PepTalk 2017
PepTalk 2017
Archived Content

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Extractables and Leachables
Toxicological and Biochemical Challenges in Packaging and Delivery
January 24-25, 2013 


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7:15 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee


Understanding Risk to Patient Safety in Pharmaceutical Container-Closure Systems 

8:15 Chairperson’s Remarks

Diane Paskiet, Ph.D., Associate Director, Scientific Affairs, West Pharmaceutical Delivery Systems

8:20 Safety Concerns for Biopharmaceutical Product Contact Materials and the Regulatory Landscape

Diane Paskiet, Ph.D., Associate Director, Scientific Affairs, West Pharmaceutical Delivery Systems

A background on the issues associated with suitability of materials commonly used in the manufacture and containment of biopharmaceutical products will be presented along with applicable regulations. Knowledge of materials in contact with biopharmaceuticals under all process environments and during storage should be assessed for the impact and significance to drug product quality.  These materials should be considered early in development phases and expectations will be outlined with reference to regulatory guidance documents consistent with the ICH quality paradigm.

8:50 Managing the Risks of Leachables from Polymers Used in Pharmaceutical Applications

Michael A. Ruberto, Ph.D., President, Material Needs Consulting, LLC

Polymers, such as plastic and elastomers, are quickly becoming the material of choice for the fabrication of container closure systems, devices, and single use processing equipment.  These materials often contain stabilizers, colorants, fillers, and other specialty additives, making their formulation much more complex than metal or glass, and therefore, a greater risk for leachables.  Topics discussed in this presentation will include polymer/additive chemistry, factors that affect migration from polymers, and case studies to demonstrate the application of a materials assessment for risk management.

9:20 Essential Considerations in Establishing the Compatibility of Pharmaceutical Solution Products and their Associated Packaging

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

When an aqueous pharmaceutical product is packaged, the product and its packaging interact chemically.  Such an interaction could change the composition of the drug product, potentially impacting its safety, efficacy, stability or purity.  This presentation considers the essential aspects of the various test procedures which can be used to ascertain the magnitude and impact of the interaction, thereby establishing the compatibility between the packaging and the packaged product.   Specifically, a three stage process for chemically establishing the safety of a packaging system will be discussed.

9:50 Selected Poster Presentation: Assessing and Overcoming Vaccine-Container Interactions – Is Silicone a Challenge?

Jianxiu Zhao, Ph.D., Senior Scientist, BD

10:05 Coffee Break in the Exhibit Hall with Poster Awards

11:00 Extractables and Leachables for Parenteral and Alternative Administration Devices

Kurt L. Moyer, Ph.D., Director, Research, NSF Pharmalytica

Medical devices involved in drug delivery are now required to demonstrate drug compatibility and to evaluate extractable and leachables from the medical device into the drug product.  Meeting this new expectations of the CDRH can be challenging in that any given study design is not universally applicable to all devices.  Two study designs, incorporating the essential regulatory elements, have been developed. Selection of the study design is based upon whether a leachable is most likely to enter a patient through migration into a drug product or by direct migration into the patient from tissue contact.  The rationale behind selection of the overall experimental design strategy and interpretation of the resulting data will be presented.

11:30 The ELSIE Extractables/Leachables Database: Sharing Knowledge and Minimizing Risk

Kim Li, Ph.D., Senior Manager, Corporate Environment, Health and Safety, Amgen and Co-Chair of the ELSIE Safety Information Working Group

The Extractables and Leachables Safety Information Exchange consortium has developed a database containing safety information on chemical compounds identified from the pooled knowledge and experience of ELSIE members. The database provides a streamlined source of relevant safety information allowing companies to make knowledge-based decisions early in the pharmaceutical development process.  The shared knowledge base  can also help reduce duplicative studies and research across companies. The impetus for and benefits of the database, as well as an example of the database will be presented.

12:00 pm Container Closure Systems Panel Dicussion with Morning Speakers

12:30 Close of Morning Session

12:45 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own


Case Studies 

2:00 Chairperson’s Remarks

Adam Goldstein, Ph.D., Senior Manager, Manufacturing Sciences, Genentech, Inc.

2:05 Impact of Extractables/Leachables from Filters on Stability of Protein Formulations

Min Huang, Ph.D., Principal Scientist, Pharmaceutical R&D, Pfizer, Inc.

The work presented evaluates the stability of a model IgG2 formulation that has been spiked with filter membrane extractable/leachable stock solution. It was found that extractables/leachables from filter membranes may have impact on protein formulation stability and caution should be exercised during protein filtration, especially when filtering small volumes and in pre-formulation or high-throughput screening studies.

2:35 Full Scale Implementation for a Disposable Bulk Freeze Application, ROI a Case Study

Adam Goldstein, Ph.D., Senior Manager, Manufacturing Sciences, Genentech, Inc.

This talk will explore the industry drivers for implementing a disposable application for bulk freeze applications and explore the returns on investment and carbon foot print savings by implementing a disposable application.  Emphasis on compliance and gains from disposable vs stainless steel systems will be the emphasis of the talk. 

3:05 Extractables & Leachables in Pre-Filled Syringes and Cartridges: Impact on Drug Product Quality and Safety Profile for Biologics

Joël Richard, Ph.D., VP, Peptides, CMC & Engineering, Ipsen

Extractables and Leachables (E&L) from the various components of the primary packaging can contaminate liquid formulations of biologics in pre-filled syringes and cartridges. They typically leach from the surface of glass barrels or are extracted by the formulation from the rubber stoppers and plungers. These are typically metallic compounds, silicone oil droplets and organic compounds, such as unreacted oligomers and curing agent residues. Then, they can interact with the protein molecules, chemically degrading them, modifying their higher order structure or forming composite impurities such as mixed micelles, or protein aggregate nuclei on particulates. These impurities in the final drug product may have a strong impact on product quality attributes and immunogenicity profile of the protein formulation. A methodology to check the compatibility of the liquid protein formulations with the components of the primary packaging, as well as to address E&L assay and characterization, will be presented and discussed.

3:35 Characterization of Chemical Degradation Products of Peptide Therapeutics by Mass Spectrometry

Peter Nielsen, Ph.D., Scientific Director, Protein Chemistry, Novo Nordisk

Chemical stability is of critical importance in the design and formulation of new peptide therapeutics. We have identified various chemical degradation products in peptide drug candidates. The reactions included deamidation, adduct formation, hydrolysis, and isomerization as well as covalent aggregation. The challenges and strategy for characterization of these modifications using top-down mass spectrometry and ion mobility mass spectrometry will be discussed.


4:05 Implications of Glass Degradation

Deirdre PiedmonteDeirdre Piedmonte, Ph.D., Principal Scientist, Drug Product Development, Process and Product Development (P&PD), Amgen

4:35 End of Conference

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