Webinar: Improving Efficiency In Media and Buffer Production To Enable You To Get To Market Rapidly

Transcript

[Eliza Berry] 0:03
Good morning or good afternoon everyone, depending on where you are joining us from, and welcome to today’s webinar. My name is Eliza Berry from Business Review, and I will be your host for today. It is our pleasure to have ILC Dover with us today. We will be presenting today’s webinar titled “Improving Efficiency in Media and Buffer Production.” Today’s guest speaker is Dave Howes, Regional Sales Manager. I’d like to welcome you to our platform on 24. You’ll notice that this webinar is browser-based, so if we disconnect for any reason, please just click on the link that you received via email to rejoin the session. In order to ask questions, you can send them in via the questions widget. Just type them into the box at the top left-hand corner of your screen and click submit. We will allocate some time at the end of the session to address any questions or thoughts that you may have. Please use the yellow help widget if you require any assistance, and you can move, resize, and maximize any of the windows in front of you to get a better view of the slides. But now, please allow me to welcome Dave.

[Dave Howes] 1:09
Thank you, Eliza. Hello, everyone. Good morning, good afternoon, or good evening, depending on your location. Welcome to today’s presentation.

1:25
I’d like to kick it off quickly with the executive summary. As you know, in the biopharma sector today, we are using more and more powder in ever-increasing volumes. For those with experience in processing and handling powders, it’s far more challenging than handling liquids. In response to this, our organization has developed and delivered a solution for your powder handling challenge that will allow you to cut significant time off your biologics processing.

2:15
One thing I always like to ask my audience is why you should listen to this presentation. If you’re experiencing, like many people, an ever-increasing volume of powder in your process, or you see this happening soon, you might ask yourself if you are happy with your present powder handling operations. Is it labor-intensive, time-consuming? Is it one of the biggest challenges you have to maintain a good GMP environment? If you’re answering these questions in the positive, I believe this presentation will be just what you’re looking for.

3:07
Let’s talk about some of the industry trends. Large-scale single-use manufacturing is greatly increasing. The table on the right side of this slide captures some reasons why the industry is moving in that direction, particularly in the biologics sector. Continuous processing, on-demand media and buffer production, and the need for closed systems to support GMP manufacturing are key trends. Customers are also looking for versatility in their manufacturing, as they may regularly change the final product. Additionally, there is a push to minimize and eliminate the need for cleaning in place, not only for the design challenges of cleaning equipment but also the time and effort required for validation.

4:34
There are specific challenges when moving from Phase 2 to manufacturing. In Phase 1 and Phase 2, liquid media or buffer are more commonly used. Using liquid becomes a greater challenge when you ramp up production due to the space required to store and handle liquids, shorter expiry dates, and higher shipping costs. Many of these challenges can be solved by moving to powdered media and buffer, and that’s where we offer solutions.

5:34
Once you’ve moved towards powdered media and buffer, you might face challenges such as existing packaging not working with your process, uneven distribution of powder from large packaging, and changes in powder particle size or properties. Open manway charging for powder poses contamination risks, and there’s a major drive to keep manways closed. This requires an alternative reliable method for powder addition. Multiple charges of media and buffer increase powder handling, presenting significant processing challenges.

[Eliza Berry] 7:16
Thank you, Dave. Okay, everyone, it’s now time for today’s poll. The polling question today is: What is your biggest hurdle when making large media and buffers? The options are: powder handling, mixing, on-time delivery, storage, or other. Please select your options now. We’ll give everyone a couple of minutes to respond. Just a reminder, if you have any questions, you can send them via the questions widget at the top left-hand corner of your screen and click submit. We will allocate time at the end of the session to address any questions or thoughts you may have. Okay, it looks like everyone has made their selection, so let’s move to the results. All right, we have some interesting results. 66.7% voted for powder handling and 33.3% for mixing. Interesting. I’ll pass it back to you now, Dave. Thank you, everyone, for voting.

