Chain Constraints Research Articles

Trade group expects US chemical rebound in 2022

Supply chain constraints in 2021 dampened what should have been a healthy recovery from the 2020 pandemic doldrums for the US chemical sector. But the logistics snarls may be easing, meaning that next year should be when an unfettered industry rebounds strongly, according to a year-end report from the American Chemistry Council (ACC), a trade group. US chemical production volumes fell 3.5% in 2020, the year the COVID-19 pandemic shut down broad swaths of the economy for months, including key chemical markets such as car manufacturing. The ACC expects the industry to finish 2021 with production growth of 1.4% and expand by a robust 4.3% in 2022. T he council forecast a year ago that the industry would enjoy a 3.9% rebound in 2021, but the economy has faced issues such as congested ports and shortages of truck drivers and other workers. “You have this big surge of demand, and

A method for campus-wide SARS-CoV-2 surveillance at a large public university.

The systematic screening of asymptomatic and pre-symptomatic individuals is a powerful tool for controlling community transmission of infectious disease on college campuses. Faced with a paucity of testing in the beginning of the COVID-19 pandemic, many universities developed molecular diagnostic laboratories focused on SARS-CoV-2 diagnostic testing on campus and in their broader communities. We established the UC Santa Cruz Molecular Diagnostic Lab in early April 2020 and began testing clinical samples just five weeks later. Using a clinically-validated laboratory developed test (LDT) that avoided supply chain constraints, an automated sample pooling and processing workflow, and a custom laboratory information management system (LIMS), we expanded testing from a handful of clinical samples per day to thousands per day with the testing capacity to screen our entire campus population twice per week. In this report we describe the technical, logistical, and regulatory processes that enabled our pop-up lab to scale testing and reporting capacity to thousands of tests per day.

Hybrid immunity versus vaccine-induced immunity against SARS-CoV-2 in patients with autoimmune rheumatic diseases.

Hybrid immunity versus vaccine-induced immunity against SARS-CoV-2 in patients with autoimmune rheumatic diseases.

Influence of Supply Chain Management Strategies on Performance of Medical Supply Chain Organisations in Kenya

Institutions within the medical supply sector have consistently faced substandard supply chain results because of failure of timely deliveries on the part of suppliers failing to quickly respond to deliver medical shipments. This indicates the procurement role having inadequacies as a key component of an organization since it does not deliver on maximized effectiveness and a reduction of costs based on poor supply chain management plans. A critical purpose of the study was the intention to identify influence of supply chain management strategies on performance of medical supply chain organisations in Kenya. More so, the analysis deals with the degree information integration impacts on Organization performance; to evaluate the impact of warehousing on performance; to examine the impact of outsourcing on performance; and to evaluate the influence of lean supply chain on performance of medical supply entities across Kenya. Direction will through be relying on the resource-based theory as well as the supply chain constraints principle. The analysis will adopt a descriptive study approach; with the targeted size comprising of 30 medical supply entities. The study participants included 2,529 staff of pharmaceutical supply chain entities within Kenya. Determination of the sample group was by Yamane’s concept that led to to a group of 345 participants. Accessing the participants was by stratified and simple random sampling approaches. Towards indicating dispersion and central tendency, standard deviation and respectively, with the inferential statistics being analysed by multiple regression and correlation analysis. The study findings reveal that performance of medical supply organizations in Kenya was significantly related with supply chain information integration (p < 0.05), warehousing (p < 0.05) and outsourcing. Despite this, the association among differentiation strategy and performance was insignificant at p > 0.05 but only significant at p <0.1). It was also found that while lean supply chain had a negative influence on performance (t = -.528, p >0.5) information integration, warehousing and outsourcing had positive influence on performance (information integration: t = 16.461, p <0.05; warehousing: t = 19.671, p <0.05; outsourcing: t = 15.528, p <0.05). The result of these outcomes is that the leadership across medical supply organizations in Kenya need to adopt information integration, warehousing, and outsourcing, which would positively contribute to performance. Medical supply organizations in Kenya should continue emphasizing on supply chain strategies. The outcomes of the study may assist organisations in drawing plans or improving existing strategies governing supply chain management across institutions.

