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CASSS Community News - March 21, 2019
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Registration is Closing Soon for the April Nlab Discussion Group

Don’t miss this meeting of the NLab Discussion Group on 8 April, which will focus on Phase Appropriate Specification Setting. The following topics will be discussed:


- Corné Stroop of Merck Sharp & Dohme, will present on "Expectations for Phase appropriate Specifications for Early stage Protein Therapeutics"

- Bart van Montfort with Janssen Vaccines and Prevention, will discuss "Specification Setting for Adenoviral-based Vaccines in Various Phases of Clinical Development"

Registration is FREE, however you must pre-register by 31 March in order to attend.

DC Discussion Group on Analytical QbD – Registration Closing March 29

Take advantage ofFREEregistration and join the DC Discussion Group on Thursday, April 4 for an afternoon of learning and networking. Featured speakers include:


- Tim Schofield with CMC Sciences LLC, will discuss "A Lifecycle Approach to Bioassays Validation"

- Jeremy Springall with AstraZeneca, will talk about "Analytical Quality by Design – What Does This Look Like?"

There will be no on-site registration. Don’t miss this opportunity to exchange new ideas and connect with colleagues!

Click here to visit the CASSS website for a list of all previous topics with links to the available speaker presentations.





Don't Miss Out on Being a Mentor– Deadline Extended!

Last year, CASSS and the Johns Hopkins University School of Medicine(JHU) Professional Development and Career Office piloted a mentor matching program to help postdocs translate their research knowledge to careers in industry. We are now recruiting mentors for this year's program and we've extended the deadline.

Over 60 students have signed up for the program and we don't want to leave any mentor-less. You are invited to sign-up for the rewarding experience. To apply, visit the CASSS-JHU Mentor Match Program.

(First-time users: register via the Non-JHED Login and go to the “Request to Join” tab to formally apply to the program.)










Cell & Gene Therapy Products (CGTP) Topics Announced

Last year's inaugural CGTP 2018 Symposium focused on cell and gene therapies, and demonstrated the benefits of an ongoing open forum for dialogue and the exchange of scientific and technical advances–the basis of evolving regulatory practices for this diverse array of innovative products.

This year's Symposium will be held June 10-12, 2019 at the Hyatt Regency Bethesda Hotel in Bethesda, MD. Below are the topics that will be covered:

- CGT Accelerated Development - CMC Strategies, Opportunities and Implications for RMAT Designation

- Cell Therapy - Analytical Characterization and CQA Assessments

- Gene Editing Technology

- Neoantigen-based Immunotherapies

- Process Development, Validation and Late Stage Development

- Facility Design for CGT

- Cell and Gene Therapy Comparability and Change Control Considerations

- Regulatory Updates from Across the Globe

Early Bird registration ends March 29, 2019.

Congratulations to This Year's AT Europe Poster Winners!

This year's winners were announced on the concluding day of the conference. Sara Carillo and Krzysztof Bielikowicz– congratulations!

Sara's poster is titled "CVA-MS Analysis to Investigate The Effects of Leachables From Single-Use Bioreactors On Monoclonal Antibodies." She provided additional background on the poster topic:

"Understanding the effects of biomanufacturing changes, such as the introduction of single-use technologies, is pivotal to preserve drugs safety and efficacy. High data quality native MS coupled with charge variants separation proved to be a tool able to give both ID and PTMs info on biotherapeutics molecule to highlight any deviation from the expected product."

Krzysztof's is titled "Non-consensus Glycosylation of ScFv x FAB Bispecific Antibody." He added:

"Our poster on the topic of detecting and characterising of so-called non-consensus glycosylation of a bispecific molecule was the first time Glenmark’s Analytical Development team participated in AT Europe symposium. We are very thankful for the award and recognition by the community it represents."

To see Sara's and Krzysztof's posters, click here.







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