This Year's Sponsors

Platinum Sponsors

MasterControl, Inc.

MasterControl Inc. is the leading provider of cloud-based quality and compliance software for life sciences and other regulated industries. Our mission is to help our customers to bring life-changing products to more people sooner. Use the MasterControl Manufacturing Excellence? solution to digitize and automate manufacturing data to help you reduce errors and accelerate product release times – thereby delivering immediate, measurable value to your business. Join over 1,000 companies worldwide that use our solutions to achieve new levels of excellence across product development, clinical trials, regulatory affairs, quality management, supply chain, manufacturing and postmarket surveillance. Learn more at www.mastercontrol.com.

Project Farma

Project Farma is an industry leader in providing project management, validation, engineering and consulting services with a proven track record in gene and cell therapy. We partner with gene and cell therapy organizations in addition to healthcare, pharmaceutical, bio-pharmaceutical companies to support finding ground-breaking treatments and solutions. Our gene and cell therapy clients include early stage startups, establish cell and gene therapy companies and CMOs / CROs. We are committed to helping advance cutting-edge medicines by leveraging our deep knowledge and broad experience in cell and gene therapy to meet any new challenges.

SmartLabs

SmartLabs provides teams of all sizes enterprise-grade labs customized within weeks for any stage of research or modality and can be reconfigured within days as your research evolves. Outsource your infrastructure and avoid the extensive costs of traditional lab builds while your own teams accelerate your research in a private lab.

Gold Sponsors

Anaplan, Inc.

Anaplan transforms the way you see, plan, and lead your business. By dynamically connecting financial, strategic, and operational plans in real time, Anaplan gives you the power to anticipate change, address complexity, and move at market speed. Anaplan’s Connected Planning platform lets you view and contextualize current performance, forecast future outcomes to fuel growth and mitigate risk, and optimize costs so you can make faster, more strategic decisions. Anaplan helps more than 2,400 market-leading customers in over 50 countries navigate their daily planning challenges with confidence.

Silver Sponsors

AbbVie

AbbVie Contract Manufacturing partners with companies across the globe to develop, scale and manufacture pharmaceutical products and bring them successfully to market.

Drawing on more than four decades of success as the manufacturing division of AbbVie, we have the depth of experience and the technical knowledge to navigate issues and deliver the innovative solutions customers need. We are much more than a CMO – we are your partner for success.

With foresight, scientific expertise and passion we anticipate the technical and compliance challenges along the entire pharmaceutical development journey through to commercialization. We see the complete picture to deliver our customer’s vision.

With full access to global state-of the-art facilities and world-class talent, our customers have come to depend on our service and quality to deliver real-world results.

Compliance Architects LLC

Compliance Architects LLC delivers high-value compliance, quality, and regulatory consulting services to companies directly regulated by the U.S. FDA and other global regulatory authorities. With capabilities ranging from quality systems implementations to audits, inspection readiness, enforcement remediation, and outsourced compliance services, Compliance Architects LLC has the experience, expertise, and delivery capability to significantly improve your company?s business outcomes. Jack Garvey is CA?s founder and CEO, a chemical engineer and a practicing regulatory attorney, and has spent his entire career helping companies navigate the challenges at the intersections of science, engineering, business, and law.

Dot Compliance

Dot Compliance is the first ready-to-use, AI-powered eQMS for Life Sciences.

Packed with generative AI capabilities, Dot Compliance’s eQMS enables pharmaceutical, biotechnology, and medical device manufacturers to deliver to market quickly and cost-effectively.

Dot Compliance is trusted by many life sciences companies worldwide and is fully compliant with 21 CFR part 11, EU-Annex 11, and supports ISO 9001, 13485, 14971, and 27001.

