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

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

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.

AbbVie Inc.

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

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.

Ajinomoto Bio-Pharma Services

www.AjiBio-Pharma.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

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

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.COM

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

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

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

Rapid Micro Biosystems

www.rapidmicrobio.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

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

Thermo Fisher Scientific

patheon.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.

www.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.

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

www.avitide.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

Enterprise System Partners Global Corporation

www.enterprisesystempartners.com

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 prevent and treat diseases, that impact the health of humans worldwide. Core competencies are in viral vaccines (live and attenuated) and injectable biologics. 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.

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

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

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

Emergent Biosolutions

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

Skyland Analytics