The presence of active pharmaceutical ingredients (APIs) and other chemicals in wastewater has caused concerns in recent years due to its potential risk to the environment and society. Thus, the aim of the study is to investigate ways to minimize the release of chemicals from a large-scale pharmaceutical industry to an industrial wastewater treatment plant. The large-scale industry that is studied is located at Cambrex Karlskoga AB and the process that is investigated is the production of the intermediate R1-MR2E, from a carboxylic acid and an alcohol through an esterification. The investigations are performed by modifying a HPLC-UV method and mapping the release of the carboxylic acid and R1-MR2E as well as examining possible ways of minimizing the release by optimization of the crystallization of the recirculation of the carboxylic acid and of the product R1-MR2E. The method used in the investigation is mostly the modified HPLC-UV method. The optimizations are performed by examining the effect of the maturation time on the crystallization of the recirculated carboxylic acid, and by investigating the effect that a concentrated solution has on the pH of crystallization. The results indicate a possibility to remove the washing water of the recirculated carboxylic acid in order to minimize the release of the compound and R1-MR2E without affecting the quality of R1-MR2E. The results also show that a minimized amount of solvent can be used in the crystallization of R1-MR2E without affecting the process. / Förekomsten av aktiva läkemedelsingredienser (API) och andra kemikalier i avloppsvatten har orsakat stor oro de senaste åren på grund av dess potentiella risk för miljö och samhälle. Syftet med studien är därmed att undersöka sätt att minimera utsläppet av kemikalier från en storskalig läkemedelsindustri till ett industriellt reningsverk. Den storskaliga industrin som studeras är Cambrex Karlskoga AB och processen som undersöks är produktionen av intermediatet R1-MR2E, från en karboxylsyra och en alkohol genom en esterifiering. Undersökningarna utförs genom att modifiera en HPLC-UV metod och kartlägga utsläppet av karboxylsyran och R1-MR2E, samt genom att undersöka möjliga sätt att minimera utsläppet genom optimering av kristalliseringen vid återcirkulation av karboxylsyran och av produkten R1-MR2E. Metoden som används i undersökningarna är mestadels den modifierade HPLC-UV metoden. Optimeringarna utförs genom att undersöka effekten som mognadstiden har på kristallisationen av den återcirkulerade karboxylsyran och genom att undersöka effekten som en koncentrerad lösning har på kristallisationens pH. Resultatet indikerar en möjlighet att avlägsna tvättvattnet vid återcirkulering av karboxylsyran för att minimera utsläppet av föreningen och R1-MR2E utan att påverka kvaliteten på R1-MR2E. Resultatet visar även att en minimerad mängd lösningsmedel kan användas i kristallisationen av R1-MR2E utan att påverka processen.

Background: In a globalised world and increased interconnected business environments effective resilience capabilities are pivotal for disruption mitigation. In the pharmaceutical industry this concerns the phenomenon of medicine shortages and high geographical sourcing dependencies resulting in severe consequences for healthcare providers and patients. Purpose: Analysing challenges affecting resilience in the upstream of the pharmaceutical supply chain network and root-causes of the heparin sourcing shortage. This study aims to find resilience strategies to effectively manage future heparin sourcing shortages. Method: This qualitative case study analysed the dynamic phenomenon of supply chain network resilience in a German listed healthcare company. Semi- structured interviews were conducted based on non-probability purposive sampling. The empirical findings were analysed according to the thematic analysis. Conclusion: The findings indicate that insufficient management of challenges impacting the supply chain network resilience leads to medicine shortages. Driven by the ethical obligation the pharmaceutical supply chain network particularly has to deal with external hurdles and sourcing dependencies created by complex product characteristics.

This article examines predictors of the future market value of microcap pharmaceutical companies. This is problematic since the large majority of these firms seldom report positive net income. Their value comes from the potential of a liquidity event such as occurs when a key drug is approved by the FDA. The typical scenario is one in which the company is either acquired by a larger pharmaceutical firm or enters into a joint venture with another pharmaceutical firm. Binary logistic regression is used to determine the impact of the firm's drug treatment pipeline and its investment in research and development on the firm's market cap. Using annual financial data from 2007 through 2010, this study finds that the status of the firm's drug treatment pipeline and its research and development expenses are significant predictors of the firm's future stock value relative to other microcap pharmaceutical firms.