Emerson Automation Solutions

Reduce Time to Market, Lower Costs and Increase Operating Efficiency From medication to devices, life science and medical device manufacturers strive to create innovative and reliable products that help people lead healthier lives. Emerson has the automation expertise and technology to solve your greatest cGMP manufacturing challenges and create effective solutions for improving your data management, real-time product quality, reliability, and operating costs within Biotechnology, Pharmaceutical, Packaging and Medical Devices. From design to implementation and start-up to on-going optimization, rely on Emerson to stay competitive in a global economy.

Grand River Aseptic Manufacturing

Grand River Aseptic Manufacturing, Inc. (“GRAM”), a prominent aseptic fill-finish contract development and manufacturing organization, delivers biologics, small molecules, and vaccine capabilities for liquid and lyophilized vials, syringes, and cartridges. Grand River Aseptic Manufacturing’s 300,000 sq. ft. of sophisticated GMP space supports customers’ drug products with advanced equipment, innovative technology, and a breadth of experienced team members.

Kindeva Drug Delivery

Kindeva Drug Delivery is a global CDMO offering fill-finish of vials, PFS, and cartridges, with a special focus on drug-device combination products. We develop and manufacture products across a broad range of drug-delivery formats, including injectable, microneedle, pulmonary, nasal, and transdermal. Our service offerings span early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. We offer a full suite of Analytical Services including extractables & leachables, CCIT, medical device testing, and elemental impurities. Kindeva serves a global client base from our state-of-the-art manufacturing, research, and development facilities located across the U.S. and U.K.

ParkourSC

ParkourSC delivers agility and transparency in supply chain operations for pharmaceutical, life sciences, and biologics companies, to drive strategic innovation and resilience, enable timely decisions, narrow demand and supply variances, and increase revenue.

Our digital supply chain operations platform improves patient outcomes by ensuring compliance, quality, and timely delivery of sensitive therapies. The platform provides a “command center” to predict at-risk situations in the supply chain by monitoring the performance of every entity, flagging quality and compliance risks, automating workflows across organizations, fostering collaboration to resolve issues and prevent waste, and to bridge the gap in planning and execution cycles by automatically delivering real-time updates to planners.

Rapid Micro Biosystems

Rapid Micro Biosystems® (RMB) creates, sells, validates, and services innovative products for fast, accurate, and efficient detection of microbial contamination in the manufacture of cell and gene therapies, pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products. The company’s Growth Direct® is the only fully automated, non-destructive growth-based system for multiple QC test applications: environmental monitoring, water, bioburden, and sterility testing. Automating rapid compendial QC micro testing ensures data integrity, compliance, and operational efficiencies. RMB is dedicated to providing groundbreaking technology and products to support companies in their journey to achieve greater reliability, efficiency, and better predictability, ultimately providing higher quality products for improved patient outcomes.

Univar Solutions

Redefining distribution for the pharmaceutical industry

Univar Solutions is a global partner to our customers and suppliers for the value-added distribution of chemistry and related products and services. We are a committed ally, with the capabilities and know-how to help our partners anticipate, navigate and leverage meaningful growth opportunities.

Univar Solutions Pharmaceutical Ingredients utilizes our global distribution network and deep industry expertise to provide unparalleled connectivity across life science markets with reliable supply of pharmaceutical ingredients from leading brands. With one of the most expansive product portfolios of high quality APIs, excipients, intermediates, and solvents combined with innovative and custom supply chain solutions, we are proud to answer when reliability, scale, and security of supply are the most critical factors. We serve primary and secondary pharmaceutical markets offering a vast portfolio of raw materials and specialty ingredients ranging from animal health, dental, and ophthalmic to diagnostics, drug synthesis, and biopharmaceuticals. With 15,000+ products in our portfolio from more than 400 suppliers around the world, Univar Solutions has ingredients you need for all types of drug delivery dosage forms, prescriptions, and over-the-counter medications.

