Patheon
At The Cutting-Edge Of Drug Discovery And Manufacturing

The pharma industry is facing a bevy of challenges in developing quality drugs owing to the challenges in procuring the right resources and equipment to address the toughest development challenges. To keep the cost in check and improve brand performance, pharma companies need to take the right decisions from the word go. Patheon, by Thermo Fisher Scientific, is a leading drug contract development and manufacturing organization (CDMO) catering to hundreds of pharmaceutical companies. Under the aegis of Thermo Fisher Scientific, Patheon follows its parent company’s core principles of enhanced simplicity, speed, and quality for its clients across the pharmaceutical and biotechnology sectors.

Through its pharmaceutical development and manufacturing services, Patheon provides a comprehensive, integrated, and highly customizable set of solutions to help businesses of all sizes satisfy complex development and manufacturing needs at any stage of the pharmaceutical development cycle. The company is backed by scientific and technical excellence, which is combined with passion for quality services. Its scientists, chemists, and technical experts seek out opportunities for operational improvements across the enterprise to ensure delivery of quality medicines from the get go. The company strives to simplify the supply chain process and focus on exploring avenues where the operations can be optimized for its offerings to be presented to clients in innovative ways.

The team at Patheon takes pride in solving clients’ unique challenges and speeding molecular discovery through early phase trials. It draws on years of experience and deep expertise to reduce the risk and raise the bar on quality. Patheon’s high-quality APIs and intermediates are made in the same facilities and to the same stringent standards for maximum quality and care of the innovative products being developed. The company plays a key role in various aspects including: developing product proof of concept to confirm market interest; providing innovation for product lifecycle management; providing solutions for Rx, OTC and tablet to softgel switches; enhancing bioavailability to obtain quicker onset of action; and offering formulation options for specific patient populations including pediatrics and geriatrics.

With solutions available for faster time to market through integrated API solutions, Patheon’s clients can expedite their journey from clinical to commercial API production.

Quick to Clinic™ allows clients to have Phase I product manufactured, labelled, packaged and delivered to the clinic in as little as 14 weeks from receiving their API

Specifically, Patheon brings high value through its services in the areas of route scouting, process development, clinical supply manufacturing, and tech transfer and upscaling of new and existing processes. Some of the key capabilities of the company include: continuous improvement of existing processes, expertise with difficult-to-manufacture APIs, innovative solutions to manufacture complex API, high potency compounds and controlled, substances.

Patheon also offers comprehensive analytical services, commercial supply manufacturing, supply chain management, spray drying, micronization, and physical characterization. The company brings unique specialization of microreactor flow chemistry and focuses on continuous processes on small reactor scales to deliver improved product quality and higher yields. Patheon’s advanced catalysis technologies can reduce timelines from years to months. Moreover, its interdisciplinary route scouting expertise, chemocatalysis and biocatalysis, proprietary biocatalytic processes, and experience with large-scale complex processes that development-only labs do not offer. The company also bring to bear its 20 years of experience to lead the way in polymeric API technology. This aids clients in creating completely unique products by combining proprietary process technologies, polymer science, advanced synthesis and large-scale cGMP expertise.

What’s more, in late-stage trials and beyond, the clients’ drug substance will be manufactured at a cGMP commercial production facility where a team of experts works continuously to optimize processes, increase outputs and reduce timelines. The company’s clinical and commercial batch manufacturing capabilities include: a comprehensive array of technologies, services, and solutions; flexible manufacturing solutions; scalable processes; dedicated teams and multiple facilities for clinical and commercial scale manufacturing; total capacity in excess of 800,000 L with reactors as large as 16,000 L; access to a streamlined end-to-end supply chain; full regulatory support with CMC documentation; regulatory approvals to work with controlled substances and highly potent compounds;

Moreover, the company’s process validation ensures a reliable commercial supply. In clinical phases and as part of the establishment of the commercial supply of API, Patheon provides a complete validation package according to regulatory and cGMP guidelines, including: quality by design (QbD) and Proven Acceptable Ranges (PAR), process validation with critical parameters, validation of analytical assays, release testing, stability studies at required ICH conditions. What’s more, life science companies partner with Patheon for commercial sample distribution because of its logistics expertise and unmatched track record of delivery to representatives in the field or directly to healthcare practitioners.

A Comprehensive Solutions Portfoli

Patheon offers a variety of solutions to address the unique innovation challenges. To elaborate, Quick to Clinic™ allows clients to have Phase I product manufactured, labelled, packaged and delivered to the clinic in as little as 14 weeks from receiving their API. That’s up to 1 month faster than most standard timelines. Another solution that uses Predictive Modeling, Quadrant 2™ can predict the most promising solubility enhancement technology and excipient combination to meet clients’ clinical and business objectives, at the earliest stages of development. The solution uses clients’ compound’s individualized data to that end.

Quick to Care is a fully integrated program for new and emerging companies looking to streamline their drug development. With this program, Patheon combines clients’ drug substance, drug product development, and clinical manufacturing into a single solution to accelerate their discovery to proof of concept, saving an average of 14-20 weeks of development time.

Continuous Manufacturing: With continuous manufacturing, API and excipient materials are moved non-stop through an integrated equipment train, eliminating hold times between processing steps and essentially eliminating the idea of “batch” manufacturing.