Pharmaceutical Technology Editors

Univar Solution’s Grace Syloid FP and XDP Silica

Univar Solutions' Grace Syloid FP and XDP Silica is a multifunctional excipient designed to solve powder flow and caking challenges in various pharmaceutical applications. Manufactured in the United States, Syloid silica is an engineered hydrated silicon dioxide produced under controlled conditions. It meets US Pharmacopeia, European Medicines Agency, Health Canada, and Brazilian Health Regulatory Agency requirements.

Syloid silica’s design combines adsorption capacity, particle size, density, and internal surface area to provide multifunctional benefits or to optimize an application. This is intended to help minimize the number of excipients used and simplify the complexity of formulations while expediting manufacturing and ultimately improving the efficacy of the final dosage form.

Articles

Univar Solutions' Grace Syloid FP and XDP Silica is a multifunctional excipient designed to solve powder flow and caking challenges in various pharmaceutical applications.

Multifunctional Excipient

In part of the session "Upgrading and Updating Aging Facilities: Quality and Business Advantages" at the PDA/FDA Joint Regulatory Conference, Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses how to upgrade facilities in an efficient manner and other highlights from his presentation.

 You can implement, you know, new technology within existing processes, we've seen that that some of the older processes can be refurbished, at least if it's only certain stages within the process. I mean, ultimately, what comes immediately to mind is always the filling system, which is the most critical system. But also, when it comes to, you know, new enhanced technologies, when it say, let's say, infiltration, that you have new enhanced sterilizing grade filters, you can at least bring them into the intermediate steps, for example, within the bio processes and gain enhancement in regard to total throughput and flow rates, you can utilize very specific processing steps to improve the efficiencies, you can also reduce when it comes to single use process technology, for example, what we see is that certain cleanroom classifications in some of the upstream processes could be reduced and therefore, you start reducing energy costs or your operating costs. You can also have some new cleanroom technologies, for example, you will utilize, which will reduce or process intensify. And therefore, you gain much more compact footprint. So I think you cannot go out there and say, "Well, I will now enhance my entire process immediately have an existing process, I think that's pretty much impossible, because you actually bite off too much. And you might suffocate on that bite." But if you do in stage improvements, and if you look back into preventative maintenance, for example, when it comes to improvement, or when you go into new facility designs, look at the new facility designs, bring the new technology into the new facility design. And then also on that side, though, having said this, don't reinvent the wheel over and over again, when you have a good state of the art facility and process in your new processes. Also try to clone the sales processes so that you gain much higher efficiencies. And you also know where are the downfalls, where the upswings, learn more from on these types of designs. 

 So ultimately, what I show is, you know, the typical building of contamination control strategies. And a lot of the focus is, you know, testing, testing, testing, quality measurements, etc. But the foundation of control contamination, control strategy is the facility and process design, as well as training people and doing the appropriate process validation of these processes. And I think that's one focus, which we also need to look at is what can be done, and we got to that foundation, we need to have the foundation done appropriately and build on something solid instead of quicksand. And so you cannot test quality into your into the process, you cannot test quality into a product. And that's the lesson and the learning philosophy in our industry for decades. Having said this, you know that and that's the reason why I'm preaching on that foundation that we gained the right processes, and the right facility designs. And then you know, you have the controls on top of that built on that foundation. Having said this, we also recently saw that, you know, when you look at annex one, for example, there's previous posterization integrity testing, I mean, a test integrity test after the sterilizing grade filter, your last barrier in front of the foul line is sterilized and then you do integrity tests. And you manipulate the downstream side of that sterile filtrate side of the filter. That testing quality into your product, in my opinion, with a manipulation of the filtrate side, sterile filtrate side, a higher risk. So it seems like we talk about contamination control strategies, and specifically focus groups and annex one. And next we know there's a there's, in my opinion, risk elevation. So I think there's still a lot of work which needs to be done on discussing together with the suppliers, with the consultants, with the industry, and with the regulators of how we can improve these processes to a build a better foundation, and then build the right controls and do not over build these type of controls so that we start testing quality into your product.

Videos

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses how to upgrade facilities in an efficient manner and other highlights from his presentation.

Improving Facilities in an Efficient Manner (PDA/FDA Joint Regulatory Conference 2023)

In part of the session "Continuous Manufacturing and Publication of ICH Q13" at the PDA/FDA Joint Regulatory Conference, Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future. 

Continuous manufacturing is here. An evolution of pharmaceutical quality over the last several decades started with adoption of risk based approaches, as this analytical Technology and Quality by design have set the stage for adoption of continuous manufacturing. What's needed for approval of continuous manufacturing packages is the same as what's needed for batch processes. A demonstration of pharmaceutical quality demonstrate that you understand your product and your process and that you have the capability to operate a well controlled process, consistent with manufacturer's quality guide.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future. 

Continuous Manufacturing is Here to Stay (PDA/FDA Joint Regulatory Conference 2023)

In part of the session "Continuous Manufacturing and Publication of ICH Q13" at the PDA/FDA Joint Regulatory Conference, Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.