Workshop Sponsors

Applied Materials

Applied Materials provides pharma manufacturers an opportunity to leverage decades of experience in increasing productivity in semiconductor manufacturing. SmartFactory Rx™ is a suite of advanced manufacturing software which enables pharma companies to achieve unprecedented levels of productivity, quality and compliance from their plants and supply chain refined through 30 years of leadership based on Industry 4.0 principles. Our software solutions provides a real-time, data-driven plant environment that senses factory activity, predicts performance, prescribes effective actions, and optimizes DoE and control. Our pharma team, powered by SmartFactory Rx Digital Platform, enables customers to optimize quality and productivity in pharma manufacturing. This intelligent and flexible platform allows non-programmers to enable data-driven decisions from shop floor to top floor.

Axplora

Axplora, founded by merging Farmabios, Novasep and PharmaZell in 2023, is a Group of more than 2,000 skilled, dedicated employees producing pioneering innovative and evergreen APIs. Axplora offers API products and CDMO solutions to more than 900 customers serving millions of patients with gastrointestinal, respiratory, inflammatory and liver diseases. The Group helps deliver essential medicines through rapid, sustainable, and reliable processes underpinned by over 15 core technologies including Hazardous Chemistry, Chromatography, ADCs, Steroids, Continuous Processes, Lipids & HPAPIs.

Boehringer Ingelheim Biopharmaceuticals GmbH

Boehringer Ingelheim is a leading research-driven biopharmaceutical company and creates value through innovation in areas of high unmet medical need.

As one of the world’s largest manufacturers for biopharmaceuticals with in-depth experience in this field, the company is an industry pioneer and collaborates with top 20 pharma companies and innovative biotechs.

Boehringer Ingelheim BioXcellence™ reliably supplies innovative therapies that transform lives, today and for generations to come. We create solutions with our partners, building on our can-do attitude to improve patient health.

Our business is empowered by 5,000 dedicated and well-trained employees in development, quality and manufacturing and has access to a global manufacturing network providing the entire production chain from DNA to Fill & Finish. Our track records, both in commercial and clinical supply speak for themselves – since we started offering contract manufacturing in 1995, we have successfully brought 40 biologics to the market and have transferred and optimized more than 150 development and manufacturing projects at all stages from our customers to our facilities, as well as within our network.

While collaborating with our partners we never lose sight of the patients that depend on biopharmaceutical therapies. We offer capabilities to complement your expertise, so together we can deliver better therapies.

Honeywell

Honeywell solutions provide Life Sciences companies with unparalleled quality, operational insights and performance. Through process automation and seamlessly connecting data across the life sciences value chain, we harness the potential of cutting-edge digital technologies lifecycle services and predictive analytics to speed decisions and the delivery of innovative products. Our mission is to guide life sciences enterprises, regardless of their scale or digital evolution phase, towards delivering safer products, enhancing business and patient outcomes, and upholding rigorous regulatory compliance standards.

Visit our booth to learn how Honeywell is shaping the future of digital quality and manufacturing excellence for the life sciences industry; with AI-Enabled TrackWIse Digital QMS, the new Honeywell Life Sciences Applications Suite and Honeywell Manufacturing Excellence Platform.

INCOG BioPharma Services, Inc.

INCOG has been designed and built from decades of experience with a clear purpose: to deliver better CDMO services in the injectable drug product space.

With our dedicated team, best-in-class processes, and state-of-the-art equipment, we deliver meaningful results and stand-out customer experiences. We are here to strive for the best—for our team and for our customers. We are in it with you from the moment we start work on your project. We go above and beyond to understand your requirements, meet your needs, and foster a truly collaborative partnership.
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Founded in June 2020, INCOG BioPharma Services offers development and manufacturing services to both early phase and late phase biopharmaceutical companies. We are located on the northeast corner of Indianapolis in Fishers, IN.

LLumin Inc.

