Already Registered? Log In Now Not Registered?
Complete this form to enter the webcast. Already Registered?

(* indicates required field)

Complete this form to enter the webcast.
(* indicates required field)



*Denotes required.


Is our understanding of stability changing?

Now available on demand!

Event Overview:

In this exclusive Drug Digest video interview, Chris Spivey, Editorial Director, Pharmaceutical Technology, talks with industry experts about various aspects of drug product stability testing. Stability studies involve a drug substance tested under storage conditions and assess its thermal stability and sensitivity to moisture. Over the last decade there has been some intermixing of supply chain storage and distribution systems, and traditional formulations taking these storage and delivery systems into account – continuous monitoring comes to mind. While long-term testing should be performed over a minimum of 12 months at 25 °C ± 2 °C/60% RH ± 5% RH or at 30 °C ± 2 °C/65% RH ± 5% RH. The intermediate and accelerated testing should cover a minimum of 6 months at 30 °C ± 2 °C/65% RH ± 5% RH. Accelerated Predictive Stability (APS) studies, carried out over a 3–4-week period and combining extreme temperatures and RH conditions (40–90 °C)/10–90% RH, have emerged as novel approaches to predict the long-term stability of pharmaceutical products in a more efficient and less time-consuming manner. 

This episode of Drug Digest is sponsored by: 
  • Solvias
Key Learning Objectives:
  • Most important aspects to test for in considering formulation choices, eg crystallization
  • Is there a commercial trade-off to these choices?
  • Understand potency loss versus microbial activity in high water content formulations
  • Are accelerated tests an unalloyed aid, or are there downfalls?
  • Special consideration needed for excipients versus API’s – (eg glycerol degradation)
  • Delivery method formulation dependent stability considerations
Who Should Attend:
  • Medicinal chemists
  • CDMOs
  • Formulation scientists
  • Manufacturers
  • Excipient and API manufacturers
  • Purchasers and supply chain
  • QA/QC personnel
  • R&D personnel
  • Development scientists


Featured Speaker

Nitin Swanaker
Nitin Swanaker
Pharma Applications Manager
BASF

Nitin Swanaker is a Formulation scientist with over 16 years of combined (academic research/training/industrial) experience, and a very strong track record of publications, primarily focused on various formulation aspects of small, peptide and protein molecules for oral and parenteral applications. He has vast experienced in solid, solution, suspension, semisolid products and novel drug delivery systems such as lipid- and polymer-based drug delivery systems (proliposomes and liposomes, liquid crystalline particles nanoparticles and microspheres) including their targeted drug delivery counterparts. He is well-versed in various characterization techniques used in formulation development, possesses a good understanding of various regulatory guidelines and cutting edge concepts and technologies. 


Geoff Carr
Geoff Carr
Former Director, Analytical Development
Thermofisher Scientific/Patheon


Geoff Carr PhD, has retired after over 45 years experience of working in the pharmaceutical industry and currently provides training and consultancy services to pharmaceutical companies with an emphasis on the application of good chemistry in the development of new pharmaceutical products. Previously, he was appointed as Manager, Analytical Development at Patheon Inc, Canada in 2000 and progressed to Director, Analytical Development, Thermofisher Scientific/Patheon until 2023. Prior to that, he held positions of Manager, Analytical Sciences at Celltech-Chiroscience, UK, Head of Analytical Development at Medgenix, Belgium and before that at Wyeth Research, UK. He originally started his career in pharmaceutical analysis at The British Pharmacopoeia Laboratory where he held several posts and was finally appointed Head of the Laboratory. His academic background is a PhD in synthetic organic chemistry awarded by University of London, UK. He has been a Member of various British Pharmacopoeia Committees, a UK representative to Committees of the European Pharmacopoeia and Member of USP Committees including a Member of the 2015-2020 Cycle USP General Chapters – Physical Methods Expert Committee. He is the author of numerous publications including journal articles and book chapters as well as presentations and workshops at international conferences on various topics related to applications of analytical chemistry during the development of pharmaceutical products. This includes a 8 module distance learning course on Pharmaceutical Stability Testing



For any technical questions please contact Jorge de la Bandera:  JdelaBandera@mjhlifesciences.com