Pharma infra: Gearing for new realities

A complex and evolving regulatory landscape, the combined threat of existing and emerging diseases, innovative new technologies, need for agile R&D and manufacturing operational models, etc. are driving pharma and lifesciences companies to take diverse steps to increase their innovation potential, curb R&D and manufacturing costs, improve productivity and reduce time to market. Ramping up their physical and digital infrastructure is a key aspect of this endeavour and this requires careful design, equipment and technology planning and operation strategies.

For instance, animal facilities that are key to accurate R&D results or regulatory compliance of products need to be built by taking into account various aspects like compliance with standards in bioethics, animal and employee welfare, etc.

Likewise, building a combined GMP and bio-containment environment is a multi-faceted undertaking that requires an equilibrium among various sets of requirements like biosafety risk assessment, use of new production technologies, use of modular solutions to ensure GMP and biocontainment, air management systems to maintain hygiene and biosafety procedures, etc.

So, in this article, let’s examine some of the key considerations for the design and construct of multi-product pharma R&D and manufacturing facilities.

Flexibility and adaptability: It has become an imperative for new-age pharma facilities to be agile, adaptable and flexible, be it for research or manufacturing, to get the best outcomes, meet evolving market demands and regulatory expectations. Flexibility includes the ability to expand and allow reconfigurations easily to aid a variety of uses.
And, as companies expand their markets and product portfolios, it has become vital to be efficient and get rid of the need for new facilities for every new product. Thus, these facilities have to be multi-functional and multi-disciplinary, designed and built using optimised layouts and workflows, to encourage innovation, ensure the highest standards of quality and support the shift towards value-based care. As a result, the design of pharma infrastructure too is developing to meet budding demands and trends.

Modern pharma labs and facilities have to be logically laid out and all the resources should be easily available. They have to be modular, flexible and scalable, said SM Mudda, Managing Director, Misom Labs, speaking at the Pharma LabNext Conclave 2021, recently organised by Express Pharma. He added that modern labs handle a lot of potentially hazardous compounds for highly potent drugs. So, lab design has to account for containing them while you’re working in the lab. Likewise, in manufacturing, facility design should assure better controls, quality and safety measures.

Speaking at the same event, Naresh Narasimhan, Principal Architect and Managing Partner, Venkataramanan Associates, explained that designs for labs should not be inflexible spaces that will not be suitable five years later when an organisation’s requirement changes. On the contrary, with the help of a lifecycle cost analysis, they should be modified or built in such a way that they can be refigured quickly to accomodate the extra services that will be needed in the times to come.

He asserted that flexibility balanced with functionality to change the very nature of the laboratory itself, indicating clever engineering, is crucial while designing a lab.

To cite an example, there are pharma R&D labs with movable benches and articulated arms fixed on the ceilings that travel along with the benches to deliver services. The aim is to rapidly and effortlessly restructure a lab to suit the change in workflows and shift to new projects without undertaking huge architectural and engineering overhauls.

Cohesive and collaborative: The lifesciences industry has understood the need to function in a collaborative milieu – both internally and externally. Therefore, apart from optimising cost, resources and technical performance, pharma facilities and laboratories also have to be holistic in design. As open science and R&D partnerships become increasingly important, pharma labs have to facilitate collaboration between individuals and teams, and provide integrated synergies to encourage creativity and innovation that support project goals.

Elaborating on this point, Narasimhan detailed how earlier labs were closed rooms with maybe fire doors or access doors, where each lab did its own thing and the interaction between scientists was fairly minimal. Now, as collaboration increases in the sector, one of the innovations is creating open labs with a lot of glass. Speaking about the work done by his firm, he said, “We put a lot of glass and the desk spaces of the scientists are very close to their workstations so they can move between them very easily. The goal is always to increase output and encourage innovation. We have created a lot of spaces in the laboratories, where scientists from these different disciplines, technicians as well as business leaders are able to meet and exchange ideas easily.”

There are numerous such considerations about design, equipment and operation in new pharma manufacturing plants as well. Next-generation manufacturing, which is expected to be predictive and adaptive, will need design approaches and strategies that enable scalability, flexibility, innovation, quality and regulatory best practices.

Experts also reveal that the growing use of Internet of Things (IOT) in R&D and manufacturing environments are encouraging modular approaches in the design and construction of manufacturing facilities and labs in the lifesciences sector that will break down organisational and informational silos.