Meeting clinical needs for and sidestepping supply chain threats to COVID-19 testing through continuous process improvement

Abstract Introduction/Objective The first human case of SARS-CoV-2 infection was reported in December of 2019. By late February 2020 evidence of community transmission in the United States was documented and soon it developed into a global pandemic. On March 11, 2020, the Mayo Clinic Arizona’s Microbiology Laboratory introduced a PCR test for diagnosis of SARS-CoV-2 infection. Even as testing demands exponentially increased, the hospital relied on timely results to assist in directing patient care. In order to provide timely results in the face of continuously emerging supply chain threats, we needed to increase our capacity for SARS-CoV-2 PCR testing by reducing technologist time and reagent waste, without impacting turnaround time or other quality metrics such as repeat rate. Methods/Case Report Technologist time was measured in hands-on time per specimen. Reagent use was defined by the volume of lysis buffer (the primary rate limiting reagent due to supply chain constraints) used per sample. Turnaround time was measured from receipt in lab until result verification and the rerun rate is the percent of specimens with an internal control (IC) failure, an indicator of specimen or process quality. Unnecessary steps were determined using a process map, spaghetti diagram and waste walk. Improvements included simplifying steps, changes to protocols and lab design. Impacts of the improvements were measured for 5 months post-implementation. Results (if a Case Study enter NA) Process improvements reduced technologist time per sample by 30.8 seconds and decreased critical reagent needs by 23.6%. Improvements led to $104,000 in just reagent savings over 5 months. Turnaround time and rerun rates were not negatively impacted. Conclusion By creating the leanest possible workflow, we were able to meet the demands for accurate and timely SARS-CoV-2 results. In future workflows, we will continue to implement lean processes and ensure the most efficient use of limited resources.

Comparison of real-time RT-PCR and RT-PCR/MALDI-TOF methods for SARS-CoV-2 detection in saliva

Abstract Background The coronavirus disease 2019 pandemic has accelerated the need for rapid validation and implementation of assays for detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) in diagnostic specimens. Multiple molecular methods have received emergency use authorization by the U.S. Food and Drug Administration for detection of SARS-CoV-2 in upper respiratory specimens, with testing of nasopharyngeal (NP) specimens serving as the foundation for these assays. However, supply chain constraints and the need for improved ease and safety of collection have prompted consideration of other specimen types as alternatives to NP specimens for detection of SARS-CoV-2. Here, we compared two methods for SARS-CoV-2 detection in saliva: the Roche cobas® 6800 SARS-CoV-2 real-time RT-PCR Test (“Roche”), which tests for viral ORF1ab (target 1, T1) and envelope E genes (target 2, T2); and the Agena Biosciences MassARRAY® SARS-CoV-2 Panel/MassARRAY® System (“Agena”), which tests for targets in the ORF1ab gene (ORF1, Orf1ab) and nucleocapsid N gene (N1, N2, N3). Methods Sixty saliva specimens collected within 48 hours of SARS-CoV-2 detection in an upper respiratory (anterior nares or NP) specimen from the same individual were tested in both the Roche and Agena platforms. Each system was evaluated for overall detection results and agreement with results of matched upper respiratory specimens. In addition, we determined the limit of detection (LoD) for each system and its component targets using an in-house SARS-CoV-2 standard generated from pooled positive saliva specimens quantitated against a commercially available standard (ZeptoMetrix NATSARS(COV2)-ERC). Results Both platforms demonstrated a similarly high sensitivity (97%) and specificity (100%) when compared to matched patient upper respiratory specimens and had high agreement with one another (Cohen’s κ = 0.9321, p = 2.6x10-13). Overall, the LoD (copies/mL) for the Roche assay was four times lower than that of Agena for saliva specimens (390.6 v. 1562.5). Furthermore, we determined that the LoD differed among the target components of each assay. The experimental LoD was comparable across Roche targets, but probit analyses indicate T2 has greater sensitivity (LoD: 228.6), Of the five Agena targets, the N2 target had the lowest LoD (1562.5). Conclusions In sum, we demonstrate that saliva is an acceptable specimen for testing in both the Roche cobas® 6800 SARS-CoV-2 real-time RT-PCR Test and the Agena Biosciences MassARRAY® SARS-CoV-2 Panel/MassARRAY® System, and both provide sensitive and specific detection of SARS-CoV-2 in saliva specimens. Although there was a high level of agreement between platforms, the LoD was lower for the Roche compared to the Agena assay with T2 and N2 being the most sensitive targets on each platform, respectively. The addition of saliva as an acceptable specimen and understanding the sensitivity for testing on these platforms can further inform public health measures for screening and detection to combat the pandemic.

