview on Module 3 requirements for biopharmaceuticals
• Pharmaceutical development
• MCB/MWCB development
• Manufacture of Drug Substance and Drug Product
• Consistency in manufacture
• Process validation: sterility, aseptic process, transport
• Impurities - sources, detection methods and removal
• Final product container types

Characterisation, quality control and analytical techniques
• Development of analytical methods
• Characterisation vs routine testing
• Setting Specifications for in-process-controls, finished product release testing and stability testing

DAY 3: THURSDAY, 26 JANUARY 2012 (09.00-17.30)

DAY 4: FRIDAY, 27 JANUARY 2012 (08.30-16.30)

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