Pharmaceutical Technology Europe - November 2012 - (Page 2)

Examining the Growing Challenge of Extractables & Leachables Extractables and leachables (E&L) are a growing area of concern for regulators, necessitating more oversight from pharmaceutical manufacturers. Pharmaceutical Technology Europe conducted an industry roundtable to find out more about how extractables and leachables are being approached in the pharmaceutical industry. Participating in the roundtable were: Piet Christiaens, scientific director at Toxikon Europe; Andrew Feilden, chemistry operations director, at Smithers Rapra; Allen Kesselring, scientific director at EAG Life Sciences; Paul Killian, analytical technology R&D manager at Merck Millipore; and Wayland Rushing, senior scientific advisor at ABC Laboratories. PharmTech: What are the most common causes and types of E&L? Are certain drug-delivery and packaging components or product types more at risk? Feilden (Smithers Rapra): Leachables can come from any part of the supply chain or manufacturing process. Issues can arise from the container– closure system itself, the secondary packaging, the manufacturing process and even the storage environment. Typically, the longer the contact time and larger the contact surface area the higher the degree of risk of leachables. The drug-delivery systems most at risk are inhalation aerosols and injectable suspensions. As a rule of thumb, the container–closure systems for these types of products have a large elastomeric content that tends to produce more leachables. Another area of major concern for regulators is biological formulations. Even though a leachable in its own right may be safe, it may have a significant impact on the properties of a biological formulation, such as aggregation, particle formation or other product quality issues. Kesselring (EAG Life Sciences): E&L studies are traditionally associated with orally inhaled nasal drug products, ophthalmic products and injectable products. The quick and efficient transport of material to the bloodstream, which make these drug-delivery routes highly effective, also makes them susceptible to impurities arising from the packaging (this near-direct exposure concern also extends to many topical, transdermal and implantable products). In addition to route of delivery, exposure quantity and length of use are other key considerations that must be evaluated during E&L testing. Killian (Merck Millipore): I perform E&L studies on single-use processing equipment. The most Getty Images/Jochen Tack 2 EXTRACTABLES & LEACHABLES 9 ALZHEIMER’S DISEASE 5 NEWS 10 BLOGS 7 QUALITY BY DESIGN 11 TECHNOLOGY 8 BIOSIMILAR mAbS 12 STAFF

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - November 2012

Pharmaceutical Technology Europe - November 2012
Contents
Cover Story: Examining the Growing Challenge of Extractables & Leachables: An Industry Roundtable
News Bites
Applying Quality by Design for Extended-Release Hydrophilic Matrix Tablets
EU Sets Guidelines for Biosimilar Monoclonal Antibodies
Will Europe Discourage the Launch of New Alzheimer’s Drugs?
Blogs: Roche Under Investigation; Q3 Financial Reports
Top IT Technologies

Pharmaceutical Technology Europe - November 2012