Azzur Group

From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to our labs, training centers and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world’s leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.

azzur.com

Deloitte

Across life sciences, you’ll find innovators who are developing therapies, treatments, devices, and cures for society’s most pressing health challenges. Alongside them, you will find Deloitte. We connect the right people, partners, and technologies to orchestrate and deliver the business of science.

www.deloitte.com

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.

www.projectfarma.com

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.

www.compliancearchitects.com

Dot Compliance

Dot Compliance offers the industry’s first ready to use Quality Management Solution powered by the Salesforce.com platform. The Dot Compliance Suite includes an extensive set of off-the-shelf ready quality and compliance pre-configured processes, enabling customers to deploy quickly and cost-effectively. Dot Compliance ready-to-use solutions include full project validation services and product validation packages and are fully compliant with 21 CFR part 11, EU-Annex 11 and support ISO 9001, 13485, 14971, and 27001.

Eliminating costly customization and professional service fees, Dot Compliance ready-to-use solutions allow life science organizations to quickly deploy and manage processes such as Controlled Documents, Training Management, CAPA, Customer Complaints, Audits, Supplier Quality, Risk Management, Equipment and Maintenance, BOM and more.

Dot Compliance offers the industry’s most cost-effective quality and compliance management solution available, allowing users to easily deploy flexible and scalable solutions.

www.dotcompliance.com

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.

www.emerson.com/en-us/industries/automation/life-sciences-medical

Grand River Aseptic Manufacturing

GRAM is a leading parenteral CDMO delivering customized solutions to meet clients’ fill and finish needs from development through commercialization. With capabilities for biologics, small molecules, and vaccines, GRAM’s advanced technology and staff support pharmaceutical development and cGMP manufacturing, analytical testing, and regulatory filing.

www.grandriverasepticmfg.com

Körber Pharma Software

Körber Pharma Software, formerly Werum IT Solutions, is the world’s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. Our out-of-the-box PAS-X software is run by the majority of the worlds to 30 pharmaceutical and biotech companies and by many mid-sized manufacturers.

Our software product: Werum PAS-X MES is recognized as the world’s leading Manufacturing Execution System (MES) for the pharma, biotech and cell & gene therapy industries. We offer a full-scope MES solution comprising the PAS-X software product and pre-configured content for pharmaceutical, biotech and cell & gene processes completed by consulting, training and support services. PAS-X is a mature standard software product with full functionality that can be implemented within a comparably short time.

Körber is an international technology group with about 10,000 employees, more than 100 locations worldwide and a common goal: We turn entrepreneurial thinking into customer success and shape the technological change. At the Körber Pharma we are delivering the difference along the pharma value chain with our unique portfolio of integrated solutions.

www.koerber-pharma.com

Resilience

Resilience is a technology-focused manufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company aims to build a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely and at scale. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives.

resilience.com

Sharp Services

Sharp is a global leader in pharmaceutical packaging and clinical trial supply services. For 70 years, we’ve provided solutions to pharma and biotech clients from phase I trials through to commercial launch and lifecycle management. With facilities in the United States, United Kingdom, Belgium and the Netherlands and 30+ clinical depots globally, covering every region of the world, we are engineered to deliver.

Through our partnership with Berkshire Sterile Manufacturing we offer specialist isolator-based filling of vials, syringes, cartridges and containers, as well as lyophilization and terminal sterilization.

Learn more at www.sharpservices.com

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.

smartlabs.com

Stratus

For leaders digitally transforming their operations to drive predictable, peak performance with minimal risk, Stratus ensures the continuous availability of business-critical applications by delivering zero-touch Edge Computing platforms that are simple to deploy and maintain, protected from interruptions and threats, and autonomous. For 40 years, we have provided reliable and redundant zero-touch computing, enabling global Fortune 500 companies and small-to-medium sized businesses to securely and remotely turn data into actionable intelligence at the Edge, cloud and data center – driving uptime and efficiency. For more information, please visit www.stratus.com

Tulip Interfaces, Inc

Tulip, the leader in frontline operations, is helping companies around the world equip their workforce with connected apps—leading to higher quality work, improved efficiency, and end-to-end traceability across operations. With Tulip’s cloud-based platform, those closest to operations can take advantage of composability and edge connectivity to digitally transform processes, guide operators, track production, and gain a real-time, holistic view of operations.

Companies of all sizes and across industries, including complex manufacturing, pharmaceuticals, and medical devices, have implemented composable solutions with Tulip’s platform to solve some of the most pressing challenges in operations: error-proofing processes and boosting productivity with guided workflows, capturing and analyzing real-time data, and continuously improving operations.

