Following Guidelines During a Crisis

The guidance states, "These preventative measures can include steps to prepare personnel such as: * "Educating employees on topics such as, in the case of a pandemic, personal hygiene (hand washing and coughing and sneezing etiquette), social distancing, and appropriate use of sick leave * "Encouraging employees to get immunized as appropriate by providing information on local vaccination services or by offering on-site vaccination services, if reasonable * "Providing information for and encouraging employees to develop family emergency preparedness plans * "Reviewing CGMP [current good manufacturing practice] regulations regarding appropriate sanitation practices and restriction of ill or sick employees from production areas (see 21 CFR [Code of Federal Regulations] 211.28)" (2). Examples include: * "Production equipment routine maintenance * "Utility system performance checks and maintenance (e.g., air temperature, lighting, compressed air) * "Environmental monitoring of facilities such as cell culture, harvesting, and purification rooms during production * "Stability testing for certain drug products and components * "Periodic examinations of data and of reserve samples" (2). EMA, Guidance on the Format of the Risk Management Plan (RMP) in the EU-in Integrated Format, EMA/164014/2018 Rev.2.0.1 accompanying GVP Module V Rev.2 Human Medicines Evaluation (EMA, 31 October 2018).

Supplements purchase intention: young consumer's perspective

PurposeThis study aims to investigate the factors that influence young consumers' purchase intention towards dietary supplements (DS) in Malaysia.Design/methodology/approachThe supplement industry in Malaysia has been growing rapidly recently due to a paradigm shift in healthcare management, from curative to prevention. Thus, it has sparked interest to conduct a study on the factors that influence young consumers' purchase intentions towards DS. With a response rate of 74.5%, a survey questionnaire was used to elicit data from 149 Gen-Y respondents who consume supplements on a regular basis.FindingsThe results revealed that the influencing factors towards purchase decisions among these Gen-Y respondents aged between 17 and 25 are based on product knowledge and product quality. The implications of these findings and directions for future research are outlined at the end of this paper.Originality/valueThis study offers empirical insights from the perspective of an emerging digital economy on the factors that influence young consumers' purchase intentions towards DS in Malaysia.

Automating Biopharma Manufacturing

"With the advance of data science enabling factors such as easy access to scalable memory and computing resources;our growing competence in collecting, storing, and contextualizing data;advances in robotics;[and] the quickly evolving method landscape driven by the open-source community, the benefits of automation and simulation are becoming accessible in the notoriously complicated realm of biopharma manufacturing," says Marcel von der Haar, head of product strategy data analytics at Sartorius. "Plug-and-play" capabilities of automation systems, which enable flexible manufacturing and faster technology transfer, are more important than ever, he says. Walvax Biotech's new COVID-19 mRNA vaccine plant in China is another example of an intelligent and digital plant;it uses Honeywell's batch process control, building and energy management solution systems, and digital twins to monitor assets (5). "Automation brings in the data for machine learning to model the dynamic processes of cell growth and map it against the multiple dimensions provided by advanced sensors," explains Brandl.

Scaling Up Fast

The added pressure of meeting accelerated deadlines during a pandemic presents additional challenges for process development, materials supply, equipment acquisition and installation, and process validation. Experience of model design and in the identification of potential critical process parameters (CPPs) are crucial to the successful scale up of new chemical entities (NCEs). Supply chains must secure sufficient supply of additional raw materials to meet expanded production. [...]it is important to accept only projects that fit the capabilities of the organization to avoid failure, especially in times of drug shortages.

