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.

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

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 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

Cognate Bioservices Inc.

Cognate BioServices is a leading contract development and manufacturing organization specialized in cell and cell-mediated gene therapies, DNA/Plasmid and Viral vectors with the acquisition of Cobra Biologics in the UK and Sweden earlier this year. We pride ourselves in the level of quality and experience logistics support we bring to the table with both companies being commercial ready to supply expertise and capacity from the ground up. We are unique in a number of ways, including but not limited to:

Our late stage experience in personalized cellular therapies and complex biologics and pharmaceuticals for over 20 years in multiple geographies;
A wide range of operating, technical and leadership experience spanning cellular immunotherapy and regenerative medicine and biotechnology;
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 as well as the development and manufacture of drugs.

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, fill/finish and regulatory support for protocol and IND development for complex products involving multiple drug substance intermediates all the way to minimally manipulated primary cells and intermediates used to support cells therapies at Cobra Biologics

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.

www.compliancearchitects.com

DCI, Inc.

www.dciinc.com

Operations & Quality Systems Improvement Experts (OQSIE)

Consulting company focused in Manufacturing, Quality Systems and Supply Chain. We help solve difficult operational problems and compliance issues. Three lines of service:
1) SOW-based Consulting support; 2) SOW-based Workforce Solutions; and 3) Technology Solutions.

oqsie.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 groundbreaking 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.

projectfarma.com

Cytiva

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.

cytivalifesciences.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

ProPharma Group

ProPharma Group is the truly global, independent, single-source provider of regulatory, compliance, pharmacovigilance, and medical information services serving pharmaceutical, biotechnology, and medical device companies. Our team of experts brings a comprehensive portfolio of regulatory and compliance solutions to help solve complex challenges in a dynamic regulatory environment. With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

www.ProPharmaGroup.com

Samsung BioLogics

Samsung Biologics is a fully integrated contract service provider offering development, manufacturing, and testing services, all from a single location. We provide highly tailored solutions to clients while meeting the evolving needs of the global healthcare industry.

With proven regulatory approvals and the largest single-site capacity, Samsung Biologics is a trusted CDMO partner of choice and is uniquely able to provide seamless offerings from cell line development to final fill/finish as well as laboratory testing services at every stage for biopharmaceutical products.

Our facilities are all cGMP compliant holding 364KL total capacity with scales ranging from 1KL and 5KL to 15KL. We continue to invest and upgrade our capabilities through two 1K single-use bioreactors that provide further flexibility and efficiency in accommodating a wide range of client demands.

Samsung Biologics plans to expand its plant 4 with the largest single plant with a capacity of 256 KL.

We believe and are committed to an on-time, in-full delivery of the products we manufacture with our flexible manufacturing solutions, operational excellence, and proven expertise.

www.samsungbiologics.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, Inc.

Founded in 1994, Sparta 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 QMS 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.

www.spartasystems.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.

patheon.com

Analytical Lab Group

We are industry leaders in the specialty contract lab space and comprise FDA- and EPA-focused laboratories across the United States, with facilities in the San Francisco, Minneapolis and Boston areas.

The ALG team is focused on Helping Protect Life® through infection prevention, with the most comprehensive testing solutions in the antimicrobial, pharmaceutical, medical device, biotech and healthcare spaces. Our facilities are GLP/cGMP compliant, FDA registered, DEA registered and ISO/IEC 17025:2017 accredited.

analyticallabgroup.com

Aventior, Inc.

Faster data extraction for CMC and Compliance using AI.

Our CPV Automation platform delivers a 6X improvement in processing speed and achieves a near-zero error rate in data extraction (including hand-written data). It has significantly helped companies to reduce their cost of compliance and, storing and processing pharma/biologics manufacturing data.

The CPV Automation solution automates data extraction for the biotech industry (especially for CAR-T, Gene therapy, cell therapy companies) and is specifically focused on processing paper batch record (scanned PDFs and documents) generated during external manufacturing and vector formulations.

aventior.com

CherryCircle Software, Inc.

www.qbdvision.com

IDT Biologika

IDT Biologika is a global biopharmaceutical contract development and manufacturing organization that specializes in the production of innovative live viral vaccines and viral vectors for gene and immune therapeutics. This includes process development, API production, sterile dosage filling, primary and secondary packaging, quality control and cold storage. IDT Biologika handles every step in manufacturing and packaging of small clinical batches and of large-scale commercial products. Our fully integrated services at our sites in the US and Germany are underscored by our commitment to quality and operational excellence that flows through our best-in-class process and cGMP (up to BSL2) manufacturing capabilities meeting FDA, EMA and ANVISA standards. We supply our clients products in vials, pre-filled syringes (with and without safety devices), autoinjectors or as combination products. IDT Biologika is unique in its ability to accommodate the development, testing and manufacture of products for the world’s leading biopharmaceutical companies.

www.idt-biologika.de

Just Evotec Biologics

www.justbiotherapeutics.com

KND Labs

KND Biopharma is an enterprise-level supplier and best-in-class producer of hemp-derived Active Pharmaceutical Ingredients (APIs). We support top pharmaceutical companies as their trusted CBD source.

KND Biopharma’s hemp is certified organic and is greenhouse grown, under strict climate-controlled measures to ensure purity and quality.

kndlabs.com

Lonza

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

Northway Biotech

Northway Biotech, a global biologics CDMO since 2004, located in the US (Waltham, MA) and Europe (Vilnius, Lithuania), provides end-to-end drug development and cGMP manufacturing services. The company’s wide-ranging expertise and vertically integrated service offering translate to the ability to rapidly execute multiple projects from its state-of-the-art GMP facilities while ensuring full process and product compliance at all research stages and commercial manufacturing.

Northway Biotech has full technology capabilities starting with cell line development; upstream and downstream process development; scale-up for clinical manufacturing; process characterization and process validation for commercial launch and steady-state cGMP manufacturing as well as dedicated DP lines for its clients for aseptic fill & finish in liquid, lyo, and PFS.

Key highlights:

• Full-service biologics CDMO with end-to-end capabilities: from gene to drug product
• Excellence in quality – proven track record with cGMP-certification
• Successful completion of 100+ mammalian and microbial projects since 2004
• 70+ clients worldwide
• High responsiveness and 100% focus on the client‘s commercial success

northwaybiotech.com

Skyland Analytics

Founded in 2015 and headquartered in Boulder, Colorado, Skyland’s core team has worked together for over 20 years and has deep expertise in life science manufacturing, IT systems, data analytics, validation and product quality. Having developed the ‘first generation’ product-process data information solution, the team has applied this experience to deliver a ‘next generation’ platform that leverages cloud-based technology to deliver better, faster solutions with a much lower total cost of ownership.

skylandanalytics.net

Stelis Biopharma

stelis.com

TOWER Cold Chain

TOWER Cold Chain Solutions’ passive KryoTrans® thermal containers provide a solution to reduce the total cost of shipping. TOWER provides a developing global infrastructure with full-service centres across the US, Europe, Asia-Pacific & South Africa creating a flexible service.

For over a decade TOWER has led the way with its innovative solutions for the reusable controlled-temperature market. Currently servicing and supplying 30 of the world’s top pharma and pharma 3PL companies: these players trust TOWER containers and the simplicity and reliability they bring.

With zero-temperature-excursion phase-change technology TOWER containers are simple to store, load, ship, unpack and store.

towercoldchain.com

AGC Biologics

www.agcbio.com