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""Tech transfer making it as a risk free approach in pharmaceutical and biotech in
1.
International Journal of
Management (IJM), ISSN 0976 – 6502(Print), ISSN 0976 - 6510(Online), Volume 5, Issue 8, August (2014), pp. 01-09 © IAEME INTERNATIONAL JOURNAL OF MANAGEMENT (IJM) ISSN 0976-6502 (Print) ISSN 0976-6510 (Online) Volume 5, Issue 8, August (2014), pp. 01-09 © IAEME: http://www.iaeme.com/IJM.asp Journal Impact Factor (2014): 7.2230 (Calculated by GISI) www.jifactor.com 1 IJM © I A E M E TECH TRANSFER: MAKING IT AS A RISK FREE APPROACH IN PHARMACEUTICAL AND BIOTECH INDUSTRY Samaraj S.Thiyagarajan, PMP Biogenn Corporation, Austin, Tx, USA, 78749 ABSTRACT Tech transfer is a common methodology for transferring new products or an existing commercial product to RD or to another manufacturing site. Transferring product knowledge to the manufacturing floor is crucial and it is an ongoing approach in the pharmaceutical and biotech industry. Without adopting this process, no company can manufacture its niche products, let alone market them. Technology transfer is a complicated, process because it is highly cross functional. Due to its cross functional dependence, these projects face numerous risks and failure. If anidea cannot be successfully brought out in the form of a product, there is no customer benefit, or satisfaction. Moreover, high emphasis is in sustaining manufacturing with highest quality each and every time. It is vital that tech transfer projects need to be executed flawlessly. To accomplish this goal, risk management is crucial and project team needs to use the risk management approach seamlessly. Keywords: Risk Management, Tech Transfer, Pharmaceutical, Biotech, Risk Assessment, Risk Mitigation. INTRODUCTION Pharmaceutical companies increasingly adopting acquisitions and mergers is becoming a trend. One of the main goals after merger is to leverage the synergies of both companies and to do that tech transfer projects are crucial (Teller J et al. 2014). With regulatory agencies increasing their vigil on tech transfers, planning and executing these projects become more interdependent on effective risk management. In pharmaceutical and biotech product life cycle, the process of transferring product and process is becoming increasingly complex and cumbersome. To make the transfer more thoughtful and metrics oriented, FDA had added numerous guidance and regulations through CFR and QSR. High importance is given to Process Validation (PV) and clear guidance wasissued by FDA in January 2011. FDA focuses to ensure variability of process and parameters are controlled and sufficient in the face of the rigors of a commercial production environment. Also, a
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International Journal of
Management (IJM), ISSN 0976 – 6502(Print), ISSN 0976 - 6510(Online), Volume 5, Issue 8, August (2014), pp. 01-09 © IAEME critical aspect to measure the successes of transfer projects is to verify parameters that are established during development are holding as developed and confirmed parameters, even at the scale up manufacturing. 2 For executing successful transfer of the product and process from one site to another site requires an extensive and adequate risk management process. With squeezing margins and reduced profits, it is imperative to execute and sustain transfers with pristine quality (Thamhain H. 2013). For achieving the goal of successful transfers, pharma companies are increasingly adopting several project management strategies. A core strategy that needs to be developed and executed efficiently is risk management. A robustly developed product if not transferred with meticulous care will lead to several production and regulatory issues along the life cycle of the products. To understand the risks, it is critical to know how risks are categorized. Risks are categorized as known risks and unknown risks (Samaraj S T. 2014). Known risks are the ones that can be identified, analyzed and risk mitigation strategy can be established beforehand. The alternative to this is the unknown risks, which may present itself at any point in the project. To handle this type of risk, the transfer team needs to be prepared (Krane H P et al. 2012) This article discusses about optimal risk management strategies for each phase of the tech transfer project. In order to develop a successful strategy, potential risks need to be enumerated, analyzed and registered by the project team (Kutsch E and Hall M. 2009). A comprehensive risk management plan will be drafted. The team uses various risk management tools to identify, analyze, and register the risks. Risk mitigation is brainstormed and executed. Each phase of the tech transfer project has several potential risks. Successful identification of all potential risks is the first step in a more complex endeavor. PROJECT SCOPE AND PLANNING For an organization to turn its mission into a meaningful purpose, the only vehicle exists is “project”. Hence, project planning and initiation is the foremost pivotal task for an organization. In particular, high risk projects like tech transfer in pharmaceutical industry need to be planned to utmost usefulness without any room for error (Teller J. 2013). It is critical to understand the risks of inadequate planning. Most management in pharma or biotech industry is mainly concerned about the bottom line. It is common there