Top Considerations for the Development of Inhaled Biologics

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Presenter:

Ashleigh Wake

Business Development Director,

Intertek Pharmaceutical Services

Following graduation, Ashleigh joined Zeneca as Biotransformation Chemist followed by technical and operational management roles with AstraZeneca and Syngenta before joining Intertek. She has a background in mass spectrometry and a career of over two decades as an operational/technical team leader and study director for projects spanning the drug development process (including metabolism, pharmacokinetics studies and API/product characterization, CMC support analytics, and International Council for Harmonisation stability studies). Ashleigh has specialized in the design and delivery of regulatory (GXP) studies relating to the physiochemical and biological activity of biomolecules including oligonucleotides, proteins, monoclonal antibodies (mAbs), and vaccines and is currently responsible for strategic growth and business development at Intertek’s good manufacturing practice (GMP) compliant centre of excellence for biologics characterization in Manchester, United Kingdom.

About this event:

Date: October 5, 2020

Time: 11 am EDT | 8 am PDT |
5 pm CEST

Duration: 15 minutes

Inhaled and nasal biologics continue to grow in importance as advantages presented both by targeted delivery to the lung and systemic delivery for other diseases or treatment pathways are driving this increased attention. In this webinar, Ashleigh Wake describes the top development considerations for inhaled or intranasal biologic analytical development.

These include the need to meet regulatory requirements of ICH Q6B for a well characterized biologic as well as the specific respiratory testing outlined in documents such as the European Medicines Agency (EMA) guideline on the pharmaceutical quality of inhalation and nasal products (June 2006) or the US Food and Drug Administration (FDA) metered dose inhaler (MDI) and dry powder inhaler (DPI) products quality considerations guidance (April 2018).

In addition to specific orally inhaled and nasal drug product (OINDP) tests, Ashleigh will highlight key testing programs to fully characterize the biological entity and establish whether the device delivery mechanism has adversely affected parameters, including structure, purity (higher order structure, aggregation, degradation, etc.), and the activity (potency). She will also touch on strategic formulation and device selection which are necessary to optimize delivery.