Freeze Drying: The Experts' View - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Freeze Drying: The Experts' View
Lyophilisation is often necessary for pharmaceutical products to improve stability or shelf-life. However, the process can present difficulties, particularly when scaling up from the laboratory to commercial production. We bring experts together to discuss best practices for developing a lyophilisation process, including quality by design (QbD) and design space.


Pharmaceutical Technology Europe


Page/Steiner: The most important aspects of understanding the process are those that give an insight into the experience of the individual vial rather than simply measuring the integrated effect on the headspace. Simple aggregated measurements, such as chamber pressure or more complex measurements like the application of mass spectrometers to the chamber gas, all have value for overall process control.

To understand the range of process conditions caused by both forced and natural variation within the overall system of the equipment, the vials and the product, it is important to be able to characterise the range of experiences of individual vials. However, the problem is that techniques examining the individual vial that can be used during development and validation are frequently difficult to deploy in a large production dryer.

Pikal: The key properties to measure are product temperature and primary drying time. Unfortunately, product temperature in given vials cannot be measured in a representative way. Insertion of temperature probes reduces the degree of supercooling, making the measured temperatures nonrepresentative of the batch as a whole. This problem can be circumvented, however, by using controlled ice nucleation, but although this technique is now available in both laboratory and production equipment, it is not routinely used in manufacturing. Hopefully, this will change in the near future. There are also indirect ways to measure batch average temperature, such as MTM or TDLAS that could be used in manufacturing (particularly TDLAS), but so far, this is not common practice.

Henning Gieseler is Group Leader, Freeze Drying Focus Group, in the Division of Pharmaceutics at the University of Erlangen-Nuremberg.

Yves Mayeresse is Director, Manufacturing Center of excellence filling and freeze-drying operations, at GSK Biologicals.

Steven Nail is a Principal Scientist at Baxter Pharmaceutical Solutions.

Trevor Page is Group Technical Director at GEA Pharma Systems.

Michael J. Pikal is Professor of Pharmaceutics at the School of Pharmacy, University of Connecticut.

Manfred Steiner is Area Sales Manager at GEA Lyophil GmbH.


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
27%
Attracting a skilled workforce
27%
Obtaining/maintaining adequate financing
14%
Regulatory compliance
32%
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 WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
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
Source: Pharmaceutical Technology Europe,
Click here