is much oversight on what pharmaceutical products transfer project entails. Many innovative products suffered in the upstream manufacturing after they were transferred. One of the main reasons is the execution of the projects without complete planning and understanding of the risks associated (Teller J. et al. 2014). A common risk, which lead to project failure is; putting together a plan without understanding the sending and the receiving (pitching and catching site) site’s culture, facility requirements, regulations, time constraints, budget and scope of the project. These risks were not fully identified, or even if identified, they were not characterized and assessed for its occurrence and its impact. To make a project successful, risks associated project planning need to be clearly identified and addressed. PROJECT SCHEDULE An important factor for any project, irrespective of industry, is the project schedule, without which there is no metrics to measure. In tech transfer projects, a high level project schedule will be developed initially with very little information about the scheduled activities. Risks of this approach need to be captured or assessed during the planning stage (Kuchta D. 2014). A transfer project can be as efficient as only when the project schedule developed with an understanding of known risks and having a contingent plan based timeline for tackling the unknown risks. Once the project is initiated and project team formed and the transfer activities are understood, the team develops detail task
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International Journal of
Management (IJM), ISSN 0976 – 6502(Print), ISSN 0976 - 6510(Online), Volume 5, Issue 8, August (2014), pp. 01-09 © IAEME based schedule. The detail work breakdown structure is compiled; the team then establishes a more task level timeline. Few of issues and risk during this process includes the sponsors of the project are totally unaware of the operating mechanisms in both sending and receiving sites. Failure of the team to comprehensively understand the scope and the actual work required to execute the project on time. Few failures based on the historical data includes: Failure in terms of not having a contingency plan for mitigating any unforeseen issues (Yang Q Lu et al. 2014). Inadequate time scheduled for dealing with regulatory, environmental, and other problems. Team’s unfamiliarity with the products and process is a risk.Failure to have clear-cut milestones and gate reviews in the project schedule will lead to project not following the track for completion (Khamooshi H and Golafshani H. 2014). A common pitfall during the scheduling is to understand the market demand for the products that are in the transfer pipeline, leaving the business with either short supply in the market. It is crucial for the project team to understand risks of this nature and it will make the project team to navigate the project more successfully. 3 ESTABLISHING THE PROJECT TEAM There is no formal risk assessment for the team formation, but this as crucial as any other factor to the success of the transfer project. Upper management’sfailure to take the cultural difference between the sending and receiving sites in its perspective may result in numerous issues after the products were transferred (Zhang J and Wei W X 2012).Risks of not having a complete representation from impacted departments should be assessed. Some of the prevalent risk associated with the transfer project team involves;failure of the team to understand the culture difference between the sending and the receiving sites.Project manager not understanding the operational differences between the two sites will be a risk.Lack of motivation and engagement could also be a potential risk factor for successfully completing the project (Fernandes G and Ward S.2014). This risk will rate high in risk analysis, because as there may be some potential for job loss in the sending site. This will de-motivate the team members and prevent them from imparting their full knowledge to the receiving site. Especially if the subject matter specialists arenot cooperating,the transfer process may suffer significantly. Risk assessment and risk mitigation steps should be focused to resolve this problem. GAP ASSESSMENT Pharmaceutical tech transfer projects cannot be executed with high success, unless a complete gap assessment is performed (Pedram Alaedini et al. 2007). Gap assessment is to identify the gaps between the sending sites and the receiving sitein the areas indicated in the figure 1. Without knowing the existing difference for all the aspects shown in the figure 1, a transfer project cannot be completed successfully. It is a potential form of risk assessment. Certain projects may not have any form of gap assessment. These projects may have a hard time in keeping the project on track as new challenges occur at every stage. In some instance, the project team realizes the importance of understanding the gap,and will then initiate the process midpoint in the transfer (Wiliam Schmidt and Ian Uydess. 2011). For any tech transfer projects, mainly transfer between sites, this is a critical step in the project. Risks or weakness in this process needs to be identified. The incomplete nature of the gap assessment process and how it could potentially impact the project and process during and after the transfer is crucial for avoiding any unforeseen challenges.