A spinoff out of MIT, the company is headquartered in Somerville, MA, with offices in Germany and Hungary. You can learn more and get started for free at Tulip.co.

tulip.co

Aizon

Aizon is an AI software provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and other smart factory technologies focused on optimizing production and quality within highly regulated industries. The Aizon platform seamlessly integrates unlimited sources of structured and unstructured data to deliver actionable insights across all manufacturing sites. Aizon offers an intuitive way to gain meaningful operational intelligence by enabling real-time visibility and predictive insights in a GxP compliant manner with end-to-end data integrity.

www.aizon.ai

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 provide 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 from early process development to full-scale pharma manufacturing. This intelligent and flexible platform allows non-programmers to enable data-driven decisions from shop floor to top floor.

www.appliedsmartfactory.com/pharmaceutical

Boehringer Ingelheim Biopharmaceuticals GmbH

One of the world’s largest manufacturers of biopharmaceuticals and an industry pioneer with in-depth experience, Boehringer Ingelheim BioXcellence™ so far has supplied more than 40 commercial products through its global network.

We reliably supply innovative therapies and create solutions with our partners, building on our can-do attitude to improve patient health.

www.bioxcellence.com

INCOG BioPharma Services

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.

www.incogbiopharma.com

Russell Reynolds Associates

Russell Reynolds Associates is a global search and leadership advisory firm. Our 425+ consultants in 46 offices work with public, private and nonprofit organizations across all industries and regions. We help our clients build teams of transformational leaders who can meet today’s challenges and anticipate the digital, economic and political trends that are reshaping the global business environment. From helping boards with their structure, culture and effectiveness to identifying, assessing and defining the best leadership for organizations – our teams bring their decades of expertise to help clients solve their most complex leadership issues.

www.russellreynolds.com

Sparta Systems, A Honeywell Company

Sparta Systems, a Honeywell Company, brings leading-edge quality management solutions to regulated industries. With TrackWise® and TrackWise Digital®, Sparta provides enterprise and cloud-based QMS software solutions that help companies go to market faster and deliver the highest standards for product quality, compliance and customer satisfaction. Sparta is an innovator in its field and is driving smart quality with first-of-its-kind AI-enabled quality solutions. By applying the latest digital technologies, our products simplify the process of quality management and guide customers toward proactive quality.

The combination of Sparta Systems and Honeywell brings together Sparta Systems’ quality management leadership with over 100 years of industrial and software expertise from Honeywell. Together, Sparta and Honeywell will shape the future of digital quality and operational excellence for the life sciences industry.

spartasystems.com.

AbbVie Inc.

Vision. Expertise. Success.

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.

www.abbviecontractmfg.com

Altruist Biotechnology

Altruist Biotechnology 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/en

“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.

www.altruistbio.com/en

Apeloa Pharmaceutical Co. Ltd

Apeloa has expertise in the development and manufacturing of APIs, Intermediates, and RSMs for small molecules. With over 3 decades of experience, Apeloa’s contract development services are utilized globally to support end-to-end development of small molecule drugs into commercial production. With our 10 manufacturing sites and 3 R&D labs, Apeloa can support your needs with our technology advantages, including:

Flow Chemistry (R&D and Manufacturing scale)
Bioproduction & Fermentation
High Potency Production
Crystallization & Particle Engineering
Expertise with many chemical reactions at production scale
Advanced Analytical equipment

https://apeloacdmo.com/

BD Medical - Pharmaceutical Systems

As a partner of choice for pharmaceutical and biotech companies across the globe, BD Medical – Pharmaceutical Systems provides a broad range of parenteral drug delivery systems including glass and plastic prefillable syringes, safety and shielding systems as well as advanced drug delivery solutions that help ensure pharma meets its drug delivery goals while considering drug complexity, viscosity and dosing volume.

With an emphasis on patient-centered innovations and strong technical expertise, BD Medical – Pharmaceutical Systems partners with pharmaceutical and biotechnology companies to help them achieve their combination product commercialization goals. We support product launch and life cycle management through a comprehensive set of services and solutions that help to de-risk the combination product development process.

More information available @ drugdeliverysystems.bd.com
Contact us @ drugdeliverysystems.bd.com/contact-us

Enhanced Information Solutions Inc.