Africa's “Seed” Revolution and Value Chain Constraints to Early Generation Seeds Commercialization and Adoption in Ghana

The study aims to deepen understanding of how Early Generation Seeds value chain constraints impede commercialization and adoption of High Yielding Varieties (HYV) or improved Maize seeds by smallholders in Ghana within the broader strategies of a “Green Revolution for Africa”. Using qualitative and quantitative information obtained through one-on-one interviews with 15 key informants, a household survey from 110 smallholder farmers and document reviews, we discuss constraints and bottlenecks engendered by value chain structures, processes and mechanisms in Ghana's formal seed distribution system. Seven main challenges were identified that undermine trust and hinder the expansion of HYVs: (1) the limited capacity of public institutions, (2) constrained capacity of the emerging private sector, (3) a lack of well-defined, fair and enforceable contracts between stakeholders in the delivery system, (4) land-tenure limitations, (5) poor forecasting of farmers' demands for seeds by research institutions and seed producers, (6) sparse marketing arrangements for improved maize seeds, and (7) concentration of power to control seed supply in the hands of few institutions. We argue these seven issues weaken power asymmetry within the maize seed value chain's governance mechanism to create nodal points that give prominence to key public institutions, NGOs, and research institutions who control the production and distribution of improved seeds. Ultimately, trust among actors and its value chain outputs is undermined, negatively affecting the commercialization, availability, and adoption of improved seeds. Moving forward, upgrading the maize seed value chain must be pursued through targeted public and private sector relationships that acknowledge diverse actors' critical roles in the value chain.

Fruit marketing, its efficiency and supply chain constraints in India: A case study

Study investigated the agribusiness opportunities, marketing channels and marketing efficiency of different supply chain systems for two important fruit crops kinnow and aonla (Indian gooseberry) in Rajasthan. Two districts, viz. Sriganganagar and Jaipur, having highest area under cultivation of these crops in the state, were purposively selected. Information was collected from 120 farmers, 30 wholesalers (traders/Contractors) and 30 retailers during the year 2009-2011 for both the crops. Further 25% of sample households were again revisited during 2019-20 to find changes in marketing of these selected fruit crops. The producers' share in consumer's rupee was 32% and 28% for kinnow and aonla, respectively. The marketing efficiency index in dominant channel was 0.48 in kinnow and 0.38 in aonla. The most common and important constraint in marketing of fruits was cartelisation among traders. The imperfect market structure forces the farmers to enter into a forward contract that sets a minimum price, rather at the dissatisfaction of the farmer, as an insurance against possible lower price at later stages. Establishment of multi-fruit processing units in production area, development of infrastructure at major market centres, and establishing export value chain for kinnow and necessary support/incentives for orchard management for timely disposal of kinnow fruits are suggested as strategies to improve the marketing efficiency.