Fundamental concepts of continuous manufacturing and Q13 are new to many in the pharmaceutical industry. Continuous manufacturing generates a lot of data that can be transformed into product and process knowledge. Building widespread knowledge experience in covert with continuous manufacturing for pharmaceuticals in industry and among regulators will take some time. To introduce [fleeing leisure]: A pharmaceutical development and manufacturing requires communication and collaboration among people with training in different fields, chemists, biologists, pharmaceutical scientists, and engineers, especially chemical engineers. If you don't know any chemical engineers, get to know them, as their core undergraduate training is rooted in the continuous manufacturing fundamentals highlighted in Q13. We build cross disciplinary teams and help them to really facilitate that knowledge sharing especially among teams that have similar job functions. Knowledge of chemical engineering fundamentals, plus experience with the aspects that are particular to the pharmaceutical industry will be a powerful force for modernization in pharmaceutical manufacturing. We also need to determine the best ways to present new types of information for industry and regulators to communicate effectively. conferences such as this one are a great way to share best practices.

 The words in the [bracket] are an assumption of what is being said, as we have not gotten confirmation yet from the speaker about what exactly is being said.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.

Highlights of ICH Q13 Session (PDA/FDA Joint Regulatory Conference 2023)

In part of the session "Upgrading and Updating Aging Facilities: Quality and Business Advantages" at the PDA/FDA Joint Regulatory Conference, Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

 Patient safety is paramount for any processes which you see in the pharmaceutical/biopharmaceutical industry, meaning when, when we, our aim, our ultimate aim is to create therapies for patients who are, you know, ill, sick people, we want to cure, we want to have treatments, we want to have therapies, we produce medicines for them. And these medicines need to be free of contaminations. These medicines are there to heal a person and not to endanger a person. So patient safety in that regard means we need to elevate the safety and quality of these products, the processing of these products, the facilities where these products are produced, and so that we don't have any contaminations within the product, which could, again, potentially endanger or kill the patient. And so when we talk about increasing or enhancing patient safety, within my presentation at the PDA/FDA conference, I'm talking there about new technologies, where we see that they are older technologies, for example, in a critical field step, which could create a potential risk or higher risk of contamination. And when we see advancements in technologies, which say, closed systems are isolated by first systems, they enhance the environment or the protection of that fluid, the protection of that critical step, and, therefore enhance the patient safety. And I think, ultimately, we see the developments in the airline industry, we see the developments in the car industry, we also need to develop and enhance our technologies within our industry constantly. And so within that presentation, I talk about these new technologies, and be kind of like the technology scout for the industry and make suggestions and bring forward some creative ideas and some new technologies, which have these creative, creative ideas encompassed.

 Well, that's a very good question. I think the one part, which I found very astonishing, when we had the Aging Facility Task Force, we had, you know, we submitted a survey to the industry. And it was very interesting, we segregated it into analytics process and facility. Analytics, number one, was very much neglected. It was not the first line of defense, but it was, there was really not even a motivation by a lot of people joining this type of that group, that group in the Aging Facility Task Force. The other part, which we found also very surprising was the technology scouting question. We asked the question- are you actually do technology scouting? And it was very interesting to see that, you know, the level of technology scouting is very low. And so I think when I give that type of presentation, I'll want to highlight that there are much better technologies out there, there are technologies out there which take the human factor, which is the highest contamination, so it's really out of some of the processes. And we should utilize these technologies. So for example, single use process technology is a really good technology because it's a it's a good first barrier against, you know, the environment, the typical environment out there. So it's a trunk, it's a closed system, you can use a set of connections to, again, half the product, not getting in contact with the outside world. It's a very good technology. It's a very good positive technology, but it needed 20 years to be adopted mainstream in the industry. So what I want to highlight is there is new technology out there. And what I also want to highlight is that we are too slow to adopt new technology.

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

The Definition of Patient Safety and Implementing Technologies (PDA/FDA Joint Regulatory Conference 2023)

In part of the session "Continuous Manufacturing and Publication of ICH Q13" at the PDA/FDA Joint Regulatory Conference, Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency.

 Manufacturing technologies such as continuous manufacturing, offer a number of benefits. Advantages of continuous manufacturing compared to other manufacturing include increased venture productivity, decreased capital cost, smaller cadence size and footprint and decreased cycle times or the ability to make product faster. You can also streamline your process flows with continuous manufacturing. There are several options if you'd like to increase your manufacturing output, you don't necessarily have to increase [imminent size]. Instead, you could run for a longer time. Or you could run at a higher mass flow rate. You also have the option to duplicate equipment not to scale out. Pharmaceutical quality assures the availability, safety and efficacy of every dose. This powerful yet simple statement, we hear a lot about safety and efficacy and rightly so. However, advanced manufacturing technologies such as continuous manufacturing, also have the potential to modernize pharmaceutical manufacturing and avoid or reduce drug shortages. I think drugs are of no use to patients if they're not available.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses how advanced manufacturing technology can improve things such as cost and efficiency.