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QUALITY BY DESIGN
An efficient approach to quality design of peptide APIs.
Article by Michael Postlethwaite, Bachem AG
As an organization, we encompass the concept of quality as the core of all our processes and activities as an efficient approach for peptide APIs that is applied in close partnership with our sponsors. It is important that we recognize a formal methodology for the approach of building quality into every project by designing processes following the principles of Quality By Design (QBD). QBD is “A systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and control, based on sound science and quality risk management.” and is encompassed under ICH Q8 At the very beginning of the development lifecycle, the sponsor is involved in discussions and decisions related to the desired product quality. This process builds from the deep foundations of Bachem’s prior knowledge, using our experience to identify risks emerging from the theoretical and early practical design of a manufacturing process. In this stage the first opportunities to understand the relationship between the individual process steps and the product quality target profile arise. At the same time we start to introduce control strategies, or monitoring strategies as appropriate and to place the design of the manufacture onto the correct path. Good examples of this relationship would be the reliance of Identity on SPPS, or purity on the characteristics of the purification process. The journey through development is very well established, starting with feasibility work or transfer from the customer (non-GMP), through early phase GMP work (Phase 1 / early Phase 2), into process validation (Phase 2 / Phase 3) and finally launching into commercial market supply.
The principles of QBD do not stop once a process has been validated for commercial supply. In this phase, the process must be monitored for continuing quality performance, but also subjected to a systematic assessment of potential improvements. This is through a process of Continued Process Verification (CPV), which calls for identification of CAPAs, risks and improvement opportunities through the comprehensive and statistical analysis of data collected through successive manufacturing campaigns. This naturally also provides a continuing increase in the process understanding. In this stage Bachem takes the approach to formulate a CPV plan, written and agreed together with the customer, which defines the monitoring strategy and ensures the process is always optimized. Any actions identified for improvement can be undertaken through a rigorous change control system, maintaining compliance with the quality management systems. Bachem’s approach to Quality By Design starts at the very beginning of the development cycle, and continues as long as we manufacture that product (even after process validation). Science and knowledge are the keystones to adopting and driving process and quality risk mitigation activities. The process is designed around the quality of the material, and is focused on patient safety at all times. We stand by the principle that in partnership with our customers we strive to build quality into each and every stage of a manufacturing process.
What is your official job title at Bachem?
Business Development Manager
How long have you been with Bachem? Where did you work before Bachem?
Bachem for 3 years – First in intercompany projects, then in Project Management and now in Business Development team. Before I worked in GSK & Pfizer UK, and for A*Star in Singapore.
Briefly, what do you do at Bachem?
Responsible for business in the UK (but with extra projects in Europe)
What is your academic background/degrees or training?
BSc and PhD, specializing in Neuroscience
What do you like to do outside of work (interests, hobbies)?
Passionate about old cars, but little time to follow actively. Winter sports and playing music also rate highly. Being from the UK, I can also claim passion for beer tasting.
How is the Marketing & Sales team partnering with their customers?
We work with increasing day-to-day engagement with customers – listening and learning as well as providing interactive advice and service oriented discussion.
How big is the Marketing & Sales team at Bachem and how are they set up?
Like the whole of Bachem, the sales and marketing are growing quickly – we are set up to be very interactive with each other, and this helps us progress our business.
What is your business motto?
Bring engagement and confidence to the product.
Have you had any particular expectation when you came to Bachem and have these been fulfilled?
I expected a collaborative working atmosphere, but the friendliness and helpfulness of everyone far exceeded this.
Do you like to communicate any key message to the reader?
Engagement brings confidence – we can use that to sell our products and services.
What is your preferred peptide?
Being a former Neuroscientist, Ziconitide fascinates me from its mode of action, as it opened a new strategy for management of chronic pain.
Thank you very much Michael.