Biotech facility design However, Environmental Monitoring Systems (EMS)—which track critical parameters such as temperature monitoring, humidity Oct 21, 2024 · Choosing the right building for your biotech company isn’t just about square footage or proximity to major highways; it’s about finding a facility that supports innovation, safety, and growth. Apr 12, 2024 · Biopharmaceutical facility design is a critical aspect of the industry. Read how this lead to high flexibility in Junshi's large-scale biotech plant. In fact, a survey by Dec 1, 2012 · Multiproduct facilities are increasingly integral to corporate biologics network and supply chain strategies. Oct 14, 2025 · Ever wondered what it takes to build a large-scale biotech manufacturing facility? Alfredo Martínez Mogarra, a seasoned Bioprocess Engineer with over 30 years of experience and Chief Operations Manager at VIVEbiotech, reveals the secrets behind successful biotech facility design and scale-up. Jul 28, 2016 · Explore modern facility design options and configurations, and the realities of building a facility around the SUS process technology Since the early 1990s, when the “upstart” biotech industry realized that its future success would be heavily influenced by the ability to manufacture multiple products within the same facility,Hill, D. Overall cost pressures in the global health system, regional requirements to deploy manufacturing rather than centralize manufacturing in one location, technology enhancements in cell biology and format, flexibility to accommodate multi-product campaigns with different production schedules, and speed-to-market are among Facility design and layout should be appropriate for the intended operations (closed vs. IPS is comprised of an integrated team of design professionals and technical specialists with extensive backgrounds in biotechnology, pharmaceuticals, consumer healthcare, and medical device facility design. Manufacturing capacity strategies ensuring appropriate facility design and procedural controls to manage the risks of producing multiple products are critical to the successful deployment of commercial and clinical supply plans. open operations, aseptic processing requirements, multi‐product and manufacturing capacity considerations) We are a specialist biotech construction company. Dec 1, 2012 · A number of recent improvements in the engineering of high-titer expression vectors, in biopharmaceutical process development, and in facility construction have converged to present new opportunities for cost-effective, flexible, biomanufacturing facility construction. Com- Jan 9, 2023 · Discover the latest trends in life science building design with these 10 key features that will shape the future of the industry. The term cGMP means current Good Manufacturing Dec 27, 2023 · Typically, DQ involves three phases in pharma and biotech facilities. End-to-End Services: Turnkey providers manage all aspects, including project management, equipment installation, validation, and training. 9 (1989): 20–6. “Biotechnology Facility Requirements, Part 1, Facility and Systems Design. These systems play a critical role in controlling HVAC, lighting, and energy efficiency, ensuring that facilities operate within optimal conditions. Added to these capabilities is in-depth regulatory compliance with FDA and CBER regulations, and cGMP and Facility design and regulatory framework A key component of process control is facility design and operation. ” BioPharm International 2, no. , and M. This article is the third in a six-part series on how single-use systems are changing the modern biotechnology facility and process design paradigm. Boehringer Ingelheim is one of the leading contract manufacturers of biologics worldwide, with a strong network of sites in Europe and the USA. May 21, 2021 · Consulting with a single-use supplier at the facility design stage will result in better definition of bioproduction space requirements. With many years of experience dedicated solely to the pharma and biotech industry, our broad expertise and interdisciplinary approach to facility design enables us to deliver holistic solutions within: Cleanroom cGMP facilities Biocontainment facilities Active pharmaceutical ingredient (API) facilities Testing and qualification When hiring Apr 5, 2024 · Agile bio/pharma manufacturing facilities utilize multipurpose designs to support diverse unit operations and enhance operational flexibility. How do organizations decide upon the design of biomanufacturing facilities? Are there any guidelines that the manufacturers can follow? What if an organization manufactures several different products in a single facility? NNE challenged Junshi to choose a modular facility design. Dec 26, 2018 · Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. Incorporating Security Into Controlled Substance/Biotech Facility Design For most organizations, security is primarily focused on protecting one or more facilities and all people and data from physical and cyber intrusions. . Jun 23, 2016 · Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies. We provide solutions ranging from conceptual planning to full service (engineering, procurement, construction management, and validation) in the life sciences industry. Discover how modular design, smart technology and stronger regulatory collaboration are transforming biomanufacturing into agile, data-driven environments ready for the next generation of therapies. In a fast-evolving industry where breakthroughs in medicine and technology hinge on controlled environments, getting the space right could make or break your company’s success. Dec 26, 2018 · This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance. Sep 10, 2018 · Key Biotechnology Lab Design and Facility Management Considerations Whether a lab is being designed to focus on biotechnology, energy, specialty chemicals, or pharmaceuticals research, effective lab design and facility management are critical. In the UK, these regulations are guided by the Medicines and Healthcare products Regulatory Agency (MHRA) and align with EU GMP