Challenges for both unique and common sterile filling projects and how risks can be mitigated
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.
in this series
Episode 9
The ABCs of formulation development for aseptic manufacturing
Episode 10
Aseptic filling challenges for intravitreal drug products and other small volume fills
Episode 1
Getting your product to the patient: Everything you need to know about labeling, kitting, storage, and distribution
Episode 2
Engineering runs in fill finish: What are they and are they necessary?
Episode 3
Enhancing sterility assurance in isolator-based aseptic filling
Episode 4
Aseptic filling techniques for highly viscous drug products
Episode 5
Reducing loss in fill finish for high-value drug products
Episode 6
Why your container and closure choice matter in sterile fill finish
Episode 7
Aseptic filling of unstable drug products: Everything you need to know about formulation, filling, storage, and more
Episode 8
Unique challenges with specialty containers in sterile filling
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.
Viscous drug products requiring aseptic filling present a host of unique challenges in formulation, sterile filtration, and filling. These products require special equipment to be able to move the solution, special filters to sterilize the product, and uncommon techniques to maintain consistent fill volumes across a fill and reduce product volume loss.
In this webinar, we describe common challenges of viscous filling from solutions that are 100 cP to those reaching 1,000,000 cP to get the desired result: a sterile drug product that is safe to inject.
The number of biologics and complex drug products reaching clinical trials and the market is on the rise. Many of the active ingredients in these products are incredibly expensive or time consuming to produce. High-value drug products, like these, can cost upwards of $500,000 for only a liter of drug product – the same volume that many fill finish CMOs will tell their clients to expect to lose during their drug manufacture.
In situations like these, it is highly important to reduce drug product volume loss to reduce cost and meet supply requirements for clinical studies. In this webinar, we describe a plethora of solutions to reduce volume loss, including a few risky “solutions” that should be avoided during drug product manufacturing.
When there are so many important aspects to developing and manufacturing a sterile drug product, container closure materials are often overlooked. However, the vial, syringe, stopper, or plunger you choose can have important implications for your drug product.
In this webinar, we describe what matters when deciding on your container closure materials. We also discuss the effects your primary container closure can have on your drug product stability, efficacy, and manufacturing process. We will describe how to avoid supply shortages, where substitutions can and can’t be made, and a new container closure product to protect your product!
Sometimes the best therapies are hard to manufacture. When a drug product is unstable (e.g. light sensitive, shear-sensitive, temperature-sensitive), formulation and sterile filling become increasingly more complex.
In this webinar, we discuss what a typical fill finish process looks like, how this may affect your unstable drug product, and techniques to protect your product during formulation, filling, storage, and distribution. We review several common drug product sensitivities and outline solutions to protect your drug product.
Some drug products require special containers. Depending on the container type and drug product requirements, finding a CMO to accommodate these unique needs can be a challenge.
In this webinar, we describe the challenges and solutions to filling specialty containers, how to maintain sterility, and important considerations for finding a cooperative CMO to fill your specialty container.