[Dave Howes] 8:51
I apologize, we seem to have lost the audio. I’m back now. The mute button is exceedingly powerful in today’s environment but it does help to use it properly. Regarding the poll results, it’s interesting and underlines that powder handling is one of the biggest challenges we face in any manufacturing environment, particularly in the biologics field, where there’s an ever-increasing need to use more powders. This is where ILC Dover can become the vendor of choice. We have a heritage in solving problems by combining our material design, engineering, and manufacturing expertise. The photographs here present an array of challenging solutions we have provided. We bring the solution, and that is the pedigree of our company. The concepts of delivering solutions to your powder handling challenges are just where we come from, and we’ve been involved in this as a dedicated problem solver for powder handling since the mid-90s. Based on this expertise and industry demand, we have developed a single-use solution for powder handling called the EZ BioPac®.

10:38
The EZ BioPac® is designed specifically for powder transfer and containment. This isn’t a product adapted from another use but specifically for powder handling. It fits into your process without requiring significant changes and addresses contamination concerns while eliminating the need for extra cleaning validation, saving time and cost. It uses an industry-wide validated film, providing a solid foundation for your powder handling needs.

11:37
One advantage of the EZ BioPac® is its large fill opening. Unlike typical powder handling bags with a single small opening, our bag has a full-diameter opening for easier filling.

12:09
In biologics manufacturing, precise amounts of powder are required. The large opening on our bag makes it extremely easy to access for fine-tuning the material.

12:35
Our bag design includes a protective skirt that covers the bag during filling, preventing spills from contaminating the outside of the bag and eliminating the need for additional cleaning.

13:07
The EZ BioPac® has a separate discharge outlet, allowing for a dedicated nozzle for filling and emptying, which improves process efficiency.

13:36
Our ArmorFlex 114 film, with inherent anti-static properties, ensures that the product does not cling to the bag, reducing waste and maintaining accurate charges.

14:16
We make the EZ BioPac® to fit your process. It is available in sizes from 5 to 100 liters and a range of outlet sizes with tri-clamp flanges.

14:56
The quality of the EZ BioPac® is underlined by numerous certifications. Our dedicated quality team will help you introduce the bag to your specific application with full and complete documentation.

15:31
Next, we’ll show you a video demonstrating how the EZ BioPac® works.

15:45
As open suite biopharmaceutical manufacturing has evolved, single-use containment for powder transfer has proven its value, but not all single-use systems are alike. Our EZ BioPac® system improves productivity and profitability compared to competitive two-dimensional bags. Our three-dimensional bags offer faster filling, easier handling, faster and more complete discharging, and minimal product retention. Designed specifically for powder handling, our bags feature a large round opening for easy filling and fine-tuning, a protective skirt to prevent contamination, and a separate conical discharge outlet. Made with ArmorFlex 114 polymer, the bags minimize product retention. Available in capacities from 1 to 100 liters with various sanitary flange sizes, the EZ BioPac system reduces cross-contamination risk, changeover time, and cleanup time, enhancing productivity and profitability. Learn more at the ILC Dover website.

[Eliza Berry] 19:01
Okay, everyone, it’s time for our second polling question. What problem would incorporating EZ BioPac® into your process most help with? The options are contamination or cleaning, speed of process, ease of use, or other. Please select your answers now. We’ll give everyone a moment, and then we’ll reveal the results. Remember, you can send in questions via the questions widget at the top left-hand corner of your screen and click submit. We’ll allocate time at the end to address any questions or thoughts you may have. Okay, it looks like everyone has made their selection, so let’s reveal the results. Interesting. 50% voted for contamination or cleaning, 16.7% for speed of process, and 33.3% for ease of use. I’ll pass it back to Dave. Thank you, everyone, for voting.

[Dave Howes] 20:12
Thank you, Eliza. I learned from my previous error and controlled my mute button perfectly this time. Very quickly, just presenting some data here. This is actually from one of our customers who have been using the EZ BioPac® extensively and reported significant time savings plus greatly improved ease of use from using the EZ BioPac® compared to what they were previously using for their powder handling. The first slide here shows some information regarding the dispensing process, and secondly, the receipt and sampling process and how it affects the overall hydration process. I think this data is telling its own story and would be more than happy to discuss in detail other experiences and examples that we’ve had from the industry.

