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Analytical Method Development and Validation

Patheon offers the full breadth of advanced analytical technologies for support of early-stage formulation for clinical trial materials. By maximizing the efficiency and flexibility for analytical and formulation development in a non-GMP environment, we are able to quickly establish a solid foundation for your product development. Our analytical development also includes:

  • IND Phase-appropriate method validation
  • Protocol driven stability studies

By having analytical method development and validation seamlessly integrated into a complete development program driven by an experienced dedicated team, Patheon is the most rapid and cost-effective way to go from molecule to market.

Method Development and Validation Studies

  • Cleaning residual assays
  • Stability indicating assays using UPLC and HPLC (including forced degradation studies)
  • Related substances, chiral purity, residual solvents analysis
  • Dissolution testing
  • Preservative assays
  • Physical methods (laser diffraction, Karl Fisher water determination)
  • Nasal spray characterization (droplet size, spray pattern, spray content uniformity)

Case Study: Reliable Analytical Method Development and Validation

The Challenge A medium-size pharmaceutical company approached Patheon to develop and validate a method for quantification of several potential genotoxic impurities (GTIs) in their drug substance. The customer’s procedure, which included a derivatization step prior to analysis, suffered from variable recovery. 

The Solution After reviewing the technical information and chemical structures, Patheon recommended a direct method based on LC/MS. A triple quadrupole LC/MS/MS procedure based on multiple reaction monitoring of parent/fragment ion pairs offered the high speed and sensitivity required for this method. 

The Outcome Patheon’s method was successfully validated over a range of 1 to 21 ng/mL for six  potential GTIs with good linearity (r ≥ 0.99) and recovery (94 to 112%).

Ask The Experts

James C. Mullen

James C. Mullen
Mr. Mullen is currently Chief Executive Officer of DPx. He joined Patheon Inc. in 2011 as CEO and ha
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Andrea Como

Andrea Como
Mr. Como oversees our technology transfer and technical business management teams at our sterile and
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Franco Negron

Franco Negron
Mr. Negron serves as Senior Vice President, North America Commercial Operations and Global Integrati
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Anil Kane, Ph.D., MBA

Anil Kane, Ph.D., MBA
Dr. Kane has more than 25 years of experience in the science and business of taking molecules throug
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Ann Newman, Ph.D.

Ann Newman, Ph.D.
Dr. Newman’s expertise is in solid-state chemistry: physical forms, polymorphism, salts, cocrystals,
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Antonio Magnelli

Antonio Magnelli
Mr. Magnelli serves as Senior Vice President, European Commercial Operations within the global CMO b
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Kaspar van den Dries, Ph.D.

Kaspar van den Dries, Ph.D.
Based at our Tilburg facility in the Netherlands, Dr. van den Dries leads Patheon’s European researc
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Mike Lehmann

Mike Lehmann
Mr. Lehmann is currently President, PDS and Interim Head of Drug Product Sales and Marketing of DPx.
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Robert A. Lipper, Ph.D.

Robert A. Lipper, Ph.D.
Having ushered multiple products to market though the entire development process, Dr. Lipper is an e
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Bob Zinser, M.S. Chemistry, MBA

Bob Zinser, M.S. Chemistry, MBA
Mr. Zinser offers Patheon customers the advantage of more than 39 years’ experience in pharmaceutica
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Manja Bouman

Manja Bouman
Ms. Bouman is currently the President, Bio business unit at DPx.
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Lukas Utiger

Lukas Utiger
Mr. Utiger is currently President, Fine Chemicals and Integrated Offering at DPx. Previously he serv
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Geoff Glass

Geoff Glass
Mr. Glass was appointed President of Banner Life Sciences™ in 2012. He joined Patheon in 2009 as Sen
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Joseph A. Fix, MBA, Ph.D.

Joseph A. Fix, MBA, Ph.D.
With 30 years of experience converting discoveries into businesses, Dr. Fix holds 24 patents, includ
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John S. Kent, Ph.D.

John S. Kent, Ph.D.
With over 35 years of experience, Dr. Kent offers expertise in overcoming development challenges for
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K. George Mooney, Ph.D.

