PDA EU00182 Practical Guidance on Formulation Development for Lyophilized Pharmaceuticals

Seville, Spain
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Lyophilization (Freeze-drying) has been used within the pharmaceutical industry for many years to improve the stability of therapies. However, developing a freeze-dried formulation that remains safe and stable and can also be freeze-dried efficiently can be difficult, requiring additional time, resources, and experience.

This course will provide an overview of how to develop a freeze-dried formulation. It will go through Quality by Design principles and how to apply this methodology to the formulation design of a wide range of freeze-dried products containing a range of active agents, including small molecules, proteins, cells, and other novel therapies. It will also review the stresses experienced during the freeze-drying process, possible degradation routes of active molecules, and how to select excipients and formulations to overcome these. The course will also provide guidance on how to determine the critical temperature of formulations and how to adjust the formulation to influence the critical temperature to make the freeze-drying process can be more efficient. And will discuss potential formulation screening methodologies, common decisions, and issues that can occur during the formulation development of freeze-dried products.

  • Gain a basic understanding of the lyophilization process, together with the factors that influence the product and process.
  • How to apply Quality by Design to developing a lyophilized formulation and common Critical Quality Attributes of lyophilized products.
  • Understand degradation routes of products during freeze drying and the function of excipients
  • Characterization to determine a product critical temperature prior to freeze-drying.
  • Methodology for formulation screening and characterisation of formulations.

Standard Registration

Member Price

€ 1.055

GovernmentMember Only

€ 1.055

Health AuthorityMember Only

€ 1.055

Early Career ProfessionalMember Only

€ 1.055

StudentMember Only

€ 1.055

AcademicMember Only

€ 1.055


€ 1.055

See Qualifying Criteria for Member Types.


WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

Thursday, 14 September 2023

Welcome, introduction to the course, Instructor and participant introductions, and review of learning objectives

Lyophilization Process Overview

Quality by Design for formulation Development of Lyophilized Products

11:00 Coffee Break

Target Product Profile and Critical Quality Attributes of Lyophilized Products

Overview of Excipients Used in Lyophilization and their purpose

13:30 Lunch Break

Stabilising effect of amorphous Cryo-/Lyo- protectants

Determining the Critical Temperature of Formulations and Selection of Excipients to Improve the Critical Temperature.

Formulation Screening Methods 

16:15 Coffee Break

Product Characterization

Questions and Discussion

End of Training Course

Agenda is subject to change.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA recommends the reservation at the following hotel

Melia Lebreros
C. Luis de Morales, 2
41018 Seville

Tel: +34 954 57 94 00

PDA Europe has reserved a limited number of rooms by 01 August 2023.

Book your room at the PDA Group Rate via the above-mentioned reservation button.

The hotel is located in the heart of Seville, next to the Royal Alcazar and the Plaza de Espana including a 270 qm swimming pool and a fully equipped fitness area.

How to Get Here
By Air The hotel is only 8 kilometers away from Seville International Airport.
By Car On site parking is available. Please contact the hotel for more information.