[Bioprocess training] Commercial manufacturing of ATMPs and biologics - Pathway and drivers to process efficiency and GMP compliance

Saffuan Kudus saffuan at global-engage.com
Wed Feb 22 09:21:31 GMT 2023


BIOPROCESSING TRAINING COURSE

[COMMERCIAL MANUFACTURING OF ATMPs AND BIOLOGICS](http://clicks.global-engage.com/ls/click?upn=e9O1-2F5ZqMjEqz5WnJDogcUTkMbmhOanqSg8-2FMOdsUlX3-2BOoYEBeQZPT2vCfDXK6jy3-2FQhKpIdhJXjAe0P8OKUZJwxelY5vbXtyKkkHjw3yR-2FgsnJSPfeRzCAcRSfS1EkgSnLDarq8lx8QqcaZmmPNJD8EhuW7elw-2FYJatHnEtnlYqnvpSUoewU5NnXZKOxkAzRgUlNhG4kQdcvL4pnU738zWhHBnWovJNrmhRpxa3zg-3D8zw__ukxCIbfu9NN0Q2j9Ijgl-2FVVUngLWO8E7jwq4T7Bulv9CTENPc7zNVPiti79Aogmmzeb9jSrxZJaHoDIsouPBm4Tvv0jVX-2BHIc8gJAa2yV4U1d62CqseyHQr7zNPI1GdVtqlCKnRhYGKB-2FhSw1K0t1LvLZP2ld1-2FdyZ-2BGS1OBd9F3bVEUBXqgyghJSz8dnvb6uMA2igzzrsfYMulEEBLsMMZ-2F40PK9-2B6g-2F7xgbwN4oUcmR17DN4-2FoFZ-2BH6e5q-2FfwiWbHdE-2FcOLNRra9WaOrihruraY3aAIoS0Uff0wPYexqWol2dck9nRVyInRRkYfTSn

Pathway and drivers to process efficiency and GMP compliance

17-18 MAY 2023 | DUBLIN, IRELAND

Hi ,

The number of approvals of ATMPs (Advanced Therapy Medicinal Products) and biologics are now increasing as they advance through clinical trials into commercial manufacturing.

The challenges in adopting advanced technologies in compliance with GMP requirements are high. At the same time, new regulations intended to support manufacturers taking advantage of the new possibilities presented by these technological advances are coming into force.

Join us in this 2-day training course at Castleknock Hotel, Dublin. This training will cover the challenges of commercialisation in ATMP manufacturing.

This workshop will take place immediately after the [4th Global Bioprocessing, Bioanalytics and ATMP Manufacturing Congress.](http://clicks.global-engage.com/ls/click?upn=e9O1-2F5ZqMjEqz5WnJDogcUTkMbmhOanqSg8-2FMOdsUlX3-2BOoYEBeQZPT2vCfDXK6jMONCr-2FTlc5aLBMrf1WRf3XQTTj08-2FDwUE57PVAtEk9vUu7Ul11w0-2BiYZqjzQeAiK-2BTfia4b7la2J0ePmyWDc3yny2RJV8gsVif-2F4vm7JqeQD6YlPW6-2BMdD08p6YEP0-2FrKgXepMDMJ-2BfcsPBGxSgJfPNnPcV3E2iSBO1izYXAwjg-3De6Dp_ukxCIbfu9NN0Q2j9Ijgl-2FVVUngLWO8E7jwq4T7Bulv9CTENPc7zNVPiti79Aogmmzeb9jSrxZJaHoDIsouPBm4Tvv0jVX-2BHIc8gJAa2yV4U1d62CqseyHQr7zNPI1GdVtqlCKnRhYGKB-2FhSw1K0t1LvLZP2ld1-2FdyZ-2BGS1OBd9Hj8lvRIuz4MfHL3PtpW5AYaJzQKaSFHxf11Tu9eld2Ird8SSdep15E68xYEAAka7RnBFiah-2BVkRINk-2B7OVIh1fQCAtTiWzGihtlvUjzFWR8l7r2P7g3-2FY46IenSnKBJRQ9uhsFlZEBlA-2FDhXX0e1li

DAY 1 : 17 MAY

Building a bioprocessing and fill & finish platform for commercial GMP compliant manufacturing

