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Articles & White Papers

Challenges, Risks, and Strategies for Biologic Substance Manufacturing

ORC International’s study highlights issues inherent in forecasting biologic drug substances. From discussions with pharmaceutical and biotechnology industry leaders, it is clear that demand forecasting is a significant challenge when planning biologic drug substance production. The biologics development and approval process is typically long and complicated, increasing the risk of accurately forecasting demand. Overestimating demand can lead to higher per unit cost and disposal expenses, and underestimating it can result in missed market opportunities and negative reputational consequences for the company. ...View More

Solutions to Today’s Biomanufacturing Challenges

Author: John Ward, Vice President, Engineering
Biopharmaceutical companies take on a lot of risk developing new large molecule drugs. With more complex molecules in development, changing capacity needs, uncertain forecasts and increased competition, the market demands flexibility and innovative approaches to address today’s new challenges. ...View More

Multiplexing: Managing Risk with Proven, Single-Use Solutions

Author: Marc Goemans
When pharmaceutical companies introduce a new drug to market, they invest enormous amounts of capital, and assume equally enormous amounts of risk. As it usually takes three-to-four years to prepare manufacturing capacity for the large scale production of a new product, the decision as to how much volume a company will need often must be made before Phase III trials are completed. ...View More

Implications of Inaccurate Forecasting on Biologics Drug Substance Manufacturing - White Paper

Author: ORC International
An Independent Executive Research Study by ORC International examines how large molecule drug substance manufacturing and demand forecasting is riddled with complexity. The long cycle time and short shelf life of a biologic drug substance makes it difficult to adapt the supply chain with agility, even at the earliest stages of development. ...View More

Biopharma Advances Demand Specialized Expertise

Author: Scott Lorimer
Scott Lorimer, vice president of global operations at Patheon Biologics shares insights on biopharma market developments and the implications of biosimilar drug approvals in an article published by BioPharm International. ...View More

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Phase Appropriate Formulation Process Design

Author: Anil Kane, Ph.D., MBA
Appropriate use of sound science applied at critical junctures will improve efficiency in the high-wire act of drug development. ...View More

Formulation Development: An Innovative, Simulation-Based Approach

Author: Tom Reynolds, PhD, Matt Wessel, PhD, Sanjay Konagurthu, PhD, and Marshall Crew, PhD
In order to improve productivity, companies have been leveraging computational chemistry to screen and identify potential drug candidates at the earliest stages of drug discovery. These methods are a viable approach to shortening development timelines and achieving better success. ...View More

How Broadening the Analysis of Compound Factors Allows for Predictive Solubility Solutions - White Paper

Author: Marshall Crew, Ph.D.
The Biopharmaceutics Classification System (BCS), developed by the U.S. Food and Drug Administration to simplify and accelerate the drug development process, helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing. ...View More

Solid Dosage Outsourcing Trends

Author: Tim Wright
Kaspar van den Dries, director, research & development, Europe at Patheon, is featured in an article on solid dosage outsourcing trends published in Contract Pharma. The market continues to evolve as blockbusters are replaced by more targeted treatments that have unique requirements. ...View More

Solid Dosage Outsourcing: Mergers, Expansions, and New Technologies

Author: Matthew Knopp
Eric Jayjock, director of continuous manufacturing at Patheon, and Kaspar van den Dries, senior director, formulation sciences, solid dose and softgels at Patheon, discussed outsourcing, mergers and acquisitions, expansion plans and continuous manufacturing in an article published by Tablets & Capsules. ...View More

Ingredients See a Drive for More Science

Author: Susan Birks
Marshall Crew, vice president of global PDS scientific excellence at Patheon, discusses the latest trends driving developments in ingredients, in an article by Susan Birks, published in Manufacturing Chemist. ...View More

Solubilization Technology

Author: Sanjay Konagurthu, Ph.D.
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. With the emergence of new techniques to improve solubility, low solubility compounds are more likely to advance to the clinic. ...View More

