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Patheon

Pharmaceutical Drug Product Development

Preformulation Screening

With speed and efficiency, evaluate the physical and chemical properties of your drug substance for a clear understanding of the path to Phase I clinical studies and beyond. Patheon gives you access the full breadth of advanced analytical technologies and preformulation services.

  • Chemical purity analysis
  • Physicochemical properties
  • Solid form definition and analysis
  • Molecular structure analysis
  • Excipient compatibility testing
  • Amorphous vs. crystalline solid state testing
  • Aqueous and solvent solubility
  • Solution and solid state stability
  • Vehicle screening for ADME and toxicity

Working with Patheon at this early phase opens the door to a partnership that can take you all the way to commercial supply. Fully integrated services that deliver speed, flexibility and a streamlined supply chain. One partner, one team, one seamless solution customized to your needs.

Formulation Development

Take your discoveries to the proof of concept milestone with speed and efficiency while laying a firm foundation for commercial success. Patheon has helped clients receive more NDA approvals than any other CMO.* By offering the full range of analytical, formulation and dosage form technologies and solutions, we can tailor a lean, fully integrated drug formulation program precisely suited to your molecule and business. One that will accelerate your project to first-in-human studies and beyond.

You will also have access to the speed and agility of a non-GMP environment, and unique solutions you won’t find anywhere else. Patheon Quadrant2® employs computer modeling and fundamental science to improve bioavailability. Patheon Quick to Clinic™ delivers high-quality Phase I clinical supplies in as little as 12 weeks.

Nobody gets you to clinical trials faster than Patheon. And nobody gives you access to more early-phase dosage formulation choices with a program more closely tailored to your needs.

  • Blend in capsules
  • API in bottles
  • API in capsules
  • Blend in bottles
  • Lyophilized vials
  • Sterile liquid in vials
  • Softgels

*Source: PharmSource ® Trend Report, March, 2016.

Solubility Enhancement

Considering that 90% of drug candidates have bioavailability issues, making sure your program is prepared for all phases of clinical trials from the very start is the fast way forward.  Patheon Solubility Enhancement Services approaches BCS II and IV drug substance solubility issues a fundamentally different way that identifies the solubility enhancement technologies most likely to work before you get started. That helps eliminate rework and worry later on.

Try the  Patheon Solubility Solution Finder and then talk to a Patheon solubility expert to see how we can help meet the needs of your molecule, timeline and budget with a custom-tailored complete solution. Even if it means another company handles your solubility enhancement process.

With Patheon Solubility Enhancement Services, you get a partner you can trust with the skills your discovery deserves: Comprehensive analytical services. Preformulation characterization and technology screening. Formulation design and process development built upon computer modeling and Quality by Design principles. Proven cGMP clinical-scale manufacturing. And an array of solubility technologies that includes proven solutions not available anywhere else.

Analytical Services

Achieve repeatable high quality and robust process design at every phase of your large and small molecule pharmaceutical development projects with access to a comprehensive array of analytical services.

  • Physical and chemical definition and analysis
  • Process development and validation
  • Analytical development and validation
  • Impurity tracking
  • In-process production support
  • Stability testing for various ICH climatic zones
  • Genotox studies
  • PAR studies

We have cGMP labs staffed by highly experienced teams within each of our manufacturing and development sites. From a small quantity of your active pharmaceutical ingredient (API), you can gain the scientifically sound data you need for regulatory submissions and to guide your next steps. High-quality analytical data for high-quality products, processes and business decisions.

Manufacturing Process Development

Build quality and robust repeatability into your manufacturing process. Do it during early phases to accelerate through later phases and into commercial production upon approval. Because our capabilities span the full breadth and depth of the pharmaceutical development life cycle, because we have the experience of thousands of projects, we know what your process needs to succeed today and tomorrow. With Patheon you’ll get a process that is reliable, efficient and built to deliver repeatable quality.

Dosage Forms

Every molecule offers unique technical challenges, just as every client has specific business requirements. The more options that are available, the more precisely you will be able to meet these needs. This is why we offer such an expansive range of choices in dosage forms and technologies.

Oral Solids

Bring more than 40 years of experience to your project. Access a remarkable range of conventional and specialized oral solid dose form options. Further expand your options with innovative combinations of these forms and a variety of controlled-release technologies. All these choices are executed with the expansive scientific resources and expertise to rapidly develop successful formulations for even the most complex APIs including highly potent compounds and controlled substances.


Conventional

  • Immediate-release tablets
  • Powder-filled capsules
  • Powders, granules and coated beads

Specialized

  • Liquid-filled capsules
  • Controlled-release tablets
  • Multilayer tablets
  • Fast-dispersible tablets

Steriles

Access extensive sterile pharmaceutical product development capabilities, including world-class expertise in lyophilization. With Patheon you’ll also have access to state-of-the-art commercial-scale GMP manufacturing for prefilled syringes and cartridges. Ready-to-use dosage forms enable self administration of parenterals that once required a clinical visit. As the healthcare industry seeks to move treatments into the home, Patheon is investing in capabilities that will keep you ahead in the evolving marketplace.

