November 23, 2022 Biological-Based Drugs Overcoming Challenges to Biopharmaceutical Development
WHY I SHOULD JOIN THE WORKSHOP:
Drug modalities have grown increasingly complex over time: chemically derived small molecules were followed by biological medicines, and peptides, proteins, monoclonal antibodies, cell & gene therapy products are actually used more and more for prevention and/or treatment of diseases, including rare ones. Biologics-based drugs have been increasing their market share over the last decade and according to many studies, global market size is expected to reach 750 billion USD in 2028, with a subsequent increased demand for manufacturing and testing processes outsourcing.
During biopharmaceutical lifecycle, different matrixes such as raw materials, reagents and standards, process intermediate and drug substance play a key role to obtain the final biological drug product. They should be evaluated from different points of view based on the stage in which they are used and also the characteristics that should have or not to guarantee a proper final product.
This Workshop will provide a wide and comprehensive overview of critical aspects, technical considerations and strategies for establishing appropriate characterization of biologics matrixes including raw materials and intermediate from biochemistry and bioassay testing perspective. By attending, participants will gain valuable insight from our first class expert’s expertise on how to obtain meaningful data to be used during different phases of product development, validation up to quality control and will also have the opportunity to bring specific questions and case studies along to the Workshop for discussion.
9:00-9:30 Gathering & Registration ( light refreshments)
9:30-11:00 “State of art: bio-pharmaceutical testing” Overview of biological products characterization from chemical and bioassay perspective:
- Biological product definition
- Insights on the need of characterization of a biological product
- Which characterization stands for and strategies can be implemented according to ICH Q6B
11:00-11:30 Coffee break
11:30 – 13:00 “How to approach a successful testing to different matrixes (raw materials, reagents and standards):
- Technical approach
- Testing, equipment
- Critical issues
13:00-14:00 Lunch break
14:00- 15:30 Discussion Case study: “The adventure of biolgics drugs in the reign of Chemistry and bioassays”
- Examples of testing strategy
- GMP approach to different matrixes
WHO SHOULD PARTICIPATE:
This course offers a rewarding experience and is particularly relevant to the following key figures:
- R&D Manager,
- QA Manager,
- Regulatory Manager,
- Production Manager,
- Packaging Manager,
- CMC Manager
- Validation Manager.
EVENT KEY NOTE SPEAKER:
Giulia Mancini, PhD is the Lab Manager of the bioassay testing team, under biologics business unit, in Eurofins BPT in Milan, Italy.
After her Master Degree in Medical biotechnology and molecular Medicine from University of Milan, she holds PhD in Biochemical Science.
During her academic career, she received different oral communication prizes, as well as, numerous awards for her research. Over both PhD and 2-years PostDoc activities she has the possibility to collaborate with different research institution both in Europe and the United states, strengthening her multidisciplinary skills.
Then, after 2-years of Post-Doc she joint the company and she contributes to the activation and development of the new-sub BU bioassay.
She lends her R&D experience to support the development, implementation and validation of cell based bioassay and immunoassays testing. Moreover, she has strongly contributed to the creation and activation of a new BSL2 area, designing the Labs and planning their fluxes
Nowadays, she manages as team of 12 people and she currently supports the development of new technologies and testing in the group.
Giuseppe holds a Chemistry and Pharmaceutical Technologies degree and a Ph.D in Neuroscience from the University of Cagliari. He has a vast experience as bioanalytical researcher through Chromatography method development and validation mainly related to pharmacokinetic studies by LC-MS and LC-MS/MS. In his previous experiences as GLP Laboratory Manager he has successfully managed different projects in a wide range of areas and he has been involved in Studies of Bioequivalence in collaboration with the National Research Council for drug product and impurities qualitative/quantitative characterization. Since 2017 he has been working at Eurofins BioPharma Product Testing Italy at first as Project Leader of extractables & leachables studies and for the last three years as Manager of a Chemical Laboratory working in GMP focusing on Biologics products characterization and analysis.
Feel free to contact us
** Israel Time Zone
** Please note, the number of places is limited, register now to guarantee your participation