Aseptic Processing in Manufacture of Sterile Products & ATMPs
Aseptic Processing in Manufacture of Sterile Products & ATMPs

Course Description

There is a significant increase in Aseptic processing as more and more products and advance therapies are developed with biological mechanisms that are impacted by Terminal Sterilisation. The revision and implementation of EU GMP & PICS Annex 1 has significantly impacted Aseptic processing; in design, control, qualification, monitoring and product testing.  

It is important to understand the international significance and impact of Annex 1 and ICHQ9(R1) revisions. PICS has 52 active members, including the US FDA, and now we are starting to see regulatory observations and citations considering requirements of Annex 1 and implementation of enhanced QRM principles. Add to that the requirement to complete Contamination Control strategies that cover all (16) elements detailed in Annex 1 for all products and all processes; specific CCSs not generic the impact is high.  

This 3-day online training will cover the key CGMP regulation revision that impact Aseptic processing providing essential knowledge to meet compliance. Details will be provided of manufacturing technologies to improve efficiencies and GMP compliance together with guidance on how to prepare a Contamination Control Strategy (CCS) and if required aseptic-containment strategy. The training extends into process operations covering best practices; Good aseptic technique, good Cleanroom behaviour together with good training practices (including increased use of VR (virtual reality).

The connection between Control Strategies though CMC and GMP, including Cross contamination Control strategies will be discussed for ATMPs and Biologics. Small and large molecule processing will be considered in downstream processing where bioburden control applies and connection to Aseptic process with Fill and Finish in different dose form.

  • GMP regulation changes and their impact on Aseptic processing
  • QRM what this really means and how it is applied
  • Connection of CMC, GMP and Cross Contamination Control strategies
  • Contamination Control Strategy (CCS) and considerations in aseptic processing
  • Barrier separation technologies, alternatives for aseptic processing of different product types e.g. Pharmaceuticals, Biologicals, ATMPs and Toxic products – small and large batches
  • Application of single use systems, RTU: Ready to Use product containers and closures in barrier technologies considering transfers into Grade A and bio-compatibilities
  • Application of large batch vial filling for liquid and freeze-dried products considering environmental zoning in transfers, application of UDAF, localised UDAF and Grade A air supply plus the surrounding environment
  • Integration of automation with GMP compliance in manufacturing environments
  • How to apply EM and PM as measures of collective effectiveness of contamination control measures
  • Digitalisation of data, data analysis/ trending and data to support batch release
  • Future trends in aseptic processing 

Changes in regulations and new GMP requirements challenge all industries but also considering the growth in biologics/ ATMPs for more targeted personalised/ individualised medicines and the paradigm shift away from big ‘block buster products’ the need to understand aseptic processing and regulatory expectations has never been more current. Vaccines have become a new ‘Block buster’ manufactured at large batch scale that use biologics requiring aseptic processing with high efficiencies provided by automation.

New aseptic processing platforms are following five ‘pillars’ that characterise an advanced approach, including: Flexibility, Modularity, Intensification, Digitalisation and Automation.

  • Flexibility is required for adaptive approaches as new products are developed and different dose forms and presentations may be required. Flexibility applies in process design to combine closed systems (single use systems) with barrier technologies that are required in more open aseptic processing steps e.g., Filling – container closing.
  • Modularity is required to enable pre-designed modules to be configured to meet different product and manufacturing platform requirements. The pre-design element is a cost and time saving facilitating faster project delivery and reduced time to market.
  • Intensification is the combination and integration of process steps to increase efficiencies, reduce manufacturing space, typically specific manufacturing platforms are intensified in one GMP Cleanroom to reduce in-process transfers and improve contamination control. Scale up and Scale out applies to facilitate commercialisation.
  • Digitalisation applies through the complete process in control and monitoring. Process controls, process variables including critical process parameters (CPPs) are characterised as a ‘digital twin’ to the manually applied process and process monitoring data (EM and PM) as digital formats facilitate more real time proactive responses to deviations and efficient and assessable/ visible trend metric analysis that can drive continuous improvement.
  • Automation to improve process efficiency and repeatability over manual processes (avoiding human error) and improved contamination control (avoiding interventions). GMP guidance cannot be prescriptive for all processes and products so applying QRM to accommodate alternative processes has become key to introduction of new technologies and methods that are developing to support new product bio-processing and manufacturing – learn about these challenges and practical experiences via case studies.

Aseptic Processing in Manufacture of Sterile Products & ATMPs

October 28 - 30, 2024, Live Online Training
$2,250
James L. Drinkwater

James L. Drinkwater is the current Head of GMP Compliance at Franz Ziel Germany. James is based in the UK for the global role and separately supports the Not-for-profit society: Pharmaceutical and Healthcare Sciences Society: PHSS an educational platform in GxP. James is the ex-Chairman (10 years) of the PHSS and currently Co-leads the Annex 1 and CCS Guidance focus groups.