  • Liquid small volume parenterals (SVP)
  • Liquid large volume parenterals (LVP)
  • Lyophilized vials
  • Prefilled syringes
  • Cartridges

Softgels

Most patients, especially children and seniors, prefer softgels. With Patheon, you’ll have access to a broad palette of shapes, sizes and colors, as well as unique chewable, topical and suppository options.

Softgels offer many advantages, and Patheon offers the expertise to help you take full advantage of all of them:

  • Precise control of drug release rate and site of absorption
  • Lower dose levels with higher bioavailability
  • Faster drug action and reduced food effect
  • Hermetic seal for oxygen-sensitive APIs
  • Mask unpleasant tastes and odors
  • Opacity range from clear to opaque for light-sensitive APIs
  • Liquid, suspension, semi-solid and solid fill materials of any viscosity
  • Alkali or acidic gelatin shells formulated for each fill material
  • Reduced exposure risks for high potency compounds

Softgels are easily scaled for every phase of development. That’s because clinical batches are made the same way and on the same equipment as commercial runs. Plus, Patheon gives you access to specialized technologies to meet the needs of your molecules and markets, including advanced solutions for enhancing solubility and bioavailability.

  • Softgel Capsules
  • Twist-Off Softgels
  • EnteriCare® Softgels
  • LiquiSoft™ Softgels
  • Versatrol™ Softgels
  • Solvatrol™ Softgels
  • Soflet® Gelcaps
  • Chewels® Chewable Gels

Clinical Batch Manufacturing

High-quality clinical trial materials to support your pursuit of regulatory approval. Fit for purpose formulations for Phase I and IIa studies, and a comprehensive range of finished dosage forms for Phase IIb and III studies. We have years of experience and an inspection record that is second to none. The reliability of our quality is further proven by our Right First Time/On-Time delivery track record.

With speed, flexibility and a full range of services, we will be responsive to your changing requirements and evolving needs as your project progresses through clinical trials.

  • cGMP manufacturing at all scales
  • Small molecules and biologics
  • Oral solid, sterile and softgel dosage options
  • Quality by Design process development
  • Full analytical support and stability testing
  • Over-encapsulation and matching placebos
  • Materials for dose escalation studies
  • Registration batches
  • CMC documentation for regulatory submissions

Clinical trial material manufacturing is only one of our fully integrated pharmaceutical development services. Our facilities are designed with a commonality of equipment from clinical batch to commercial for seamless scale up. The Patheon OneSource™ program aligns development of your drug substance and drug product for the most efficient path to market, taking months off your development timeline. Patheon Quick to Clinic™ can accelerate your molecule to first-in-human studies in as little as 12 weeks.

Unique Solutions

The “right solution” is the one that most directly addresses the specific needs of your molecule, timeline and budget. This is true of everything we do, and vividly demonstrated by our unique solutions.

These highly customizable pharmaceutical development offerings seamlessly bring together core capabilities and proprietary technologies from across functional areas to overcome your most critical challenges – solubility, bioavailability, and accelerated proof of concept. No other CDMO can help you achieve your goals with more speed, efficiency, quality and value than Patheon.

  • Patheon Quadrant2®
  • Patheon Quick to Clinic™

Patheon Quadrant2® – Bioavailability enhancement design technology.

Patheon Quadrant2® is our computer-assisted formulation design platform for bioavailability enhancement. Following Quality Target Product Profile (QTPP) guidelines, it enables faster, broader and more rigorous formulation design and development. The scientifically disciplined approach of Patheon Quadrant2® pays off at every stage of the product life cycle. Additional complimentary technologies include a free drug assay, phase diagrams, physical stability mapping and analytical development.

Patheon Quick to Clinic – High-quality Phase I clinical trial materials in as little as 12 weeks.

Only twelve weeks from receipt your API, Patheon Quick to Clinic™ can deliver bulk clinical trial materials for first-in-human trials. That includes a one-month stability study so you have all the data you need to make informed proof of concept decisions and complete regulatory submissions.

Quick to Clinic- Clinical Trial Material Development

Right First Time/On-Time delivery performance at Patheon is second to none, as is our regulatory track record. Patheon Quick to Clinic™ delivers maximum speed without compromising quality. What’s more, this accelerated program gives you access to five flexible dosage forms.

  • Blend in capsule
  • API in bottle
  • API in capsule
  • Blend in bottle
  • Softgel

Nobody can get you to Phase I clinical trials faster with more dosage forms, higher quality and a drug product with more built-in investment value.

Do you want to learn more?

We look forward to learning about your specific needs, please contact us.

USA
+1.919.226.3200
GLOBAL
+1.866.Patheon