Accenture

Accenture is a leading global professional services company, providing a broad range of services and solutions in strategy, consulting, digital, technology and operations. Combining unmatched experience and specialized skills across more than 40 industries and all business functions—underpinned by the world’s largest delivery network—Accenture works at the intersection of business and technology to help clients improve their performance and create sustainable value for their stakeholders. With 482,000 people serving clients in more than 120 countries, Accenture drives innovation to improve the way the world works and lives. Visit us at www.accenture.com.

Applied Materials

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.

http://www.appliedmaterials.com/automation-software/products/pharma

Boehringer Ingelheim Biopharmaceuticals GmbH

In sharing with the corporate values and beliefs, Boehringer Ingelheim BioXcellence™ is organized as its own stand-alone business unit, empowered by its’ innovative and motivated individuals. With over 35 years of biotechnology experience, the combination of our more than 3,600 dedicated and expertly trained employees in development, quality and manufacturing along with a global network of locations, we are capable of providing the entire production chain from DNA to Fill & Finish. Our track record of accomplishment speaks for itself: Since our inception of offering contract manufacturing in 1995, we have successfully brought more than 30 biologics to the market.

Working with 15 of the world’s Top 20 Pharma and many innovative biotech companies, we never lose sight of the patients that depend on these breakthrough therapies.

www.bioxcellence.com

Emerson Automation Solutions

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

GE Healthcare Life Sciences

The Life Sciences business of GE Healthcare provides a wide range of bioprocessing products and services that enable the development and manufacture of high-quality biotherapeutics and vaccines. Using our knowledge and expertise, we support our customers in increasing speed to market, while avoiding unnecessary costs and improving quality and performance in drug manufacturing. As a provider of high-quality products, customized technical and commercial services, as well as design and construction of complete biomanufacturing solutions, we support the biopharmaceutical industry in making health visions a reality.

Modality Solutions

Modality Solutions is the leading biopharmaceutical cold chain engineering firm in the world. We combine three types of firms into a single source of expertise for your cold chain management integration: a cold chain regulatory filing authority, a logistics network operations team, and an integrated experienced staffing firm. Services include ensuring compliance with cold chain regulations, delivering cold chain thermal packaging design/qualification and controlled-environment logistics solutions, conducting transport simulation testing, providing staffing augmentation, decreasing development cycle times for faster route-to-market, developing transport validation strategies to support global regulatory applications and supporting clinical trial operations. Modality Solution’s Advantage Transport Simulation Laboratory™ concurrently exposes product and packaging to all five environmental hazards – temperature, shock, vibration, humidity, and pressure as they occur during real-world distribution.

www.modality-solutions.com

AbbVie

AbbVie Contract Manufacturing has been serving our partners for more than 35 years across ten of our manufacturing facilities located in both North America and Europe. Our contract development and manufacturing capabilities span both small and large molecule API including classical fermentation, chemical synthesis and biologics. In addition to APIs, we are offering extensive experience and technical solutions in the area of drug product manufacturing which includes traditional tablet and capsule production with emphasis on DEA controlled drugs, potent, ADCs and hot melt extrusion. Lastly, we can also package your product regionally and also offer prefilled syringe manufacturing capabilities.

www.abbvie.com

Ajinomoto Bio-Pharma Services

Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan, and India, providing comprehensive development, cGMP manufacturing, and aseptic fill finish services for small and large molecule APIs and intermediates. Ajinomoto Bio-Pharma Services offers a broad range of innovative platforms and capabilities for pre-clinical and pilot programs to commercial quantities. Our worldwide teams are dedicated to providing a high level of quality and service to meet our client’s needs.

www.AjiBio-Pharma.com

BioLife Solutions, Inc.

BioLife Solutions is the leading developer, manufacturer and supplier of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media for cells and tissues. Our proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the regenerative medicine, biobanking and drug discovery markets. Our biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death; offering commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function.

www.biolifesolutions.com

Camfil Clean Air Solutions

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.

www.camfil.com

Cognate Bioservices Inc.

