HIPRA Biotech Services, a Contract Development and Manufacturing Organization (CDMO), boasts more than 50 years of scientific and technical experience and offers comprehensive contract development and commercial manufacturing services in a range of biologics technologies and modalities. Because reliable access to essential medicines depends on manufacturing infrastructures designed for flexibility, redundancy, and rapid scale-up, HIPRA has spent decades refining these capabilities across a network built to support highly variable vaccine demand and multiple technology platforms.

In this conversation with Contract Pharma, Eduard Viladesau, Managing Director, HIPRA Biotech Services, highlights how the company brings engineered flexibility to the CDMO market, offering biopharma companies a partner with deeply integrated facilities, standardized modular designs, and a workforce trained for agile biologics production. He discusses lessons learned from the COVID-19 pandemic, supply chain risk mitigation, redundancy as a driver of agility and more.

Contract Pharma: What are the most important lessons HIPRA Biotech Services took from the COVID-19 pandemic and how has HIPRA translated those lessons into tangible changes?

Eduard Viladesau: The three main lessons we took from COVID-19 were:

1. The need for highly accelerated development processes
2. The need to ensure access to critical raw materials and components
3. The need for facility and equipment design that accommodates significant swings in demand in the short term and a high level of redundancy and modularity

On the first point, we redesigned our development processes to significantly accelerate the time from antigen/recombinant molecule design to drug product vial by incorporating exclusive equipment and highly tailored processes in order to meet the stringent timelines of pandemic or critical drug demand preparedness, in the context of the EU’s “100 day mission.” This approach was recognized by the EU including us in the SPEEDCELL program.

On the second point, since COVID-19 we have adopted a systematic review of all critical components and raw materials in the supply chain, secured local/regional suppliers wherever possible, and implemented other mitigation measures including multi-sourcing and strategic stocks.

On the third point, our facility design philosophy, even from before COVID-19, was already very well suited to these requirements. All our facilities feature a high level of modularity and redundancy:

• We start doing the engineering years ahead of demand (during design phase). We design the internal spaces and facility infrastructure so that they can be gradually fitted, initially via unprogrammed expansion spaces that can be built out without disrupting other production as demand increases.
• We have multiple suites with platformed layouts and equipment, each with independent material and personnel access, as well as dedicated HVAC systems.
• Within each suite, we have multiple reactors that can be run in parallel on the same or different products, using single-use technologies and Clean-in-Place/Steam-in-Place (CIP/SIP) to virtually eliminate the risk of cross-contaminations.

Our capabilities on the second and third points have been recognized by the EU’s Health Emergency Preparedness and Response Authority (HERA) by making HIPRA part of EU-FAB, a framework that defines a European network for sufficient and agile manufacturing capacities for pandemic preparedness. HERA’s selection highlights that HIPRA is valued for its vast experience in a wide variety of recombinant protein vaccines and state-of-the-art development and manufacturing facilities.

Contract Pharma: Many CDMOs talk about flexibility, but HIPRA emphasizes engineered flexibility. What does that mean in practical terms, and how is it embedded into your facilities and processes?

Viladesau: In our development facilities encompassing R&D, process and analytical development, we have partnered with OEMs of high-throughput screening equipment to customize their designs to enable even faster cell line development and process optimization than commercially available. We have also entirely redesigned our internal processes to make the most of these capabilities and shorten the cell-to-vial timeline to the limit of what is possible in biological processes.

In our GMP Manufacturing facilities, modularity, flexibility and agility are embedded in our facility design and operation. We have our own internal engineering team who draw on 50 years of experience and lessons learned in facility design, automation and utilization, coupled with strategic partnerships with top OEM manufacturers for critical equipment that ensures our most recent facilities feature a state-of-the-art design that is highly aligned with our standard equipment platforms and adaptable to our automation and debottlenecking approaches.

With highly modular layouts, preset expansion spaces, platformed suites and equipment, independent material and personnel access, dedicated HVAC systems, and wide adoption of single use technology, we are uniquely able to tailor processes, enable parallel operations, dramatically reduce cross-contamination risks and achieve world-class batch success rates.

Contract Pharma: How do you balance flexibility with regulatory rigor, especially when facilities are designed to support multiple products, platforms, or rapid changeovers?

Viladesau: It mainly comes down to how we approach CDMO project management and set up of the project team that collaborates with the CDMO client. Quality and regulatory experts are embedded in our CDMO project management core teams from the start. This ensures that all processes and products always uphold the highest standards on both fronts with clear line-of-sight to any risks and mitigations that could impact our GMP facilities. These experts represent our more than 30 years of successful GMP certifications and regulatory authority inspections from numerous health agencies.

In addition, the project management team includes Process Development and Manufacturing technical experts, who inform each CDMO project to enhance the robustness and fit-to-platform of tech transferred processes, including striking a balance when facility adaptations may be needed to expand our capabilities or if additional process optimization might be recommended. The combination of quality, regulatory and technical expertise continuously involved in the client project lifecycle and setting up efficient communication pathways with our clients strengthens our support model and ensures we provide rigor in all areas that lead to successful manufacturing and regulatory scrutiny.

Contract Pharma: How does redundancy contribute to both agility and reliability?

