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1. Host Cell Proteins During Biomanufacturing

   Baik, J.Y.; Guo, J.; Lee, K.H. (October 2019, Current applications of cell culture engineering)

   Lee, G.M.; Kildegaard, H. Faustrup; Lee, S.Y. (Ed.)

   Host cell protein (HCP) impurities, endogenous proteins expressed from host cells, can challenge biopharmaceutical manufacturing. Certain HCPs can persist even after downstream purification, leading to adverse impacts on drug stability and potentially, patient safety. Thus, the quantification and control of HCPs is critical. Although many improvements have been made in HCP quantification and control methods, HCP-associated risks cannot be completely eliminated. A better biophysical understanding of Chinese hamster ovary (CHO) HCPs and advancement of monitoring assays will lead to better controlled biopharmaceutical manufacturing. This chapter will discuss (i) current HCP removal processes for various product types, (ii) the impact of residual HCPs on drug efficacy and safety, (iii) HCP quantification and monitoring methods such as proteomics approaches and enzyme-linked immunosorbent assays (ELISA) using anti-HCP antiserum, (iv) HCP control approaches in both upstream and downstream processes, and (v) future directions for effective HCP risk management strategies. 

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2. Cells as Biofactories: Parallels Between Biopharmaceutical Manufacturing and Industrial Biotechnology

   Cordova, L; Lee, KH (August 2023, Industrial biotechnology)

   Industrial biotechnology and biopharmaceutical manufacturing leverage biology to enable cellular systems to serve as factories to produce molecules of value to humankind. These biotechnological processes utilize diverse host organisms and address applications from biofuel, polymer building blocks, antibiotics, and whole cell therapies. Industrial biotechnology can address environmental and sustainability goals in addition to chemical production. In a similar fashion, the field of biopharmaceutical manufacturing has and continues to produce life-saving medicines. Despite these diverse applications, these fields rely on common biological themes and require similar approaches for genetic and metabolic engineering as discussed in this review. Through advances in synthetic biology, targeted genetic engineering, DNA sequencing, adaptation and high-throughput screening, industrial biotechnology and biopharmaceutical manufacturing utilize the same framework for efficient biochemical production which can be leveraged in current and future collaborations to enable rapid innovation. 

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3. Bridging the Workforce Skills Gap in High Value Manufacturing through Continuing Education

   https://doi.org/10.18260/1-2--32423  

   Johnson, M. D. (January 2019, ASEE annual conference)

   Research shows that there is a growing need for skilled workers in the area of advanced manufacturing; this refers to making use of new technologies and advanced processes to produce products that have high value. More importantly, U.S. government employment data reveals that there is lack of supply of skilled workers in the manufacturing sector. Furthermore, it has also been widely cited in industrial literature that there is a concern regarding the job readiness of fresh college graduates and the gaps in skills sets needed to be successful in an industrial setting, especially in the engineering or manufacturing fields. One approach to bridge the skills gap is to provide customized continuing education to current the workforce as per the industry need. This paper presents a case study of such customized continuing education offered by Texas A&M University for oil and gas industry in Houston, Texas. Specifically, as a part of National Science Foundation Advanced Technological Education project, two professional development sessions were organized in the summer of 2018 in Houston targeting the energy industry. Both programs were two-days long and focused on two key aspects of high value manufacturing: manufacturing operations excellence and manufacturing quality excellence. The professional development sessions were focused on materials and inventory planning, production economics, manufacturing quality, non-destructive evaluation, statistical process control, and lean/ sixsigma. The continuing education programs and course materials were developed based on the feedback from the industry advisory board for the Manufacturing Center of Excellence at Houston Community College, which is a collaborating partner on the ATE Grant. As a part of assessment of the programs, industry participants in the both sessions were given comprehensive surveys asking for their feedback on the applicability of the educational sessions. Overall, the participants rated the sessions very highly on the organization and the relevancy of the program topics and learning materials. The participants also felt that they learned new information through these programs. 

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4. Review of the Use of Metals in Biomedical Applications: Biocompatibility, Additive Manufacturing Technologies, and Standards and Regulations

   https://doi.org/10.3390/met14091039  

   Ladani, Leila; Palmieri, Michael (September 2024, Metals)

   Advanced manufacturing techniques such as Additive Manufacturing (AM) have grown rapidly in major industries such as aerospace, automotive, and biomedical device manufacturing. Biomedical industry has benefitted immensely from AM because of its flexibility in design and its rapid production cycle. Powder bed processes are the major production technique for metal-based AM implants. This paper serves as a comprehensive review on the research efforts being made using AM to develop new patient centered medical devices. This review focuses on AM of the most common metals for biomedical applications, Magnesium alloys, Cobalt-Chromium alloys, pure Titanium, Titanium alloys. Several different aspects are discussed including biocompatibility and osseointegration, application of specific metals in different types of implants, their advantages and disadvantages, mechanical properties in comparison to bone, and their production technologies. Regulatory and quality assurance hurdles that are facing new innovations made using AM are discussed. 

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5. Evaluation of a Combined MHE-NMPC Approach to Handle Plant-Model Mismatch in a Rotary Tablet Press

   https://doi.org/10.3390/pr9091612  

   Huang, Yan-Shu; Sheriff, M Ziyan; Bachawala, Sunidhi; Gonzalez, Marcial; Nagy, Zoltan K; Reklaitis, Gintaras V (September 2021, Processes)

   The transition from batch to continuous processes in the pharmaceutical industry has been driven by the potential improvement in process controllability, product quality homogeneity, and reduction of material inventory. A quality-by-control (QbC) approach has been implemented in a variety of pharmaceutical product manufacturing modalities to increase product quality through a three-level hierarchical control structure. In the implementation of the QbC approach it is common practice to simplify control algorithms by utilizing linearized models with constant model parameters. Nonlinear model predictive control (NMPC) can effectively deliver control functionality for highly sensitive variations and nonlinear multiple-input-multiple-output (MIMO) systems, which is essential for the highly regulated pharmaceutical manufacturing industry. This work focuses on developing and implementing NMPC in continuous manufacturing of solid dosage forms. To mitigate control degradation caused by plant-model mismatch, careful monitoring and continuous improvement strategies are studied. When moving horizon estimation (MHE) is integrated with NMPC, historical data in the past time window together with real-time data from the sensor network enable state estimation and accurate tracking of the highly sensitive model parameters. The adaptive model used in the NMPC strategy can compensate for process uncertainties, further reducing plant-model mismatch effects. The nonlinear mechanistic model used in both MHE and NMPC can predict the essential but complex powder properties and provide physical interpretation of abnormal events. The adaptive NMPC implementation and its real-time control performance analysis and practical applicability are demonstrated through a series of illustrative examples that highlight the effectiveness of the proposed approach for different scenarios of plant-model mismatch, while also incorporating glidant effects. 

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