Innovations Meet Growing Demand for Prefilled Syringes

Syringe innovations also increase patient and caregiver safety and efficiency and reduce waste of product and packaging materials. "Since it is already packaged ready for the injection, the prefilled syringe saves time and avoids unneeded handling prior to the actual application, minimizing the risk of the injection errors, dilution errors, or non-sterility issues [that are a risk in] multi-dose containers," explains Wenzel Novak, global senior director of business development at Gerresheimer Medical Systems. [...]the advent of a silicone-free design, "Pharmaceutical manufacturers seeking to avoid silicone-induced aggregation and sub-visible particles have had to choose vials even when they wanted to offer other delivery options," said Christiane Gumera, product specialist at W.L. Gore & Associates. [...]automation decreases labour requirements, diminishes the difficulties of working in a cleanroom with full personal protective equipment, and reduces the likelihood of repetitive motion injuries." [...]information technology systems supporting serialization can communicate with the customer's system to ensure that the serial numbers applied are unique and traceable across the network of product manufacturing sites the customer may be using."

The Influence of Social Media and Sustainability Advocacy on the Purchase Intention of Filipino Consumers in Fast Fashion

The large consumption of fast fashion brings many negative environmental impacts. Filipino consumers love and buy fast fashion because it is relatively cheap but trendy, and there are lots of fashionable designs to choose from. Despite the shortage in water supply and disposal issues of fast fashion, people still continue to purchase. The lack of awareness of consumers on sustainable fashion consumption led the researchers to conduct a study that aims to identify factors affecting Filipino consumers' buying decisions on fast fashion using the combined theory of planned behavior, elaboration likelihood model, and hedonic motivation. A total of 407 participants were gathered through a convenience sampling approach, and the data collected were analyzed using structural equation modeling (SEM). The result shows that attitude towards fast fashion is the highest contributing factor to purchase intention. While social media positively affects purchase intention, sustainability advocacy negatively impacts the consumers' intention to buy fast fashion. The awareness of sustainability leads to consumption reduction of fast fashion garments. Surprisingly, perceived product price and quality do not show a significant influence on purchase intention. Incorporating sustainability advocacy on social media may be a great strategy to encourage the sustainable consumption of fashion garments. The findings of this study could be a great tool to influence fashion companies and government institutions to promote sustainability awareness and transition marketing strategies to the sustainable consumption of fashion.

Innovative Ingredients Fortified Nutrients Enriched Biscuits and Cookies: Quality and Sensory Analyses

Global suffering from COVID-19 has necessitated augmenting the immunity systems of humans through consumption of macro-micro-nutrients and antioxidant-enriched fortified foods. In this article, fortifications of popular bakery products, viz. biscuits, cookies, have been reviewed, encompassing the novel fortifying ingredients and innovative methods employed with an emphasis on the overall enrichment in the final product quality. A few notable features concerning novel fortified biscuit and fortified cookie have been decisively summarized. Wheat flour blended with 40% sesame-cake flour resulted in a fortified biscuit possessing higher protein (16.6%), crude fat (16.95%), and dietary fiber (8.2%) with acceptable sensory characteristics. About 9% toting up of chicken-eggshell dried-powder could result in high Ca content in biscuits with customary changes in texture and sensory properties. A remarkable 5% addition of bee pollen to wheat flour appreciably improved the nutrient compositions (carbohydrate 65.18%, protein 7.32%, and total dietary-fiber 1.47%) along with high polyphenol and antioxidant potentials. Notably, mixing fish fillet protein concentrate with wheat flour could yield enhanced nutritional content (protein 14.63-19.52%, fat 16.2-16.5%), as well as augmented amino acids. Remarkably, wheat flour fortified with fermented jack bean flour resulted in an overall fortified biscuit with substantial carbohydrate, crude protein, fat, fiber, ash, and appreciable macro-micro mineral contents and sensory characteristics. Innovative fortified cookies were made by blending wheat flour or Brewer's spent grain flour with one or more ingredients, e.g. full fat soya, mushroom, cardamom powder, moringa leaves, coconut, sweet potato flour rendering amplified values of nutrients, superior physical properties, increased mineral and flavonoid contents and organoleptic qualities.Copyright © 2023 Bentham Science Publishers.