START TIMES

10:00 AM New York time

7:00 AM Los Angeles time

2:00 PM London time

3:00 PM Vienna time

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Course Description

There is a significant increase in Aseptic processing as more and more products and advance therapies are developed with biological mechanisms that are impacted by Terminal Sterilisation. The revision and implementation of EU GMP & PICS Annex 1 has significantly impacted Aseptic processing; in design, control, qualification, monitoring and product testing.  

It is important to understand the international significance and impact of Annex 1 and ICHQ9(R1) revisions. PICS has 52 active members, including the US FDA, and now we are starting to see regulatory observations and citations considering requirements of Annex 1 and implementation of enhanced QRM principles. Add to that the requirement to complete Contamination Control strategies that cover all (16) elements detailed in Annex 1 for all products and all processes; specific CCSs not generic the impact is high.  

This 3-day online training will cover the key CGMP regulation revision that impact Aseptic processing providing essential knowledge to meet compliance. Details will be provided of manufacturing technologies to improve efficiencies and GMP compliance together with guidance on how to prepare a Contamination Control Strategy (CCS) and if required aseptic-containment strategy. The training extends into process operations covering best practices; Good aseptic technique, good Cleanroom behaviour together with good training practices (including increased use of VR (virtual reality).

The connection between Control Strategies though CMC and GMP, including Cross contamination Control strategies will be discussed for ATMPs and Biologics. Small and large molecule processing will be considered in downstream processing where bioburden control applies and connection to Aseptic process with Fill and Finish in different dose form.

  • GMP regulation changes and their impact on Aseptic processing
  • QRM what this really means and how it is applied
  • Connection of CMC, GMP and Cross Contamination Control strategies
  • Contamination Control Strategy (CCS) and considerations in aseptic processing
  • Barrier separation technologies, alternatives for aseptic processing of different product types e.g. Pharmaceuticals, Biologicals, ATMPs and Toxic products – small and large batches
  • Application of single use systems, RTU: Ready to Use product containers and closures in barrier technologies considering transfers into Grade A and bio-compatibilities
  • Application of large batch vial filling for liquid and freeze-dried products considering environmental zoning in transfers, application of UDAF, localised UDAF and Grade A air supply plus the surrounding environment
  • Integration of automation with GMP compliance in manufacturing environments
  • How to apply EM and PM as measures of collective effectiveness of contamination control measures
  • Digitalisation of data, data analysis/ trending and data to support batch release
  • Future trends in aseptic processing 

Changes in regulations and new GMP requirements challenge all industries but also considering the growth in biologics/ ATMPs for more targeted personalised/ individualised medicines and the paradigm shift away from big ‘block buster products’ the need to understand aseptic processing and regulatory expectations has never been more current. Vaccines have become a new ‘Block buster’ manufactured at large batch scale that use biologics requiring aseptic processing with high efficiencies provided by automation.

New aseptic processing platforms are following five ‘pillars’ that characterise an advanced approach, including: Flexibility, Modularity, Intensification, Digitalisation and Automation.

  • Flexibility is required for adaptive approaches as new products are developed and different dose forms and presentations may be required. Flexibility applies in process design to combine closed systems (single use systems) with barrier technologies that are required in more open aseptic processing steps e.g., Filling – container closing.
  • Modularity is required to enable pre-designed modules to be configured to meet different product and manufacturing platform requirements. The pre-design element is a cost and time saving facilitating faster project delivery and reduced time to market.
  • Intensification is the combination and integration of process steps to increase efficiencies, reduce manufacturing space, typically specific manufacturing platforms are intensified in one GMP Cleanroom to reduce in-process transfers and improve contamination control. Scale up and Scale out applies to facilitate commercialisation.
  • Digitalisation applies through the complete process in control and monitoring. Process controls, process variables including critical process parameters (CPPs) are characterised as a ‘digital twin’ to the manually applied process and process monitoring data (EM and PM) as digital formats facilitate more real time proactive responses to deviations and efficient and assessable/ visible trend metric analysis that can drive continuous improvement.
  • Automation to improve process efficiency and repeatability over manual processes (avoiding human error) and improved contamination control (avoiding interventions). GMP guidance cannot be prescriptive for all processes and products so applying QRM to accommodate alternative processes has become key to introduction of new technologies and methods that are developing to support new product bio-processing and manufacturing – learn about these challenges and practical experiences via case studies.

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Aseptic Processing in Manufacture of Sterile Products & ATMPs

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