Cognate BioServices is a leading contract development and manufacturing organization specialized in cell and cell-mediated gene therapies. We pride ourselves in the level of quality and experience we bring to the table. We are unique in a number of ways, including but not limited to:

• Our late stage experience in personalized cellular therapies;
• A wide range of operating, technical and leadership experience spanning cellular immunotherapy and regenerative medicine;
• A commitment to commercial readiness and PAI inspection for personalized and off-the-shelf cellular immunotherapy products including but not limited to, Car-t, TCR, TIL, MIL, DC, and NK cells.

In our operating history we’ve successfully manufactured and delivered products to and from the US, EU and Asia, and we’ve handled all aspects of the supply chain, manufacturing, storage, shipping and clinical trial logistics, and regulatory support for protocol and IND development for complex products involving multiple drug substance intermediates all the way to minimally manipulated primary cells.

www.cognatebioservices.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.

http://compliancearchitects.com

Cryometrix

Cryometrix manufactures high performance liquid nitrogen-based equipment for processing, storage, and transportation. Our Ultra Low temperature freezers can freeze as low as -160°C in 2.5 hours; Blast freezers reach internal temperatures as low as -90 °C in under ten minutes; with a very tight temperature uniformity. All of our freezers are low maintenance, 100% Stainless-Steel construction, made in the USA, have upright freezer access, use up to 90% less energy than compressor based systems, and are backed by our industry leading 20 year warranty on the cooling system. To view our complete line of liquid nitrogen-based freezers, please visit cryometrix.com.

Deloitte Consulting LLP

Deloitte Life Sciences

Innovation starts with insight and seeing challenges in a new way. Amid unprecedented uncertainty and change, life sciences stakeholders are looking for new ways to transform their organizations using digital innovation and technologies. Deloitte’s team of thinkers and doers can help you imagine, deliver, and run your digital manufacturing operations and supply networks to address tomorrow’s challenges and opportunities—providing a platform to help generate critical insights, optimize business processes, and automate manufacturing and supply chain activities. Our global life sciences and health care practice of more than 12,400 helps clients transform uncertainty into possibility and rapid change into lasting progress. Comprehensive consulting, financial advisory, risk management, audit, tax and related capabilities deliver value at every step, from insight to strategy to action. Learn more: www.deloitte.com/us/lifesciences

Emergent BioSolutions

Emergent provides contract manufacturing services for both bulk drug substances and sterile injectable drug products. Our state-of-the-art, single-use BDS facility enables turnkey upstream and downstream support for eukaryotic, microbial, and viral expression. Our Fill/Finish services include vials and syringes for both liquid and lyophilized products. We also offer lyo cycle development and optimization. Our global manufacturing network currently produces over 20 commercial products and support a host of clinical stage programs.

www.ebsi.com/CMO

Fluor

Fluor is one of the world’s largest publicly-traded engineering, procurement, construction (EPC) and maintenance companies. For more than a century, Fluor, through its operating subsidiaries, has become a trusted global leader by providing exceptional services and technical knowledge. We transform the world by building prosperity and empowering progress. Clients rely on Fluor to deliver world-class solutions that optimize their assets, improve their competitive position and increase their long-term success.

fluor.com

Levitronix Technologies Inc.

levitronix.com

METTLER TOLEDO

Mettler-Toledo Process Analytics is a leader in process and pure water monitoring instrumentation used in pharmaceutical and biotech applications, offering systems for the measurement parameters of pH/ORP, dissolved oxygen, TOC, dissolved CO2, and conductivity. METTLER TOLEDO’s innovation continues with the introduction of the 7000RMS analyzer for on-line microbial monitoring.

www.mt.com/pro

Operations & Quality Systems Improvement Experts (OQSIE)

OQSIE is an execution-based firm supporting problem solving, improved management visibility and critical staff augmentation needs.

Problem Solving: Through ex-top tier consultants / senior industry experts, we support structuring and execution of key initiatives.

Technology: Improve productivity in manufacturing, warehouse / distribution centers, laboratories, and quality systems deploying real-time alerts when performance deviates, and a real-time management dashboard.

Critical Staff Augmentation: We provide highly experienced resources through a rigorous, multi-dimensional process for qualification process to identify ‘good’ consultants.