Quality and selling price dependent sustainable perishable inventory policy: Lessons from Covid-19 pandemic

This paper addresses the impact of the Covid-19 lockdown on the warehousing of perishable items facing demand-side shocks, mainly those with selling price and product quality dependent demand, for example, fresh fruits, meats, vegetables, packed foods, etc. Along with demand-side issues, such an inventory system consumes a significant amount of energy in terms of freshness, increasing carbon tax and dwindling the firm's total profit. We formulate two-warehouse inventory models of perishables items using the first-in-first-out (FIFO) dispatching policy under two different Covid-19 lockdown scenarios. The two-warehouse system primarily consists of an owned warehouse (OW) and a rented warehouse (RW). Two different lockdown scenarios are considered as;(i) the lockdown during the consumption of goods in OW and (ii) the lockdown during the consumption of goods in RW. The demand rate is assumed to decline and surge by a finite volume as lockdown is forced and relaxed. The proposed models help in assessing the impact of lockdown on (i) product quality, (ii) product cost, (iii) inventory level, (iv) freshness keeping efforts, (v) investment in green technologies, and (vi) carbon cap and trade policy. We determine the above six parameters to maximize the firm's total profit. The key findings of this model suggest that yield is primarily affected due to carbon cap and trade policy, lockdown period, item price, backlogging, and variation in the holding costs in OW and RW. These models may assist the small, medium, and large firms involved in perishable or cold supply chains to assess the effect of Covid-19 like disruption and take corrective measures to maximize their profit.

BUSINESS STRATEGIES OF SNACK FOOD PRODUCT EXPORT PERFORMANCE: A STRUCTURAL EQUATION MODEL ANALYSIS

Over the past several years the COVID-19 pandemic has devasted Thailand‘s economy while simultaneously destroying the ability of numerous snack food enterprises to sell their home-grown products domestically and to export to the broader international community. Therefore, the purpose of the research was to investigate which factors affected the export performance (XPE) of Thai One Tambon One Product (OTOP) entrepreneur snack food products. From a list of OTOP export producers, the authors used systematic random sampling across six Thai regions to select the study‘s 311 export entrepreneurs. The structural equation model (SEM) analysis used LISREL 9.1 to determine the validity of the causal model and the variable interrelationships and how they affected OTOP snack food XPE. The SEM results revealed that innovative products (IPT), innovative processes (IPS), packaging design (PAD), the marketing mix strategy (MMS), and product quality (PDQ) all positively influenced XPE. Also, the total effect values for MMS, PAD, PDQ, IPT, and IPS, were 0.27, 0.22, 0.21, 0.15, and 0.05, respectively. Nine of the eleven hypotheses examined were supported, with PAD being shown to strongly influence MMS. This paper makes a significant contribution to the global discussion concerning rural poverty reduction, rural employment, and entrepreneurial handicraft export performance. © 2023, Virtus Interpress. All rights reserved.

Joint Decisions of Components Replacement and Spare Parts Ordering Considering Different Supplied Product Quality

In addition to equipment maintenance decisions, spare parts ordering decisions from different suppliers play a key role in reducing related costs (e.g., maintenance, inventory and ordering costs). Since suppliers may use different production technologies and materials, spare parts (or products) from different suppliers can be different in quality. Nevertheless, in recent studies, the quality of spare parts is rarely considered to incorporate both equipment maintenance and spare parts ordering. In this paper, we investigate the joint optimization of condition-based maintenance and spare parts provisioning policy under two suppliers with different product quality. We formulate a sequential-decision problem with a Markov decision process and consequently obtain an optimal maintenance and ordering policy by an exact value iteration algorithm. To improve computation efficiency, based on the principle of sequential optimization, we develop heuristic methods. Extensive numerical experiments are conducted to assess the overall performance of the developed heuristic methods. Compared to the optimal method, results showed that the average cost gap is about 2% and computation time is reduced by 94% on average under the proposed heuristic method. Note to Practitioners—This paper is motivated by the observation that automobile industries tried to integrate emergency suppliers from which spare parts have different quality into maintenance schedules to avoid stockout and reduce equipment failure during the Covid-19 pandemic. Specifically, the article focuses on balancing the trade-offs between condition-based maintenance and inventory management from two suppliers with different lead times and spare parts quality for multi-unit systems. On the one hand, effective maintenance scheduling relies on spare parts for replacement to ensure the stability of production. On the other hand, inventory management needs to select the supplier with appropriate lead time and product quality to reduce the ordering cost and avoid stockout based on the degradation states of equipment. The joint optimization of these two aspects serves to reduce the total maintenance and ordering cost. Nevertheless, most existing research aims to optimize them separately. In this paper, we formulate the joint decision problem considering the two aspects based on a Markov decision process. We obtain an optimal maintenance and ordering policy by an exact value iteration algorithm and present heuristics to improve the computation efficiency when the system contains multiple machines. Practitioners can implement the proposed methodology to make condition-based maintenance and inventory management when spare parts with different qualities are ordered from two suppliers. To balance cost and computational efficiency, it is suggested to implement the optimal policy by an exact value iteration algorithm when the number of machines is small in the system and use the heuristic methods when the number of machines is large (i.e., usually larger than 3). IEEE