LLumin, the leader in enterprise asset management and predictive maintenance CMMS+ software, is well known for its software in pharmaceutical and food/bev. applications. LLumin’s expert team possesses decades of experience in the manufacturing and asset management software industry, developing CMMS+ as a IOT and Industry 4.0 first Asset Performance and Maintenance Management solution suite. CMMS+ manages and protects pharmaceutical companies’ infrastructure, assets, and their operations. Proven to deliver ROI by improving Asset Uptime and OEE levels, CMMS+ extends the life of asset lifecycles and enables a higher return on asset investment. The software elevates maintenance results by improving information exchange and collaboration among all internal and external resources.

Exhibitors

Altruist Biologics

Altruist Biologics is a leading CDMO company in China (spin off from Innovent Biologics) focusing on the development and commercial manufacturing of antibodies, fusion proteins, ADCs, gene and cell therapies and other drugs. Altruist is committed to “Helping customers develop affordable and high-quality biopharmaceuticals to patients across the world”. The company has established an experienced international talent team with over 1,300 employees.

Altruist has helped our clients with 30+ INDs in China, 10+ INDs in US, 3 INDs in Australia, 8 NDAs in China, and 1 BLA in US. We are now manufacturing four commercial antibody products with over 700 successful commercial batches completed.

Altruist currently has a total capacity of 60,000 liters in Suzhou meeting the GMP requirements of the FDA, EMA, and NMPA. The facility has been audited by the FDA and Eli Lily GQAAC. There will be an additional 170,000 liters ready in 2023Q4 with multiple 20,000L bioreactors.

Altruist offers an end-to-end solution that includes:
Ÿ Cell line development, process development/optimization, analytical method development
Ÿ Clinical sample production (200L/500L/1,000L/3000L, liquid/lyo/PFS/AI), PCPV, BLA filing, PAI
Ÿ Commercial manufacturing (3,000L/4,500L/20,000L, liquid/lyo/PFS/AI)
For more information you could visit: www.altruistbio.com

“Perseverance for Altruism, Ingenuity for Sustainability” is our commitment to achieve a win-win partnership. Altruist Biotechnology is committed to providing high-quality, industry-leading fully integrated services, and assisting our clients to deliver innovative medicines to benefit more patients.

Continuum Consulting

Elemental Machines

Elemental Machines’ Intelligent Operations Platform leverages the best of Internet of Things (IoT) technology and custom hardware/software solutions, delivering actionable insights to operators in life sciences, biopharma labs, biobanks, analytical labs, and manufacturing facilities. By connecting the physical and digital worlds, the platform simplifies, optimizes, and augments operations. Leaders in science, facilities, and technology trust Elemental Machines’ ecosystem for insights that accelerate innovation, predict outcomes, and shift from reactive to proactive management. With scalable solutions from incubator to enterprise, custom integrations to fit each operation’s unique needs, and a wide ecosystem of partnerships, Elemental Machines ensures operational excellence and the future-proofing of lab and manufacturing processes.

eschbach North America, Inc.

At eschbach, we inspire pharmaceutical manufacturing teams to work smarter by connecting human intelligence with data. Our Shiftconnector® enterprise platform is a robust and easy-to-use SaaS solution that helps maximize teamwork and improve overall performance at pharmaceutical facilities worldwide. Shiftconnector helps pharma teams improve efficiencies while safeguarding production quality at the highest levels and ensuring compliance.

When there are breakdowns in the communication chain, different teams and tiers become misaligned. Features like the Shiftconnector Collaboration Tier Dashboards remove siloed communication across teams. Visualization tools that integrate complex data from operational tools like SAP allow teams to monitor progress toward key performance indicators (KPIs) and make necessary adjustments anytime, 24/7. Shiftconnector can be configured by an organization at the site level or across teams globally.

By integrating real-time data, Shiftconnector provides pharma manufacturing teams with transparent communication that is essential and transformative. Find out why global leaders like Roche, Bayer, Sanofi and others trust Shiftconnector for their facilities.