K. George Mooney, Ph.D.
Dr. Mooney has 35 years’ experience in pharmaceutical sciences and exploratory drug development. He
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Harry Gill

Harry Gill
Mr. Gill serves as Senior Vice President, Quality and Continuous Improvement at DPx.
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Laura Parks

Laura Parks
Ms. Parks serves as Sr. Vice President, Corporate Operations and Strategic Initiatives at DPx.
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Larry Gatlin, Ph.D.

Larry Gatlin, Ph.D.
Dr. Gatlin is an industry veteran with more than 36 years of scientific and leadership experience. H
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Enrico Corona

Enrico Corona
Since joining Patheon in 2003, Mr. Corona has been vital in the development of new liquid and lyophi
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Ray Guidotti

Ray Guidotti
Mr. Guidotti serves as Vice President of Global Engineering and Capacity Planning. He joined Patheo
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Stuart Grant

Stuart Grant
Mr. Grant is currently Chief Financial Officer and Executive Vice President of Finance and IT at DPx
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Lynn Van Campen, Ph.D.

Lynn Van Campen, Ph.D.
With more than 30 years of drug development experience, Dr. Van Campen is an expert in the establish
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Geoff Carr, Ph.D.

Geoff Carr, Ph.D.
Dr. Carr offers Patheon customers 36 years of applying analytical science to the creation of pharmac
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Giuseppe Cassisi, MBA

Giuseppe Cassisi, MBA
With a solid foundation of marketing and sales, and expertise in the licensing of generics and drug
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Mark A. Staples, Ph.D.

Mark A. Staples, Ph.D.
Having worked 32 years with all early to mid-stage companies, Dr. Staples is an expert at the early
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Rodney Pearlman, PhD.

Rodney Pearlman, PhD.
An expert in the development of scientific and business strategies for start-ups, Dr. Pearlman bring
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Rebecca Holland-New

Rebecca Holland-New
Mrs. Holland New serves as Chief HR Officer and Senior Vice President, Human Resources and Corporate
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Michael Lytton

Michael Lytton
Mr. Lytton is currently General Counsel and Executive Vice President of Corporate Development and St
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Gordon Marr, Ph.D.

Gordon Marr, Ph.D.
Dr. Marr is an expert in computer-aided analytical method development, optimization and validation f
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Gary Shope

Gary Shope
Mr. Shope serves as Chief of Staff. Previously, he worked as an international business adviser for t
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Harry Gill

Harry Gill
Mr. Gill has amassed a broad range of expertise in his 25 years of global pharmaceutical operations
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Jason Vaughn, Ph.D.

Jason Vaughn, Ph.D.
Dr. Vaughn has expertise in early and preclinical development of liquid, semi-solid and solid dosage
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Mirko Gabriele, MBA

Mirko Gabriele, MBA
An expert in scale-up and technology transfers, Mr. Gabriele’s 10 years of pharmaceutical industry e
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Roman Hlodan, Ph.D.

Roman Hlodan, Ph.D.
Dr. Hlodan is an expert in the development of biopharmaceuticals, including analytical method devel
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Stefano Chiaramonti, Ph.D.

Stefano Chiaramonti, Ph.D.
With 17 years of experience in pharmaceutical development and operations leadership in Europe, and a
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Stephen Closs

Stephen Closs
Mr. Closs possess more than 23 years of experience in formulation development, tech transfer, scale-
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Leah Appel, Ph.D.

Leah Appel, Ph.D.
Dr. Appel has over 20 years’ experience in the pharmaceutical industry developing drug delivery tech
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Tony Pidgeon

Tony Pidgeon
Mr. Pidgeon has nearly three decades of experience in the formulation and process development of ste
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Bret Berner, Ph.D.

Bret Berner, Ph.D.
Dr. Berner holds more than 40 patents in various areas of drug delivery, but is an internationally r
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William E. Weiser, Ph.D.

William E. Weiser, Ph.D.
Dr. Weiser is an expert in analytical method development and validation for APIs and drug products.
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