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Samsung Biologics is an end-to-end CDMO partner of choice, providing highly tailored solutions to clients while meeting the evolving needs of the global healthcare industry.
With proven regulatory approvals, we provide seamless offerings from cell-line development to final fill/finish as well as biosafety testing at every stage for biopharmaceutical products.
Our plants are cGMP compliant holding 364KL with a wide range of bioreactor scales. To meet growing market demand, we are currently expanding capabilities with the addition of an mRNA vaccine DS manufacturing suite and construction of a new plant 4 that will hold 620KL total capacity upon completion.
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. Follow us on LinkedIn. For more information, visit azzur.com
Cellares is creating the future of cell therapy manufacturing and accelerating access to life-saving cell therapies. The company is developing a one-of-a-kind solution to overcome the limitations associated with manufacturing cell therapies that are more affordable and widely available to patients in need. With Cellares’ proprietary platform—the Cell Shuttle—biopharma companies, academic research centers, and CDMOs will no longer have to compromise by either choosing a manufacturing platform that is semi-automated but lacks workflow flexibility, or one that provides customization but not the end-to-end automation needed to manufacture at scale. The company is headquartered in South San Francisco, Calif.
Cytiva is a global provider of technologies and services that help advance and accelerate the development and manufacture of therapeutics. Previously GE Healthcare Life Sciences, Cytiva’s diverse portfolio includes well-recognized brands such as ÄKTA, Amersham, Biacore, FlexFactory, HyClone, MabSelect, Whatman and Xcellerex. Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the delivery of transformative medicines to patients.
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.
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 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.
Applied Materials provides pharma manufacturers an opportunity to leverage decades of experience in increasing productivity. 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. The suite is a data & application integration platform which provides: advanced process analytics & control, real-time production planning & scheduling, predictive maintenance, and knowledge advisor for creating a continuous learning environment for knowledge capture and reuse. Solutions are rapidly implemented by non-programmers using this intelligent & flexible platform to enable data-driven decisions from the shop floor to top floor.
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.
3M solutions work to optimize your processes, applying our biopharma experience, material science and proprietary technologies to help you develop highly effective purification solutions. Our solutions are designed for upstream and downstream processing. These solutions are focused on 3M innovative technologies for the development and manufacturing of recombinant proteins including mAbs, vaccines, and therapeutic plasma proteins.
Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. Leveraging 675,000 ft² across five US-based scientific campuses, Alcami serves pharmaceutical and biotech companies of all sizes providing customizable and innovative solutions for analytical development, clinical to commercial sterile and oral solid manufacturing, packaging, microbiology, cGMP biostorage, environmental monitoring, and pharmaceutical support services. Alcami’s private equity ownership includes Madison Dearborn Partners and Ampersand Capital Partners. For more information, please visit alcaminow.com and masy.com.
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.
DCI, Inc., founded in 1955, is a world leading manufacturer of stainless steel storage and processing vessels, agitators, and integrated systems for the food, dairy, beverage, pharmaceutical, biopharmaceutical, biotech, animal health, chemical, cosmetic, and wine industries. DCI’s portfolio of products and services includes tanks, pressure vessels, and processing equipment such as processors, fermenters, bioreactors, silos, horizontal and vertical storage tanks, aseptic media and batch tanks, mixing tanks, whey crystallizers, DCI Dynamixer, and the VARO HPT. In addition to our standard equipment, DCI also custom-engineers and builds equipment to fit your company needs and certifies your tank to meet all your ASME, ASME-BPE, PED, CE, FDA, CRN and 3A requirements.
In April 2019, Emerson acquired Bioproduction Group (Bio-G), a leader in simulation, modeling, and scheduling software for biomanufacturing. Bio-G’s scheduling and modeling systems combined with Emerson’s extensive life sciences technology and expertise portfolio will help companies bring therapies for cancer, diabetes, and other illnesses to patients sooner.
Life sciences companies continually look to accelerate the production of patient therapies and the Bio-G Scheduling software helps them accurately predict future plant resource availability to optimize manufacturing production. The scheduling software delivers an instantaneous view, accessible across an organization, into the current and future state of the plant, providing decision support to help increase facility uptime and reduce schedule-related product losses.
For more information visit www.emerson.com/rtms.
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.
IDBS provides cloud-based solutions to meet the unique data management challenges faced by Life Sciences teams throughout the product and process lifecycle and across the supply chain. Our innovative Polar platform is the industry’s first digital data backbone enabling customers in research, development and manufacturing to efficiently and compliantly access critical data and insights to make faster, smarter decisions with greater confidence.
IDBS serves thousands of users across hundreds of organizations around the globe, including 23 of the top 25 pharmaceutical companies and more than 250 small and medium-sized pharma and biopharma companies, CROs, CDMOs, and CMOs.
MaxCyte® is a leading provider of cell-engineering platform technologies and is responsible for helping to bring next‐generation cell-based therapies to life. The Company’s technology is employed by leading drug developers worldwide, including 20 of the top 25 global biopharmaceutical companies. Our Flow Electroporation® technology and next-generation ExPERTTM platform enable our partners to accelerate, streamline, and improve the drug development process from the early stages of research to commercialization. Founded in 1998, MaxCyte is headquartered in Gaithersburg, Maryland, U.S.
QbDVision is an innovative software company pioneering the development of modern digital solutions for the pharma/biotech industry to accelerate the manufacturing development cycle, increase the probability of technical success, and help get therapeutic breakthroughs to patients that much faster.
For many of the newest therapies being developed, the associated manufacturing processes are complex and the next generation of software solutions need to move the industry away from document-centric and spreadsheet-centric information management. QbDVision has assembled a group of industry veterans with 100+ years of collective experience in process development, tech transfer, pharmaceutical quality, and regulatory compliance to develop the next generation of structured data solutions that will dramatically increase R&D efficiency.
