Strategy Development Process Research Articles

Automated disposable small scale reactor for high throughput bioprocess development: A proof of concept study

The acceleration of bioprocess development for biologics and vaccines can be enabled by automated high throughput technologies. This will alleviate the significant resource burden from the multi-factorial statistical experimentation required for controlling product quality attributes of complex biologics. Recent technology advances have improved clone evaluation and screening, but have struggled to combine the scale down criteria required for both high cell density cell culture and microbial processes, with sufficient automation and disposable technologies to accelerate process development. This article describes the proof of concept evaluations of an automated disposable small scale reactor for high throughput upstream process development. Characterization studies established the small scale stirred tank disposable 250 mL reactor as similar to those of lab and pilot scale. The reactor generated equivalent process performance for industrial biologics processes for therapeutic protein and monoclonal antibody production using CHO cell culture, Pichia pastoris and E. coli. This included similar growth, cell viability, product titer, and product quality. The technology was shown to be robust across multiple runs and met the requirements for the ability to run high cell density processes (>400 g/L wet cell weight) with exponential feeds and sophisticated event triggered processes. Combining this reactor into an automated array of reactors will ultimately be part of a high throughput process development strategy. This will combine upstream, small scale purification with rapid analytics that will dramatically shorten timelines and costs of developing biological processes.

Re-examining participatory research in dropout prevention planning in urban communities

This paper explores the concept of what a community-based participatory dropout prevention planning process might entail. Specifically, it looks at a year-long research project that brought together formerly incarcerated school non-completers, researchers, and local policy-makers (stakeholders) to address low high-school completion rates in the community. Using our own project as a case study, we reflect on the challenges and promises that emerged when the knowledge of adults in urban communities, who themselves often did not complete school, become central to dropout prevention idea generation, strategy development, and decision-making processes. We re-examine the ‘participatory’ process using participatory action research principles as an analytical lens focusing on three central concepts: control, collaboration, and commitment.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Strategy development based on intangibles in SMEs – an integrated approach

The approach in this paper is based on the principles of action research and rapid prototyping. The paper shows the current status of a ‘bottom-up’ research process dedicated to continuously developing and improving management instruments that suit the requirements of small and medium-sized enterprises (SMEs): pragmatic, easy-to-use and generating direct practical benefit. As a result, this paper links the concept of intangibles to the practical strategy development process in SMEs. The integration shown concerns several challenges: (1) Integrate the internal and external perspective on intangibles, and, by that, link the concept of intellectual capital (IC) as a resource-based view with the concept of customer value as a market-based view. (2) Integrate the theoretical concept of IC with a methodology for comprehensive strategy development. (3) Integrate the formulation and implementation of business strategies taking into account the actual practice in SMEs.

Engaging Development Partners in Efforts to Reverse Malnutrition Trends in Pakistan

After two decades of failed efforts to launch a national nutrition programme and nutrition action largely limited to low coverage interventions, a promising multisectoral nutrition scenario is unfolding in Pakistan led by provincial and regional officials and a well‐coordinated group of development partners. The process has emerged from the confluence of three recent events in the country: the floods of 2010 and 2011; the passing of a constitutional amendment in 2010 which had the effect of dissolving the federal government's Ministry of Health and devolving responsibilities for health and nutrition to the provinces and regions; and a National Nutrition Survey in 2011 with results indicating that chronic malnutrition in the country had actually deteriorated over the previous decade. This article discusses the paths leading from these events to the present opportunities to address malnutrition aggressively and systematically, examines the sensitisation, advocacy and strategy development processes employed, and presents both the potential promise and the risks involved in the new provincial and regional nutrition undertakings.

Cultivating Food Connections: The Toronto Food Strategy and Municipal Deliberation on Food

This paper shares an exploratory case study of the development of the Toronto Food Strategy as an urban food strategy, through the lens of public health. It asks: what is a food strategy and how does it work? We will answer these questions through an analysis and discussion of the Food Strategy development process and attention to three key mechanisms: (1) framing or directing attention to the diverse policy instruments that deal with food, (2) brokering working relationships between diverse stakeholders and across existing governance arrangements, and (3) leveraging existing resources. We also distinguish the work of the Food Strategy from the role of food policy councils in how they cultivate deliberative spaces to catalyse policy change.