IDA Ireland

As the government investment development agency for Ireland, we’re focused on attracting multinational investment. We provide free advisory services and on-the-ground support to help companies worldwide establish and grow their operations here.

Our dedicated team connects multinational companies to investment opportunities, market insights and business environment analysis. Whatever your sector, our tailor-made support offers instant access to the very latest information on talent acquisition, regulation, incentives and turnkey property opportunities.

Make the most of your investment journey. Talk to us today about all the extraordinary benefits Ireland has to offer.

L7 Informatics, Inc.

L7 Informatics reimagines data intelligence for modern life sciences and healthcare organizations. Beyond simple data management, L7 provides tools that optimize the flow of information between process and people, unlocking innovation at every stage of the clinical, research, and manufacturing value chains. Our comprehensive operating environment and software stack bring flexible, secure, and collaborative data intelligence to your entire operation. From regulatory compliance and workflow orchestration to customized applications and integrations, our end-to-end transformation engine helps organizations solve today’s challenges and realize tomorrow’s opportunities. L7|ESP™ is designed to unlock innovation at every stage of the clinical, research, and manufacturing value chain. From data and workflow orchestration to custom apps and integrations, L7|ESP is an end-to-end transformation engine to help solve today’s challenges and realize tomorrow’s opportunities.

The L7 Manufacturing Execution System (MES) offers a unified platform approach to manufacturing operations management. While traditional MES is rigid and siloed from other systems and equipment, leaving operations still relying on forms and spreadsheets, L7 MES provides a holistic manufacturing operations management experience. Additionally, the L7 MES system is designed for developing and progressing seamlessly to CGMP production. We are CGMP-ready and provide the flexibility to support the early-stage process development, capturing and curating your data resource across your journey to clinical and commercial production.

ProPharma

For over 20 years, ProPharma has improved the health & wellness of patients by providing advice & expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs & introduce new therapies. As the world?s largest RCO, ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle; offering an end-to-end suite of fully customizable consulting solutions.

Selkirk Pharma

At Selkirk, our goal is to become your most reliable partner for aseptic Fill/Finish services. In our new state-of-the-art facility, we provide high yield manufacturing of your critical products to meet patients’ needs. Our facility is purpose-built for contract manufacturing with unidirectional process flows, advanced SKAN isolators and high yield Bausch & Stroebel filling equipment. Vial capacity currently available.

Sterling Pharma Solutions

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in providing small molecule API development and manufacturing services to the pharmaceutical industry, specialising in handling challenging chemistries.

Sterling manages the most complex API and API intermediate challenges from proof-of-concept to commercial manufacture, as well as Antibody Drug Conjugate (ADC) development and manufacturing services.

At Sterling we believe that whilst science can be complex, partnerships should be simple. That’s why we have redefined the CDMO experience with a partnership centred approach marked by transparency, collaboration and trust; a Partnership Development and Manufacturing Organisation (PDMO).

Sterling has six facilities employing more than 1,350 people: its HQ in Cramlington and a site in Newcastle, UK; a facility in Cork, Ireland; sites in North Carolina and Wisconsin, US; and a dedicated bioconjugation and ADCs facility in Deeside, Wales.

Whatfix

Whatfix, a Digital Adoption Platform, works with several pharmaceutical and life sciences companies in the US including Grifols, Sanofi, and Ferring Pharmaceuticals, to drive their digital transformation journey and business outcomes. Its in-app guidance and just-in-time support assists users to perform complex, critical tasks on applications such as Laboratory Information Management Systems (LIMS), Electronic Lab Notebook (ELN), Quality Management Systems (QMS), Clinical Trial Management Systems (CTMS), and more. This further helps keep employees up-to-date with quality policies, increase speed-to-market of drugs, and improve patient and worker safety.

