The high cost of bringing a new pharmaceutical drug to market in the United States is well-documented, with estimates as high as 12 years and USD 2.6 billion.1
Image Credit: BIOVIA, Dassault Systèmes
Numerous factors drive this cost, including rework due to inadequate access to information from earlier experiments, data mining inefficiency, and loss of intellectual property (IP).
The objective of drug development is to be the “first to file” for authorization of a new drug to maximize return on investment (ROI) and boost profit potential while also manufacturing a good quality product and ensuring that it is regulatory compliant.
For a drug development program to succeed, process and product knowledge must be managed along the entire product lifecycle. Knowledge management is a systematic approach to obtaining, storing, examining, and distributing information associated with a product, its components, and the production processes used to create it.
Knowledge sources include prior knowledge, pharmaceutical development studies, process validation studies, innovation, manufacturing experience, continual improvement, change management activities, and technology transfer activities.2
Technology transfer intersects law, science, engineering, government, and business.3 Within drug development, technology transfer relates to moving information, data, and knowledge across diverse domains, such as research and development (R&D), commercialization, and production, so that new products can be accessed by the public (Figure 1).
Technology transfer carries greater significance when any activities like research, production, and development are outsourced to third-party contract establishments.
Figure 1. Technology transfer will occur between research, the different areas of development, quality assurance and quality control, manufacturing, and commercialization. This includes parameters, data, methods, and documentation. Image Credit: BIOVIA, Dassault Systèmes
Over the last few decades, replacing paper-based data management platforms has been seen as a way to speed up this process. While electronic systems have decreased cycle times and compliance risk, there are still issues in departmental silo systems and the non-standardization of data across the drug development continuum.
The result is inefficiencies, poor data mining, and stalled collaboration across various domains. To fulfill the requirement of drug development companies for adequate data and technology transfer, standardization of data and technology transfer across the whole pharmaceutical product lifecycle is necessary.
A system that covers several domains must also satisfy various purposes and needs. For example, researchers require an electronic environment for process management and compliance that supports flexible authoring and more structured execution.
In production, access to data produced in development enables companies to examine and modify the parameters of a formula to make improvements that can enhance factors such as yield, product purity, and production cost. Effective deployment of an integrated informatics solution can resolve ineffective data and technology transfer problems.
Three keys to successful deployment
1. Establish a single application platform
Conventionally, the transfer of techniques between development and quality control (QC) areas in drug development requires companies to physically move the development team to the production site for lengthy periods to guarantee accurate and complete technology transfer. This process burdens establishments and could result in information being lost or incorrectly incorporated.
Life science establishments aim to enable and enhance the administration of R&D information in addition to manufacturing QC and batch record data. Fragmented systems have been used to close the gap between instruments used in the lab and data management platforms.
Customized interfaces of these systems necessitate tailored coding and substantial information technology (IT) support, increasing ownership cost, risk of validation, and compliance violations.
However, an integrated scientific informatics system closes the gap between tools used in the lab, such as laboratory information management systems (LIMS), electronic laboratory notebooks (ELNs), and other scientific applications. This system is engineered to transfer data and information through domains to facilitate “cross-talk” and enhance organizational productivity.
Scientific documentation requirements change drastically in a controlled environment as a product travels from R&D to commercialization. What was comparatively open and unregulated in drug discovery becomes more organized for QC in manufacturing.
Processes are driven by the necessity for regulation compliance, Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), Good Manufacturing Practice (GMP), and other constraints.
When institutions can electronically acquire and convey structured and unstructured data in a single platform spanning the product lifecycle, management can better understand the process and product quality. In the product development process, data can be leveraged upstream and downstream.
2. Follow ISA-88 and ISA-95 standards
The global standard for batch control in manufacturing is ISA-88. ISA-95 is the standard for the integration of enterprise and control systems.4 Together, these standards refer to how software is programmed to permit data and technology transfer between a variety of domains in product development (Figure 2).
Figure 2. ISA-95, the international standard for an automated interface between enterprise and control systems, acts as the operating framework for manufacturing. ISA-88 defines the physical model and is especially focused on the level of the process cell and the lower levels. Image Credit: BIOVIA, Dassault Systèmes
Quality by Design (QbD) initiatives are required by both the European Medicines Agency (EMEA) and the Food and Drug Administration (FDA), emphasizing that quality should be incorporated into a product as a central part of the development process from the initial phases of its lifecycle to final commercialization using standardization for control and consistency.5
The ISA-88 and ISA-95 process definitions were extracted from QbD initiatives to help establishments embed quality into their processes and reduce risks.
