ARTICLES BY TRISHA GLADD
Quality Risk Management: Reduce Risk By Embracing It
Despite the resources available to help companies develop a QRM program, such as the ICH Q9, there are several challenges that commonly prevent a successful implementation. Ghada Haddad, director in global sterile and validation at Merck, suggests several best practices that can help overcome these issues.
Quality Takes Center Stage At ISPE Event
As the pharmaceutical landscape continues to change and evolve, it is up to you to not only determine how to raise the bar for innovation but also do so with the utmost focus on quality. If you take a look at the ISPE/FDA/PQRI Quality Manufacturing Conference agenda, attendees will see this is an opportunity to learn how to accomplish just that.
Top Single-Use Suppliers Make Standardized Equipment A Reality – Part 2
Industry experts offer the benefits of standardized single-use equipment to both suppliers and users, as well as how it addresses some of the biggest objections to equipment standardization, as well as offer insight from the eyes of a user.
Top Single-Use Suppliers Make Standardized Equipment A Reality – Part 1
While standardization of single-use equipment for end users would mean a plug-and-play approach that would facilitate the implementation of single-use in their facilities, some believe there are suppliers who do not want to move forward with it because they are fearful they will reduce or eliminate their ability to differentiate themselves and remain competitive. However, the argument may be a moot point soon.
Genentech Offers Insight To Increase CMC Development Efficiency
To streamline CMC development each case will have different risks and constraints leading to product-specific CMC approaches, there are general opportunities where pharmaceutical development companies can streamline development and reduce these effects.
What Is the Industry Underestimating About An ADC Supply Chain? – Part 2
In this article, Dan Bell, vice president of regulatory compliance and technical affairs for Marken, discusses regulatory challenges, and both he and Nathan Ihle, Ph.D., VP of CMC Strategy and Management at Seattle Genetics, offer best practices to apply when planning your ADC supply chain.
What Is the Industry Underestimating About An ADC Supply Chain? – Part 1
Because not all companies can create all three components of an antibody drug conjugate (ADC) in-house, the next option is to work with a partner. In doing so, you should anticipate several challenges along the way. The question is—will you be surprised to find out what they are?
Is The Single-Use Standardization Debate Slowing Down Adoption?
Without single-use standardization, the customization required to build a single-use facility may prevent a full-scale adoption of single-use technology. So how do we move forward? Maybe, by taking a look back.
How Can Cell Culture Conditions Affect Biologic Product Quality?
When it comes to the development of new biotherapeutics, particularly glycoproteins and other post-translationally modified proteins, it is important that such modifications do not alter the activity, pharmacokinetics, or stability of a protein nor provoke immunogenicity in the patient. By understanding what factors can change a protein, as well as the steps to detect and analyze those changes, the risk of doing so is reduced and the efficacy and safety of the drug is preserved.
Merck Champions Single-Use By Addressing Emotion Vs. Science
Lowering the cost of medication is the key to the US gaining a stronghold on the global pharmaceutical market. As anyone knows, in order to lower the cost of medication, the cost of manufacturing will need to be lowered as well. According to Chris Smalley, Ph.D., director of validation compliance at Merck, single-use technology (SUT) could be the hero.