THE ROLE OF DIGITAL MARKETING INTERVENTIONS IN E-ADVOCACY LEVERAGE CAPACITY: A CULINARY BUSINESS BREAKTHROUGH TO COUNTER THE COVID-19 PANDEMIC

Introduction/Main Objectives: This research aims to study the important factors behind achieving the e-advocacy leverage capacity that determines the success of a business in the sphere of digital marketing. Background Problems: In response to the increasing competition in the world of online culinary businesses due to the COVID-19 pandemic, businesses have to enhance strategic marketing to improve consumer loyalty. Novelty: This research model contributes to the development of a concept about consumer advocacy from the perspective of strategic marketing, which is still a limited area of study. Research Methods: The research model was applied to 220 respondents (Indonesian culinary business owners) using a survey that was processed with AMOS SEM. Finding/Results: This research convincingly identifies two significant building factors for e-advocacy leveraged capacity, namely promotional attractiveness and digital affinity direction. Conclusion: Companies' marketing strategies focus not only on maintaining close customer relations but also on ways to intervene with customers so that they are willing to advocate products or brands through digital media.

Assessing deviations for HPCs obtained during COVID-19 (ADHOC): Evaluating impact of the COVID-19 pandemic on cellular therapy products and processes, the BEST collaborative study.

BACKGROUND: The success of allogeneic hematopoietic stem cell transplantation is dependent on a world-wide network of collection centers providing donations that predominantly have been infused as fresh cells. The logistics chain that supports the just-in-time delivery model for stem cell and immunotherapy products was severely stressed by the COVID pandemic, and in early 2020 a number of national and international bodies recommended that cells should be cryopreserved at the collection or transplant center to avoid interruptions in their acquisition or delivery to patients who had started conditioning. STUDY DESIGN: To assess the potential consequences of such pandemic-related deviations to normal practice, we surveyed nine international laboratories to determine if the characteristics or transplant outcomes of allogeneic stem cell donations differed in the immediate periods before and after the switch to routine cryopreservation. RESULTS: Nine centers on two continents provided data for 72 HSC donations just before, and 71 just after, switching to cryopreservation for allogeneic HSC products. No statistically significant differences between the period before and after cryopreservation were noted for time from product collection to receipt, product temperature at receipt, or CD34+ cell viability at receipt. There was an indication of slower absolute neutrophil count recovery after cryopreservation was required (mean time of 15 vs. 17.6 days). DISCUSSION: While there were no apparent changes to most parameters studied, there was an indication of slower neutrophil engraftment that will need to be examined in larger, longer term studies.

Comparative Assessment of the Binding and Neutralisation Activity of Bispecific Antibodies Against SARS-CoV-2 Variants.

