You are cordially invited to the seminar 'Advanced analytical techniques for API and drug product characterisation’, which will take place on 17 October 2022 from 8:30 am to 4:00 pm.
Issues with API variability across batches and suppliers? Discrepancies between test and reference product? Not understanding the original product? Problems with the manufacturing process or stability results?
JCI and Kapaji as a unique partnership of academic and industrial experts will show you on real-life examples how sophisticated and non-standard analytical techniques can help you understand and control the API and drug product behavior within development and in routine production.
- 8:30 – registration and morning coffee
- 9:15 – meeting kick-off with introduction of JCI and Kapaji
- 9:45 – 12:30 first block of presentations
Slot 1 9:45-10:30 – Preformulation – from API characterization up to small formulation trials – Pavel Calta
- Coffee break: 10:30-10:45
Slot 2: 10:45-11:30 – Degradation testing and stability studies for API and drug products – Pavel Calta
Slot 3: 11:45-12:30 – Drug product reverse engineering – Pavel Calta
- 12:30-13:30 lunch and networking
- Slot 4: 13:30-14:15 – Smart analytical techniques as tool for effective API and drug product development – dr Jakub Dybaś
- Slot 5 14:15-15:00 – Non-standard in vitro testing to understand similarity between the test and reference pair – Pavel Calta
- Coffee break 15:00-15:15
- Slot 6 15:15-15:45 – Drug formulation of biologics. Challenges in QC and NanoTempers answer to it
- Closing remarks 16:00
During the meeting, participants will have a unique opportunity to expand their knowledge and exchange experiences related to cooperation models for outsourcing research services and expertise in innovative pharmaceutical projects. There will also be interesting examples of ongoing projects and the opportunity to learn about the latest laboratory equipment for the analysis of biomolecules from Nano Temper.
Venue of the event: Lifescience Park JCI, M. Bobrzyńskiego 14 street, – Cracow
Price : 200 Euro net
Registration takes place through the portal: konfeo.pl
The workshop will cover all key parts of drug product development. The experts will show you the combination of standard and non-standard analytical tools on real case studies.
Preformulation – from API characterization up to small formulation trials
The preformulation is a critical phase of generic drug product development where the scientific relationship between API physicochemical properties and knowledge of the original drug product will define the first small formulation trials and overall success. Do you know which tests are needed for extensive API characterization? Do you know how to overcome IP restrictions? Do you know how to identify critical quality attributes for API and the original drug product? Do you know if the API supplier fits your needs? The Preformulation presentation will answer those questions and show you how to approach these questions in a scientific fashion and hence increase the success rate of your drug product development.
Degradation testing and stability studies for API and drug products
Identification of degradation mechanisms and understanding how to minimize the degradation rates for long-term/accelerated stability is a challenge for nearly every project. Do you want to know how to set up effective degradation testing? Do you have the right stability-indicating method? Are you able to distinguish whether the degradation impurity is coming from API, formulation process, or interaction with the excipient(s)? The degradation presentation will illustrate on real case studies, how to gain insight into the drug product purity in a fast and efficient manner.
Drug product reverse engineering
Reverse engineering is a complex approach covering standard and non-standard analytical techniques to understand everything about the investigated drug product. Do you need to know everything about the original drug product or about your competitor as part of a new development or product lifecycle management? Do you need to solve troubleshooting during manufacturing? Do you need to understand drug product stabilization? Do you want to develop an exact copy of the original for the biowaiver approach? The reverse engineering presentation will show you how to crank out all the information you need.
Smart analytical techniques as tool for effective API and drug product development
Smart analytical techniques can effectively support all phases of drug product development. Everyone knows the theory but the experimental design to understand critical attributes regarding API release or stability is always a challenge. Real case studies for Raman mapping and scanning electron microscopy can boost your own development.
Non-standard in vitro testing to understand similarity between the test and reference pair
Everyone knows dissolution testing. Everyone is looking at the API release within the physiological range. Is it enough, though? Do you know the disintegration mechanism of your tablet? Do you work with pharmacokinetic data? Are you able to distinguish whether the formulation process has an impact on API release? Are you using non-standard conditions for dissolution testing – small volumes, different media, pH switch, etc.? Did you observe solid form conversion during the API release? The non-standard in vitro testing presentation will show you how to use the dissolution data to the max.
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