21:21
In conclusion, let’s review what is key about the EZ BioPac® and how it can help you with your media and buffer production and moving your process through to market far more rapidly than you may be presently experiencing. The optimum single-use powder container that gets you to market faster is the EZ BioPac®. It’s a product designed for the use of powder by powder experts. As we’ve shown, the pedigree of the company making this product is second to none and ensures both quality and completely sound function of the product that you’re using. We can eliminate all the time and effort associated with cleaning validation. It greatly reduces contamination concerns and enhances your GMP operation. Ultimately, it saves time for each and every powder handling step, which, when multiplied by the number of batches you’re operating and the number of powder charges you’re making, will have a significant impact on how quickly your product is delivered to the marketplace. I appreciate you listening to the presentation today and am happy to hand back to Eliza.

23:02
Thank you so much, Dave. Everyone, it is now time for the Q&A section. We’ve received some interesting questions, so I’ll be asking Dave some of these. Just a reminder, you still have time to submit any questions you may have, so please feel free to submit those in the Q&A box.

Q&A Session

[Eliza Berry] 23:21
The first question we have today is: We use open powder handling, and it works well enough. Why should I change?

[Dave Howes] 23:26
Well, the answer to that is don’t change because of what I’m telling you today on this presentation. Please continue to do what is best suited to your operation and manufacturing philosophy. However, if your existing practices require a change for whatever reason, and you want to move to an improved powder handling situation, please reach out to us. We believe we have the optimum solution. We state that based on its extensive use in the industry already. Whenever you need assistance with making changes to your present operation, we’re here to help you.

[Eliza Berry] 24:19
That’s great, thank you so much, Dave. The second question we have is: What are the other benefits of working with ILC Dover?

[Dave Howes] 24:24
I think as we highlighted earlier, one of the key things is we have been specialists in powder handling and powder transfer since we began working with our first client that drove us into this particular area, Eli Lilly, in the mid-90s. It has been the focus of our business. We have deep expertise in engineering, design, and manufacturing of these products. We have other things too that will help you with how to get your powders handled better within your process, fulfilling all the needs generated by the typical GMP operation today.

[Eliza Berry] 25:21
Thank you, Dave. We have another question here: The bags we use have broken in the past. What is your experience?

[Dave Howes] 25:27
Fundamentally, our experience is exceedingly good. We have a bag that’s very tough and robust due to our expertise in film and manufacturing. You saw earlier a picture of the spacesuit. Thankfully, there has never been a spacesuit failure. Our suits are used in one of the toughest environments in the universe. One particular issue in the design and manufacture is pinched seals versus lap seals. Take a close look at the seals on your existing powder bags. Many bags use a pinched seal design, notorious for being a failure point. We use lap seals. Our expertise in fixing and forming plastics has existed for 70 years and applies to every product we make today. The feedback from the industry is that we don’t have failures.

[Eliza Berry] 26:49
That’s great, thank you, Dave. The next question is: Do you have adequate manufacturing capabilities to maintain supply?

[Dave Howes] 26:57
We do. We have manufacturing sites in both the US and Ireland. In fact, the one in Ireland is currently undergoing a significant expansion to further increase our capacity. In terms of total capacity, there are no concerns at all. We look forward to being challenged further by our customers and will respond accordingly with further increases in manufacturing capabilities.

[Eliza Berry] 27:41
Thank you. It looks like we’ve got time for one more question: How hard is it to validate this film into my process?

[Dave Howes] 27:47
The difficulty of validating the film is very much driven by our customers and their needs. However, we have an excellent quality department that will guide you through the process and support you in any way you wish. We have already been validated at every major pharmaceutical and biopharmaceutical producer in the world and are ready to help do the same for you and get our film and products validated for your use as soon as possible.

[Eliza Berry] 28:34
That’s great, thank you. That just leaves me to thank Dave for a great presentation and to ILC Dover for sponsoring this session. To the attendees, you will receive an email shortly telling you how you can access the on-demand version of this webinar. You can also access this through our website, which is www.business-review-webinars.com. We look forward to sharing further presentations with you, so please keep an eye out on our website and follow us on Twitter @BRWebinars for daily updates. Join our LinkedIn group, Business Review Webinars. Thank you once again, and I hope you all have a lovely day.