In general, what are some current issues facing pharmaceutical companies in regards to powder containment and handling?
Historically, biologics have been manufactured in large stainless steel bioreactors. The powdered media and buffers was charged by open manways, allowing powder to escape, and increase the chance of contamination. This was fine when one product is being made inefficiently at large scale. Now we have higher titer cell lines and make more than one product at a time and this is no longer acceptable.
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Currently, what are some of the existing technologies used for powder containment, handling, and transfer? What are their shortcomings?
The most common has always been dumping powders out of buckets which can make a mess. The next solution was to try and use existing bags that were designed for single use liquid applications. These bags had single openings that made the bag to a specific weight really difficult. Dispensing from these bags is non-optimal and customers often needed to add of rinse lines to ensure all the powder was dispensed into the reactor. The bags are generally made of films that would break if dropped. These old solutions are frustrating for customers to use and will not work in the single use continuous bioprocessing production world we are headed toward.
Can you describe the latest state-of-the-art technologies/systems/methods for powder containment and transfer? What benefits do these technologies offer?
ILC Dover has designed a single use powder handling bag from the ground up,the EZ BioPac®. Our product is not an afterthought left over from single use liquid applications. We have a solution that has a specially designed top opening that makes filling and weighingsimple and when filling is complete the top opening can be easily closed and secured without contaminating the outside of the bag, eliminating extra cleaning steps. Our proprietary film is anti-static and meets regulatory requirements. The film properties in addition to being robust to protect from breakage, has properties that ensures all the powder quickly and completely flow out of the bag. The bags are available in a variety of standard connection interfaces to simplify connection to closed charging ports.
Why is your film a differentiator?
ArmorFlex® 114 was specifically developed for the handling, containment and dispensing of powders typically used in the Pharm and BioPharm market. It is the premier film for powder handling and containment in the market today and is being used by Pharma and BioPharm companies around the globe. Already validated for use as a product contact film at most major pharma and biopharma companies, our regulatory-compliant film offers integral staticdissipative properties, very high tensile and tear strength, high visual clarity, excellent flow properties and a 5-year shelf life. Moreover, it is gamma-irradiation compatible and designed from the ground up for modern powder-handling applications.
What product(s) has ILC Dover introduced that implement the latest technologies in powder containment and handling? Can you provide us how this helps get projects to market more quickly?
For instance, media prep/cell production—where the EZ BioPac system can help immensely—is followed by as many as eleven buffering operations. In each of those, an EZ BioPac system can reduce total production time significantly. We find the total to be in the range of 46 man-hours—more than a full work week not including the potential for additional cleaning validation in case something were to go wrong. While every manufacturer would have to apply its own logistics and cost factors to determine its real potential savings, all of our testing and field experience indicate the savings is substantial. We would welcome the opportunity to work with you to calculate just how much the use of EZ BioPac powder transfer systems could contribute to your success.
In addition to the EZ BioPac® Single-Use Containment System and other products, does ILC Dover offer other services/expertise to assist pharmaceutical companies with their unique powder containment and handing needs? Can you provide an example?
ILC Dover has been containing drug manufacturing, since starting in the ’90s with Eli Lilly. We have years of experience handling and producing high potency API. Now we are applying that experience to Antibody Drug Conjugates (ADC) to help the next generation of drugs get to market in a way that protects both the drug and the workers. In addition we have a whole line of products to enable you to mix powders that are hard to get into solution with much greater speed. We have a lump breaker that breaks up any lumps and then it goes into our JetMixer that using a patented venturi system that nullifies shear and excessive heat, while assuring complete powder mixing.
Looking ahead, how will ILC Dover continue to offer its current and future customers the best available technology and expertise for powder handling, transfer and containment?
We have a continued focus on the future with a pipeline of new products to help manufacturing drugs faster, easier and safer. Our sales, marketing and engineering teams are in customer’s facilities weekly helping to solve problems and learning about the challenges customer’s face every day. We use this knowledge gained to innovate additional products and solutions that help to keep our customers able to focus on drug production and driving compliance, effectiveness and efficiency in their product processes. We are always pushing beyond boundaries. Stay tuned.