As increasingly sophisticated treatments emerge almost monthly, effective technology transfer between biopharmaceuticals and manufacturers is more important than ever. Ken Foreman, Senior Director of Product Strategy at IDBS, explains how a good digital strategy can help you avoid common technology transfer mistakes.
Biopharmaceutical Life Cycle Management (BPLM) is the key to bringing new therapeutic and life-saving medicines to the world. It covers all stages of drug development, including the identification of drug candidates, clinical trials to determine efficacy, manufacturing processes, and supply chain activities to deliver these drugs to patients.
Each of these vertical pipeline operations typically exist in different parts of the organization, with people, equipment, and digital tools tailored to those needs. Technology transfer is the process of bridging the gaps between these different parts to transfer development, production and quality assurance information.
However, even the most established biotech companies face challenges in successfully implementing technology transfer. While some methods (such as monoclonal antibodies and small molecules) are suitable for platform approaches, others (such as cell and gene therapy) are relatively new to the industry, and the complexity and variability of these new treatments continue to add to an already fragile process Increase pressure.
Technology transfer is a complex process involving multiple actors in the supply chain, each adding their own challenges to the equation. Biopharmaceutical sponsors have the power to manage the entire program, balancing supply chain building with their rigid planning needs to speed time to market.
Downstream technology recipients also have their own unique challenges. Some manufacturers have talked about accepting complex technology transfer requirements without clear and concise instructions. Lack of clear direction can negatively impact product quality and often hurt partnerships in the long run.
Establish a supply chain early in the technology transfer process when selecting the most suitable manufacturing facility. This includes an analysis of the manufacturer’s plant design, their own analysis and process control, and the availability and qualification of the equipment.
When selecting a third-party CMO, companies must also evaluate the CMO’s readiness to use digital sharing platforms. Producers providing lot data in Excel files or on paper can interfere with production and monitoring, resulting in lot release delays.
Today’s commercially available tools support the digital exchange of recipes, certificates of analysis, and batch data. With these tools, process information management systems (PIMS) can transform technology transfer from static activities to dynamic, ongoing and interoperable knowledge sharing.
Compared to more complex procedures involving paper, spreadsheets and disparate systems, the use of PIMS provides a continuous process for reviewing processes from management strategy to full compliance with best practice with less time, cost and risk.
To be successful, a technology transfer solution within a healthy marketing and marketing partnership must be more comprehensive than the solutions described above.
A recent conversation with the Global COO of a Leading Industry Marketing Director revealed that the number one barrier to decoupling between BPLM stages is the lack of a commercially available technology transfer solution that covers all parts of the process, not just end production. scene. This need becomes even more important in biopharmaceutical expansion programs for the large-scale production of new therapeutics. In particular, raw material suppliers need to be selected, time requirements considered, and analytical testing procedures agreed, all of which require the development of standard operating procedures.
Some vendors have solved some problems on their own, but some BPLM activities still don’t have solutions out of the box. As a result, many companies buy “point solutions” that are not designed to be integrated with each other. Dedicated on-premise software solutions create additional technical hurdles, such as communication across firewalls with cloud solutions, the need for IT departments to adapt to new proprietary protocols, and cumbersome integration with offline devices.
The solution is to use an integrated data highway that simplifies data management, movement and exchange between different tools.
Some people believe that standards are the key to solving problems. ISA-88 for batch management is an example of a manufacturing process standard adopted by many biopharmaceutical companies. However, the actual implementation of the standard can vary greatly, making digital integration more difficult than originally intended.
An example is the ability to easily share information about recipes. Today, this is still done through lengthy Word document sharing control policies. Most companies include all components of S88, but the actual format of the final file depends on the drug sponsor. This results in the CMO having to match all control strategies to the manufacturing process of every new client they take on.
As more and more vendors implement S88 compliant tools, changes and improvements to this approach are likely to come through mergers, acquisitions and partnerships.
Two other important issues are the lack of common terminology for the process and the lack of transparency in data exchange.
Over the past decade, many pharmaceutical companies have undertaken internal “harmonization” programs to standardize their employees’ use of common terminology for procedures and systems. However, organic growth can make a difference as new factories are set up all over the world, developing their own internal procedures, especially when making new products.
As a result, there is growing concern about the lack of foresight in data sharing to improve business and manufacturing processes. This bottleneck is likely to intensify as large biopharmaceutical companies continue to move from organic growth to acquisitions. Many large pharmaceutical companies have inherited this problem after acquiring smaller companies, so the longer they wait for data exchanges to be processed, the more disruptive it will be.
Lack of common terminology for naming parameters can lead to problems ranging from simple confusion among process engineers discussing procedures to more serious discrepancies between process control data provided by two different sites that use different parameters to compare quality. This can lead to incorrect batch release decisions and even the FDA’s “Form 483″, which is written to ensure data integrity.
Sharing of digital data also needs to be given special attention in the early stages of the technology transfer process, especially when new partnerships are established. As previously mentioned, the involvement of a new partner in a digital exchange may require a culture change throughout the supply chain, as partners may require new tools and training, as well as appropriate contractual arrangements, to ensure continued compliance by both parties.
The main problem Big Pharma faces is that vendors will give them access to their systems as needed. However, they often forget that these vendors also store other customers’ data in their databases. For example, the Laboratory Information Management System (LIMS) maintains analytical test results for all products manufactured by CMOs. Therefore, the manufacturer will not grant access to LIMS to any individual customer in order to protect the privacy of other customers.
There are several ways to solve this problem, but additional time is required to develop and test new tools and procedures provided by vendors or developed in-house. In both cases, it is very important to involve the IT department from the very beginning, as data security is paramount, and firewalls may require complex networks to exchange data.
In general, when biopharmaceutical companies evaluate their digital maturity in terms of BPLM technology transfer opportunities, they should identify key bottlenecks that lead to cost overruns and/or delays in production readiness.
They must map the tools they already have and determine if those tools are sufficient to achieve their business goals. If not, they need to explore the tools the industry has to offer and look for partners who can help close the gap.
As manufacturing technology transfer solutions continue to evolve, BPLM’s digital transformation will pave the way for higher quality and faster patient care.
Ken Forman has over 28 years of experience and expertise in IT, operations, and product & project management focused in the software and pharmaceutical space. Ken Forman has over 28 years of experience and expertise in IT, operations, and product & project management focused in the software and pharmaceutical space. Ken Foreman has over 28 years of experience and expertise in IT, operations and product and project management focused on software and pharmaceuticals. Ken Foreman has over 28 years of experience and expertise in IT, operations and product and project management focused on software and pharmaceuticals. Prior to joining Skyland Analytics, Ken was Director of NAM Program Management at Biovia Dassault Systemes and held various director positions at Aegis Analytical. Previously, he was Chief Information Officer at Rally Software Development, Chief Commercial Officer at Fischer Imaging, and Chief Information Officer at Allos Therapeutics and Genomica.
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