Latent Variables-Based Process Modeling of a Continuous Hydrogenation Reaction in API Synthesis of Small Molecules

Continuous manufacturing can be benefited by the use of the Quality by Design (QbD) strategy for robust process development and by the use of Process Analytical Technology (PAT) for real-time process monitoring and control. A successful implementation of QbD and PAT for continuous processes relies on a robust and information-rich process model as a basis for process understanding, monitoring, and control. Compared to first principles and other empirical models, a latent variables-based process model is capable of decomposing multidimensional process data into a few orthogonal latent variables and of providing accessible process understanding/visualization and control within the latent variable space. This study is an extension of our group’s earlier effort (Liu et al., J Pharm Innov 6:170–180, 2011) to explore the utility of latent variables-based process modeling in pharmaceutical manufacturing processes. The case presented here is the first application of latent variables-based modeling to a reaction process in small-molecule active pharmaceutical ingredient route synthesis, i.e., a continuous-flow hydrogenation. A particular reactor configuration and operation was used in this proof-of-concept study. It was found that time-variant profiles of pressure in the flow tube reactor served as an effective indicator of gas–liquid interaction within the reactor, thus determining process outcomes, i.e., the extent of reaction and enantiomeric excess (ee), given the importance of process set points. In addition, a design space of process parameters predicted to produce optimal outcomes, i.e., extent of reaction greater than 98 % and ee higher than 93 %, was established in order to provide a flexible operation space for performing the reaction with desired process outcomes. The capabilities of latent variables-based process modeling have been well demonstrated as applied to a continuous-flow hydrogenation reaction, regarding its improved process understanding and the potential for process optimization & control as well. Future efforts will be focused on continuing understanding of the capabilities and limitations of such a methodology on a fully-automated control scheme for continuous flow reaction.

Neglected stakeholder groups: conceptualising a dynamic model for neglected stakeholder analysis and engagement

Stakeholder analysis is well-established as a means by which policy makers and organisations gauge the interests of their salient stakeholders. This paper explores the application of stakeholder theory to ‘neglected stakeholders’ and explores the risks involved in assuming that disparate stakeholder groups lack power. This paper uses two case studies of Recreational Vehicle users whose interests and power were underestimated during a strategy development process. The rapid responses and formation of power of this neglected group via social media highlights the changes in stakeholder interactions that have emerged with the use of the Internet. They also demonstrate that managers and policy makers must now utilise iterative stakeholder analysis techniques that are reactive, and which respond to previously neglected stakeholder groups.

A meta-analysis of writing instruction for students in the elementary grades.

In an effort to identify effective instructional practices for teaching writing to elementary grade students, we conducted a meta-analysis of the writing intervention literature, focusing our efforts on true and quasi-experiments. We located 115 documents that included the statistics for computing an effect size (ES). We calculated an average weighted ES for 13 writing interventions. To be included in the analysis, a writing intervention had to be tested in 4 studies. Six writing interventions involved explicitly teaching writing processes, skills, or knowledge. All but 1 of these interventions (grammar instruction) produced a statistically significant effect: strategy instruction (ES = 1.02), adding self-regulation to strategy instruction (ES = 0.50), text structure instruction (ES = 0.59), creativity/imagery instruction (ES = 0.70), and teaching transcription skills (ES = 0.55). Four writing interventions involved procedures for scaffolding or supporting students' writing. Each of these interventions produced statistically significant effects: prewriting activities (ES = 0.54), peer assistance when writing (ES = 0.89), product goals (ES = 0.76), and assessing writing (0.42). We also found that word processing (ES = 0.47), extra writing (ES = 0.30), and comprehensive writing programs (ES = 0.42) resulted in a statistically significant improvement in the quality of students' writing. Moderator analyses revealed that the self-regulated strategy development model (ES = 1.17) and process approach to writing instruction (ES = 0.40) improved how well students wrote. Supplemental materials: http://dx.doi.org/10.1037/a0029185.supp

