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.
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.
Boehringer Ingelheim Revolutionizes Filling Line Flexibility
Every pharmaceutical manufacturer has one ultimate goal in mind—to deliver a safe and effective drug to market quickly at the lowest cost possible. This desire is what drives many companies to constantly re-examine their processes and technology to ensure they’re using the best methods to achieve this outcome. At Boehringer Ingelheim, experts wanted to design a new filling line that was smaller than the traditional large isolator filling line yet still maintained a lot of the aspects of traditional filling lines—the goal being to not only maintain safety and quality while speeding up production but also to reduce costs.
Is A Customer-Centric Strategy A Fit For Pharmaceutical Manufacturing?
In an industry such as pharmaceutical manufacturing, which typically focuses on improving operational excellence or coming up with the next big drug, is a business strategy with a customer-first focus the right fit?
Merck Uses Automation And Disposables To Drive Upstream Process Development
Automation and disposable technology have offered considerable efficiency improvements to speed cell line development; however, a major challenge with process development for biologics is how labor intensive it can become. Many different interactions and parameters can impact product quality and product titer, which typically requires iterative rounds of statistical experimentation using up to 20 reactors or more per study. For cell culture mAb processes, this development work can take three to four months to complete, which adds considerable cost for a company in multiple ways. Because of this challenge, Dr. David Pollard, executive director of BioProcess Technology & Expression, BioProcess Development at Merck, and his dedicated technology group wanted to see how the benefits of automation and disposable technologies could be translated into tools to drive high throughput upstream process developmen