Biovia - Dassault Systems

Dassault Systèmes BIOVIA provides a scientific collaborative environment for advanced biological, chemical and materials experiences that help science- and process-driven companies develop higher quality products faster and more cost-effectively. BIOVIA’s sophisticated enterprise system of modeling, simulation, laboratory and quality management allows customers to discover, design, deploy and deliver innovative sustainable and competitive products to consumers globally. Using BIOVIA technology organizations can access, organize, analyze and share scientific, quality and process data throughout the product lifecycle in regulated and non-regulated environments. BIOVIA integrates key components of a corporate quality strategy connecting and automating quality and compliance processes and advances Quality to enterprise-wide Business Excellence in a sustainable manner. BIOVIA solutions are helping more than 2,000 companies globally in the pharmaceutical, biotechnology, energy, chemicals, aerospace, consumer packaged goods and industrial products industries to enhance innovation, increase productivity, improve quality and compliance, reduce costs and accelerate time to market.

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.  The suite is a data & application integration platform which provides: advanced process analytics & control, real-time production planning & scheduling, maintenance management including predictive maintenance, and knowledge management 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

Bioproduction Group

Bio-G is solely focused on one thing: delivering the highest quality modeling and scheduling software solutions to biomanufacturing companies. Our clients consistently achieve high return on project investment, verifiable increases in capacity and productivity, and measurable cost savings.

Headquartered in Berkeley, California, Bioproduction Group (Bio-G) is a privately held company specializing in real-time modeling systems. Bio-G has modeled more than 35% of global biomanufacturing capacity and our clients include small developmental companies as well as large clinical, commercial, and CMO manufacturers with sites ranging in size from small perfusion fed vessels up to 200K liters of capacity. These sites use a variety of processes including batch, fed-batch, and continuous manufacturing, and utilize stainless steel, disposable, and hybrid technologies within their facilities.

Boehringer Ingelheim

Boehringer Ingelheim Biopharmaceuticals Contract Manufacturing is represented by its brand Boehringer Ingelheim BioXcellence™. As a leading biopharmaceutical contract manufacturer with more than 35 years of experience it has brought more than 30 biopharmaceutical products to the market. Boehringer Ingelheim BioXcellence™ offers tailor-made contract development and manufacturing services to the biopharmaceutical industry, providing the entire production technology chain from DNA to fill and finish under one roof at its facilities in Biberach (Germany), Vienna (Austria), Fremont (USA) and Shanghai (China).

Boehringer Ingelheim BioXcellence™ can secure product supply throughout the entire product lifecycle—transferring customer projects at any stage, delivering to almost any scale and thereby makes outsourcing easy.

www.bioxcellence.com

Camfil

The world leader in clean air technology and air filter production, Camfil is the foremost supplier of filtration and terminal housings to the Life Science industries. Products include ePTFE & glass media HEPA, ULPA and molecular filters, Containment, Dust Collection and energy-efficient HVAC/ASHRAE housings and filters. Our LCC & CREO software programs are leading-edge.

We provide the tools to achieve sustainability, maintain high air quality and reduce airborne contaminants, while lowering total cost of ownership.

Emergent BioSolutions

Emergent BioSolutions 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 microbial, mammalian, and viral cell lines. Our Fill/Finish service offerings include vials and syringes, for both liquid and lyophilized products (including lyo cycle development). Our manufacturing facilities (located in Baltimore, MD) currently produce 20 commercial products, and a host of clinical stage (Phase 1 – 3) programs.

www.ebsi.com/CMO

Entegris

Experts in materials science, analytics, manufacturing excellence and high purity packaging and dispense.

Entegris Lifesciences provides product purity, faster time-to-market, while protecting process quality, efficacy and efficiency. From R&D, labs, utilities, CIP, upstream, downstream, buffer media prep to drug substance storage and final filling, Entegris delivers high performing, inert and low E&L solutions for single-use and full-scale processes.

www.entegris.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.

