Building agile biopharma manufacturing facilities using PodTech™’s podule™ clusters
In recent years, the world has seen tremendous advancements in biopharmaceutical product development, ease of doing business, clinical trials, expedited reviews, and other aspects that have made it easier for ordinary people to access essential treatments. A column by a biopharma operations subject matter expert (SME) in a digital pharma publication highlighted an important fact – to support these amazing developments in the biopharma world, we need a new manufacturing facility paradigm. One that can simplify and aid rapid product development and launch. One that can make biopharma production more agile.
Prefabricated portable pharmaceutical factories to enable agile manufacturing.
Pharma manufacturing facilities designed as matrices of standard or identical cleanroom elements are crucial to enabling agile manufacturing. Prefab pharma modules—with modules being connectable to one another and designs which allow versatility and simultaneity in operations—are the answer to the increasing need for creating agile manufacturing capacity.
Not only can prefab pharma manufacturing units be built up quickly and efficiently, but the “plug-and-play” and flexible nature of the modules also allows manufacturers to simultaneously manufacture a diverse portfolio of products.
Consider our rapid test manufacturing facility in the UAE. Developed for a leading medical device manufacturer in the Emirates, the facility was designed to produce a wide range of cutting-edge diagnostics. Think hormone marker test kits for HCG, LH, HAV, and IgM; liver disease test kits; tropical disease test kits for infectious diseases ranging from Covid-19 to chikungunya to two types of influenza; respiratory disease diagnostics, tests for non-viral infectious diseases, as well as specialised tests for women’s health, gastrointestinal diseases, inflammation markers, and even sexually transmitted diseases.
This factory of the future comprised only four pods. One utility pod which provided essential utilities, environmental controls, maintenance and repair systems, and other support services. And three production pods to produce and package the company’s diverse product portfolio.
The need for flexible and multipurpose pharma manufacturing facilities.
Production requirements vary through the development, clinical trial, and launch phases of any health product’s life cycle. For this reason, the factories of the future—like our rapid diagnostic test manufacturing unit in the UAE—should be multipurpose in the true sense of the word. They should be capable of producing at the same time multiple products, manufactured using diverse processes and technologies, and at a wide variety of production scales.
This speed, efficiency and agility are particularly crucial today, when climate change is widening the geographical range of many infectious diseases and the threat of pandemics and epidemics still looms over our heads. In his article, the SME we spoke of earlier listed the features that are essential in a facility that truly supports agile operations i.e. operations which can respond to the rapidly-evolving climate and epidemiological circumstances of our times.
To begin with, such a facility must have process type- and scale-agnostic operating areas; think a podule™ cluster by PodTech™, with each podule™ being connectable to every other, moveable skid-mounted equipment to easily shift between process types, and the addition (or removal) of podules™ when the need to scale up (or down) arises.
For a pharma manufacturing facility to truly support agile operations, it must also be able to increase or decrease the number of areas needed to execute a process. It must allow the separation of unit operations when the production process demands it. It should facilitate easy, efficient and safe movement of materials and personnel between pods. The addition or removal of unit operations must not interfere with ongoing operations. There must be options for the transfer of raw, in-process, and manufactured materials between unit operations. Most critically, there should be a way to quickly isolate process failures or potential hazards from other areas and processes.
Achieving agile, flexible, and scalable operations with PodTech™.
At PodTech™, we believe that biopharma manufacturing capacity building should be child’s play. Easy enough that manufacturers can keep up with evolving production demands at different stages in the product development, trial, or market rollout stages. Quick enough to address health and/or humanitarian crises. Efficient enough that even large established pharma manufacturing players can pivot and adapt when they need to.
At PodTech™, we believe that biopharma manufacturing capacity building is for everyone.
That is why we want to bring the plug-and-play biopharma manufacturing revolution to you. We want you—regardless of where you’re located or your desired scale or type of operations—to benefit from our revolutionary prefab portable pharma systems. Podule™ clusters which you can scale quickly and easily to meet your needs.
We want you to leave every small detail to us. Air handling and HVAC, building management systems (BMS), fire protection, internal utility connections, vinyl flooring, double insulation, seismic and weather proof design, and unidirectional or bidirectional personnel and material flow, as you need. The standard inclusions in all our projects comprise not only engineering, automation and project management but also factory acceptance testing, site testing, commissioning, and qualification documentation. As the icing on the cake, we also offer optional technology licenses and tech sharing for fill and finish, inhalation suites, onco and novel products with established manufacturers from around the world.
Democratising access to agile manufacturing.
For us at PodTech™, prefab portable pharma factory systems are crucial for all countries to achieve autonomy in strategic, economic, and public health matters. They are a means to carve out a path to manufacturing self-sufficiency. They are a way for countries that have historically been sidelined or overlooked to gain a seat at the global health table.
We would love for you to change the world with us. Our podules™ have applications across the production of small molecules, APIs, chemicals, biopharmaceuticals, cellular and gene therapies, and vaccines. They are also the ideal solution for rapid response during crises, be they epidemics, pandemics or biodefense situations. Our standard podule™ designs make it even easier for you to get your operations off the ground, whether you’re involved in gene therapies, small scale cell therapies, contained filling areas, inoculation suites, sampling and dispensing, patient recovery, 3D printing and drying, R&D, or diagnostics, labs and testing.
Whatever you want to achieve in biopharma capacity building, we’ve got your back. Reach out today.