Strategy deployment systems within the UK healthcare sector: a case study

PurposeThe purpose of this paper is to examine an organisation‐wide restructuring exercise by investigating the effectiveness of strategy development and deployment processes in a National Health Service (NHS) Community Health Services (CHS) organisation.Design/methodology/approachThe authors used an embedded single‐case study approach to gather and analyse rich data in order to understand how an organisation can develop and deploy its strategy, and to appreciate the key tools, techniques and issues related to this process. A range of data collection methods, including archival records, interviews, observations and questionnaires, was employed to permit triangulation of the results.FindingsThe research led to an understanding of how the Balanced Scorecard (BSC) and the Closed‐Loop Management System (CLMS) can be adapted to support the local CHS. In total, 17 key areas for success are presented and used to assess the current capability within the case study organisation.Research limitations/implicationsThe authors’ investigation examined the potential for improved strategic development and deployment through the adaptation of the BSC and a CLMS within a NHS CHS organisation.Practical implicationsA six‐step conceptual model is presented which can be used to guide organisations. The model permits the assessment of capability in order to highlight current strengths and weaknesses.Originality/valueAs a suitably skilled workforce is required for the successful implementation of any management system, the research expanded the scope of the study by including an assessment of the organisation's readiness for adapting formal strategy deployment systems.

Executive education stimulates strategic thinking and action

PurposeTo describe how a major Swiss company revitalized its organizational capabilities by using the combined know‐how of an experienced provider of executive education and the expertise of its top managers to reinvent its approach to strategy development.Design/methodology/approachOutlines a six‐month program combining project‐based action learning in small teams with short periods of formal discussion, coaching and presentations on strategy development, implementation and associated leadership skills.FindingsLonza is a leading international supplier to the pharmaceutical, healthcare and life science industries with a strong presence in the USA, Asia and Europe. With a large production base in Switzerland, the company was facing significant challenges in 2010 – not least because of the appreciation of the Swiss franc. And with nine independent business units operating with a high degree of autonomy, achieving a fully integrated corporate strategy with a clear set of investment priorities was, understandably, proving difficult. Lonza's senior management is mostly made up of highly qualified chemical engineers, biologists or pharmaceutical experts. Still, despite the high level of education only a small number of these experts had any formal training in strategy development, and those who had were not aligned with regards to the understanding and processes of strategy development.Practical implicationsEmphasizes that whilst the University of St Gallen provided a structured strategy development process, the content of the strategy was the responsibility of program participants.Social implicationsPoints out that this approach ensured that participating managers owned and were committed to the resulting strategy as well as strengthening their individual capabilities.Originality/valueHighlights the value of taking a real‐time action‐learning approach to executive education and shows how this can generate immediate benefits for organizational development as well as in financial terms.

A four-phase AHP–QFD approach for supplier assessment: a sustainability perspective

Recently, companies have become increasingly aware of the need to evaluate suppliers from a sustainability perspective. Introducing the triple bottom line (economic, social, and environmental performance) into supplier assessment and selection decisions embeds a new set of trade-offs, complicating the decision-making process. Although many tools have been developed to help purchasing managers make more effective decisions, decision support tools, and methodologies which integrate sustainability (triple bottom line) into supplier assessment and selection are still sparse in the literature. Moreover, most approaches have not taken into consideration the impact of business objectives and requirements of company stakeholders on the supplier evaluation criteria. To help advance this area of research and further integrate sustainability into the supplier selection modelling area, we develop an integrated analytical approach, combining Analytical Hierarchy Process (AHP) with Quality Function Deployment (QFD), to enable the ‘voice’ of company stakeholders in the process. Drawing on the sustainable purchasing strategy development process, our AHP–QFD approach comprises four hierarchical phases: linking customer requirements with the company's sustainability strategy, determining the sustainable purchasing competitive priority, developing sustainable supplier assessment criteria, and lastly assessing the suppliers. An illustrative example is provided to demonstrate the application of the proposed approach.

