Nelson Labs

Large-volume parenteral drug applications are characterized by high-volume doses of a drug product, which are administered intravenously. Flexible bag systems, which contain a combination of different materials, are often used as container/closure systems. An effective extractables and leachables testing program is needed to determine possible sources of contamination.

In this webcast, learn about the definitions and regulatory requirements for extractables and leachables testing of large-volume parenteral products. Typical sources of extractables and leachables in flexible bag systems for parenteral use will be reviewed and specific challenges associated with large-volume parenteral applications will be highlighted. Case studies on different designs of extractables studies will be discussed.

By attending this webinar, attendees will learn:

Regulatory requirements for extractable and leachable testing

Typical sources of extractable and leachable in flexible bag systems for parenteral drugs

Challenges specific to large-volume parenteral drug applications

 May 20, 2021, 2pm EDT | 1pm CDT | 11am PDT

On demand available after final airing until May 20, 2022

Webcasts

***Thursday, May 20, 2021, 2pm EDT | 1pm CDT | 11am PDT***  Flexible bag systems used for large-volume parenteral drug applications contain different materials that pose potential sources of contamination. In this webcast, learn about the sources of extractables and leachable, testing programs, regulatory requirements, and challenges specific to large-volume parenteral applications. *** On demand available after final airing until May 20, 2022.***


Testing of Packaging Systems for Large-Volume Parenteral Drugs: Extractables Study Design and Challenges

Articles

Addressing Fallacies of Extractable and Leachable Qualifications for Lyophilized Drug Products

http://promo.mjhlifesciences.com/biopharmacongress/

The COVID-19 pandemic has disrupted the routine of in-person events, the need for sharing information and building key supplier connections for bio/pharmaceutical development and manufacturing has never been greater.

The 2020 Bio/Pharma Virtual Congress event will connect bio/pharma formulation, development, manufacturing, and quality experts with a full day of technical presentations, panel discussions, interviews, and vendor meetings, through an interactive portal.

This online event will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry.

Adare, Aizon, BASF, Beckman Coulter, Catalent, DocuSign, Honeywell, Lighthouse, Lonza Pharma and Biotech, LSNE, Mikart, Nelson Labs, Qualicaps, Shimadzu, suez and VAI

Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT

On demand available after airing until Nov. 11, 2021.

*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021

2020 Bio/Pharma Virtual Congress

When selecting and qualifying the primary packaging for lyophilized drug products, an obvious question is: How deep should one go into the extractables and leachables qualifaction process of a lyophilization container?

As the drug product is in a solid state, it is expected that the interaction between the lyophilized drug product and the components of a lyo-container will be low. This is also reflected in the 

 <1664> Monograph on Leachables and the EMA Guideline on “Plastic Immediate Packaging Materials” (2005).

However, the mechanism of interaction between the lyo-cake and the rubber stopper of a lyo vial is not always fully understood. The interaction mechanism is based upon outgassingof the rubber stopper, where the lyo cake acts as an adsorbent. Not only can this lead to substantial accumulation of the volatile and semi-volatile leachable compounds onto the lyophilized drug product, it may also induce chemical reactions between the leachables and the drug product, (i.e. when the adsorbed leachables show electrophilic properties).

The webcast will explain the outgassingmechanism of the lyo-stoppers, which may lead to further accumulation of leachables adsorbed onto the lyo-cake. In addition, an experimental testing strategy will be explained that covers both the discovery, identification, and quantification of those leachables, as well as the formation of secondary leachables through chemical reactions between these reactive leachables and the drug product and its ingredients.

Understand the need to perform extractable and leachable evaluations for lyophilized drug products from a scientific perspective.

Understand the interaction mechanism between lyo-vial system components and the drug product (outgassing)

Understand a combined testing protocol can determine the presence and concentration of both the leachables, accumulated onto the lyo-cake, as well as the secondary leachables that were formed after a chemical reaction with the drug product (ingredients)

Piet Christiaens, PhD Scientific Director, Nelson Labs Europe

 Thursday, Oct. 15, 2020 at 2pm EDT| 1pm CDT| 11am PDT

	On demand available after final airing until Oct.15, 2021

Would you like to learn more about the E&L qualification process of the primary packaging for lyophilized drug products? Then make sure to attend this 45-minute webinar, given by Piet Christiaens scientific director at Nelson Labs Europe.

Live: Thursday, Oct. 15, 2020 at 2pm EDT| 1pm CDT| 11am PDT

On demand available after final airing until Oct. 15, 2021

The Necessity of Extractable and Leachable Qualifications for Lyophilized Drug Products: Some Fallacies Addressed

http://www.pharmtech.com/pt_w/access_compatibility

	Drug-device combination products offer options for the convenient delivery of drugs to patients. Because the patient frequently interacts with the drug and device, assessment of the compatibility of a device with certain drugs is crucial.

	The compatibility of the drug and device components requires analysis of many different aspects including drug stability, chemical compatibility, and biocompatibility. These aspects need to be in balance to establish a healthy relationship within the combined products and to avoid any danger to the patient. 

	In this webcast, learn about the necessity of a good relationship between the drug and the device for the benefit of the patient.

	During this 40-minute webcast, will review the following:

		The regulations and practical applications of combined products

		The different aspects of drug-device compatibility assessment in general

		The theoretic procedures behind the determination of drug stability, chemical compatibility, and biocompatibility

Lise Vanderkelen, PhD, Pharmaceuticals and Microbiology Expert, Nelson Labs Europe, a Sotera Health Company

	Ruth Verplaetse, PhD, Study Director, Nelson Labs Europe, a Sotera Health Company

 Tuesday, May 19, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

	On demand available after airing until May 19, 2021.

For drug-device combination products, the compatibility of the drug and device components requires analysis of many factors. In this webcast, learn about regulations and drug-device compatibility assessment steps that are necessary to protect patients.

Live: Tuesday, May 19, 2020 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

On demand available after airing until May 19, 2021.