Evolving CMO-Sponsor Relationships

Franco Negron, senior vice president, North America commercial operations and global integration at Patheon, discussed how the relationship between sponsors and contract manufacturing organizations have evolved into being more strategic and solutions-oriented in an article "Evolving CMO-Sponsor Relationships" published by Genetic Engineering & Biotechnology News. ...View More

Patheon Fosters Innovation and Delivers Industry-leading Service in Brabant

BOM Foreign Investments article "Patheon fosters innovation and delivers industry-leading service in Brabant" features Patheon's Tilburg plant that specializes in the development and manufacture of ‘softgels’- capsules containing liquid doses of medicines and nutritional supplements. The company’s local clients include household names such as Pfizer, Perrigo and Reckitt Benckiser. ...View More

Impact of Incorrect Forecasts on New Product Launches

Pharmaceutical companies around the world are under tremendous pressure – from regulators, legislators, payers, and patients – to reduce the cost of drugs. In response to the outcry for cost-cutting, pharmaceutical company leaders are examining every aspect of their business to determine where they can derive savings, particularly when planning for the launch of a new product. ...View More

Solving the OOS Problem with Continuous Manufacturing

Author: Eric Jayjock, PhD
The goal of Pharmaceutical Process design has long been to implement a fixed process that can produce on-spec materials, which can be confirmed by quality testing. ...View More

Operational Excellence: In a Flexible Manufacturing Environment

Author: Franco Negron, President, Drug Product Services
One of the most critical elements for a pharmaceutical company launching a new drug product is forecasting market demand. Countless variables such as the competitive landscape, reimbursement and market acceptance, influence and contribute to how well a drug performs on the market. Franco Negron, President of Drug Product Services at Patheon, reviews the requirements to operate efficiently in a flexible manufacturing environment. ...View More

Built To Fail: How Today's Manufacturing Options Leave Pharma At Risk

When planning for the commercialization of a new product, pharmaceutical manufacturing executives must plan for capacity needs very early in the process. Download this whitepaper to learn about key variables that manufacturing executives should consider when evaluating flexible manufacturing solutions for commercial manufacturing projects. ...View More

Patheon's Mullen: Drug Price Debate Could Shape Pharma's Future

Author: Frank Vinluan
Frank Vinluan writes in an article "Patheon's Mullen: Drug Price Debate Could Shape Pharma's Future," published in Xconomy: "Even as Patheon CEO Jim Mullen sees promise in the scientific advances made in drug development, he says many of the pharmaceutical industry’s challenges ahead are economic." ...View More

Does Demand Forecasting Keep You Awake at Night?

Author: James Mullen
James Mullen, CEO of Patheon, discusses the demands of pharma forecasting in an article "Does Demand Forecasting Keep You Awake at Night?" published by Life Science Leader. ...View More

Tightening The Supply Chain: Patheon Aims To Transform Pharma Outsource Manufacturing

Author: Marc Wortman
Pharmaceutical Commerce magazine Nov/Dec issue features an in-depth question and answer piece with Patheon CEO James Mullen. Patheon’s efforts and successes transforming contract manufacturing is profiled in the December issue of leading industry trade magazine, In Vivo. ...View More

The Timely Rise of the CDMO - White Paper

Why revisit your supply chain? The cost of bringing new drugs to market continues to rise. Regulators are demanding more (and more detailed) clinical evidence. Today’s complex molecules – small and large – require an enormous range of technologies that usher in new challenges. ...View More

Streamlining Pharma Drug Development: Yes, It’s Time. - White Paper

The path from molecule to market isn’t getting any easier. A new model for success: focus on what you do best — and outsource the rest. ...View More

A Cure for Pharmaceutical Supply Chain Complexity - White Paper

Author: Lukas Utiger and Mike Mencer
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. This is due to the complexity that has come with new drugs, more complex production technologies and evolving regulatory requirements. ...View More

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