guidelines. Over the years, we’ve successfully worked with large and small clients in designing and constructing biomanufacturing facilities and sites that meet clients’ product process flows. Engineering, architectural and construction solutions for flexible, efficient facilities in the rapidly evolving biotechnology industry. Our experience includes the design of traditional biotech facilities as well as Advanced Therapy ones. Nov 23, 2013 · Expansions and renovations to existing biological facilities, and construction of new facilities, provide a unique opportunity to rethink basic design strategies and use new technologies to build a better facility that will improve compliance. Feb 20, 2025 · GMP or Good Manufacturing Practice regulations for pharmaceutical and biotechnology facility design are crucial to ensure manufactured product quality, patient safety, and compliance with regulatory standards. Since the market's inception, we have designed or built more than 75 biotech facilities that produce more than three-quarters of today's biotech sales. It covers considerations for airflow design, material and personnel flows, HVAC criteria, and regulatory compliance. Design Qualification (DQ) is a documented process in the pharmaceutical industry that systematically demonstrates and ensures that a particular equipment design meets the pre-established requirements and intended purpose. By incorporating flexible design features in initial facility construction, biotechnology companies can move from pilot to production operations and market entry in a timely and cost-effective manner. Our international team of biomanufacturing & biotech experts design and construct facilities. Biotechnology companies are consistently looking for ways to reconcile an uncertain demand profile created by an ever-changing product pipeline against an existing manufacturing capacity. org Sep 24, 2024 · In this guide, we'll explore how to craft a state-of-the-art biotech laboratory design that meets the needs of modern researchers while optimizing space, workflow, and productivity. O’Neal provides total solution biopharmaceutical projects offering full-service site evaluation, master planning, architectural design, engineering, procurement, and construction capabilities for GMP manufacturing, research and development, process support, facilities, and utilities. Because only a small fraction of products ever make it to market, biotech manufacturers must find ways to minimize their risk by deferring their investment in additional capacity until absolutely necessary Oct 20, 2025 · Pharma and Biotech Facility Design - SpecPulse – Issue #5. Decades of Experience In the Life Sciences Market We're proud to have partnered with the nation's top-5 biotechnology and top-5 pharmaceutical companies. DPR is leading the way in building advanced Research & Development, cGMP manufacturing and individualized medicine therapeutic facilities. Beatrice. Kaiser Global Engineering designs, supports construction, and inspects technically complex facilities worldwide. Jun 6, 2025 · Explore biotech facility design best practices, cleanroom strategies, and modular solutions that support growth, flexibility, and regulatory success. The concept of a multi-product manufacturing facility for biological products is not new,7 and the advent of this type of facility has been a boon to the biotechnology industry. Ballroom single-use biomanufacturing design Lessons learned from implementing a modified ballroom concept and points to consider for your facility design Hixson’s Comprehensive Approach to Pharma & Biotech Facility & Lab Design At Hixson, we’ve been designing and engineering cGMP spaces for over 50 years…and we use this accumulated knowledge and experience for the benefit of our pharmaceutical and biotech clients. New GMP Allogeneic cell therapy manufacturing facility incorporates a state-of-the-art, fully-electric design. The module models the best practices by examining a food science facility, a vivarium facility, an academic research building, and a commercial biotech lab space. The facility's design is based on NNE’s Bio on demandTM concept. We can work with you to develop a next-generation biotech facility design that is cost-effective and responsive to a diversified product line. The evolution of requirements M ultiproduct facilities are increasingly integral to corporate biologics network and supply chain strategies. Projects Biotech cGMP facility to support Chinese growth plans Boehringer Ingelheim builds its first biotech facility in Asia. See full list on ispe. The number of biologics approved for therapeutic applications and clinical trials […] The document discusses the design of biotech manufacturing facilities. Module Three – Case Studies This module employs four case studies to illustrate the principles of current and future practices for the design and construction of research facilities. the quest for flexible manufacturing assets Sep 30, 2024 · Turnkey solutions provide a comprehensive approach to setting up a biotechnology facility, covering everything from design to commissioning. Feb 24, 2025 · In pharmaceutical and biotech facility design, Building Management Systems (BMS) are often a top priority from the outset. It also provides examples of biotech plant designs in Puerto Rico and Ireland and discusses lessons learned from expanding an existing biotech facility, including issues with material handling, maintenance Biotechnology Fluor designed and constructed the world's first biotech manufacturing facility for Genentech back in 1982. With biotechnology facility design expertise and the ability to mitigate risk through facility programming, layout and technology selection, O’Neal can deliver a range of capabilities to fit your needs and budget. Success lies in early coordination across process, utilities, validation, automation, and infra. This article describes a 30,000 ft2 facility designed to accommodate phase 1, 2, and 3 clinical trials. Pharma facility design is one of NNE's key services. yud40 ga2asb wjr tc kk0 xhl9rf qyfghje ycfodcr 1osw3j 3ke