January 13 - 17, 2014
Renaissance Hotel and Palm Springs Convention Center Palm Springs, California

A Community Dedicated to the
Evolving Field and Future of Biotherapeutics

Cambridge Healthtech Institute’s Second Annual
Extractables and Leachables
Addressing Toxicological and Biochemical Challenges for Drug Product Integrity
January 16-17, 2014


In biopharmaceutical drug development and manufacturing, containers, drug combination products (inhalers, pens, insulin pumps and implants) and even disposable equipment may release low molecular weight chemicals into the product and possibly compromise the biological safety and efficacy of the drug product. This conference covers how testing for extractables and leachables (E&L) should be conducted, how to control E&L in drug product, how to comply with regulatory guidance and how to ensure the quality of your product.

Join with colleagues from around the world in this discussion of the key challenges and solutions for E&L testing and see how experts are avoiding impurities to deliver a safe and stable product.

 


Day 1 | Day 2 | Download Development Brochure | Speaker Biographies 

THURSDAY, JANUARY 16

1:00-1:45 pm Conference Registration


Regulatory Guidance, Toxicological Considerations and Updates 

2:00 Chairperson’s Opening Remarks

William P. Beierschmitt, Ph.D., DABT, FATS, Regulatory Strategy Lead, Worldwide Research and Development Drug Safety Research & Development, Pfizer, Inc.


Keynote Presentations

2:05 Determining Suitability of Plastic Packaging Systems for Therapeutic Products: USP Standards

Desmond HuntDesmond G. Hunt, Ph.D., Senior Scientific Liaison, Department of Standards Development, United States Pharmacopoeia

The presentation will discuss the overview of USP strategies for extractables and leachables. The presentation will discuss newly developed and revised USP chapters, appearing in pf 39 (5) September-October 2013, standards related to plastic materials characterization and extractables and leachable testing. It will also discuss other changes in compendial standards related to metal and glass containers.

2:45 A Detailed Discussion of the USP Chapters Related to Extractables and Leachables, specifically <661> Plastic Packaging Systems and Their Materials of Construction and <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems

Dennis JenkeDennis Jenke, Ph.D., Baxter Distinguished Scientist, Technology Resources, Baxter Healthcare Corp.

Pharmaceutical products are manufactured, packaged, stored, delivered and/or administered in systems with plastic components. Interactions between the product and such systems can affect the product’s quality. The USP Packaging, Storage and Distribution Expert Committee has been tasked with delineating a general chemistry-based approach for establishing the safety and quality of plastic systems and their material of construction and to embody this strategy into specific USP general chapters. The purpose of this presentation is to discuss and justify the contents of the individual established chapters.

3:15 Assessing Material Compatibility for Use in Manufacture, Storage and Delivery of Biologics

Diane PaskietDiane Paskiet, Ph.D., Director, Scientific Affairs, West Pharmaceutical Services

Chemicals with potential to leach from materials used in the manufacture and storage/delivery of biologics can pose significant risks to product quality. The nature of biologics brings to bear challenges for qualifying product contact material for intended applications. This presentation provides background, on broad range of material considerations including current regulatory perspectives and best practices for identifying potential leachables and impact to biologics.

Toxikon3:45 Key Considerations in Designing an Extractable and/or Leachable Study

Iannone_JohnJohn Iannone, Program Manager and Technical Specialist, Toxikon Corporation

A system must be well understood when designing Extractable/Leachable studies. A lack of industry consensus results in comparing study outcomes with very different study designs, which is cumbersome. This presentation highlights key considerations enabling adequate modeling to examine a system for its E/L profile. Impacting aspects will be outlined and a strategy for designing an E/L study will be presented.

4:00 Refreshment Break in the Exhibit Hall with Poster Viewing

4:45 The Toxicological Risk Assessment of Extractables and Leachables: Practices and Procedures to Ensure Patient Safety

William BeierschmittWilliam P. Beierschmitt, Ph.D., DABT, FATS, Regulatory Strategy Lead, Worldwide Research and Development Drug Safety Research & Development, Pfizer, Inc.

The toxicologist should establish the safety of chemicals originating from the container closure system of a parenteral product. At the extractable stage (i.e. what chemicals might migrate into the drug during storage), the toxicologist should perform a preliminary risk assessment to ensure that there are no serious safety matters identified should these extractables later present as leachables. Subsequently, comprehensive risk assessments are performed on the leachables to ensure patient safety.

5:15 ADME Considerations for Risk Assessment of Extractables and Leachables

Christopher BrynczkaChristopher Brynczka, Ph.D., Senior Toxicologist, Toxicology, Gradient Corp.

The evaluation of extractable or leachable hazard begins with compound identification and quantitation. Assessment of risks associated with clinical exposures to these compounds additionally requires consideration of administration route and disposition within the body. The absorption, distribution, metabolism, and elimination (ADME) of identified chemicals frequently differentiate between a hazard and low risk. Risk assessment using this informed approach is essential to accurately define exposure hazards and may eliminate undue follow-on testing.

5:45 Close of Day



Day 1 | Day 2 | Download Development Brochure | Speaker Biographies 

 

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      Premier Sponsors: 

EMD Millipore 

 Novozymes (white) 

PerkinElmer NEW 2009 

 Protein Simple  

  

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Training Seminars 

Mon-Tues, January 13-14 

Biologics Formulation and Delivery  

 


Buzz Sessions
BuzZ Sessions are facilitated, small-group discussions. Interactive participation leads to problem-solving solutions and future collaborations around focused topics.
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