Q1 Scientific have curated a new webinar series following feedback from clients. This webinar series is designed for those working in the pharmaceutical, medical device and life sciences sectors with responsibility for designing and managing stability studies.
View the Q1 Scientific webinar series
These webinars aim to provide an insight into stability study design and what it means for you. During the webinars Dr. Mark Powell shares his experience and addresses key questions.
If you missed our live webinars then the good news is that we recorded them all for you. You can now catch-up online using the links below.
Stability Study Design – Bracketing and Matrixing
Wed, Aug 12 14:00
Biopharmaceutical Stability Studies
Wed, Sep 16 14:00
Temperature Excursion and Cycling Studies
Wed, Oct 21 14:00
Stability Study Design – Bracketing and Matrixing
Wed, Aug 12 14:00
Join Dr. Mark Powell as he discusses stability study designs and all you need to know about bracketing and matrixing.
Stability programmes are a costly undertaking, especially for products that have multiple strengths and packaging configurations, where a full study design will require every configuration to be evaluated for three registration batches at each time point. The use of reduced study designs such as bracketing and matrixing can reduce the cost of formal stability studies. This webinar describes when the use of such approaches is allowable, together with their associated benefits and risks.
Topics covered include:
- Overview of ICH Q1D – Bracketing and Matrixing Designs
- Bracketing study designs
- Bracketing study risks
- Matrix study designs
- Matrix study risks
- Combined bracketing and matrix study designs
- Summary of risks and benefits
Biopharmaceutical Stability Studies
Wed, Sep 16 14:00
Join Dr. Mark Powell as he discusses Biopharmaceutical Stability Studies.
Stability is a particular problem for biopharmaceutical products because the physical and chemical stability of peptides and proteins are often very sensitive to storage and transportation conditions. The purpose of this webinar is to explain the typical approach for the design of a stability study for biologics. The webinar also covers the specific challenges of these product types as well as typical degradation mechanisms.
This webinar will cover:
- Overview of ICH Q5C – Stability testing of biotechnological/biological products
- Specific stability challenges for biologics
- Protein and peptide degradation pathways
- Evaluating stability – typical tests
- In-use stability
- Stability after reconstitution
Temperature Excursion and Cycling Studies
Wed, Oct 21 14:00
Join Dr. Mark Powell as he discusses Temperature Excursion and Cycling Studies.
Temperature excursions during shipment can cause the recall of drug product lots, leading to delays in supply and loss of revenue. Data from a well-conducted temperature excursion and/or cycling study can be used to justify such excursions. There is currently no harmonised guidance dealing with the impact of temperature excursions during distribution or the effect of freeze/thaw cycles on liquids and semi-solids. This webinar reviews best practice in these areas.
This webinar will cover:
- Overview of regulatory guidance
- Temperature excursion risks to physical and chemical product stability
- Evaluating possible excursions using supply chain knowledge
- Temperature excursion studies
- Thermal cycling studies
- Transportation control strategy
About the speaker Dr. Mark Powell
Dr. Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a Senior Analytical Chemist.
Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016. He has worked at a senior level in a number of companies with responsibility for analytical development and equipment qualification. In 2010 Mark was appointed Scientific Manager of a UK-based pharmaceutical CRO, with responsibility for guiding the direction of drug development programmes as well as establishing collaborations with academia and instrument manufacturers.
In 2013, he set up his own company to provide training and consultancy services to the pharmaceutical industry. His consultancy work has involved, amongst other things, managing the analytical aspects of pharmaceutical development programmes and conducting data integrity audits. He is in demand as a trainer in topics such as pharmaceutical development, chromatography, spectroscopy, dissolution testing, data integrity, control of impurities, technical writing, stability/stress studies and sample preparation.
Can we help you?
Q1 Scientific offer a complete stability sample management service and can organise and secure your sample inventory. We offer:
- ICH compliant and non-ICH stability storage chambers which are monitored 24/7, 365 days of the year and have built-in safeguards
- Custom conditions to meet the specific storage requirements of any project
- Fully validated systems and equipment
- A monitoring and alert system and emergency back-up generators
- A complete stability study sample management service with sample receipt and return documentation along with notifications for scheduled pulls for testing
- A secure cloud-based documentation solution for your sample management
- Temperature controlled transfer and transport
- Access to a team of highly experienced pharmaceutical industry experts who are trained in recording cGMP compliant data
With tightly controlled temperatures and humidity rates at our spacious cGMP facility, we can store and manage any samples over the full life cycle of your stability plans.
To discuss how we can help you with your stability storage contact the team today.
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