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International Journal of
Management (IJM), ISSN 0976 – 6502(Print), ISSN 0976 - 6510(Online), Volume 5, Issue 8, August (2014), pp. 01-09 © IAEME 4 PROCESS MAP One of the foremost tasks in project planning and execution is to create a detailed process map for all the parts that will be transferred. Process maps are an excellent source for identifying the risks at each and every step of the process. Failure to develop a process map or a map that did not capture all relevant and necessary steps in the process will create problems for the receiving team (Bikash Chatterjee and Mark Mitchell. 2012). As high emphasis is given to LEAN manufacturing and more and more pharmaceutical companies adopting that approach shed light on the importance of “Value Stream Map’, whichin addition to the process map significantly reduces risks. A transfer team should comprehend the risks of not utilizing both these vital tools for their benefit. Like any other aspects in the transfer project, risks that were not identified, analyzed and mitigated will result in considerable constraint for the success of the tech transfer. Value stream maps serve as a great deal in identifying the non-value add activities, also, assess and minimize risks from eliminating those non value add activities. FACILITY More importantly, and often overlooked aspect in the tech transfer project is the foot print of the sending site and the comparative assessment of the receiving site. Often times, the management when assessing the synergies, they form the opinion about the ease of adaptation or modification of the footprint at the receiving site, but they fail to understand the extent to which the receivingorganization can be flexible (Lam Wei Chak Joseph. 2007). Even if the receiving site can be adapted to the requirements, a thorough assessment of financial requirements to eliminate any risks should be properly budgeted in the project. Project teams should be able to identify and mitigate these risks, failure to capture and act upon these risks will lead to project overrunning the budgeted costs. Few critical risks identified from the past projects are: • Risks from facility floor plan not conducive for certain manufacturing process flow. • Risk from suboptimal environmental factors like temperature, humidity, airflow. • Risks due to potential natural uncertainties like tornado, snow, wild fire, floodingetc., which may threaten the normal operations of the plant.
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International Journal of
Management (IJM), ISSN 0976 – 6502(Print), ISSN 0976 - 6510(Online), Volume 5, Issue 8, August (2014), pp. 01-09 © IAEME 5 • Access and transport facilities to the plant. • Risks including available recycling and waste disposal facilities. • Risks involving facility sanitation and cleanliness, especially if the transferred product is GMP manufacturable quality. PRODUCT CHARACTERIZATION Product characterization is an important aspect of a transfer project, both from RD and from other commercial sites. If the product transferred lacks an adequate characterization, it assumes significant risks in terms of product manufacturability, safety to users, and regulatory compliance (Butler M S 2004). Few critical risks that project team needs to identify during the transfer activities include, but not limited to are: risks due to inadequate product characterization with respect to product requirements and Target product profile.The team need to be aware of the risk from incomplete transfer of product stability studies and related data. In some instance, receiving site may not perform an adequate product physical characterization, especially for API and filler materials.Often times, characterization of molecular and particulate aspects of the products will not be fully vetted in the receiving site;thesejeopardize the continuous manufacturing of the products without any failure in in-house and in the field (Clarke, G S 1994).Raw materials availability and characterizations of their impurities and their impact on the final performance of the products need to be elucidated and both teams should understand the risks.Due to frequent mergers and transfers, critical information like PRD, Trace matrix, voice of the customers could be lost or unavailable from the database. PROCESS CHARACTERIZATION/ PROCESS VALIDATION The core of the transfer is transferring the process efficiently so that any manufacturing unit can adapt it. Due to the nature and significance of this step, the risks assessment becomes an inherent and important process in this phase of tech transfer project (Riley C M and Rosanske T W. 1996).Critical risks that we normally assess include the following: • Risks of failure to develop a robust process in the first place. • Risks including process, not able to withstand the variance in the inputs. • Risks including the adapting of the process to achieve the specification required. • Failure due to developing a process that might be inundated with numerous non value add activities. • The risksof having the flow of the process, not suitable for the receiving site layout. • Risks from the broken process with low capability index, resulting in producing more failed products. • Risks from fixing the process that results in utilizing resources more than planned. • Inadequate development of the master validation plan, resulting in failed validation. • Risks of not addressing the regulatory requirements in the validations. • Due to timeline constraints, performing a less number of process validations than the standard three batch requirement. • Risks of validation providing ambiguous or unreliable data. • Risk resulting from inadequate cleaning validations.