Background: Neutralising antibodies against SARS-CoV-2 are a vital component in the fight against COVID-19 pandemic, having the potential of both therapeutic and prophylactic applications. Bispecific antibodies (BsAbs) against SARS-CoV-2 are particularly promising, given their ability to bind simultaneously to two distinct sites of the receptor-binding domain (RBD) of the viral spike protein. Such antibodies are complex molecules associated with multi-faceted mechanisms of action that require appropriate bioassays to ensure product quality and manufacturing consistency. Methods: We developed procedures for biolayer interferometry (BLI) and a cell-based virus neutralisation assay, the focus reduction neutralisation test (FRNT). Using both assays, we tested a panel of five BsAbs against different spike variants (Ancestral, Delta and Omicron) to evaluate the use of these analytical methods in assessing binding and neutralisation activities of anti-SARS-CoV-2 therapeutics. Results: We found comparable trends between BLI-derived binding affinity and FRNT-based virus neutralisation activity. Antibodies that displayed high binding affinity against a variant were often followed by potent neutralisation at lower concentrations, whereas those with low binding affinity also demonstrated reduced neutralisation activity. Conclusion: The results support the utility of BLI and FRNT assays in measuring variant-specific binding and virus neutralisation activity of anti-SARS-CoV-2 antibodies.

Increasing Furniture Manufacturing SMEs' Business Performance Through Absorptive Capacity and Product Quality

Purpose: This study discusses the phenomenon of the uncertain sustainability of SMEs in developing countries. SMEs face various challenges in the dynamics of a competitive environment, which threaten their growth and sustainability. This study aims to address a research gap between company's internal resources, in the form of absorptive capacity, and its business performance. By using product quality as a mediator, which has never been studied before, this research presents a novelty to answer the existing research gap using the Resource Based Theory (RBT) perspective. Research design, data and methodology: Using quantitative method, data are collected from 164 respondents, who are owners or managers of furniture manufacturing SMEs in Gerbangkertosusila Area, East Java, Indonesia. The data are analyzed using Partial Least Square (PLS) – Structural Equation Modeling (SEM). Results: The findings show that absorptive capacity has a direct and significant effect on business performance and indirectly through product quality. Conclusion: Furniture manufacturing SMEs are advised to focus on developing absorptive capacity reflected in good product quality, in order to improve their business performance. This is especially important to survive the crisis caused by the Covid-19 pandemic. Thus, the results of this study contribute to the development of RBT, and there are several suggestions for further research. © Copyright: The Author(s) This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://Creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid.

The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Controls (CMC) Community hosted two virtual panel discussions focusing on several novel regulatory review pathways for innovative oncology products: Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid (PQAAid). The panel sessions were held on August 27, 2021, for the discussion of RTOR, and January 21, 2022, for the discussion of Project Orbis and the PQAAid. Both panel sessions included representatives from the US Food and Drug Administration (FDA) and subject matter experts from the pharmaceutical and biotechnology industries, with the aim of facilitating knowledge sharing on CMC-specific advantages, challenges, eligibility criteria for participation, and operational modifications instituted through the utilization of these acceleration initiatives. Key topics included managing cross-regional regulatory CMC requirements, adapting to expedited development timelines, coordinating interactions between health authorities and industry, and potential opportunities for future improvement and expansion of these programs. As RTOR, Project Orbis, and PQAAid are relatively new initiatives, the experiences shared by the panel experts are valuable for providing deeper insight into these new regulatory pathways and processes.

Firm Finances and the Spread of COVID-19: Evidence from Nursing Homes

We find that firms' financial resources play an important role in mitigating the spread of COVID-19. We study nursing homes-whose residents account for over one-third of all U.S. COVID-19 deaths-at a time when investment in risk mitigation was costly and critical. Facilities with less liquidity and those experiencing more severe cash flow shocks had more cases of COVID-19. The importance of cash flow is further supported by tests exploiting state-level variation in Medicaid reimbursement expansion. Evidence on personal protective equipment supplies suggests a lack of financial resources leads to lower investment in risk mitigation. (JEL G30, G32, I10) Received June 30, 2021;editorial decision September 25, 2022 by Editor Andrew Ellul. Authors have furnished an Internet Appendix, which is available on the Oxford University Press Web site next to the link to the final published paper online.

