Q&A with Claudia Roth, President, Vetter Development Service, USA - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Q&A with Claudia Roth, President, Vetter Development Service, USA
Claudia Roth, President of Vetter Development Service USA, discusses trends in single-use technology for clinical manufacturing.

Pharmaceutical Technology
Volume 37, Issue 7, pp. 68

Claudia Roth, PhD
President, Vetter Development Service USA


Claudia Roth
PharmTech:
What is driving the trend toward single-use systems in clinical manufacturing?

Roth:
Drug companies are facing ever-increasing cost and time pressures in the early development field. For example, they are looking for opportunities that best optimize critical processes in clinical manufacturing, including methods to achieve shorter turnaround times of drug products. Another challenge is the need to have scalable processes and batch sizes during these phases, while ensuring investments such as filling equipment stay within reasonable limits. Being in the development stage of the drug substances also demands flexibility; one needs to be able to react quickly to changes that happen at short notice.

PharmTech:
Why are single-use systems an advantage in clinical manufacturing?

Roth:
Single-use systems provide an intelligent response to many challenges. For example, these systems allow for greater efficiency because they are already well proven and can make available commercial manufacturing know-how for smaller batches, which is a part of early development. Modern single-use solutions are also particularly oriented toward reducing loss of active drug substance. By deploying single-use systems, the efforts of a cleaning validation can be avoided, saving time and money in addition to enabling lead-time optimization. Also, single-use systems offer advantages in terms of quality and safety and are a lot easier for employees to use. Overall, they offer smoother processes and, therefore, contribute to optimizing costs and reducing time-to-market.

PharmTech:
When are single-use systems worth deploying?

Roth:
Single-use systems are a benefit in many areas including weighing excipients and drug substances, preparing materials, compounding, and even filtration and filling. As an example, single-use mixers have proven their value in compounding, and disposable connectors and filling needles have proven their value in filling.

PharmTech:
What does a company have to be careful of?

Roth:
It is critical that when adopting a single-use strategy, a comprehensive supplier and quality management system is put into place. This includes confirmed matching of specifications and reliable quality control. For example, in our development facility in Chicago, where we have implemented all the appropriate processes, we have had very good experiences with single-use systems in clinical manufacturing.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
26%
Attracting a skilled workforce
29%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
31%
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatcchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Obama Administration Halts Attack on Medicare Drug Plans
Source: Pharmaceutical Technology,
Click here