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PHSS Annual Conference 2019 in association with UCL Q3P
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PHSS Annual Conference 2019 in association with UCL Q3P

Challenges in Biological & Advanced Medicinal Therapeutic product( ATMP) manufacturing following GMP

10/09/2019
When: Tuesday, September 10, 2019
9:00 AM
Where: Hilton Kensington, London
179-199 Holland Park Avenue
London W11 4UL
United Kingdom
Contact: Tamsin Marshall
01793824254


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Challenges in Biological and Advanced Medicinal Therapeutic product ATMP manufacturing with GMP compliance
Biological products and ATMPs:

 

PHSS are pleased to announce their Gold Sponsor   

 Advanced
Therapeutic Medicinal Products are challenging in manufacture to meet GMP requirements and regulatory expectations and often require adaption of generic GMP guidance with a QRM: Quality Risk Management approach. Biological products and therapies that interact with biological systems have challenges in testing and biocompatibility of disinfectant residuals used in bio-contamination control. With such interconnected challenges QPs are faced with challenges in certification and release. 

 

This conference has a focus on Biological product and ATMP manufacturing with contamination control in GMP compliance and following QRM principles together with testing challenges and shared experience from QPs on certifiation and release.

8.30am. Registration and viewing of exhibition.


9.00am. Welcome and opening remarks:
PHSS Chairman James Drinkwater and handover to Chairperson Jenni Tranter. Welcome from Q3P course Director Dr Khalid Ahmad Sheikh.

 

9.15am – 10.00am. MHRA regulatory observations and expectations in processing Biological and ATMPs: MHRA speaker to be confirmed.

 

10.00am-10.45am. Contamination of biologics and ATMPs – case studies: Rene Friedrichs - RSSL Technical Specialist – Microscopy.
Contamination of biological and ATMPs can be a very serious issue, with the potential of harming patients. Therefore identifying these foreign materials is imperative and helps to establish the seriousness of these occurrences, as well as help to identify the source of the contamination, preventing a re-occurrence. This presentation will go through a number of case studies, which will highlight the variety of foreign materials that can be found in Biologics or ATMPs, ranging from protein precipitating out to microscopic machinery debris.

 

10.45am – 11.30am. Exhibition and networking break.

 

11.30am – 12.15pm. Joint presentation: Aseptic manufacturing of Biologicals/ ATMPs considering challenges in contamination and cross contamination control:

Dr Holger Kranenburg. F Ziel GmbH Aseptic Containment lead and GMP training manager. PHSS Management team and Containment special interest group member.

Contamination control, Aseptic-Containment and Bio-compatibility of VHP residues with biological/ ATMP products.

  • Aseptic processing in Isolator barrier technology and considerations in biological product and ATMP processing; Managing in-process transfers, processing viral vectors, processing Toxic-ADCs, environmental monitoring. Contamination control of Biologics/ATMPs in filing via aseptic processing and bio-compatibility of H202 disinfection agent residues:
  • Aseptic-Containment Strategy (ACS): principles and developing PHSS guidance: in support to EU GMP Annex 1 Contamination control strategy (CCS).
  • Bio-compatibility of hydrogen peroxide disinfection agents (VHP residuals) required for bio-contamination control and biological products: Analytical chemistry and efficacy impact studies.

 

Colin Newbould. Quality Director Wasdell group, Wasdell Packaging Ltd. PHSS Management team and Containment special interest group member.

Consideration in cross contamination control with reference to processing multiple products in the same facility.

  • Learnings from a new facility build in Ireland for processing multiple products.
  • Considerations for a cross contamination control risk assessment.
  • Regulatory expectations and preparing for GMP/GDP inspection.


12.15pm – 1.00pm. Overview of ATMPs, manufacturing and testing:
Robert Smith BSc (Hons), MSc, PgDip, FR PharmS Director Smiro Qualitas Ltd.
• Overview of ATMPs, manufacturing and testing, followed by some of the logistical challenges with these products and the quality challenges including some of the micro challenges
when certifying and releasing batches.

 

1.00pm – 2.00pm. Lunch and Exhibition.

 

2.00pm – 2.45pm. “Challenges for the QP working with ATMPs”: 

Sue Mann Consultancy and QP.
Key points to cover:
• Introduction and role of the QP
• Some key differences working with ATMPs
• Challenges of new guidance e.g. Annex 1 and GMP for ATMPs
• Experiences
• Final thoughts

 

2.45pm – 3.15pm. Afternoon break and Exhibition.

 

3.15pm – 4.15pm. PHSS Initiative preparation of Clarity in GMP Guidance notes:
James Drinkwater Head of F Ziel GmbH GMP compliance and Head of PHSS Aseptic processing special interest group.
Generic GMP guidance and expected revision of Annex 1 for manufacture of sterile medicinal products is considered to have specific topics that require further clarification. In addition
regulatory expectations are also to be considered with reference to MHRA Q&As and MHRA regulatory Blogs. The PHSS have identified (16) specific topics that will benefit with Clarity on
GMP guidance notes prepared by focus groups and with MHRA review before publication. This presentation overviews the sixteen topics that are now under guidance note preparation, including:
1. Assurance of sterility in Aseptic manufacturing of surfaces that contact product contact parts – New and Existing filing lines.
2. Rationale for Environmental Classification, Qualification, Monitoring for Aseptic process filing applications with Barrier technology.
3. Localised uni-directional airflw: L-UDAF as protection from airborne contamination transfer within a classified zone.
4. Leak rates and leak Integrity applied to Barrier Isolator systems.
5. Continuous particle monitoring in controlled areas including GMP compliance monitoring (at 1m3 sample volume) monitored in a 36 minute ‘walking window’ and contamination
event monitoring (at 1ft3 sample volume).
6. Risk assessment in setting EM Sample locations for monitoring during classification, qualification/ process simulations/ Media fills and during routine production operations – applies at design stage of filing lines.
7. Airflow visualisation of uni-directional airflow in GMP controlled zones including barrier systems considering CFD: computational fluid dynamics, Smoke visualisation studies and LR Method (smoke particle challenge with tracking of particle movement via particle counting).
8. Avoiding Wet loads in Moist heat sterilization.
9. Glove management strategy for Barrier system gloves-sleeves as a Life cycle.
10. VHP/vH202 surface Bio-decontamination of loads in Barrier Isolator technology and Material transfer chambers.
11. Definitions of ‘Open and Closed’ applied to Aseptic processing.
12. No-Touch-Transfer: NTT of pre-sterilised containers into Barrier technology following GMP and QRM principles. Rationale for qualification of pre-sterilised containers for NTT applications and NTT in filing lines in aseptic processing.
13. Aseptic Containment Strategy for processing toxic or biologically hazardous sterile products and therapies.
14. Contamination control strategy. Rationale and points to consider in preparation of a Contamination Control Strategy: Annex 1 requirement.
15. Media Fill design. Points to consider.
16. Cleanroom gowning and Cleanroom behaviour. Selection and good practice.

 

Free to members!

 

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 Accommodation at The Hilton Kensington has now been released, please find alternative ways to book accommodation.

 


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