IDT Biologika GmbH

IDT Biologika is a global biopharmaceutical contract development and manufacturing organization (CDMO) that specializes in the production of breakthrough vaccines and biologics to improve human health.

IDT Biologika uses innovative technologies to advance our clients’ vaccine and biologics to prevent and treat diseases that impact the health of people worldwide.
Over the last decade, IDT has created an enviable track record and expertise in live virus and bacteria vaccines technologies encompassing over 50 promising and breakthrough vaccine projects for clinical trials.

IDT Biologika offers clients a single source CDMO partner with seamless end-to-end solutions and the ability to nimbly scale projects from pre-clinical to commercialization.

Our core competencies in viral and bacterial vaccines (live and attenuated) and injectable biologics are underscored by our commitment to quality and operational excellence that flows through our best-in-class process and cGMP (and up to BSL2) manufacturing capabilities.

www.idt-biologika.de

Modality Solutions

Confidence in your cold chain. Guaranteed with Modality Solutions. 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

Operations & Quality Systems Improvement Experts

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

Optel Group

Now a Certified B Corporation, OPTEL is a leading multinational provider of traceability systems, and its mission is to use innovative technologies to create a better world. The company’s renowned solutions ensure the quality of consumer health products and help stop counterfeiting of pharmaceuticals and medical devices throughout the world. OPTEL is also adapting its technologies to create efficiencies in various other sectors ─ from health-related industries to smart manufacturing and more, all can benefit from global traceability. OPTEL’s expertise will allow diverse industries to measure, inspect, control and track a variety of elements to improve quality and make better use of resources.

www.optelgroup.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

Samsung BioLogics

Samsung BioLogics was established in April 2011, and is headquartered in Incheon, South Korea. As a joint venture between Samsung affiliate companies and Quintiles Transnational Corp., Samsung BioLogics aims to become a global leader in the biopharmaceutical manufacturing industry.

Samsung has a long, rich history of research and development work. Our biologics business builds on principles of our past achievements and brings our technological leadership to the biologics sector. With Samsung’s quality, technology and innovation, Samsung BioLogics will establish a new global standard for best practices within biopharmaceutical manufacturing and transform global healthcare as we know it.

We are committed to excellence in the development and manufacturing of bio-healthcare products. Our client-oriented business model encourages high-standard, fast-turnaround contract manufacturing partnerships. Furthermore, our state-of-the-art advanced facilities are fully compliant with global healthcare regulations and Current Good Manufacturing Practice (cGMP) standards. To better serve the patients of our partners, we provide the proper infrastructure to develop, refine, and distribute biopharmaceutical products worldwide.

www.samsungbiologics.com

Sparta Systems, Inc.

Founded in 1994, Sparta Systems is the world’s premier provider of cloud and on-premise quality management software. We offer the solutions, analytics, and expertise that speed up quality and compliance. Our solutions help to lower risk, increase efficiency, and keep consumers safe while allowing manufacturers, suppliers, and distributors to collaborate in a seamless and integrated environment. Sparta is privately owned and headquartered in Hamilton N.J, with offices across Europe and Asia. We support close to 1 million users across 700+ implementations, in more than 30 countries. Companies in life sciences, food & beverage, consumer products, discrete manufacturing and more, rely on Sparta.

spartasystems.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.

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

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

Cognate Bioservices Inc.

Cognate BioServices is a fully-integrated contract bioservices organization providing the highest level of scientific and management expertise. Cognate provides full development and cGMP manufacturing services to companies and institutions engaged in the development and manufacture of cell-based products. The combination of highly experienced staff, successful track records and cGMP facilities makes Cognate one of the most qualified contract manufacturers of cell-based products in the world today.