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International Journal of
Management (IJM), ISSN 0976 – 6502(Print), ISSN 0976 - 6510(Online), Volume 5, Issue 8, August (2014), pp. 01-09 © IAEME ANALYTICAL/QUALITY TEST METHOD TRANSFER 6 Transferring analytical method and quality control methods need to be given more attention. Developing test methods are an important process during the product development. Not having a suitable method will either result in accepting bad lots as good lot and shipping them to the customer, or rejecting a good lot as bad. Both these events will affect the business. In the first instance, bad lot mistakenly passed as good lot and released in the field will eventually fail at the customer’ s hand, making the customer unhappy and creating product recall and regulatory warnings (Green J M. 1996). On the other hand, rejecting a good lot as a bad lot after an in house testing will result in a business losing revenue, impacting the bottom line. It is utmost important to understand the risks involved in analytical transfer. Critical risks include the following. • Risks resulting from a process not well characterized for the receiving site to incorporate into their process flow. • Failure to identify bottleneck in the sampling and testing process like the methods past performance, the familiarity of the receiving site with the testing process. • Risk of testing method developed may not efficiently discriminate between good and bad products resulting in consumer risk, or business risk. • Risks associated with the variability of the assay. DOCUMENTS Manufacturing, testing protocols, SOPs: For any successful tech transfer projects, it is crucial to transfer the knowledge in pristine condition. It is also the common source of variation between the sending and the receiving sites. Every organization will have different template and documents style, and even different language. It makes transferring documents a more challenging process. In addition to the different format and language, sites may have different document management systems like SAP, E1, Agile, and many other. The project team needs to understand the risks for the manufacturing. Risk analysis and mitigation need to be planned. There are also some other risks like risks including instructions not explicitly stated for the operator to carry out without any room for interpretations.Risks including calculation errors, resulting in potential formulation errors, which could lead to potential recalls, if not captured in testing. EQUIPMENT Equipment’s are a critical part of the transfer process. In depth IQOQ protocols need to be developed. Risks are assessed; includinga greater risk is the instrument capability and variability. Risks are assessed for the instrument gage and their precision to tolerance. Risks are understood by running MSA on the instrument to understand the variability provided by the instrument to the total process variability. Risks including cost of upgrading the instrument to meet the standards. REGULATORY Major risks in any transfer projects that require regulatory approval is failing to provide data and follow the guidelines required for FDA submission. Any risks in the above category may have a cascading effect on the regulatory submissions and the sustainability of the transfer.
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International Journal of
Management (IJM), ISSN 0976 – 6502(Print), ISSN 0976 - 6510(Online), Volume 5, Issue 8, August (2014), pp. 01-09 © IAEME 7 RISK ANALYSIS As the risks are identified, the transfer team assesses them to understand their impact on the success of the tech transfer and sustained manufacturing of the products. Several approaches have been identified. The team can use both qualitative methods and quantitative methods. Qualitative risk analysis: Team can use risk probability and impact assessment. Brain storming, Monte Carlo analysis. Delphi techniques (PMBOK Guide. 2013). The team need to do a SWOT analysis. The team can use Failure mode effect analysis. Risks can be ranked based on the severity and occurrences. FMEA Figure 2: FMEA Failure mode and effect analysis helps team to identify failure modes, severity for the failure mode, effects of the failure and residual risk monitoring. Evaluation Method Figure 3: Impact analysis for each failure mode is assessed based on severity RISK MITIGATION STRATEGIES The project team based on the risk analysis need to plan for risk responses and risk mitigation strategies. Commonly adopted risk mitigation strategies are risk avoidance. If a certain risk ranks high, team can make the decision to entirely avoid that particular task or strategy for avoiding the risks in that approach. Alternatively a tech transfer team can either mitigate risks by identifying a solution or identifying a root cause approach. Figure 4: Levels of risk acceptability
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International Journal of