Examining the strategy development process through the lens of complex adaptive systems theory

The development of strategy remains a debate for academics and a concern for practitioners. Published research has focused on producing models for strategy development and on studying how strategy is developed in organisations. The Operational Research literature has highlighted the importance of considering complexity within strategic decision making; but little has been done to link strategy development with complexity theories, despite organisations and organisational environments becoming increasingly more complex. We review the dominant streams of strategy development and complexity theories. Our theoretical investigation results in the first conceptual framework which links an established Strategic Operational Research model, the Strategy Development Process model, with complexity via Complex Adaptive Systems theory. We present preliminary findings from the use of this conceptual framework applied to a longitudinal, in-depth case study, to demonstrate the advantages of using this integrated conceptual model. Our research shows that the conceptual model proposed provides rich data and allows for a more holistic examination of the strategy development process.

The New Way to Manage Content Across Platforms

Because the definition of content has expanded to include everything from text, graphics, audio, video, data, or any combination of these, determining the right mix of content to ensure relevance and profitability requires publishers to pay significantly more attention to the needs of their audience. This article guides publishers through the content strategy development process and shows how decisions made regarding content strategy influence the publisher’s content management and distribution functions as well. The article also includes a detailed list of the latest in content creation, management, production, and distribution trends, along with a clearly stated implication for each.

Development of a National HRD Strategy Model

National human resource development (NHRD) literature describes the importance of developing human resources at the national level and presents several models. These models are primarily concerned with the national contexts of developing and underdeveloped countries. In contrast, the NHRD models in the non-HRD literature focus primarily on developed countries. Both types of models describe NHRD strategies with little analytical attention to the larger societal context, which the authors argue has a deep influence on the trajectory of NHRD practices in developing countries. The authors traced the evolution of NHRD strategies through an in-depth analysis of two emerging economies—India and China. Through comparative analysis, this study identifies similarities and differences in the emergence of NHRD strategy and develops a model that provides an enriched perspective on the dynamic process of NHRD strategy development.

Rapid Crystallization Process Development Strategy from Lab to Industrial Scale with PAT Tools in Skid Configuration

Batch cooling crystallization is a commonly used separation and purification step in the pharmaceutical industry. Various properties of the crystalline product from a batch crystallizer can have a strong impact on the efficiency of downstream processes such as filtration and drying, on the formulation process and on the dissolution behaviour of the drug. Development of the crystallization processes presents a major challenge in the process development of an active pharmaceutical ingredient (API). Therefore, it is beneficial to develop a rapid crystallization process development strategy to industrial scale. In this paper we present a strategy for rapid process development and apply this strategy for androsta-1,4-diene-3,17-dione, cyclic 17-(2,2-dimethyltrimethylene acetal), a pharmaceutical intermediate produced by Merck Sharp and Dohme. The major advantages of the strategy are that there is no requirement of the crystallizer design modification, the calibration of the process analytical technology (PAT) tools can be performed at industrial scale, and the determination of the operating window can be done directly at the industrial scale. This strategy allows for process optimization directly at the industrial scale, thus eliminating the need for time-intensive scale-dependent study. The implementation of this strategy at industrial scale was performed with the help of PAT tools arranged in a unique skid-based configuration. The skid which contains both the concentration sensors and the crystal size distribution (CSD) sensors can be connected to the existing crystallizers, thereby avoiding the time and cost-intensive modifications in the crystallizer design. The modular nature of the skid offers opportunities to choose the PAT tools which complement the solute–solvent model system. The skid makes it possible to gather the relevant information concerning the thermodynamics and kinetics of the model system in situ during the crystallization runs at the industrial scale. A strategy for process development based on a sensor skid is beneficial for the industry as it is intrinsically rapid and can be combined with the development of control strategies which lead to consistent product quality.

Transdisciplinary research for supporting the inte-gration of ecosystem services into land and water management in the Tarim River Basin, Xinjiang, China

