BPR: What new products or innovations is your company showcasing at BIO 2024 this year?
This year we are delighted to share our innovative modular rapid bio-decontamination isolator – the bioquell qube. Providing all the essentials in isolation technology to protect critical bio-processing aseptic steps in a plug and play modular isolator which can be scaled up to meet client needs. For example, the bioquell qube is ideally suited to integrate into ATMP processes to help provide a completely enclosed environment, something a biological safety cabinet cannot offer. We will be sharing more details around the challenges of microbial contamination and how they could be addressed in our theatre presentation by Madison Hoal, senior global technical consultant – ATMP track, June 4th at 11:40am).
In addition, we are showcasing our CLEEN digital platform which provides users the connectivity to view key performance indicators to drive productivity and streamline compliance. Our CLEEN modules leverage Ecolab Life Sciences expertise in cleaning and contamination control to support critical quality assurance pillars such as data integrity, procedural compliance and validation processes.
Our current suite of modules are digital logbooks to replace manual transcription of data entries; CIP/COP cleaning validation management tool to automate calculations, generate protocols and reports, store and organize data for audit; and electronic Batch Manufacturing Records (eBMRs). We will also highlight Ecolab’s commitment to life sciences and collaboration through our pharma enterprise solutions team. They will be showcasing their offering across our various solutions to support every step of the drug development journey, as a total solution for Pharma.
BPR: What are you hoping to achieve from the event?
This event provides us with both the opportunity to learn and to share. We are looking forward to making connections with new customers and catching up with our existing partners. We are looking forward to being inspired by the future of biotech and to innovate aligned to the opportunities within the field. The event gives us a great opportunity to share our knowledge, through demonstrations at our booth, through our theatre presentation and through partner meetings that we are available to host throughout the entire event.
BPR: How does your company stay ahead of industry trends and developments in the pharmaceutical sector?
Ecolab Life Sciences has a team of pharmaceutical industry specialists who are connected to key thought leadership groups. Our global technical consultant team and regulatory experts works with these groups to discuss and develop strategies that address the trends developing across the globe. The team uses these insights to provide ongoing customer support, making recommendations to ease through the change control and validation processes required when optimizing operations. In addition, we attend and present at events all over the world to ensure we are at the forefront of challenges and opportunities emerging across the pharmaceutical landscape.
As innovation is at the core of what we do at Ecolab, our global research teams collaborate with customers at our facilities in North America, Europe and Asia Pacific. We take on the toughest challenges with our industry partners to bring innovative solutions to the pharmaceutical sector.
BPR: What challenges are you currently facing in the pharmaceutical market, and how is your organization addressing them?
We are challenged by our customers to ensure they can keep producing their drug products to the highest quality, efficiently and compliantly. To do that, we provide our customers with the resources needed to maintain their operations. Our processes are aligned to their standards, and we think about the security of our supply chain to ensure we deliver. Dual supply is a theme that came about during the Covid-19 pandemic and since then, available supply from different continents has become a major industry priority. The pandemic disruptions highlighted the importance of having suppliers in multiple locations to ensure business continuity.
This approach is essential to overcome regional supply constraints and foster global resilience. With production facilities in both North America and Europe, Ecolab Life Sciences is a key strategic partner for Life Sciences organizations looking for security of supply. The implementation of disruptive technologies into the regulated pharmaceutical market is a key challenge that the industry faces. Collaborating with suppliers to support compliant implementation is an opportunity where Ecolab Life Sciences can provide valuable contributions. We are constantly innovating alongside our partners to keep pace with the new and exciting digital technologies such as AI, smart devices, and predictive analytics, whilst being mindful of the regulatory framework needed to guard the safety and quality of their products.
BPR: What strategies does your company employ to ensure the quality and safety of its customers’ pharmaceutical products?
Ecolab has a long and established track record globally for providing solutions for cleaning, disinfection, and automated bio-decontamination of controlled manufacturing areas and CIP/COP of product contact equipment. Effective cleaning, disinfection and bio-decontamination are critical steps to ensure the safe and effective manufacture of products. We understand the requirements of the Life Sciences industry, our customers, and the challenges they face. We achieve this by engaging a global team of dedicated and knowledgeable specialists with industry background and experience. Additionally, we develop and maintain close partnerships with not for profit and other professional organisations dedicated to the support of research, development, manufacture, and control of pharmaceutical and healthcare Products and medical devices.
BPR: Can you provide insights into any regulatory changes or compliance issues that are impacting your business?
Like many suppliers and manufacturers in the Life Sciences space, Ecolab was paying close attention to the draft changes and then final version of EudraLex Vol. 4 and PIC/S Annex 1. The changes provided clarity and focused attention on the requirement to clean prior to disinfection, manage residues from cleaning and disinfection agents, and to fully understand and validate any dispersion systems in use (misting/fogging). There is now also a clear direction to ensure that reputable suppliers are being used by end users, and that these suppliers have been subject to suitable vendor qualification.
In addition, there have been global regulations relating to the supply of chemicals, including the Biocidal Products Regulations, REACH legislation and EPA requirements that all challenge suppliers with tightening restrictions to ensure that only appropriately registered products are in use, and all safety, efficacy, and labelling requirements are being complied with. As a specialist and experienced supplier, Ecolab Life Sciences has welcomed these changes. By partnering with vendors that comprehensively understand the requirements of the industries they serve, end users can be assured that they are using appropriate products, of the correct and consistent quality, and that continuity of supply can be assured.
BPR: Can you discuss any plans for expansion or market growth in the pipeline?
Whilst Ecolab has been involved in supporting ‘traditional’ pharmaceutical manufacturing for decades, the industry is going through transformative changes – presenting new challenges and demands for suppliers. New technologies, single use manufacturing, and novel processes using modified viruses, mammalian proteins or a patient’s own cells that are modified and returned to them, can mean an entirely new set of challenges.
Ecolab is preparing to meet these needs by ensuring its products, equipment, supporting technical documentation and data are in place to support our customers’ needs. Only by understanding the market, listening closely to the industry and partnering with them, as well as attending events such as Bio 2024 can we ensure that we are meeting this challenge and are ready to support the next generation of medicines.
