Patheon Inc.

Patheon Inc.

Patheon Inc.

Welcome to Patheon. With a commitment to quality, scientific excellence and exceptional customer experiences. Patheon is a leading provider of drug substance and drug product services for the global biopharmaceutical industry. Patheon’s global operations includes more than 8,000 scientific and professional staff at 12 commercial-scale finished dose form facilities, three API manufacturing and development operations, four biologic drug operations, one biosolution facility and nine pharmaceutical development centers across North America, Europe, Latin America, Asia and Australia.

Company details

4721 Emperor Boulevard, Suite 200 , Durham , 27703-8580 North Carolina, USA
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Business Type:
Manufacturer
Industry Type:
Pharmaceutical
Market Focus:
Globally (various continents)
Year Founded:
1974
Employees:
Over 1000

Patheon, a business unit of DPx Holdings B.V., delivers a combination of unrivaled quality, reliability and compliance, with a reputation for scientific and technical excellence to customers in the pharmaceutical and biopharma sector. A leading global provider, offering a comprehensive set of solutions to help customers of all sizes satisfy complex development and manufacturing needs at any stage of the pharmaceutical development cycle.

Services

The company enables its customers to bring drug candidates from preclinical stages through to clinical trials, the NDA approval process and, if approved, commercial manufacturing. Patheon's development and commercial manufacturing capabilities cover primarily prescription (Rx) products in solid and sterile dosage forms, as well as specialized capabilities in high potency, controlled/sustained release, and sterile manufacturing, including aseptic filling and lyophilization.

Patheon’s key capabilities for biologics include flexible, technology-based process development, clinical and commercial cGMP manufacturing for mammalian cell culture derived biopharmaceuticals and chemical bulk drug substances. Patheon can serve early, late and commercial stage markets providing end-to-end solutions to customers through its four biologics sites in the U.S., Europe and Australia.

The Patheon OneSource™ integrated offering is an end-to-end development solution focused on simplicity, speed and quality expertise in drug substance and drug product development. This offering provides solutions to customers for Phase I through Phase II products, delivering a simplified development process that drives faster, high-quality results.

Market Opportunity

The pharmaceutical industry is growing and, compared with other industries, is in the early stages of adopting manufacturing and development outsourcing strategies. Many global pharma, biotech and specialty pharma companies rely on the services of contract product development and commercial manufacturing companies to help meet growing demand and bring new drugs to market more quickly.

Patheon is the established leader in this relatively new segment of the pharmaceutical industry. With a wide range of manufacturing capabilities and significant scale in the world's two largest pharmaceutical markets – the United States and Europe – the company is uniquely positioned to serve as a strategic global manufacturing partner to the industry's leading innovators.

Patheon serves more than 400 clients, from large global providers to small emerging players in the pharmaceutical and biopharmaceutical sectors.

  • At every level of our organization, at every one of our facilities around the globe, in everything we do, each and every person at Patheon is dedicated to the five commitments that guide our company:
  • Provide the industry's leading customer experience.
  • Be the highest quality, most flexible, and most efficient producers in the world.
  • Provide the best technical and scientific solutions to solve difficult development problems and enhance product value.
  • Create a culture of engagement, ownership and a shared commitment to excellence in all that we do.
  • Operate our business in a disciplined, responsible, and ethical fashion such that our shareholders will appreciate superior returns over time.

Our Vision
Quality is a fundamental and integral part of our business and yours. At Patheon, quality is not just a department, but what drives us. Our goal is perfection every time in everything we do. With highly trained staff and innovative systems throughout the entire organization, we constantly strive to develop new ways to exceed all regulatory requirements and customer expectations while reducing costs and lead times.

Our Approach
We believe that the higher our quality, the more timely work gets finished, the lower our costs become, and thus the better business partner we are for you the customer. Each Patheon facility has an experienced quality management team who actively collects quality and compliance Key Performance Indicators from sources such as customer and regulatory audits, self inspections, local departmental meetings, trending reports, product and data reviews and non-conformance quality systems monitoring programs. These data are systematically analyzed and regularly reported to senior management, site leadership teams, and to corporate quality and operations management teams. With this vigilant and proactive approach, Patheon is dedicated to maintaining an environment of strict cGMP compliance and continuous improvement throughout our global network.

Additionally, the Patheon Quality Control Laboratory offers a full compliment of testing capabilities to support the manufacturing and release of products. This also includes post market stability monitoring services, and at some sites, analytical development services. We perform a full range of testing including release tests for U.S. Pharmacopeial Convention, European Pharmacopeial and Japanese Pharmacopeial requirements.

Our Stellar Track Record
Due to the nature of our business, Patheon's facilities are frequently audited by national and international regulatory bodies and customers more than 200 times a year. As a result of our strong compliance record, Patheon has received approvals for more than 35 pre-approval inspections and been granted nearly 20 waivers since 2006. Inspecting agencies include:

  • Food and Drug Administration (FDA), USA
  • Health Products and Food Branch Inspectorate (HPFBI) and Therapeutic Products Directorate (TPD), Canada
  • European Medicines Agency (EMEA), European Union
  • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
  • Agência Nacional de Vigilância Sanitária (ANVISA), Brazil
  • Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS), France
  • Gulf Cooperation Council (GCC), United Arab Emirates, Bahrain, Saudi Arabia, Oman, Qatar, Kuwait
  • Agenzia Italiana del Farmaco (AIFA), Italy
  • The Ministry of Health, Labor and Welfare, Japan

Where some may view regulatory supervision as a hurdle, Patheon views it as an impartial measure of excellence. Since 2007 our facilities have undergone 133 regulatory agency inspections, with 31 resulting in zero observations. That's an unheard of nearly 1 in every 4 inspections being perfect. Also, Patheon is the only sterile drug manufacturer with no warnings from regulatory agencies. While we are certainly proud of this regulatory track record, that doesn't stop us from constantly striving to perform even better.