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.
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.
Scorpius BioManufacturing is an integrated contract research and contract development & manufacturing organization (CDMO) focused on rapidly advancing your mammalian and microbial biologic programs to the clinic and beyond. With end-to-end capabilities from discovery to limited-scale commercial production, we provide a broad array of R&D, analytical testing, and manufacturing services to pharmaceutical and biotech companies. With an experienced team and new, purpose-built, U.S. facilities, Scorpius is dedicated to easily accessible, transparent collaboration and flexible biologics biomanufacturing.
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
ValGenesis delivers integrated and smart solutions that support the digital transformation of the life sciences industry. With a portfolio that covers the whole product lifecycle, ValGenesis has a digital or technical solution that brings value to each step of your validation and manufacturing processes and their related activities.
Veeva is the global leader in cloud software for the life sciences industry with a keen focus on quality manufacturing. Committed to innovation, product excellence, and customer success, Veeva serves more than 1,000 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs, CDMOs, and contract services. Veeva powers organizations to manage end-to-end quality processes in one easy to use unified cloud solution to drive speed, collaboration, and compliance.
As a Public Benefit Corporation, Veeva is committed to balancing the interests of all stakeholders, including customers, employees, shareholders, and the industries it serves.
See how Veeva can help you modernize quality manufacturing at veeva.com/qualitymanufacturing
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.
Binocs is a global provider of AI/ML based orchestrated scheduling and forecast planning needs and has been specifically designed to address the challenges in Cell & Gene therapy industry. Binocs can assist therapy developers in efficiently manage internal and external resources to create a great customer (HCPs) and patient experience by providing real-time updates and information on the development of individual therapeutics. Binocs is already supporting commercial CAR-T and many other late & early stage clinical studies.
Since our founding in 1996, CAI strives to help our clients design, deliver, operate, and maintain quality, critical manufacturing facilities by pooling our global resources of 800+ employee-owners. Our engineering, technical, and consulting services encompass all aspects of operation. We integrate people, process, equipment, systems, and facilities into a high-performance manufacturing operation. The result is a superior level of operational performance and reliability. With offices in the Americas, Ireland, the UK, Italy, Switzerland, China, India, Singapore, Korea, and Australia, we have been able to serve the needs of clients all over the world. CAI is involved in each part of the project when you need to meet a higher standard.
Our service offerings have evolved out of the needs of the customer for 25 years. Every service offering is considered a Business Area. A business area consists of a set of services that requires a unique quality system, a set of personnel with skills and experience, and a potentially unique client base. A business area requires unique knowledge of and approaches to a market segment. Within a business area there may be multiple areas of technical focus; these focus areas are mutually supportive of the business area but are not distinct business areas themselves. CAI serves clients in the following business areas:
The world leader in clean air technology and air filter production, Camfil is the foremost supplier of air filtration, terminal and containment housings to the Life Science industries.
We provide the tools to achieve sustainability, maintain high air quality and reduce airborne contaminants, while lowering total cost of ownership.
We’re a new standard of CDMO.
Designed to deliver better.
Better solutions for your drug product.
From development through commercialization.
Better experiences, designed around you.
At INCOG, we are striving for better, creating a new standard of CDMO that considers the customer’s experience from initial discussion through final packaged product delivered to patients.
Better outcomes delivered with you, for you.
The drug development journey is not simple. When working with a CDMO, you need absolute certainty that your partner understands your needs, your critical milestones and your timelines. Every decision we make about your product will be made with you, for the success of your project.
Better solutions for your drug product.
We are proud to manufacture for the future of medicine. With world-class facilities, state-of-the-art equipment and some of the industry’s most talented people, you can feel confident that your drug product is in safe hands.
At Lonza Pharma & Biotech, we provide contract development and manufacturing services that enable pharma and biotech companies to bring medicines to patients in need. From the building blocks of life to the final drug product, our solutions are created to simplify your outsourcing experience and provide a reliable outcome, at the time when you expect it. Our extensive track record includes commercialization of pioneering therapies and manufacturing of a wide variety of biological and chemical drugs. We continuously invest to solve not just the current, but also the future challenges. Together, we can bring your next medicine to life.
POMS Corporation’s industry knowledge, validation experience, and MES technology are unparalleled in the cGMP environment. POMS Corporation MES Product set the standard for manufacturing in Pharmaceutical, Biotechnology, Cell & Gene Therapy, Medical Device, Consumer Packaged Goods, and other regulated industries.
POMS is committed to improving the effectiveness, competitiveness, and compliance of regulated manufacturers by delivering proven, world-class manufacturing execution system MES solutions that integrate seamlessly with other enterprise applications.
PQE is a complete quality solutions provider (30 offices globally, 1500+ consultants).
In its 20+ years of life, PQE has worked with thousands of clients and always applied the latest technologies and discoveries to help companies achieving their full potential. As an innovation-based agency, we are constantly developing new services and updating our areas of expertise.
Yposkesi, an SK pharmteco company, is one of Europe’s largest CDMO for cell & gene therapy viral vector manufacturing. A trusted partner for companies seeking to advance clinical trials and commercialize ATMPs, Yposkesi offers a full range of services in LVV and AAV cGMP manufacturing. Within a 50,000 ft2 (soon 100,000 ft2) facility, Yposkesi operates 4 manufacturing suites for bulk DS (up to 1,000 L) and fill & finish. Yposkesi’s investment in innovation ensures that its bioprocessing platforms deliver high-quality gene-modified cell therapies and in vivo gene therapy projects.