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Editorial | Open Access | Published 30 September 2021


PHSS Overview of Monoclonal Antibodies (Mabs) Manufacturing process & Challenges for Quality Unit – 28th September Virtual Event Overview

Nammi Lakhani-Short and Tammy Hassel did a great job in 'breaking the ice' in this interactive workshop. Both presenters and delegates were at ease to ask and interact throughout the new format workshop. Areas that were discussed were Overview of different stages involved in manufacturing process, understand the language used in Biologics, understand principles of each stage and challenges faced by Quality unit. and everyone seemed to feel at ease to ask questions. The ppt content was very strong and interesting too. We are hoping this is the start of a series. If you have any ideas on areas that you feel would be best defined and explained to the membership, we are always open to ideas.

PHSS Annual Conference 15th & 16th September 2021– Overview

The 2021 PHSS Annual Conference in association with UCL Q3P was again hosted virtually split over 2 days, bringing 4 SME’s across the two days to share their valuable industry insights and experiences with the delegates from across the industry.

Firstly, we started with the PHSS Students awards, an annual event where we recognise achievements, traditionally from one student per course. However, for 2021 the candidates were of such a high calibre we decided to recognise four individuals. We were delighted to be able to announce 4 student awards for 2021, 2 from UCL, Harry Rush & Loranne Vella-Zahra and 2 from RSSL Shabnum Riaz & Drena Dourado.

The first talk was from Meenu Mathur, Regulatory Scientist from TGA (Therapeutic Goods Administration). Meenu presented on HCT products including blood and blood components - proposed changes to standards and regulatory framework.

Meenu provided thorough insights into the role of TGA, the regulatory pathway and risk-based classification. Moving on to discuss the importance of Post Market Surveillance. We were then stepped through the standards for biologicals and gaps that had been identified. Meenu provided an overview of how the standards were being remade and the assessment that was undertaken to future proof and deliver efficiencies, whilst also endeavouring to align with international best practice. The new structure of the standards was provided and she talked through the risk matrix for Donor Screening requirements, with specific reference to critical considerations by product type. By the end of September the new standards will be live with a 12 month transition in place. Notification will be required to state compliance with new standard.

Our second speaker was Di Morris, PHSS Aseptic Processing SME/Vice-Chair/AstraZeneca Presenting: Risk Assessment in Fast paced environments and considerations made. Another insightful presentation sharing experiences and thoughts as a SME, focused on understanding the misconceptions and myths.

Di provided insights into the Emergency Regulations, which all notified bodies employ to deal with unprecedented situations, clarifying everything that is involved in compliance with emergency regulations. It requires a significant amount of additional governance, dialogue, and scrutiny. The information flow and importance of this being continuous should not be underestimated. Di took the time to recognised industry achievements in managing these unprecedented times over the last 18-20 months. It is simply staggering what has been achieved through collaboration.

Di continued by discussing decision making approach and emphasizing that it should be driven by quality, safety and efficacy, and taking a view of the entire supply chain and distribution. Reference was made to a statement in Annex 15 5.16 ‘strong benefit -risk ratio for the patient’ there is always a patient who’s needs must be considered.

Di went on to highlight key principles of QRM, evaluation should always be conducted based on science and knowledge. Know what you are looking at and take appropriate action to mitigate the risk! Consider risk vs issue; issue has already happened vs risk – a preventable issue. It is vital that we understand our processes.

Moving into day 2, the presentations were led by James Drinkwater – F Ziel Head of GMP Compliance, PHSS Leader of Aseptic processing (including robotics) special interest group Presenting on: Filling ATMPs in Robotics Gloveless Isolator-cells – QRM and challenges.

This is a completely new topic for PHSS and were delighted that James could share such valuable insights. The aim of using robotics is to reduce human interaction and therefore potential errors, however GMP requirements and QRM principles still very much apply. James then went on to discuss the principle needs and challenges associated with robotics in aseptic filling, outlining the flexibility of different solutions based on full or partial automation. Focusing next on considerations for environmental monitoring (EM), robotic placement and location for monitoring positions. Highlighting the need to choose locations based on risk.

‘If an alternative approach is used QRM must apply with alternatives meeting or exceeding the current GMP requirements’

Challenges associated with horizontal UDAF were outlined, looking at design ensuring decisions are made based on data and assessment.

Fundamentally know your process and your associated risks! Mitigate and control risks with deviation detectability and response management.

The second speaker for day two was Tishwant Kanwarjit, Associate Director Quality Assurance & QP /Autolus Ltd Presenting talking about Supply Chain Challenges over the Past 18 months.

Tish provided some invaluable practical insights into his experiences with supplier management over the last 18 months. Talking initially about supplier qualification, what management tools were available and were they fit for purpose? They looked at how they could ensure on-going activities, always keeping the patient in mind and continuity of supply whilst ensuring full GMP & GDP compliance. They developed risk profiles to support this process. They experienced a positive shift in supplier relationships as additional collaboration and transparency was required, particularly moving to more virtual audits. Tish highlighted the importance on cross functional and global teams to enable them to not only continue working but to be as efficient as possible. They worked closely with MHRA throughout to ensure expectations were managed. Challenges associated with GMP inductions were highlighted, and how they overcame them, by pre-recording, making them bite sized (whilst ensuring data integrity was maintained, to cover all the critical elements. Any risk assessments that were undertaken were always cross functional to again ensure enhanced collaboration and sharing learnings across the business.

We would like to thank all delegates for their participation, speakers for sharing their valuable insights & supporting the annual conference, UCL for their continued collaboration and Oxford Biomedica for sponsoring the event.

Jenni Tranter, Chair of PHSS – Pharmaceutical & Healthcare Sciences Society.

PHSS Chair, September 2021