Process Engineering is a term that is widely applied to several different areas of drug development and commercial production of products. It's because it can be so widely applied, that Process Engineering is so important. Key concepts and physical system characteristics are used throughout the lifecycle of a drug, from process development and tech-transfer, to operational support and process optimization. Strict attention to detail and a strong understanding of the critical aspects of a drug are required to deliver a process that meets all regulatory requirements. Process Design Solutions prides itself on it's employees who posses strong technical knowledge and attention to detail. We work with our clients to ensure both parties understand the applicable critical aspects to ensure the delivery of a solution that meets and exceeds all expectations.
Process Operations Support
A core service that we provide is supporting our clients in their process operations. Whether at lab-scale or large-scale manufacturing, Process Design Solutions has the people, resources, and expertise to develop process steps in a manner that is effective, compliant, and reliable. Our Process Engineers have a long history of working with automated control systems on a variety of platforms to ensure each step for each unit operation meets all requirements and specifications. We can also help you with continuous process improvements as more data is gathered about your product. We have expertise in all steps of biopharmaceutical development and manufacturing process, including, but not limited to:
Shake flasks and BioWave bags
Stainless steel and single-use bioreactors (50 - 12,000L)
Harvest clarification, cell-separation, centrifugation, depth filtration
Chromatography (SEC, affinity, etc.)
UF/DF (stainless steel and single-use)
Cleaning / Sterilization
Autoclaves, parts washers
Media and buffer formulation
It's unfortunate that optimization of a process and a fast delivery of a project are inversely related. The expression "haste makes waste" does apply when talking about construction, start-up, and turnover of a new facility. The interest of a Capital Projects team to delivery a facility functional, on-time, and under budget commonly results in processes that are functional, but not optimal. In many cases there simply isn't enough time to fine-tune a process during start-up, which can lead to bloated operational costs down the road.
PDS can help you with your process optimization needs, whether they be CIP cycle development, bioreactor kLa studies, or any number of other areas. PDS engineers have the expertise to improve and optimize any process. We start by identifying the ultimate requirements, and working closely with a cross-functional team meet those requirements. The end result can be a reduction in manual intervention and/or process time, improvement in operator efficiency, and even a reduction in required raw materials and cleaning agents.
Using the principles of ASTM E2500 and ICH Q8, Q9 and Q10, PDS can help you in the Process Development aspect of your product. In conjunction with our Quality Risk Management team, our Process Engineers can help with identification of the product's critical aspects. Once the critical aspects are defined, the process can be developed to focus on control of those aspects and manage the risks associated with them. This will lay the groundwork for scale-up and large-scale manufacture by clearly defining the process requirements reduing the number of unknowns.
And since Process Development is a "living" process, PDS engineers can also assist with continuous process improvements and performing lab-scale studies to support larger-scale findings.
Technology Transfer is an exciting period for a company; it means they have a potential commercial need for additional product that the lab-scale cannot produce. But it's also a high-stress period - a successful tech transfer can mean product to market faster, but an unssuccesful tech transfer can result in numerous delays, budet overruns, and a decrease in morale.
Process Design Solutions has experience with a number of tech-transfers, ranging from simple scale-up, to cross-platform (stainless to single-use bioreactors), to the use of new-to-the-process purification methods. We've helped our clients convert weakly-defined processes into commercially successful production.
Alarm Remediation and Alarm Management
As consultants, we've seen a variety of companies define and manage alarms differently. While each company is free to define their alarm requirements differently, a sound justfication is required by regulatory agencies to prove they have adequate control of their process. PDS has helped our clients on a variety of different levels, from defining individual alarm conditions to the roll-out of alarm management programs. We've also established a clients' alarm remediation program in response to a 483 observation.
A complete understanding of the product's critical aspects is required in order to define the appropriate alarm requirements. A well-defined alarm management program helps to ensure a uniform application of the strategy. This results in correctly applying critical alarms where required, and avoiding nusiance alarms when possible.
Equipment Specification and Design
A well-characterized process and an appropriate alarm strategy can only go so far in the production of biopharmaceuticals. Without the right equipment in which to perform operations, successful production will be a challenge. Equipment that is undersized can result in extended unit operation durations, while equipment that is oversized is an unnecessary expense and results in waste of materials. Equipment that has been re-purposed may be cost-efficient in the short-term but be a hurdle to efficient production in the long-term.
Our Process Engineers have expertise in specification and design of any and all process equipment used in the biopharma industry. While we are not a design-build firm, we have experience working with our clients as well as builders to ensure the client's needs, and process needs, are met. Using the right process modelling and the most current industry specifications, we will work to ensure the appropriate equipment is designed and installed for effective, efficient, and compliant process operations.
Process Design Solutions' project teams are created to successfully deliver projects of various sizes to our clients. We've been responsible for delivering minor punchlist projects costing < $10,000 to capital projects with total costs up to $1,000,000. While our primary focus is on the engineering services associated with such projects, we've also been responsible for project management, quality system management, and scheduling. Depending on our clients' needs, we can provide project teams representing all disciplines, including Engineering, Validation, Automation, and Quality to deliver projects in full. We can also provide resources in the specific disciplines to support projects that have greater client representation.