This study investigates how cross-sector collaborations can mitigate value chain emissions, thereby reducing complex environmental issues. The point of departure is the Energize program, which ten pharmaceutical companies introduced at COP26 in November of 2021. Energize aims to accelerate the adaptation of renewable energy and reduce greenhouse gas emissions throughout the industry and its value chain, which refers to Scope 3 emissions. By interviewing 13 respondents from nine participating companies, the study’s objective is to increase the understanding of these collaborative activities through a case study of Energize. Moreover, it investigates and identifies the drivers to encourage collaboration, its constraints, and the factors to make a program productive. The research concludes that for a cross-sector collaboration program to become fruitful, internal factors such as corporate engagement, the importance of industry working groups, and intrinsic and extrinsic motivation are needed to exist throughout the process. Besides, external factors such as social awareness, legal requirements, and technological readiness are essential. Similar programs can efficiently try to solve complex issues by leveraging the combined bargaining power to increase the development within the value chain. Moreover, as a pre-competitive partnership, Energize has attractive benefits in reducing costly implementation processes and improving the resources of the participating actors.

The pharmaceutical industry has received increasing attention from society in recent years, mainly due to the development of vaccines to counteract the spread of Covid-19. While other industries have received sympathy for delays, inconveniences, and difficulties the pressure towards the pharmaceutical industry to produce the vaccine against the virus has increased. However, the Covid-19 pandemic has left no one untouched, it has affected the global economy, increased the unemployment rate, reduced incomes, and resulted in disruption for transportation. The Covid-19 pandemic has also left its mark in the pharmaceutical industry. When lockdowns were implemented, it caused restrictions of in country and cross border movements, hampering the transportation and delivery of pharmaceutical suppliers, causing shortages or disruptions. This has resulted in an industry where unpredictability is constant, while still aspiring to provide stability and safe products for the patients through their projects. Even though the industry is known for working on projects, it is still immature in comparison to other industries, regarding project management knowledge, and therefore also knowledge about risk management. Generally, the pharmaceutical industry is hesitant towards risk and being cautious can be beneficial when managing risk. However, the pharmaceutical industry is dependent on innovation and development of new medicines which is often associated with taking risks.  The purpose of this thesis is to provide insights into the beginning stages of risk management for projects within the pharmaceutical industry, during the covid-19 pandemic in Sweden. The Swedish pharmaceutical industry has during 2020 broken new records regarding exports and increased the volume by ten percent whereas the general export in Sweden has decreased. This study explores pharmaceutical projects’ risk identification by interviewing eight active project members who have been a part of projects both before and during the Covid-19 pandemic.  A qualitative method was chosen for this study, paired with grounded theory that has provided us with several implications for pharmaceutical projects and their risk identification. We have discovered indications for the structure of the risk identification process. This structure indicates four separate steps of the risk identification process. The first step is classifying risk, where cross-functionality plays an important role. Afterwards, the risk identification process enters the complex environment and continues to the second step. This step initiates the risk search - mixed approach, consisting of the individual and collective approaches towards risk search. Here, pharmaceutical projects can take guidance from stakeholders such as regulatory authorities. The third step is reaction which can be altered by unpredictable disruptions or governed by the stakeholders. In this case, the project re-assesses and returns to the second step risk search - mixed approach. However, if the reaction is not to re-assess, the process continues to the fourth step temporarily completed risk identification. Then, due to the long project lifespans, the project will ultimately return to the first step and repeat the risk identification process.  Our study contributes to new insights into pharmaceutical risk identification in several theoretical ways. Mainly, we have shown that contrary to previous theories, the pharmaceutical project risk identification entails the classifying of risks before the risk search. Additionally, our findings generate insights for practical purposes for project members and relevant stakeholders.