Structures employed in manufacturing — process management systems, system control, and business systems — are detailed in the software using ISA-88 and ISA-95 standards, enabling consistent storage of enterprise data in a central database. This type of standardization simplifies integration and accelerates data mining and transfer.
Using the ISA-95 and ISA-88 standards in the upfront system’s design produces a powerful data and method exchange capacity. This proficiency minimizes the time to re-implement a given technique by allowing electronic technology transfer, decreasing the costs, time, and other burdens of conventional technology transfer while simultaneously providing the process definitions for QbD initiatives.
3. Include regulatory compliance requirements
In the life science sector, adherence to regulatory requirements is compulsory. When a new product is shifted from R&D to the market to become available for sale in the United States, the FDA necessitates that electronic records be kept throughout the process in addition to electronic signatures and audit trails to guarantee compliance and data integrity.7
In R&D, documentation and workflow management platforms like ELNs need an open structure to manage experimental data, including the ability to reorder process steps, adjust the scale, and substitute parts in producing a formulation.
Researchers can record the processes they carry out and the interpretation of experimental results; however, in a controlled setting, the open format poses a compliance liability.
A system must be able to handle extremely structured operational protocols (SOPs, instrument records, etc.) within a validated system. This applies to operational reporting as well as technology transfer and data mining.
Any software application system used over all domains has to be versatile enough for R&D while being compliant with regulatory conditions to guarantee data integrity across a product's lifecycle.
Benefits of an integrated informatics solution
Drug development corporations can analyze and improve their procedure and product quality by electronically recording and accessing data from early design and development experiments through to commercialization.
A solution that can substitute paper-based systems and obsolete or fragmented electronic platforms with a well-organized electronic setting helps to streamline data access and technology transfer. Regulating data capture using a single standard data structure and format under the ISA-95 and ISA-88 standards will enable Tech Transfer.
When business guidelines and quality protocols are incorporated into the solution, companies can guarantee that information adheres to the required standards and regulations as it travels across the development continuum. A single platform design allows versatile data mining in early R&D and the assembly of more structured outputs and documents that will be needed for later regulatory submissions.
Establishments that have set up such solutions have reported7:
- A 50% decrease in cycle time
- Up to 25% enhancement in productivity
- Substantial reductions in regulatory compliance risk
Overall, an integrated informatics solution backing “science to compliance” helps enhance data mining, knowledge management, and technology transfer among the different domains — including R&D, manufacturing, and commercialization, compliance to QbD initiatives, and an overall faster time to market.
References
- Tufts Center for the Study of Drug Development.
- International Conference on Harmonisation. Pharmaceutical Quality System Q10. 2008.
- Singh, A.; Aggarwal, G. Technology transfer in pharmaceutical industry: a discussion. Int. J. Pharma. Bio Sci. 2010, 1, 3.
- Scholten, B. Integrating ISA-88 and ISA-95.
- Power, M.; Wlodarczyk P. Process definition management: using ISA- 88 and BatchML as a basis for Process Definitions and Recipe Normalization. Presented at the WBF European Conference. Nov 10–13, 2008; Barcelona, Spain.
- U.S. Food and Drug Administration. Part 11, electronic records; electronic signatures—scope and application.
- 2012 IMACS in Review, 8th Annual IMACS User Group Meeting—May 7–9, 2012, Boston, MA; 2013 PMC Suite User Conference: In Review—June 4-5, 2013, Princeton, NJ.
About BIOVIA, Dassault Systèmes
BIOVIA™ provides global, collaborative product lifecycle experiences to transform scientific innovation. Our solutions create an unmatched scientific management environment that can help science-based organizations create and connect biological, chemical and material innovations to improve the way we live.
The industry-leading BIOVIA portfolio integrates the diversity of science, experimental processes and information requirements, end-to-end, across research, development, QA/QC and manufacturing. Capabilities include Scientific Informatics, Molecular Modeling/Simulation, Data Science, Laboratory Informatics, Formulation Design, BioPharma Quality & Compliance and Manufacturing Analytics.
BIOVIA is committed to enhancing and speeding innovation, increasing productivity, improving quality and compliance, reducing costs and accelerating product development for customers in multiple industries.
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