Flexibility: Utilize our consultants in whatever capacity works you…..we work with you to meet your needs on your schedule.

www.oqsie.com

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 pharmaceuticals, biologics, biotechnology products, medical devices, and personal care products. The company’s Growth Direct™—the first and only growth-based system to automate rapid compendial QC Micro testing—ensures data integrity, compliance, and operational efficiencies driven by rapid methods and automation. 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. For more information, visit www.rapidmicrobio.com Follow RMB at @rapidmicrobio or LinkedIn.

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

Temptime

Temptime is deeply committed to improving global public health. Founded in 1987, our scientists developed the first miniaturized technology to monitor temperature exposure of vials containing the oral polio vaccine. This device continues to be the only technology that meets the strict specifications of the world’s leading health organizations, including the World Health Organization, for distributing vaccines to developing countries.

Today, pharmaceutical corporations, biotechnology companies, specialty pharmacies, and hospitals are using our devices to help improve storing and handling thousands of medical products that improve and save lives. Since the medication you use is important and can be affected by extreme temperatures, it is our mission to monitor these products with 100 percent accuracy to ensure they have not been exposed to temperature events that could damage their effectiveness. We are dedicated to continually developing new technologies that will meaningfully improve global health for years to come.

temptimecorp.com

Thermo Fisher Scientific

Thermo Fisher Scientific is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally.

Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity.

Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific Patheon, Brammer Bio and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.

patheon.com

Veeva Systems

Veeva Systems Inc. is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 775 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America. For more information, visit veeva.com.

Werum IT Solutions America, Inc.

Werum IT Solutions is the world’s leading supplier of manufacturing execution systems (MES) and manufacturing IT solutions for the pharmaceutical and biopharmaceutical industries. Its PAS-X software product is run by the majority of the world’s top 30 pharmaceutical and biotech companies but also by many mid-sized manufacturers. Werum’s manufacturing IT solutions help pharma manufacturers to increase efficiency, improve productivity, and meet regulatory requirements. Founded in 1969, the company is headquartered in Lüneburg, Germany, and has many locations in Europe, America, and Asia.

Werum is part of Medipak Systems, the Pharma Systems business area of the international technology group Körber. Körber unites around 11,500 professionals in industry-leading companies worldwide, achieving annual earnings of 2.3 billion Euros.

werum-america.com/en/it-solutions

Sparta Systems, Inc.

www.spartasystems.com

AES Clean Technology, Inc.

AES specializes in design/build of beautiful modular cGMP cleanroom solutions to serve the pharmaceutical and biotechnology industries.

The AES Modular Cleanroom System can be “fast-track” fabricated into an existing building or integrated seamlessly into new construction.

This year we debuted two new products: AES’ proprietary Litebeam, the only high-efficiency LED fixture that integrates into our walkable cleanroom ceiling system, providing flush, walk-on linear lighting, and the AES Infinity Wall, a high visibility floor-to-ceiling glass wall system.

AES assures successful cleanroom builds through our in-house turnkey services. We self-perform all aspects of the cleanroom design-build process. In-house services include design, manufacturing, project management, safety, construction labor, and QC. You can rely on us for a clean, safe, and compliant build execution.

AESCLEAN.com

Avitide

The biopharmaceutical industry has now reached the phase of full industrialization of processes for monoclonal antibody production. However, at the same time, manufacturing of other types of biologics, including novel modalities, seem to suffer from a lack of technologies that would enable similar batch industrialization and line-of-sight to integrated continuous operations. The movement towards industrial standardization of novel modalities is entirely reliant upon access to key and enabling technologies; one of which is affinity chromatography. Avitide’s unique technology platform allows for rapid development and commercial supply of custom and catalog affinity chromatography resins towards diverse therapeutic and vaccine modalities for lower cost of goods and to enable next-generation manufacturing paradigms.

www.avitide.com

ESP Part of Accenture Industry X.0

Enterprise System Partners (now part of Accenture Industry X.O.) has provided life-science solutions and services to support and enhance the digital plant since 2003. The company offers professional engineering and consulting services for manufacturing supply chain operations in biotechnology, pharmaceutical and medical devices. Enterprise System Partners has niche expertise in MES, serialization and data analytics. Being part of Accenture gives the organization worldwide resourcing and project management capabilities to support its clients.

www.enterprisesystempartners.com

groninger USA

Top players in biomanufacturing trust groninger’s proven liquid fill and finish solutions, consisting of innovative hardware and unparalleled service. Since 1980, innovation and consistent performance made us a world leader with over 1300 employees. Groninger proudly designs and manufactures a comprehensive product range for the pharmaceutical, consumer healthcare, and cosmetics industries. Your groninger machine will deliver reliable quality that meets the latest cGMP and market performance demands.

www.groningerusa.com

IDT Biologika

IDT Biologika specializes in the contract development and manufacture of viral vaccines and sterile liquid and lyophilized biopharmaceuticals, providing fully-integrated services ranging from formulation development and clinical manufacturing through to large-scale production, packaging and quality control.

