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4 Key Factors to Consider During the Design Process in Aseptic Manufacturing

Demand for the design and development of specialist aseptic manufacturing solutions is being driven by the significant growth in biological drug pipelines, the trend towards personalised medicines, increased out-sourcing of drug development and manufacturing and an ageing population with increasing life-expectancy. In addition, customers are experiencing increasing competition and growing pressures to find cures for cancer, dementia and other diseases which drive significant cost and pressures on our global health services. Consequently, there are growing demands for new manufacturing processes to develop and produce sterile drugs faster and at lower cost.

In this 2nd article in our series on Aseptic Manufacturing, we talk about the Design Process, and encourage the reader to consider what wider objectives the design process should set out to achieve for a new aseptic manufacturing challenge, whether for liquid filling, powder filling or device development, the same questions apply. 

1.     Design for De-Risking

One of the most critical objectives during the design process is to develop and de-risk the core aseptic processes involved in manufacture. From a machine and equipment perspective, it is important to specify and design equipment which will provide agility and flexibility to quickly accommodate changes in the properties of the drug (e.g. viscosity of liquids, powder flow properties etc) and in the design of the primary drug container (PDC) itself (e.g. size, shape, material selection etc). The machine must be capable of supporting the definition of the ‘Critical Quality Attributes’ (CQA) of a medical device or PDC, then based on this must perform aseptic processes that can be measured, with ability to define and record the ‘Critical Process Parameters’ (CPPs) necessary to achieve the CQA’s of the product. An important requirement directly related to the CPPs is the capability to explore tolerances and sensitivities of the process in order to ensure that necessary process control is defined and understood.

2.     Design for Demonstration

If you are at the early stages of a drug or device development, the initial focus will typically be on getting the product into clinic, targeting ‘First-in-human’ Phase 1 trials followed by higher volume manufacture for Phase 2 clinical trials. 

If a customised or specialist process is required for filling or manufacture, it is well worth considering ‘who else needs to see the process’ as you move through the product development cycle. Is the equipment just for internal or R&D use? Do you need to show this process to potential customers or regulators to pave the way for sales and regulatory approval? Do you need to persuade internal or external stake-holders before they decide on the next stage of funding for a new venture? Do you need to convince a sterile CMO or CDMO before they agree to help with manufacture of your product? Who are the other stake-holders you need to ‘keep onside’ to maximise the chances of success? 

Knowing the answers to these questions will help inform the early-stage specification of the machine; For relatively small changes in cost, it may be possible to design and build a solution that will not only develop and de-risk the manufacturing new process, but also provide a professional ‘show-case’ to customers, partners and stake-holders; Being able to demonstrate that you know how to fill and manufacture your medical device using process-representative equipment is invaluable to build customer confidence, secure regulatory support, produce GMP quality samples and ultimately sell your product (drug and/or device) to the market. 

3.     Design for Industrialisation

Always a lively topic with any new product; How many can we sell and how fast do we want to be able to make them?

These questions are typically impossible to answer in the early stages of a project due to many unknowns. The challenge is therefore defining aseptic manufacturing processes which can be quickly and economically ‘scaled-up’ or ‘scaled-out’ when the time is right. The design of scalable aseptic processing equipment is a core skill at 3P. How a product can be made in high volumes should be considered in the earliest stages of the product life-cycle as this will help inform costs, timescales and ultimately the business case for further investment. There are several factors to consider. Is it easier and faster to ‘scale-out’ with multiple lower-speed machines, or is it better to go for a single, high-speed machine? How much of the process should be automated? Can we easily recruit and use people to operate the machines? Which processes will the regulator insist we automate?  Choosing the right kind of automation partner is a critically important decision; Look for a partner who will probe and challenge with these kind of questions and who can generate options for consideration. Look at their track-record for industrialisation of other products; Do they have the experience and knowledge necessary to support you? 

4.     Design for Production; Satisfying Market Demand

Once manufacturing capability is in place, it is important to ensure that production capacity can match market demand. Previous consideration and planning regarding ‘scaling up’ (increasing the throughput of an aseptic manufacturing process) versus ‘scaling out’ (multiplying the number of machines or production lines) can be implemented. In addition, earlier-stage thinking will have considered the potential requirement to quickly and cost-effectively introduce new product variants, such as different drug doses and new device derivatives, on the same machine platform, without needing to buy new machines. 

In conclusion, choosing an automation partner with strong, well-established design processes and capability is fundamental to the success of your aseptic manufacturing project.  Look for a partner who can support the total life-cycle of the product; who can design and manufacture the appropriate type and scale of equipment, from bench-top and lab-scale equipment for R&D and early clinical manufacturing, through to pilot-scale and full-scale production lines for high-volume production. At 3P, we typically design and manufacture aseptic equipment which can be installed in existing hard-wall or soft-wall isolators, providing cGMP manufacturing capability from the earliest stages in the project.

Finally, the ability to scale up aseptic production without changing the core process is an essential factor to consider in pharmaceutical and medical device manufacturing and is typical of our approach and design philosophy at 3P. 

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