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Basics of a Sterility-Assurance Program for Aseptic-Processed Drugs and Biopharmaceuticals


October 26, 2022 - October 27, 2022


Philadelphia, PA
Hilton Philadelphia City Avenue
4200 City Ave.

Contact Information

Contact Mike Pizzi at mpizzi@nelsonlabs.com or +1 (801) 290-7524 for more information.

How do you ensure that your pharmaceutical product is tested and sterilized appropriately and ready for regulatory approval so that it is ultimately released safely to market in a timely manner?

You can learn directly from our industry experts in Philadelphia on October 26th and 27th. Join us for two days full of guidance and discussion about lab testing, sterility assurance, and regulatory expectations. The presenters include industry experts from Nelson Labs and Regulatory Compliance Associates (RCA) as well as a guest speaker from PDA – Parenteral Drug Association.

Stay tuned for the full agenda. An overview of the presentations is listed below.

Wednesday, October 26, 2022

An Introduction to Nelson Labs & Regulatory Compliance Associates 

Presenter TBD

Contamination Control Strategies Program: What Should It Look Like? 

Presented by Martell Winters, Nelson Labs

Fundamentals of an Environmental Monitoring Program

Presented by Phil Tuckett, Nelson Labs

One of the most important tools for contamination control is a formal environmental monitoring (EM) program. An EM program, when properly implemented, provides valuable information on the ongoing effectiveness of contamination-control strategies that are in place. This presentation will introduce a typical EM program in a pharmaceutical setting. Essential components that should be considered when implementing an EM program will also be discussed.

Regulatory Comparison of the Current FDA Guideline and Annex 1

Presenter TBD

Annex 1: Aseptic Processing and Associated Challenges

Presented by Susan Schniepp, RCA, and Tonya Morris, Nelson Labs

Key Considerations When Developing a Sterile-Filtration Validation for Pharmaceutical or Biopharmaceutical Product

Presented by Tonya Morris, Nelson Labs

The manufacturing of drug products, vaccines, therapies, and biopharmaceuticals can have many diverse steps, some of which may include a clarification step or a final filtration-sterilization step.  It is imperative that the manufacturing process be fully understood to successfully execute a sterile-filtration validation. This presentation will walk through the key elements to consider when developing  a filtration-validation study as well as present some common barriers and concerns that may be encountered during development and execution.

Thursday, October 27, 2022

General Extractables & Leachables Considerations for the Pharmaceutical Industry: A Helicopter View

Presented by Piet Christiaens, Nelson Labs Europe

During their production, storage/distribution, and administration, small-volume parenteral drug products leach chemicals from their manufacturing, packaging, and delivery systems. These foreign impurities (leachables) can potentially have a significant effect on the quality of the SVPs and may affect the efficiency with which the SVP is produced. To establish the effects of these impurities, drugs produced are profiled for leachables; and manufacturing, packaging, and delivery systems are tested for extractables (as probable leachables). In this presentation the scientific and practical aspects and principles of the chemical characterization of SVPs and their related systems will be introduced, including a review of the relevant regulatory guidance, standards, and best demonstrated-practice recommendations. The presentation will provide suggested best practices (dos and don’ts) for the design, implementation, interpretation, and submission of E&L studies.

Extractables & Leachables for Bioprocessing Equipment & Single-Use Systems (SUS)

Presented by Karen Pieters and Piet Christiaens, Nelson Labs Europe

Leachables in pharmaceutical products could also originate from manufacturing items (e.g., filters and bioreactors) used in the production process. With the increasing use of disposables in the pharma industry, the concern in E&L has also developed considerably in this area. Biopharma industry groups (e.g., BPSA and BPOG) have published recommendations when and how to perform E&L studies for these materials. Moreover, the USP has released chapter <665> and <1665>, which address E&L for production materials in the (bio)pharmaceutical industry. In this presentation, the different steps in the assessment of the E&L impact of a production line will be outlined. In addition, the recommendations of BPOG and USP for these materials will be discussed.

Extractables & Leachables Considerations for Small-Volume-Parenteral Applications (Pre-Filled Syringes, Vials, and Cartridges)

Presented by Piet Christiaens, Nelson Labs Europe

In this presentation, general extractables and leachables principles will be explained for small-volume-parenteral (SVP) applications, including vials, cartridges, and pre-filled syringes, as these items are the main container-closure systems used in SVP applications. In addition, a deeper dive will be made into the typical materials of construction for these container-closure systems and how knowledge of these materials can assist in the design of an E&L qualification program.

Phase-Appropriate Method Validation

Presented by Aryo Nikopour, Nelson Labs

Method validation of analytical methodologies is rigorous and challenging during clinical development. There is no explicit instruction on how much method validation is required at each phase of drug development. The presenter will provide a general approach to phase-appropriate method validation for five different method categories. The main focus will be on chromatographic methodologies, specifically stability-indicating methods.

Container-Closure-Integrity Testing

Presented by Jennifer Gygi, Nelson Labs

Container-closure-integrity testing is used to evaluate pharmaceutical containers (vials and syringes) for leaks to ensure the drug product is free from contamination through the expected shelf life. This presentation provides an overview of the various methods listed in USP 1207 for assessing container closure integrity.

Release & Stability Testing Requirements for Parenteral-Drug Products

Presented by Shiri Hechter, Nelson Labs Fairfield

Parenteral products are sterile drugs, solutions, emulsions, and suspensions. They are unique from any other type of pharmaceutical dosage form because 1) all products must be sterile and 2) all products must be free from pyrogenic (endotoxin) contamination.

Release and stability testing are a vital part of new-drug development and are conducted throughout a product’s life cycle. These studies confirm that the quality, safety, and effectiveness of drug products are preserved throughout the shelf life as an essential requirement. This presentation will provide a brief overview of the parenteral-drug product’s release testing as well as the ICH guidelines for stability testing.

Event Registration:

Registration for both days is $800 per person.

Registration deadline is October 12, 2022.

Lunch and refreshments will be served daily and are included in the seminar package. The registration fee does not include hotel accommodations.

Hotel Accommodations:

Guests planning to stay on location can coordinate their hotel reservation online. A negotiated rate of $169.00 per night has been arranged with Hilton Philadelphia City Avenue. Reserve your room at this rate. This offer is good until October 3, 2022, or until rooms are sold out.

Group Event Registration:

Groups of three or more may contact Mike Pizzi at mpizzi@nelsonlabs.com or +1 (801) 290-7524 for discounted pricing information.

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