Viladesau: On the one hand, our facilities and each suite within them, are designed with a similar design concept and layout. On the other hand, we use platform equipment (i.e. a small variety of equipment models from a select set of top strategic partner OEMs), and in each suite we install multiple of those. We segregate each suite’s materials and personnel access as well as HVAC, and we use single-use technology and CIP/SIP systems. Combined, these factors mean that we are able to run several products in parallel in several reactors (in the same or different suites), giving us great flexibility while ensuring we avoid cross-contaminations – supporting short term agility.

At the same time, we have a high level of redundancy ensuring that even if there is an issue in a reactor or suite, the others are still operational – supporting reliability. Our mid-term agility is further bolstered by our modular facility design and preset expansion model that give us a degree of optionality for expanding capacity or adding new capabilities and platforms when they make sense.

Contract Pharma: HIPRA emphasizes close integration between development, GMP production, and logistics. How does this integration accelerate timelines for clients?

Viladesau: We draw on 50 years of experience developing our own biologics products end-to-end, coupled with our recent experience in COVID-19 in fast development-to-manufacturing approaches. In addition, our portfolio of products and the various platforms we are familiar with span over 15 types of expression systems and over 300 biological entities. We feel we offer unique value for our CDMO clients, because they have a partner in us who can create solutions and advise industrialization of their product from our own extensive depth and experience.

During development, we apply the technologies and processes established during COVID-19 to deliver rapid cell line development, process development, and optimization for our clients. We combine this with our extensive industrialization and scale‑up experience from the earliest stages of process development, enabling us to guide our clients toward effective process design choices and ensure a smooth transition to industrial‑scale manufacturing.

Finally, our development and manufacturing teams are located near each other and work hand-in-hand during the initial stages of industrialization, ensuring immediate feedback and troubleshooting to ensure the smoothest possible transfer and scale up.

Contract Pharma: Beyond infrastructure, how do you train and structure teams to support agile manufacturing?

Viladesau: Workforce readiness is absolutely critical to our success. We invest heavily in preparing and accelerating skilled employees for rapid deployment. Through our dedicated on-site training center, teams work in simulated production environments to build technical capability and reinforce aseptic behaviors.

Operators must demonstrate competency through a formal qualification process before entering GMP areas. We specialize training by technology platform and area to gain familiarity, repetition and minimize mistakes. Once operators complete the qualification, they are allowed into the productive environment where they continue learning from more experienced operators and supervisors. Given our infrastructure is set up around platforms and modular equipment, we have significant critical masses of highly trained team members in each of them, enabling good load balancing between areas of the same type to support agile manufacturing.

Contract Pharma: From facility design to daily operations, what sustainability principles are built into HIPRA’s biomanufacturing infrastructure?

Viladesau: We are following a company-wide sustainability and decarbonization program geared towards achieving significant reduction in our energy and water consumption, as well as our emissions, over the next 10 years.

Already today, our facilities are designed to minimize water usage (for instance, our use of single-use equipment wherever possible) and generate as much renewable energy as possible (e.g. most of our buildings feature roofs covered in photovoltaic panels). We have also deployed a substantially electrified car and truck fleet for local transit, and designed products to reduce plastic usage (for instance, our use of folded carton trays rather than plastic trays in secondary packaging).

Contract Pharma: What investments will be most critical for sustaining flexibility over the next 5–10 years?

Viladesau: In terms of technology infrastructure, at our 200,000 square meter Campus HIPRA in Aiguaviva, in addition to the already-commissioned R&D and Microbial DS facility at that location, we are building the next set of plants and capacities to support our growth for the next 10 years. This includes a new state-of-the-art Mammalian DS facility, built following the same principles of flexibility, agility and reliability of our existing facilities, but enhancing it with up to 2,000L scale single-us bioreactors (SUB).

The first phase of the facility, once fully equipped, includes 6x 500L SUB and 6x 2,000L SUB plus corresponding downstream equipment, with reserve space for additional 1x 500L SUB and 2 x 2,000L SUB. The campus master plan also includes an expansion to the R&D building, a new QC building, new Master Cell Banking and Working Cell Banking facilities, a new PFS Fill-Finish building, as well as associated warehousing and logistics capacity. Overall, the new campus will see a €500+ million investment over the next 10 years.

From an organizational perspective, our team is growing by 10%+ per year, adding more than 200 highly qualified roles in R&D, Operations, Quality and Regulatory per year. We are also incorporating AI into our workflows in the context of a company-wide digital transformation that is also rolling out next generation MES (Manufacturing Execution System) and LIMS (Laboratory Information Management System), in addition to leveraging AI-based tools to improve communication, data management and documentation for CDMO client projects.

Contract Pharma: As HIPRA Biotech Services continues to expand its CDMO offering, what are the most important priorities shaping your strategy over the next few years?

Viladesau: Our top priority is to provide excellent service to our clients, which is why we prioritize investing for long-term partnerships and ensuring excellent delivery in focused biologics platforms, over fast growth at any cost or dispersion over too many platforms. We believe we can be of most value to mid-sized biotechs and pharma companies that can benefit from our scientific and technical excellence, grounded in our 50 years of experience in biologics and delivered through our state-of-the-art facilities and quality culture. In addition, we prioritize innovation and capacity investment, which will lead to enhanced offerings, timelines and availability for the biotech market as it grows for the foreseeable future.