Contract Pharmaceutical Development Services and Commercial Manufacturing
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Patheon specialises in pharmaceutical development and manufacturing services.
Active pharmaceutical ingredients (API) for the pharmaceutical sector
Patheon provides an integrated and customizable range of active pharmaceutical ingredients (API) and finished drug product services, including formulation development, clinical and commercial-scale manufacturing, packaging, and lifecycle management.
The company's services address small and large molecule biological drugs.
Patheon is an end-to-end integrated provider, which combines scientific and regulatory expertise and specialised capabilities. This provides clients with a single outsourced provider to address complex development and manufacturing challenges.
Patheon specialises in leading product development services and commercial-scale product manufacturing.
Development and manufacturing solutions
Patheon transforms the pharmaceutical supply chain model with innovative, flexible, and customised end-to-end development, as well as manufacturing solutions that reduce complexity and shorten time-to-market.
Clients gain access to a wide range of drug substances, pharmaceutical development, and drug product solutions for large and small molecules, including an array of oral solid, sterile, and softgel dosage forms.
This provides flexibility to choose the most appropriate chemistry, manufacturing, and controls (CMC) technologies with the confidence that the programme will be delivered on time.
The company employs new business models to help clients simplify their supply chain management activities in an increasingly complex drug development industry.
Drug substance and drug product services
Patheon is organized into three distinct business units, drug substance services (DSS), pharmaceutical development services (PDS), and drug product services (DPS).
DSS is one of the top three outsourced manufacturers of highly complex biological drug substance produced in four biological API facilities. These sites are positioned to serve 70% of the market.
Patheon provides complex small molecule APIs and flexible outsourced manufacturing solutions for large molecule biologic APIs from early development through to commercial-scale production.
PDS Patheon is a leading global provider of formulation services. The company's capabilities span the full breadth of advanced scientific services, including discovery, regulatory approval and formulation development across 40 dosage forms, as well as analytical services and life-cycle management.
DPS Patheon has developed and manufactured 20% of the top 100 drugs and 75% of the dosage forms on the market over the past decade.
Patheon has 8,700 employees, including more than 600 scientists in 25 locations in Europe, North America, Australia, and Asia.
The company has provided development and manufacturing services for approximately 400 clients for more than 700 products and molecules.
Through Patheon's integrated global network of facilities, clients needs are met, which includes expertise to pharmaceutical, biotechnology and specialty pharmaceutical companies. This expertise helps clients bring drug candidates, including pre-clinical stages such as clinical trials and commercial supply.
Patheon provides a comprehensive suite of capabilities that addresses 75% of dosage forms with expertise and specialised capacity in high-potency, controlled substances, low-solubility, sterile, modified release, and softgel technologies.
Patheon OneSource is an end-to-end development product that is simple to use, quick, and high-quality.
- OneSource streamlines supply chain activities and a project manager is assigned to serve as a single point of contact for overseeing both APIs and finished products, as well as offering customers a flexible contracting process.
- The offering can save up to 12 weeks, which is a significant improvement on the industry standard of a 15-month development cycle. In addition, Patheon can reduce redundancies through measures such as combined analytical activities, scientific collaboration, and parallel processing.
- OneSource co-ordinates joint teams to collaborate and provide input early on in the process. Patheon has established a single harmonized quality system across its global network, ensuring it adheres to its proven track record with Right First Time and On Time Delivery, drawn on years of experience with large and small molecule APIs.
Patheon offers four specific flexible manufacturing options which are the dedicated asset model, fractional ownership model, flexible network access and the 'condominium model.'
The company provides pharmaceutical and biotechnology companies with direct access to the expertise, quality, and full range of small or large molecule drug substance and solid and sterile dosage forms including:
- Small molecule APIs and cGMP production
- Process development, generic APIs and pharmaceutical intermediates portfolio
- Biologics, mammalian cGMP and non cGMP manufacturing
- Process and early development
- Drug substance characterization
- Analytical and formulation development and validation
- Clinical trial material manufacturing
- Late development and process and method development
- Release and stability testing
- Regulatory support and lifecycle management services
- Commercial manufacturing and packaging
- Tech transfer/scale-up management
- Risk mitigation services
4721 Emperor Blvd
Durham, NC 27703-8580
United States of America
+1 866 728 4366
+1 919 226 3200
Article: Formulating and Producing Tablets Containing Large, Coated Multiparticulates
Available White Papers
How to Choose the Right Solubilisation Technology for an API The proportion of poorly soluble drug compounds in the development pipeline is on the rise, with 70% to 90% of current pipeline drugs falling in the two low-solubility classes of the biopharmaceutical classification system.
A Cure for Pharmaceutical Supply Chain Complexity The pharmaceutical industry lags in the sophistication and performance of its supply chains when they are compared with best-in-class companies in other industries.
A Rapid Vehicle-Screening Approach for Formulating a Low-Solubility Compound into Liquid-Filled Capsules, from Tablets and Capsules For a drug product to exert its therapeutic effect, it must be soluble in an aqueous environment. This ensures that the active pharmaceutical ingredient (API) will provide sufficient concentration to induce gastrointestinal (GI) tract absorption.
Bridging the Gap between Early Phase Development and Commercialisation, International Pharmaceutical Industry The challenge of taking a drug candidate from discovery through to market should not be underestimated, as there can be many hurdles to face along the path.
Fast and Flexible: Early Phase Manufacturing, European Biopharmaceutical Review Early stage manufacturers of oral solid dosage forms need to be fast and flexible to generate development pathways that can cope with variable API characteristics, as well as highly potent molecules.