We understand the needs of our customers regarding responsiveness, state-of-the-art technology and integrated solutions.

www.idt-biologika.de

Lonza AG/LTD

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.

www.lonza.com

Pharmatech Associates

Pharmatech Associates is a global consultancy for the life science industry, meeting the complex needs of clients with highly experienced scientists and engineering subject matter experts. Pharmatech’s team specializes in Product and Process Development, Facilities and Capital Projects, Regulatory Compliance, and Regulatory Affairs. Pharmatech advises clients that range in size from startups to large multi-national corporations on projects in Asia, Europe and North America from its headquarters in the San Francisco Bay Area.

pharmatechassociates.com

Skyland Analytics

Leveraging cloud-based delivery of its software, Skyland Analytics helps biopharma manufacturers manage and analyze product, process and patient data to ensure data transparency and integrity throughout the product life cycle and supply chain.

Skyland PIMS® data collaboration platform centralizes management of critical product development, manufacturing and quality data required for business and regulatory reporting. Internal and external teams rapidly create and manage process definitions, establish transparency into the status of batches and manage specification and target control limits while transforming data into shared, actionable insights that provide visibility, understanding and control of process and product performance.

skylandanalytics.net 

theDevMasters, an AI Company

Developing individuals/companies to leverage Machine Learning, AI, and Deep Learning to allow for Data Driven Decisions to compete in an evolving world.

www.thedevmasters.com

Zenith Technologies

Delivering MES, Automation and Process Control Excellence to Power Patient Health
Zenith Technologies operate 100% in Life Sciences, we are world leaders in delivering manufacturing software systems that make businesses compliant and competitive. We specialize in implementing and supporting MES, automation and workflow solutions that manage and control manufacturing plants to improve operational effectiveness. We support customers through the entire manufacturing life cycle from initial consultation, through project implementation, commissioning and qualification to ongoing maintenance, training and support. Operating across five continents, our engineers and consultants are guiding and supporting clients across the globe at any given time.

www.zenithtechnologies.com

Samsung Biologics

Samsung Biologics is one-stop solution provider of contract development and manufacturing for bio-therapeutics, specially focused on mAbs. Established in April 2011, Samsung Biologics will transform the global healthcare industry over the next decade, through our quality, technology and innovation. The core business activities include Upstream & Downstream Process Development, Clinical & Commercial manufacturing, Aseptic Fill/Finish and Analytical & Biosafety testing. We are committed to operational excellence in cGMP manufacturing and Quality Assurance, to deliver values to the clients.

With our manufacturing site located in Songdo in South Korea, all plants are cGMP compliant with a dedicated Quality Control Lab & Process Development Unit, and designed as multi-product facilities to meet the requirements of the US FDA, EMA, and other global regulatory agencies. The company holds 364KL total capacity with flexible clinical & commercial scales of 1KL, 5KL and 15KL.

www.samsungbiologics.com

Boehringer Ingelheim Biopharmaceuticals GmbH

In sharing with the corporate values and beliefs, Boehringer Ingelheim BioXcellence™ is organized as its own stand-alone business unit, empowered by its’ innovative and motivated individuals. With over 35 years of biotechnology experience, the combination of our more than 3,600 dedicated and expertly trained employees in development, quality and manufacturing along with a global network of locations, we are capable of providing the entire production chain from DNA to Fill & Finish. Our track record of accomplishment speaks for itself: Since our inception of offering contract manufacturing in 1995, we have successfully brought more than 30 biologics to the market.

Working with 15 of the world’s Top 20 Pharma and many innovative biotech companies, we never lose sight of the patients that depend on these breakthrough therapies.

www.bioxcellence.com