What to look for in a prefab pharma factory solutions provider

Setting up a biopharmaceutical manufacturing facility is a significant investment. From acquiring land and building a structure that meets all regulatory standards to equipping it with the right machines, setting standard operating procedures, procuring inputs and training your staff, there’s no dearth of pressures on your time, effort and budget.

Outsourcing an important part of the process – constructing, equipping, commissioning and validating the factory – to a reliable engineering partner is one of the best things you can do. Not only does it free up your time to take care of other business demands but it also gets you access to industry experts. Experts who have worked on other biopharma factory projects and know the ins and outs of getting things done. Experts who bring learnings from other projects to yours.

Selecting the right engineering partner is one of the most important decisions you will make. This decision becomes even more critical when you opt for prefabricated pharma factory construction, given that prefab is still relatively unexplored and prefab for pharma factories even more so.

Given the still-fledgling state of this niche, it is important that you choose a partner with the relevant expertise, experience, capacity and intention. Everything from logistics and regulation to factory assembly and commissioning will be different than it is for traditional construction. There really is no room for error, given that people’s lives and health depend on the products you make.

So here’s the definitive list of things you need to consider before you pick a partner for your journey to set up a biopharmaceutical manufacturing facility.

Expertise.

Naturally, you want to be certain that the company you are partnering with has the relevant expertise. This involves not only expertise in engineering but also in prefabrication and biopharma manufacturing. After all, prefabricated construction is very different from traditional construction. Moreover, the requirements of a pharma factory system are very different from other types of industrial settings. For instance, given high standards of hygiene and product purity in the pharma industry, the factory layout should be such that personnel and material flow must be either unidirectional or bidirectional, as required.

Before you select a company, make sure that the employees on their team have the relevant educational qualifications and industry expertise. Also study their website to understand what type of projects they are equipped to help you with. For example, we at PodTech™ can provide podules™ for many diverse biopharma applications with our expertise demonstrated in the standard podules™ that we have for gene therapies, small-scale cell therapies, contained filling areas, inoculation suites, sampling and dispensing, patient recovery, 3D printing and drying areas, R&D, and diagnosis, labs and testing.

Expertise is of utmost importance because in an industry like pharma, there is no room for error.

Experience.

Speak to the company about their prior projects. Understand what kind of projects they have worked on, the geographies they are comfortable in, the timelines that they can deliver, and the scale of their projects. If it is a new company (as is likely, given that prefab pharma factories have only recently become common), assess the experience of its founders, leadership and product teams. Find out about their prior experience in the biopharma industry – projects they have worked on in other organisations or other companies they own or run in this space. This will give you a sense of the quality and client experience you can expect, helping you decide whether the company is a good fit for you.

Dedicated manufacturing facility.

Determine whether the prefab pharma solutions company you’re considering working with has a dedicated manufacturing facility equipped with all the necessary machinery. If the company engineers and fabricates the factory components, end to end, in their own unit, not only will it give you the benefit of significant time savings but you can also be assured of smoother process flow.

Regions of operation.

In prefabricated or modular construction, factory components are manufactured off-site in a factory and then shipped to the location, where they will be assembled on-site. When you pick a prefabrication partner, ensure that they operate in the region where you want to set up your factory. They should have the delivery, logistics and project management capabilities to deliver what they promise in your location. They should also have an understanding of the business and regulatory environments within which your factory will operate as these factors may impact the design and build of your facility. Finally, your engineering partner should also be capable of building a structure that will stand strong in the face of whatever environmental stresses you face in your region, whether those are extreme heat, heavy rain or any other.

Quality of material of construction.

The quality of the material with which your factory is constructed makes all the difference. It will determine the longevity of your facility. It will determine whether the building poses any risks to your biopharma manufacturing process. It will affect how eco-friendly your factory is. And it will influence how climate-resilient your operations will be.

Newer building materials may be lighter than traditional materials, but may still offer greater robustness. Do your research to ensure that your engineering partner can work with the material that is best suited to your manufacturing process.

Ability to customise.

While repeatable elements play a big role in helping you scale prefab projects rapidly, for some processes, you just need a tailored approach. If a prefab engineering partner can’t customise your pharma factory to suit your specific needs, it’s safe to say that they’re not the right partner for you. Because at the end of the day, it’s your project, your vision; your engineering partner should help you to realise that vision, not limit it.

Project management capabilities.

The work of a prefab pharma factory solutions provider doesn’t end at their factory after the components of your structure are manufactured. They are also responsible for the logistics of delivering the components to your project site and assembling them so that you have a fully functional facility. As such, your engineering partner is not just delivering a product but also implementing a project at your site. Make sure you assess and understand their project management approach and capabilities to ensure that once the project is underway, everything is smooth sailing.

Scope of service.

Sometimes, an engineering partner may only provide support with design and may hire or ask you to hire another organisation for fabrication, logistics and other stages of the process. This becomes tedious and increases the chances of error, so it’s always better to get end-to-end support from the same company. Take PodTech™, for instance. We deliver end-to-end services from automation, engineering and project management to factory acceptance testing, site transfer, site acceptance testing, and qualification documentation. Once you partner with PodTech™, you don’t have to worry about identifying and onboarding other partners – the best way to guarantee full project visibility and glitch-free progress.

Regulatory documentation support.

Setting up a factory, especially in the biopharmaceutical industry, involves engaging with multiple authorities. Since the products that the industry makes have very high stakes in terms of people’s health and lives, you need to ensure that you meet the appropriate standards, get the necessary approvals and have all the documentation to rest assured that you’ve done your job correctly and well.

Beyond factory acceptance testing, site acceptance testing, pre-validation and qualification, you have to get several permits and approvals from the health, industrial, business and environmental authorities in the region.

Regulatory documentation is complex, to say the least. Get a prefab engineering partner who can support you every step of the way. If they also have the networks and relationships to understand new markets and fast-track your approvals and permits, there’s nothing like it!

At the end of the day, your choice of prefab factory solutions provider is your own. It is a crucial decision, but there is no one-size-fits-all answer. Select the partner who does justice to your project requirements while also offering strategic support that can help you succeed in ways you wouldn’t have thought.

At PodTech™, we are committed to mainstreaming prefab biopharmaceutical infrastructure and providing scalable solutions where they are needed most. We look forward to empowering healthcare accessibility worldwide. And we hope that you will join us on this journey.