Adventitious Agents - Impurities and Contaminants - Part of PharmaLab 2015

11 November 2015

Düsseldorf/Neuss, Germany

Course No 200027

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Objectives

This Conference will provide an opportunity to reinforce and expand your knowledge of the
special area of impurities of biological origin and contaminants in biopharmaceutical entities
from initial development to the market with emphasis o
..Detection, profiling and control in drug substances, intermediates and drug products
..Practical aspects of method validation for determination
.. Testing for contamination of mycoplasma or viruses

Background

ICH Topic Q 6 B respectively the Note For Guidance On Specifications: Test Procedures And Acceptance Criteria For Biotechnological/Biological Products (CPMP/ICH/365/96) states related to Impurities and Contaminants:

“Impurities
In addition to evaluating the purity of the drug substance and drug product,…. the manufacturer should also assess impurities, which may be present. Impurities may be either process or product-related. They can be of known structure, partially characterised, or unidentified.
When adequate quantities of impurities can be generated, these materials should be characterised to the extent possible and, where possible, their biological activities should be evaluated.

Process-related impurities … i.e., cell substrates (e.g., host cell proteins, host cell DNA), cell culture (e.g., inducers, antibiotics, or media components), or downstream processing product-related impurities (e.g., precursors, certain degradation products) are molecular variants arising during manufacture and/or storage, which do not have properties comparable to those of the desired product with respect to activity, efficacy, and safety. ….

Contaminants
Contaminants in a product include all adventitiously introduced materials not intended to be part of the manufacturing process, such as chemical and biochemical materials (e.g., microbial proteases), and/or microbial species. Contaminants should be strictly avoided and/or suitably controlled with appropriate in-process acceptance criteria or action limits for drug substance or drug product specifications (section 2.3). For the special case of adventitious viral or mycoplasma contamination, the concept of action limits is not applicable, and the strategies proposed in ICH Harmonised Tripartite Guidelines “Quality of Biotechnological/Biological Products: Viral Safety Evaluation of Biotechnology Derived Products Derived from Cell Lines of Human or Animal Origin” and “Quality of Biotechnological/Biological Products: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products“ should be considered.”
Therefore, it is indispensable for manufacturers of drug substances and drug products of biological origin, to establish suitable detection systems for such adventitious agents.

Target Group

The conference addresses all personnel involved in development of drug substances and drug products from scientific staff to laboratory heads involved in R&D. The needs of Laboratory Managers, Supervisors and Analysts in pharmaceutical quality assurance and quality control departments will also be covered.

Programme

Viral safety in biologicals – The regulatory perspective
Dr. Manuela Leitner, AGES – Austrian Agency for Health & Food Safety

Challenges in Testing for Adventitious Agents during Manufacture of Biological Products
Dr. Rajesh Gupta, Biologics Quality & Regulatory Consultants

Mycoplasma – Standards and Validation
Prof. Dr. Renate Rosengarten, Mycoplasma Biosafety Services

Dive into traditional Mycoplasma culture method
Dr. France Audrey Peltier, Merck Millipore

Long-term experience regarding alternative mycoplasma testing according to EP
Dr. Thomas Hämmerle, Baxalta Innovations

Selecting a rapid mycoplasma assay supporting recombinant production
Dr. Kent Persson, Octapharma

Experiences with in-house qPCR assay for Mycoplasma detection
Henrik Salling, Novo Nordisk

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