There is a growing need for both science and practice domains to collaboratively and systematically seek knowledge-based strategies for sustainable development. In recent years, transdisciplinary research has emerged as a new approach that enables joint problem solving among scientists and stakeholders in various fields. In this paper, we aim to introduce transdisciplinary research for supporting the integration of the concept of eco- system services into land and water management in the Tarim River Basin, Xinjiang, Northwest China. While a large number of ecosystem service studies have helped to raise the awareness for the value of nature in China, a number of challenges remain, including an improved understanding of the relationships between ecosystem structure, functions and services, and the interaction of the various ecosystem services. A meaningful valuation of ecosystem services also requires the consideration of their strong spatial heterogeneity. In addition, ways to introduce the con- cept of ecosystem services into decision-making in China need to be explored. Thus, successful integration of the concept of ecosystem services into actual land and water management requires a broad knowledge base that only a number of scientific disciplines and stakeholders can provide jointly, via a transdisciplinary research process. We regard transdisciplinary research as a recursive process to support adaptive management that includes joint knowledge generation and integration among scientists and stakeholders. System, target, and transformation knowledge are generated and integrated during the process of (1) problem (re)definition, (2) problem analysis and strategy development, and (3) evaluation of the impact of the derived strategy. Methods to support transdisciplinary research comprise participatory modelling (actor-based modelling and Bayesian Networks modelling) and partici- patory scenario development. Actor-based modelling is a semi-quantitative method that is based on the analysis of problem perspectives of individual stakeholders as depicted in perception graphs. With Bayesian Networks, com- plex problem fields are modelled probabilistically in a simplified manner, using both quantitative data and qualitative expert judgments. These participatory methods serve to integrate diverse scientific and stakeholder knowledge and to support the generation of actually implementable management strategies for sustainable development. For the purpose of integrating ecosystem services in land and water management in the Tarim River Basin through trans- disciplinary research, collaboration among scientists and institutional stakeholders from different sectors including water, agriculture, forestry, and nature conservation is required. The challenge is to adapt methods of transdisci- plinary research to socio-cultural conditions in China, particularly regarding ways of communication and deci- sion-making.

A Conceptual Model for Developing Mindsets for Strategic Insight Under Conditions of Complexity and High Uncertainty

This article addresses an important, yet often underattended to, aspect of the strategy development process: fostering the use of strategic learning practices in the simultaneous practice of developing strategy and cultivating strategic mindset awareness. The need for addressing this aspect of the strategy development process is increasingly important because of the intensifying complexity of the task environment. Following a framing of this context in terms of a complex adaptive systems perspective, a conceptual model for addressing this strategic HRD challenge is presented. The model is based on two distinct, yet in terms of potential implications for HRD practice, interconnected streams of literature: strategic learning practices, and adult development theory (specifically, constructive developmental theory and developmental action inquiry). The implications for HRD practices seeking to address this need, along with implications for future research, are also discussed.

Assessment of AMBR<sup>TM</sup> as a model for high-throughput cell culture process development strategy

The development and delivery of high quality therapeutic products necessitates the need for highthrough-put (HTP) process development tools. Traditionally, these works requires a combination of shake flask and small-scale stirred tank bioreactor (STR) which are labor and resource intensive and time-consuming. Here we demonstrate a strategy for rapid and robust cell culture process development by evaluating and implementing the use of a new HTP disposable micro bioreactor (MBR) called AMBRTM system (Advanced Microscale Bioreactor) that has the capabilities for automated sampling, feed addition, pH, dissolved oxygen (DO), gassing and agitation controls. In these studies the performance of two monoclonal antibody (MAb) producing cell lines (MAb1 and MAb2) was evaluated both in the AMBR system and 3-L STR. We demonstrated that cell culture performance (growth and viability, production titer and product quality) were similar in both vessel systems. Furthermore, process control and feed optimization were demonstrated in an additional cell line (MAb3) in the disposable MBR and its performance confirmed at STR scale. The results indicate that the AMBR system can be used to streamline the process development effort and facilitate a rapid and robust cell culture process development effort for MAb programs in a HTP manner.

Design strategy for a Chemical Looping Combustion system using process simulation and Computational Fluid Dynamics

A strategy for design and optimisation of chemical processes involving multiple fluidised bed reactors is presented through a combination of standard design calculations, process simulation and Computational Fluid Dynamics (CFD). The strategy is demonstrated in designing a Chemical Looping Combustion (CLC) process that generates 12.5 kW of heat in the air reactor. The resulting design strategy will allow for very economical investigations into various design and optimisation considerations. It also offers a platform from which to conduct virtual prototyping investigations for new process concepts, which will lead to significant economic benefits when compared with a traditional experimental process development strategy.