WuXi STA

WuXi STA, an integrated part of WuXi AppTec, is an industry-leading pharmaceutical development and manufacturing capability and technology platform serving the life sciences industry with operations across North America, Europe and Asia. As an innovative Contract Development, and Manufacturing Organization (CDMO) for small molecule new drug development, WuXi STA offers our worldwide partners efficient, flexible, and high-quality solutions from preclinical to commercial uses.

Additional Sponsorships

Accenture

Accenture is a global professional services company with leading capabilities in digital, cloud and security. Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Interactive, Technology and Operations services?all powered by the world?s largest network of Advanced Technology and Intelligent Operations centers. Our 674,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.

Sponsor Of The

Clarivate

Clarivate™ is a leading global provider of transformative intelligence. We offer enriched data, insights & analytics, workflow solutions and expert services in the areas of Academia & Government, Intellectual Property and Life Sciences & Healthcare. Our connected data, deep expertise and intelligence platforms empower life sciences and healthcare companies to deliver safe, effective and commercially successful treatments to patients faster. Clarivate is home to Cortellis™, solutions for real world data, medtech, market access and commercialization and deep consulting expertise.

Sponsor Of The

Fluor

Fluor is building a better future by applying world-class expertise to solve its clients’ greatest challenges. Fluor’s 41,000 employees provide professional and technical solutions that deliver safe, well-executed, capital-efficient projects to clients around the world. For decades, Fluor has designed and built various types of biotech and bulk pharmaceutical facilities, employing batch, semi continuous, and continuous operations. We offer the life sciences industry agility and robustness through expertise in process design while providing innovative professional and technical solutions.

Sponsor Of The

Nuron

Nuron is a groundbreaking platform designed to revolutionize every stage of drug development through the use of AI, automation, and bots. By integrating all relevant scientific, engineering, and medical data and knowlege—both internal and external—Nuron automates the decision-making process across various organizations such as manufacturing, R&D, drug discovery, clinical, and medical affairs.

A significant issue in pharmaceutical manufacturing is quality deviations and failures, with about 5-10% of production batches experiencing these problems. These issues can lead to weeks or months of delays as companies struggle to identify the root causes and implement corrective and preventive actions. The repercussions of these delays are severe, often resulting in substantial financial losses and damage to the company’s reputation due to perceived reliability and safety concerns.

Nuron addresses this by amalgamating diverse types of data from production processes, analytical results, materials, and SCADA systems from both paper scans and digital sources. The platform’s custom AI capabilities enable automatic organization and analysis of this vast and diverse data. Its AI-powered Data-to-Decision modules allow users to swiftly pinpoint the origins of deviations and failures within hours, drastically reducing response times.  The platform also facilitates the creation of predictive machine learning models by leveraging historical production data, which helps anticipate product quality issues and potential failures before they occur. Additionally, Nuron leverages custom generative AI to suggest relevant corrective and preventive actions.

Nuron is currently collaborating with leading companies to implement its platform across ~ 50 manufacturing units, aiming to completely eliminate quality deviations and failures. We are also developing modules for digital twins, equipment failure predictions, and AI-powered insights for intelligent manufacturing, further enhancing its utility in pharmaceutical manufacturing. The ultimate goal of Nuron is to assist companies in constructing their “Scientific Brain,” a centralized, AI-driven decision-making hub.

Sponsor Of The

ParkourSC

ParkourSC delivers agility and transparency in supply chain operations for pharmaceutical, life sciences, and biologics companies, to drive strategic innovation and resilience, enable timely decisions, narrow demand and supply variances, and increase revenue.

Our digital supply chain operations platform improves patient outcomes by ensuring compliance, quality, and timely delivery of sensitive therapies. The platform provides a “command center” to predict at-risk situations in the supply chain by monitoring the performance of every entity, flagging quality and compliance risks, automating workflows across organizations, fostering collaboration to resolve issues and prevent waste, and to bridge the gap in planning and execution cycles by automatically delivering real-time updates to planners.

Sponsor Of The

Sponsor Of The

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