Management (IJM), ISSN 0976 – 6502(Print), ISSN 0976 - 6510(Online), Volume 5, Issue 8, August (2014), pp. 01-09 © IAEME 8 CONCLUSION Risk identification, analysis, and mitigation is an iterative process. Irrespective of project types and industry, risk management is inherent to the success of the projects. Highly regulated industry like pharmaceutical and biotech risk management guidance is formulated by the regulatory agencies like FDA and other EU agencies. Risk management is more crucial for the tech transfer projects to prevent any failure in the future at the manufacturing. REFERENCES [1] Besner C. and Hobbs B. 2012. An empirical identification of project management toolsets and a comparison among project types. Project Management Journal, 43 (5) 24-46. [2] Bikash Chatterjee and Mark Mitchell. 2012 A Framework for Technology Transfer to Satisfy the Requirements of the New Process Validation Guidance: Part 2. http://www.pharmamanufacturing.com/articles/2012/085/# [3] Butler M. S. 2004. The role of natural product chemistry in drug discovery. Journal of natural products, 67(12), 2141-2153. [4] Chuing Loo, Abdul-Rahman S H Wang C. 2013. Managing external risks for international architectural, engineering, and construction (aec) firms operating in gulf cooperation council (gcc) states. Project Management Journal, 44 (5) 70-88. [5] Clarke G. S. 1994 The validation of analytical methods for drug substances and drug products in UK pharmaceutical laboratories. Journal of pharmaceutical and biomedical analysis, 12(5), 643-652. [6] De Bakker K, Boonstra, A and Wortmann H. 2011. Risk management affecting IS/IT project success through communicative action. Project Management Journal, 42 (3) 75-90. [7] Deng X, Pheng L S, and Zhao X. 2014. Project system vulnerability to political risks in international construction projects: the case of Chinese contractors. Project Management Journal, 45 (2) 20-33. [8] Fernandes G, Ward S and Araj, M. 2014. Developing a framework for embedding useful project management improvement initiatives in organizations. Project Management Journal, 45(4) 81-108. [9] Khamooshi H and Golafshani H. 2014. EDM: Earned Duration Management, a new approach to schedule performance management and measurement. International Journal of Project Management, 32 (6) 1019-1041. [10] Krane, H P Olsson, N O E and Rolstad ÑS A. 2012. How Project Manager Çôproject owner interaction can work within and influence project risk management. Project Management Journal, 43 (2) 54-67. [11] Kuchta D. 2014. A new concept of project robust schedule. Use of buffers. Procedia computer science 31, (0) 957. [12] Kutsch E and Hall M. 2009. The rational choice of not applying project risk management in information technology projects. Project Management Journal, 40 (3) 72-81. [13] Lam W C J. 2007 U.S. Patent No. 7,269,925. Washington, DC: U.S. Patent and Trademark Office. [14] Loftus B T and Nash R A 1984. Pharmaceutical process validation. [15] Morris P. 2013. Reconstructing project management reprised: A Knowledge Perspective. Project Management Journal, 44 (5) 6-23. [16] Pedram Alaedini, Ronald D. Snee and Brian, Hage W. 2007 Technology Transfer by Design The next stage in operational advantage. http://www.contractpharma.com/issues/2007- 06/view_features/technology-transfer-by-design.
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Management (IJM), ISSN 0976 – 6502(Print), ISSN 0976 - 6510(Online), Volume 5, Issue 8, August (2014), pp. 01-09 © IAEME 9 [17] Samaraj S. Thiyagarajan. 2014. A perspective of risk assessment for product developments in biotechnology and pharmaceutical products. International journal of management (IJM).volume: 5, issue: 7:44-50. [18] Teller J. Kock A and Gem HG. 2014. Risk management in project portfolios is more than managing project risks: a contingency perspective on risk management. Project management journal, 45(4) 67-80. [19] Teller, J. 2013. Portfolio risk management and its contribution to project portfolio success: an investigation of organization, process, and culture. Project Management Journal, 44 (2) 36-51 [20] Thamhain H. 2013. Managing risks in complex projects. Project Management Journal, 44 (2) 20-35. [21] Van Leeuwen J. F et al. 2009 Risk analysis by FMEA as an element of analytical validation. Journal of pharmaceutical and biomedical analysis 50.5 (2009): 1085-1087. [22] Warren Adis Analysis of FDA’s Risk Assessment Methodology at Pharmaceutical Manufacturing Sites, Analysis of FDS’s Risk Assessment Methodology. [23] Wiliam Schmidt and Ian Uydess. 2011 Keys to Executing a Successful Technology Transfer By: Pharmaceutical Technology, Volume 35, pp. s42-s46. [24] Yang Q Lu T YaoT Zhang B 2014. The impact of uncertainty and ambiguity related to iteration and overlapping on schedule of product development projects. International Journal of Project Management, 32 (5) 827-837. [25] Zhang H. 2011. Two schools of risk analysis: A review of past research on project risk. Project Management Journal, 42 (4) 5-18. [26] Zhang J. and Wei W X 2012. Managing political risks of Chinese contracted projects in Libya. Project Management Journal, 43 (4) 42-51.
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