- Key points in advancing from research into GMP compliant
- Regulatory landscape including QbD, QRM and Quality metrics.
- Process design for commercial scale manufacturing (integrated technologies - aseptic processing, sterilisation etc.) and case studies.
- Contamination Control strategies for EU GMP & PICS

DAY 2 : 18 MAY

Process operations and training

- Skill development via training with ‘Learning by doing’
- Specific aspects of training to meet GMP compliance
- Contamination risks (identified risks) and risk mitigations (control measures) through to Fill & Finish or sterile products.
- Automation and digitalisation for process control and monitoring with data integrity

​​​​​​​.

[VIEW FULL AGENDA](http://clicks.global-engage.com/ls/click?upn=e9O1-2F5ZqMjEqz5WnJDogcfcA-2BJa3EArvsMuYi3laTZZjaxcLDaz6aVznPMFWjkgkD42EMBHi-2FhNDq6RmQpK050ku19yNrVfqhDi-2FQsYOTEiJJoR5eh3-2FJf-2FKp02Jwk1Zerd6WmJpD2oqGogE3K-2FglMIHJ1FLmuUcRoDz-2BUtCDIm7SfQ5RucGIN4qc-2BVHuqTQPTdap-2BW9JB6I6A3DjSTFrw-3D-3D4tc4_ukxCIbfu9NN0Q2j9Ijgl-2FVVUngLWO8E7jwq4T7Bulv9CTENPc7zNVPiti79Aogmmzeb9jSrxZJaHoDIsouPBm4Tvv0jVX-2BHIc8gJAa2yV4U1d62CqseyHQr7zNPI1GdVtqlCKnRhYGKB-2FhSw1K0t1LvLZP2ld1-2FdyZ-2BGS1OBd9Ef6dSUz3-2FgLV43Gc9pewpEgpccjYB6hUI9n5HKf37-2Bqi6hfnkY-2BLNh7LG5ncQXJbFRr8L-2Fy1-2BCAxIaoxxUi-2FNZx31Vo0M5Tv3NwYdzZO3hJgGqp3He7XXYCWWrcceIIEdN72lVgE9g9FVq3J5htlTR

MEET THE TRAINERS

James L Drinkwater
Head of GMP Compliance

Franz Ziel GmbH & PHSS

Head of Aseptic Processing & Co-Leader of Annex 1 & CCS Focus Groups

John Milne

Director of Training

National Institute of Bioprocessing Research and Training - NIBRT

[SEE THE PRICE & REGISTER HERE](http://clicks.global-engage.com/ls/click?upn=e9O1-2F5ZqMjEqz5WnJDogcUTkMbmhOanqSg8-2FMOdsUlX3-2BOoYEBeQZPT2vCfDXK6jy3-2FQhKpIdhJXjAe0P8OKUZFDUSjut-2FrrQLpJX-2BwvWD7apYKVZscAiaElJ-2BA30NHvDR8yiTPZ0fegsRB4EULDeOc5N2F1F74WeOM861zRtmOiQ3XgESja-2FMtkyYaKE3v4sZr75ySL45AyL1UJCgyL-2FlAWZHhGp0-2FOqMT6Fcwhgmg-3D6DkI_ukxCIbfu9NN0Q2j9Ijgl-2FVVUngLWO8E7jwq4T7Bulv9CTENPc7zNVPiti79Aogmmzeb9jSrxZJaHoDIsouPBm4Tvv0jVX-2BHIc8gJAa2yV4U1d62CqseyHQr7zNPI1GdVtqlCKnRhYGKB-2FhSw1K0t1LvLZP2ld1-2FdyZ-2BGS1OBd9GiUfZDf8xpqVKxvuu81jssapx18Bni4P-2FWZFqyO54RPoHkDvZEp-2BXRc0SZZ41gObnBwz9CXIFS9VNMaGLWqcw-2BsPHENhwpsGQQjAAtosiKHqfwKv-2BAyeKCzFu0dfTDfMDp0svJ6o13j3YSSZVy1AHm

I look forward to seeing you in Dublin and feel free to share about this event with your relevant colleágues and networks.

Thank you

Regards,

Saffuan Kudus - Marketing Manager

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