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

IDA Ireland

Ireland has a long tradition of pharmaceutical operational excellence and has been attracting manufacturing facilities from major Life Sciences companies for over fifty years. Over €10 billion in new investment has been committed in the last decade for new biotech manufacturing facilities in both drug substance and drug product. A deep pool of talented employees, an exemplary regulatory compliance record, strong government support for R&D, and zero-defect biopharmaceutical manufacturing excellence have driven this recent wave of investment in new biotech companies.

IDA Ireland is tasked with promoting, winning and further developing foreign direct investment for the country. It’s a role we perform proudly, successfully developing Foreign Direct Investment projects, with energy and expertise. We work with and support companies on their first investment in Ireland and on all of their subsequent investments as they grow and diversify their Irish footprint.

www.idaireland.com

IPS/G-CON

IPS-Integrated Project Services, LLC (IPS), a leading global provider of engineering, architecture, project controls, construction management, commissioning and qualification services, and G-CON Manufacturing, Inc., the leading supplier of prefabricated cleanrooms, have partnered to create iCON, a turnkey modular facility platform solution for the biomanufacturing industry. The collaboration provides the most flexible and rapidly deployable facility platform, meeting the modular and mobile demands of the industry. The iCON team’s broad range of technical capabilities and services along with prefabricated cleanroom PODs provides a true turnkey solution to biopharmaceutical manufacturers and CMOs with needs for production agility and capacity flexing.  To learn more, visit www.ipsdb.com.

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

MabPlex

MabPlex provides world-class solutions to biopharmaceutical clients globally. Our company is based on the quality by design (QbD) principle, from site construction to manufacturing and delivery of our clients’ biologic drugs. With an expert team adept in both chemistry and biology, MabPlex provides global CDMO services in biopharmaceuticals. Capabilities span the scope from monoclonal antibodies (mAbs) and fusion proteins to the most complicated antibody–drug conjugates (ADCs). Our manufacturing space offers flexibility and complete services from upstream cell line development to manufacturing and fill–finish of commercial drug products. Our technical expertise allows us to provide effective high-quality solutions for your biomanufacturing needs. With that, MabPlex delivers our commitment to you through our quality manufacturing.

mabplex.com

Skyland Analytics

Skyland Analytics develops cloud, based data analytics and data management software for pharmaceutical, biotech and chemical companies managing manufacturing processes and product quality across internal and external networks.

skylandanalytics.net 

Temptime Corporation

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

Veeva Systems

Committed to innovation, product excellence, and customer success, Veeva Systems has more than 650 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs.

Veeva Vault Quality applications help streamline business processes and content across global sites, suppliers, contract manufacturers, and other partners to speed workflows for greater efficiency. Vault QMS, Vault QualityDocs, and Vault Training are part of the Vault Quality Suite, bringing together quality processes, document control, and training on a single cloud platform.

Companies are adopting Veeva Vault Quality applications to modernize quality management with the number of Vault Quality customers increasing to more than 180 – including 10 of the top 20 largest global pharmaceutical companies. The number of Veeva Vault QMS customers has nearly doubled since last year, with 58 life sciences organizations using the application to manage quality processes.

For more information, visit www.veeva.com/vault-quality

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

ProPharma Group

ProPharma Group is a global industry leader in comprehensive compliance services that span the entire lifecycle of pharmaceuticals, biologics, and medical devices. With more than 1,000 colleagues worldwide, ProPharma Group provides an unmatched variety of compliance related services including medical information, pharmacovigilance, clinical safety, regulatory affairs, and a continuously expanding range of compliance, quality assurance, validation, and consulting services. As an international, independent, single-source provider, ProPharma Group is here to support your needs.

www.ProPharmaGroup.com

Accenture

Accenture’s Life Sciences group is committed to helping our clients make a meaningful impact on patients’ lives by combining new science with leading edge technology to revolutionize how medical treatments are discovered, developed and delivered to people around the world. We provide end-to-end business services as well as individual strategy, consulting, digital, technology and operations projects around the globe in all strategic and functional areas—with a strong focus on Research, Development, Sales & Marketing, Patient Services and the Supply Chain.