The journey to commercializing a therapeutic is a complex and challenging one - filled with obstacles that include building a product portfolio, ensuring patient safety, dealing with regulatory agencies, achieving economies of scale on a process typically designed at the academic level, defining a product platform, and addressing fluctuating demands - all while keeping down cost. With the ever-shrinking pool of resources and technical expertise, these can be daunting tasks to achieve.
At Pall, we understand the uphill battle you are facing, and while we can't solve all of your journey's challenges - what we can do is provide you peace of mind. One that involves delivering a robust, reproducible, and scalable process helping you move beyond roller bottles and flatware into an industrialized process. Using our global centers of excellence and our industry leading technology, we specialize in designing, optimizing, and transferring scalable processes from pre-clinical to cGMP commercial manufacturing. Choosing Pall as your process development partner will reduce your development time by leveraging our industry veterans, proven methods, and award-winning integrated bioprocess equipment. Once we design and optimize your process, you will receive specialized support and training from our local technical experts who ensure the seamless and stress-free adoption of the platform at your designated manufacturing facility that will minimize delays in your journey and deliver speed to market.
Develop Integrated and Industrial Scale Platforms
Provide Simple and Robust Manufacturing Process
Deliver Technical Transfer
The journey to commercializing a therapeutic is a complex and challenging one. We are determined to deliver a robust, reproducible, and scalable process that helps you move beyond laboratory scale process choices to those that are proven to support industrialized manufacturing.
Why Choose Accelerator Process Development Services?
We specialize in designing, optimizing, and transferring scalable processes from pre-clinical to validated cGMP ready manufacturing. Choosing Pall as your process development partner will help you minimize risk, reduce time to market, and lower the cost by leveraging our industry experts, proven methods, and integrated bioprocess equipment. Our local technical experts who will ensure the seamless and stress-free adoption of the platform at your designated manufacturing facility. This will minimize delays in your journey and increase your speed to market.
Achieving Success Through Collaboration
Our promise is to co-develop an optimal platform solution by either simplifying your current process or re-developing it from the ground up. Whatever route we take together, when we finish development it’s your process. All we retain is our pride in what we do.
We believe that the most successful projects are centered around open and synergistic partnership dialogue, and approach each project with an open mind, ready to listen to your needs and ideas. We take the time to collect the background knowledge and to ensure that development objectives are aligned at every stage with your needs and expectations.
Moving You Out of The Laboratory into An Integrated End-To-End Manufacturing Solution
We design a process with the end in mind, ensuring that it’s tailored for manufacturing environment, focusing on simplicity to reduce risk. We will deliver a platform that is not only designed to scale as you progress through the drug development cycle, but one that is versatile and gives you the flexibility to adopt additional therapeutics in your pipeline if required. Our building blocks of process development help take your process to the next level.
What to Expect
We begin by first translating existing data and goals into a detailed proposal which defines our planned approach.
Experiments are designed to quickly move towards an optimized process. Milestones conclude with collaborative evaluation to plan the next steps.
To ensure success, our scientists support transfer of a developed process through on-site support, training, and documentation.
Our Promise: Taking Your Process to The Next Step
Open and Collaborative Dialogue
Choosing Pall’s Accelerator process development services will alleviate your pain points when it comes to scaling your project to clinical manufacturing. Through our hands-on approach, our team of experts will develop a versatile technology platform that will help you accelerate your speed to market as well as develop your clinical stage strategy.
Additionally, you can rest assured that your platform is designed so that it can be deployed with multiple drug candidates, saving your both time and money. Our team not only develops a process but a fully ready to order BoM, equipment optimized to the correct specification, and customized single-use consumables ready to order.
Why Stop There?
We have formed several strategic partnerships that give you the option to tech transfer our process into a pre-fabricated modular facility that not only defers your initial capital investment but gives you the flexibility to address fluctuating demands of your drug.
Full information about this service is available from the PDF brochure.
"I was struck by the pragmatic approach in the process development work that Pall Biotech did for us. Science based and well-structured experimentation kept the project in a continuous flow and time to completion was Impressive. The team at Pall were proactive and transparent and kept a high level of communication. The outcome was a continuous purification process that fulfilled our productivity and purity goals.."
"I was pleasantly surprised at the speed and quality of the process development work performed by Pall Biotech's SLS and PDS teams. Both groups were proactive, transparent, and maintained a high level of communication. The outcome of using Pall's Cadence BioSMB platform was the significant reduction of sorbent use per gram of material. These results were first simulated and subsequently confirmed using the bench scale continuous multi-column chromatography BioSMB platform.”
Manufacturing Sciences and Technology Manufacturing Operations – Baltimore, MD