A Comprehensive Review of Modern Cold Chain Shipping Solutions

Packaging is one of the most important factors affecting the overall cold chain efficiency. This paper aims to examine the current trends of cold chain packaging by conducting a comprehensive review on the current commercially available cold chain shipping solutions. A conceptual model of the cold chain shipping solutions including the structure, categories and components is proposed to provide analytical comparisons with the existing literature. It is found that the shipping solutions can improve the overall cold chain performance in many aspects which include improving temperature control performance, flexibility, safety, sustainability and knowledge sharing of the cold chains. Despite all the advantages, there are still limitations and challenges posed which are also discussed. This is the first paper presenting an overview of commercially available cold chain shipping solutions. It not only contributes to the literature by presenting new knowledge but is also beneficial for all the stakeholders in cold chain packaging by providing practical information and guidelines.

Minimum Adapter Perspective in Indonesia: The Roles of Perceived Product Quality and Health Consciousness in Forming Customer Brand Loyalty through Customer Satisfaction and Trust

The Covid-19 pandemic entered Indonesia in early 2020 and has affected all aspects of human life especially consumption patterns. Since the Covid-19 pandemic, consumers and businesses have switched their transaction patterns from offline to online. Apart from that, this study will also discuss health consciousness because people also know the health effects of consuming too much or too often instant noodles. [...]with the many health issues arising from excessive consumption of instant noodles, this research will become more interesting when analyzed regarding the effect of health awareness on brand loyalty to instant noodles through consumer satisfaction. 2.LITERATURE REVIEW AND HYPOTHESES 2.1 Customer Brand Loyalty Brand loyalty measures how strongly consumers are "bound" to a particular brand (Tjiptnono, 2011: 110). According to So et al. (in Rahmawati and Sanaji, 2015: 252), brand loyalty is formed because of the main role of consumer experience when consuming services from the company. 2.2 Customer Satisfaction According to Zeithaml, Bitner, and Dwayne (2009, p.104), consumer satisfaction is a consumer's assessment of a product or service in terms of assessing whether the product or service has met the needs and expectations of consumers. Consumers tend to interpret prices through subjective perceptions and transfer them as "expensive" or "cheap" concepts in their memory.

Steric accessibility of the N-terminus improves the titer and quality of recombinant proteins secreted from Komagataella phaffii.

BACKGROUND: Komagataella phaffii is a commonly used alternative host for manufacturing therapeutic proteins, in part because of its ability to secrete recombinant proteins into the extracellular space. Incorrect processing of secreted proteins by cells can, however, cause non-functional product-related variants, which are expensive to remove in purification and lower overall process yields. The secretion signal peptide, attached to the N-terminus of the recombinant protein, is a major determinant of the quality of the protein sequence and yield. In K. phaffii, the signal peptide from the Saccharomyces cerevisiae alpha mating factor often yields the highest secreted titer of recombinant proteins, but the quality of secreted protein can vary highly. RESULTS: We determined that an aggregated product-related variant of the SARS-CoV-2 receptor binding domain is caused by N-terminal extension from incomplete cleavage of the signal peptide. We eliminated this variant and improved secreted protein titer up to 76% by extension of the N-terminus with a short, functional peptide moiety or with the EAEA residues from the native signal peptide. We then applied this strategy to three other recombinant subunit vaccine antigens and observed consistent elimination of the same aggregated product-related variant. Finally, we demonstrated that this benefit in quality and secreted titer can be achieved with addition of a single amino acid to the N-terminus of the recombinant protein. CONCLUSIONS: Our observations suggest that steric hindrance of proteases in the Golgi that cleave the signal peptide can cause unwanted N-terminal extension and related product variants. We demonstrated that this phenomenon occurs for multiple recombinant proteins, and can be addressed by minimal modification of the N-terminus to improve steric accessibility. This strategy may enable consistent secretion of a broad range of recombinant proteins with the highly productive alpha mating factor secretion signal peptide.