Sterile Filling 101

Sterile Filling 101

The Future of Small Scale Sterile Filling ​

Sterile Filling 101

a webinar series

In-depth solutions for your complex problems

Fill Finish can be complicated. In this series, we tackle both common and unique problems experienced by pharmaceutical and biotech companies trying to manufacture their drug product to get them to best outcome.

Webinars

in this series

Upcoming Events

Episode 4

Aseptic filling techniques for highly viscous drug products

September 7, 2022 | 1PM EST

Episode 5

Reducing loss in fill finish for high-value drug products

October 19, 2022 | 1PM EST

Episode 6

Why your container and closure choice matter in sterile fill finish

December 7, 2022 | 1PM EST

Episode 7

Aseptic filling of unstable drug products: Everything you need to know about sterile filling, lyophilization, cold chain storage, and more

January 18, 2023 | 1PM EST

[Registration currently unavailable – coming soon]

Episode 8

Unique challenges with specialty containers in sterile filling

March 1, 2023 | 1PM EST

[Registration currently unavailable – coming soon]

Episode 9

The ABCs of formulation development for aseptic manufacturing

April 12, 2023 | 1PM EST

[Registration currently unavailable – coming soon]

Episode 10

Aseptic filling challenges for intravitreal drug products and other small volume fills

May 24, 2023 | 1PM EST

[Registration currently unavailable – coming soon]

Past Events

Episode 1

Getting your product to the patient: Everything you need to know about labeling, kitting, storage, and distribution

Aired March 9, 2022

Episode 2

Engineering runs in fill finish: What are they and are they necessary?

Aired April 21, 2022

Episode 3

Enhancing sterility assurance in isolator-based aseptic filling

Aired June 1, 2022

What you will learn

Challenges for both unique and common sterile filling projects and how risks can be mitigated

What new technologies exist in sterile filling to enhance drug product quality and sterility assurance

The process of getting your drug product to your patient from formulation to distribution

What happens after your drug product is manufactured? Can your CMO label, package, and store your drug product? What details do you need to have ironed out before you ship your product?


In this webinar, we team up with Sharp to answer all of your questions and more to give you an end-to-end overview of your drug product manufacturing process. We will give a brief overview of the sterile fill finish process then an in-depth review of the transfer process to a packaging and distribution company with special considerations for high-value and unstable drug products. Sharp will then take the stage to discuss decisions you will need to make in labeling, QP, and importation, and regulatory considerations when conducting clinical trials in Europe versus the United States.

What happens after your drug product is manufactured? Can your CMO label, package, and store your drug product? What details do you need to have ironed out before you ship your product?

In this webinar, we team up with Sharp to answer all of your questions and more to give you an end-to-end overview of your drug product manufacturing process. 

Many small-scale fill finish CMOs will advocate for a practice fill (or an “engineering run”) for new fill finish project prior to performing a true sterile fill run. Engineering runs involve additional paid work and can increase lead times. This can cause many clients to question the value of an engineering run and even persuade them to forgo the engineering run altogether.


In this webinar, we discuss what an engineering run is and what it is not, including activities that happen during the run. We also provide the cost and benefits of these runs while highlighting risks for limiting or skipping an engineering run altogether.

Many small-scale fill finish CMOs will advocate for a practice fill (or an “engineering run”) for new fill finish project prior to performing a true sterile fill run. But, these runs involve additional paid work and can increase lead times, so are they worth it?

In this webinar, we discuss what an engineering run is and what it is not, including activities that happen during the run. We also provide the cost and benefits of these runs while highlighting risks for limiting or skipping an engineering run altogether.

Isolator technology is quickly being adopted by fill finish contract manufacturers everywhere for its incredible improvement in sterility assurance over restricted area barrier systems (RABS). However, no system is fool proof.

In this webinar, we highlight common situations that could allow isolator-based filling lines to become contaminated, and solutions to mitigate or eliminate these concerns. We will also introduce a new technology that offers increased sterility assurance in isolator-based aseptic manufacturing.

Isolator technology is quickly being adopted by fill finish contract manufacturers everywhere for its incredible improvement in sterility assurance over restricted area barrier systems (RABS). However, no system is fool proof.

In this webinar, we highlight common situations that could allow isolator-based filling lines to become contaminated, and solutions to mitigate or eliminate these concerns. We will also introduce a new technology that offers increased sterility assurance in isolator-based aseptic manufacturing.

Upcoming Webinar:

Wednesday, September 7th | 1PM EST

Aseptic Filling Techniques for Viscous Drug Products