Enhanced Information Solutions (EIS) is a global consulting company focused on implementing validated computer systems that optimize life science manufacturing. From manufacturing mobile apps that replace paper records to the implementation of full-featured Manufacturing Execution Systems (MES), EIS has helped 9 of the 10 largest life science companies implement software solutions that improved their manufacturing operations.  Our consultants have expertise in all stages of the software project life cycle, including vendor selection, requirements gathering, design, implementation, validation and ongoing support.  In addition, our OpsTrakker mobile app allows companies to deploy electronic logbooks, forms, or batch records in rapid time, to achieve your company’s digitalization goals.

www.eisinc.com

HiveMQ

HiveMQ gives pharma manufacturing companies a proven enterprise MQTT platform for reliable, scalable, mission-critical IoT. Our platform moves data securely between devices and the cloud at enterprise scale and is easy-to-deploy for seamless IoT messaging. The HiveMQ MQTT Platform gives pharma manufacturers the foundation to get the right data to the right place at the right time, enabling them to build out any IoT use case from supply chain optimization to enabling regulatory compliance. Visit hivemq.com to learn more.

HiveMQ.com

Myra EB Systems

Myra EB has developed the industry’s first cloud-based comprehensive platform enabling superior end-to-end process management for the pharmaceutical sector, including for the clinical stage and commercial stage companies. Myra EB Platform delivers greater efficiency and transparency to complex R&D and supply chain processes and reduces costly delays related to data management and supply chain errors.
Myra EB Platform comprises of below modules that can be used stand-alone or integrated. The system provides valuable insights for teams in CMC and Pharmaceutical Operations.

○ Shipment System
○ Data management System
○ Demand, Forecasting, and E&O (Excess and Obsolescence)

Myra EB is a pioneer in developing AR/VR-based custom training systems for manufacturing, clinical operations, and EHS. Myra EB team is composed of experienced professionals in the pharmaceutical industry that have delivered multiple successful commercial drugs generating multi-billion-dollar value.

For more info: www.myraebsystems.com

Recipharm AB

Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing almost 9,000 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material and APIs, pharmaceutical product development and development and manufacturing of medical devices. The company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US.

www.recipharm.com

STERLING PHARMA SOLUTIONS

sterlingpharmasolutions.com

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. Visit us at www.accenture.com.

Bluecrux

Founded in 2011, Bluecrux is a leading value chain consulting and technology company. Our experts and software solutions help to transform today’s supply chains into smart, efficient, and fully integrated value chains. We believe that only true collaboration leads to innovation, by converging at the intersection of our knowledge and our customers’ ambition and linking expertise with technology and problems with solutions.

We’re a community, a movement that’s built at this intersection, which we call “the Cutting X”: it’s where supply chains evolve and value chains are forged.

Our client portfolio includes some of the world’s largest companies, including Johnson & Johnson, GSK, Roche, Bridgestone, AkzoNobel, Beiersdorf, Oatly, Novartis, Pfizer and many more.

Binocs is #1 SaaS solution for scheduling and planning QC, QA, R&D and CGT operations, developed by Bluecrux. Offering AI-enhanced automatic scheduling, scenario-based planning, and end-to-end visibility, Binocs is the solution of choice to nail your operational performance.

Binocs empowers your teams to increase productivity and meet delivery targets.

www.bluecrux.com/binocs

Germfree

Germfree designs and manufactures bioGO® mobile and modular cleanroom buildings to meet FDA cGMP and USP 797/800 guidelines. Our bioGO® units provide quality, safety and durability that meets or exceeds traditional facilities while decreasing risks associated with onsite construction and accelerating time to market. Germfree provides custom pharmaceutical isolators and RABS as well as a full line of laboratory equipment including Class II & Class III biosafety cabinets and laminar flow hoods.

https://www.germfree.com/

Lotte Biologics

LOTTE BIOLOGICS was established in 2022, and is headquartered in Seoul, South Korea.

LOTTE BIOLOGICS is now entering the pharmaceutical industry as a CDMO company with the acquisition of Bristol-Myers Squibb’s Syracuse manufacturing site.

By providing innovative medicines to patients, LOTTE BIOLOGICS aims to become a Global Top 10 CDMO company in the biopharmaceutical industry.

www.lottebiologics.com

Thermo Fisher Scientific

Thermo Fisher Scientific provides end-to-end drug development, clinical trial logistics and commercial manufacturing solutions to customers of all sizes through our Patheon brand. With more than fifty-five locations around the world, the company has extensive capabilities including drug substance and product development, viral vector services, clinical trial services and commercial-scale manufacturing.

www.thermofisher.com/patheon

Vibraclean

https://vibraclean.com/

ZÆTHER

ZÆTHER is a digital consultant and outcomes provider for life science companies seeking scale, speed, and competitive advantage to get products to the world faster. 

ZÆTHER works with digital leaders and executives at global life science companies to reimagine operations and manufacturing by building a digitally enabled enterprise. 

www.zaether.com