Skip To The Main Content
2023 PDA_Training-1988x680

PDA EU00182 Practical Guidance on Formulation Development for Lyophilised Pharmaceuticals

Sep 14, 2023
Seville, Spain

  • Education
  • Europe
Register Now

Registration Options

Individual Registration

Proceed with Online Registration

Group Registration

Multi Registration Inquiry Form

left to register

Overview

A successfully optimized freeze-drying cycle will provide reliable, safe processing in an efficient manner. Each stage of the process – freezing, primary drying, and secondary drying – poses its own challenges. Many factors influence the design of the cycle, including the specific thermal characteristics of the product, the type and amount of product per batch or container, and the capabilities of the processing equipment to be used.

This training course provides an overview of how to develop an optimized freeze-drying process. It will go through each critical stage required to optimize a cycle including an overview of the freeze-drying process, formulation design of freeze-dried products, characterization of the formulation in the frozen state prior to freeze-drying, and cycle development, including the iterative approach, and the use of PAT (Process Analytical Technology) for monitoring the process.

Ask a Question

Agenda

  • Thursday, 14 September 2023

    9:00
    Welcome, Opening Remarks and Introductions

    9.15
    Introduction to Freeze-Drying

    10.00
    Factors Effecting the Rate of Sublimation

    10.30
    Coffee Break

    11.00
    Typical CQAs and Excipients in Freeze Dried Products

    11.30
    Frozen State Characterization

    12.30
    Lunch Break

    13.30
    Overview of Process Analytical Technology Used in Monitoring Primary Drying

    14.30
    Cycle Development and Scale Up: Use of the Iterative Approach

    15.00
    Coffee Break

    15.30
    Cycle Development and Scale up: Use of the Iterative Approach

    16.30
    Round-up Discussion and Questions

    17:00
    End of Training Course

Trainers

Andrew Bright
Andrew Bright
CPI
Bio
Andrew Bright
CPI

Andrew is a Principal Scientist in Formulation & Lyophilization at CPI. He Joined CPI in November 2020 as Team Leader in Analytical Formulation Development at CPI specializing in the formulation and manufacturing development of liquid and freeze-dried biologics products. Previous experience includes a Senior Scientist position at the Biopharma Group at which he developed freeze-dried formulations and conducted freeze-drying cycle optimization, and consultancy. Andrew also spent two years as a Senior Scientist at Pfizer within liquid formulations specializing in freeze-dried formulation design, process development, and scale-up. Andrew received his Ph.D. from the University of Bradford. There, he was investigating vaccine formulations with the thesis title "Mechanistic Insights into the Stabilization of Biopharmaceutical Using Glycine Derivatives" and holds a MChem in Chemistry with Pharmaceutical and Forensic Science.

Additional Information

  • Learning Objectives

    Learning Objectives

    • Gain a basic understanding of the freeze-drying process, together with the factors that influence the product and process.
    • Understand how to determine a product's critical temperature prior to freeze-drying.
    • Review formulation development to gain an understanding of typical excipients and their purpose in a formulation.
    • Learn about typical CQAs in freeze-dried products, what factors influence these attributes, and methods of monitoring and controlling attributes.
    • Learn how to develop a freeze-drying process using the traditional iterative (stepwise) approach.
    • Gain a basic understanding of typical Process Analytical Technology (PAT) to monitor the freeze-drying process and to determine whether primary drying is complete.
  • Who Should Attend
    • R&D Scientists
    • Formulation Scientists
    • Product & Process Scientists/ Managers
    • Quality Control Departments

Got a Question? We have answers

Contact Us

Travel

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.

Melia Lebreros

C. Luis de Morales, 2
Seville, Spain
Phone: +34 954 57 94 00

  • Accommodations

    PDA recommends the reservation at the following hotel

    Melia Lebreros
    C. Luis de Morales, 2
    41018 Seville
    Spain

    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.

  • Amenities

    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.

Other Options

Only 30 minutes by train from the airport to the hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants € 1.055

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Media Partners

Related Events

Related Events

Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10
[email protected]

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

PDA Members Save Substantially