Pharmaceutical industry is today struggling with its productivity as products keep failing after long and expensive development programs. The protability is further threatened by erce competition from cheaper product copies. As an attempt to increase the pipeline output, pharmaceutical companies have lately turned to the strategy of drug repositioning. By applying an already developed drug in new disease areas the lifetime of the product is prolonged and return time on already made investments elongated.  Such development is imbued by less risk than a de novo development and has proven to be a faster and cheaper way to meet the medical demand. With limited company budgets and the often many repositioning possibilities, an informed repositioning selection must be made. As such theoretical model is not publicly available this thesis takes on the task to determine which parameters to take into consideration and how these should be weighted in relation to each other in order to evaluate di erent drug repositioning possibilities. Six main topics are identied to a ect the repositioning success, these are: medical need, economic return, scientic support, timing, life cycle extenders and external relations. These ndings are derived from empirics collected during interviews with employees from ve di erent competence areas involved in repositioning initiatives, na mely: research & development, clinical studies, regulatory a airs, pricing, and commercial. By further support from literature within the elds of drug repositioning and R&D project selection a three-step repositioning model was developed. The first step in the three-step repositioning model consists of primary parameters, these are essential parameters that have to be fullled in order to perform a repositioning strategy. If any of the primary parameters are not fullled, the repositioning opportunity should be killed in a go/no-go decision. In a second step, the secondary parameters are evaluated in a scoring model in order to determine the economical outlook of each repositioning opportunity. The opportunities showing greatest economical outlook should further be evaluated in the third and nal step in the three-step repositioning model. In this nal step the di erent repositioning opportunities are evaluated by their coherence with an overall corporate strategy. By applying this repositioning model to a repositioning selection scarce company resources  ay be focused on the repositioning opportunities showing best future prospect. Evaluating the potential of repositioning opportunities in a structured way should also increase chances to succeed. If successful, a repositioning initiative may a ect both company and society as the company improves return on earlier investments, while more patients in need of treatment will receive access to it. However, the three-step repositioning model presented in this thesis should be tested for more cases and perhaps be complemented with additional parameters or di erent gradings in order to optimize the selection.

A double case study applying action research methodology was conducted in two pharmaceutical preparation manufacturers in the Netherlands to improve their manufacturing systems by implementing time-based manufacturing (TBM) practices. Following the diagnosis phase, the situation of each Company was analysed and suitable improvement interventions were selected for implementation in the Case Companies. At the end of the action research project, semi-structured interviews were taken in each Company a year later, and the achieved results of the improvement programmes were collected and analysed. This research extends the existing theory of time-based competition and demonstrates that TBM practices apply also in the pharmaceutical preparation manufacturing industry. Furthermore, this study shows how to improve TBM practices and reduce the throughput time by providing the route for improvement and implementation. Although the first Case Company did not improve the core TBM practices and manufacturing performance, its infrastructure improved through the implementation of an ERP system and further enhancement of its quality management system, illustrating that the design of the infrastructure is a key factor to become a time-based competitor. The second Case Company succeeded to improve the 2 TBM practices and throughput processes resulting in the reduction of the order cycle time and increase of the delivery dependability. Based on the data of the two Case Companies, this study demonstrated the relationship between these two manufacturing performance parameters, which indicates that manufacturers may strive for both delivery speed and delivery reliability using the same improvement plan. Adopting TBM is a long journey of many years and needs a continuous improvement infrastructure.

This thesis addresses corporate approaches to CSR stakeholder engagement in the pharmaceutical industry in the UK and Germany. Its objective is to undertake mainly exploratory qualitative research to investigate how the selected sample manages CSR. The data was primarily accessed and collected from senior executives within major pharmaceutical companies. Multiple research methods were employed to gather rich new empirical evidence which focuses on the CSR practices and perceptions of CSR managers in both countries. To examine how this ¿sensitive¿ sector responds to what could be termed the ¿CSR Challenge¿, a critical realist perspective and six codes were chosen to map the practices and to compare similarities and differences between the two countries. This research contributes to the academic literature in this field by filling significant gaps in an area which was previously under-investigated. Ultimately, the findings are employed to examine a prespecified framework which was originally developed by the author based on secondary data in separate research. Overall, the results inform, re-examine, and improve this recently published framework. The updated explanatory framework which results from the research is the main conceptual contribution of the thesis. It serves as a management tool which includes the contextual factors which influence decision-makers¿ practices and perceptions portrayed as a set of inter-related management steps. This new conceptualisation is designed to be of practical use for decision-makers when managing their stakeholder engagement activities. As a result, this research is essentially applied and normative in nature. In addition, this work presents an original contribution to the literature in its field which should be of interest to academics.

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