Supply Chain and Delivery of Antimicrobial Drugs in Smallholder Livestock Production Systems in Uganda

This study assessed the veterinary drug supply chain in Uganda, the constraints faced by the actors, and how the challenges influence the use of antimicrobial (AMs) by livestock farmers. We carried out stakeholder consultation workshops, key informant interviews and a knowledge, practices, and awareness survey with actors of the veterinary drug supply chain. We also profiled drugs stored in 23 urban and peri-urban drug shops in Lira and Mukono districts to record the commonly sold drugs. The veterinary drug supply chain is made of several actors including wholesalers, retailers, Animal Health Service Providers (AHSP) and farmers. Nearly ninety per cent of drug retailers and veterinary practitioners did not receive specialized training in veterinary medicine, and most of veterinary practitioners have been in the drug business market for more than 10 years. Antibiotics and anti-helminthics were the most stocked drugs by retailers, with antibiotics ranking highest in terms of contribution to annual financial profits, accounting for 33%. The choice of a drug by veterinary practitioners was mainly informed by past success with efficacy of the drug, and financial capacity of the client (the farmer) to meet the treatment cost. Many veterinary practitioners were not conversant with veterinary drug policies of the country, with Mukono having a higher number (72%) compared to Lira (37%). Veterinary practitioners from Lira district compared to Mukono and those mainly serving small scale farmers relative to large scale smallholders were more knowledgeable about antibiotics and AMR. Several supply chain constraints were identified as potential drivers of misuse of antibiotics that could contribute to AMR. These included low level of education of supply chain actors, particularly drug retailers, poor handling of drugs at purchase and administration practices, low enforcement of policies and regulations, and lack of awareness of stakeholders about policies that regulate drug use. Thus, future interventions to reduce misuse of AM drugs in livestock production systems in Uganda such as capacity building, should also target veterinary input suppliers, and deliberately involve a strong policy advocacy component.

High-resolution within-sewer SARS-CoV-2 surveillance facilitates informed intervention

To assist in the COVID-19 public health guidance on a college campus, daily composite wastewater samples were withdrawn at 20 manhole locations across the University of Colorado Boulder campus. Low-cost autosamplers were fabricated in-house to enable an economical approach to this distributed study. These sample stations operated from August 25th until November 23rd during the fall 2020 semester, with 1512 samples collected. The concentration of SARS-CoV-2 in each sample was quantified through two comparative reverse transcription quantitative polymerase chain reactions (RT-qPCRs). These methods were distinct in the utilization of technical replicates and normalization to an endogenous control. (1) Higher temporal resolution compensates for supply chain or other constraints that prevent technical or biological replicates. (2) The data normalized by an endogenous control agreed with the raw concentration data, minimizing the utility of normalization. The raw wastewater concentration values reflected SARS-CoV-2 prevalence on campus as detected by clinical services. Overall, combining the low-cost composite sampler with a method that quantifies the SARS-CoV-2 signal within six hours enabled actionable and time-responsive data delivered to key stakeholders. With daily reporting of the findings, wastewater surveillance assisted in decision making during critical phases of the pandemic on campus, from detecting individual cases within populations ranging from 109 to 2048 individuals to monitoring the success of on-campus interventions.

Oil immersed lossless total analysis system for integrated RNA extraction and detection of SARS-CoV-2

The COVID-19 pandemic exposed difficulties in scaling current quantitative PCR (qPCR)-based diagnostic methodologies for large-scale infectious disease testing. Bottlenecks include lengthy multi-step processes for nucleic acid extraction followed by qPCR readouts, which require costly instrumentation and infrastructure, as well as reagent and plastic consumable shortages stemming from supply chain constraints. Here we report an Oil Immersed Lossless Total Analysis System (OIL-TAS), which integrates RNA extraction and detection onto a single device that is simple, rapid, cost effective, and requires minimal supplies and infrastructure to perform. We validated the performance of OIL-TAS using contrived SARS-CoV-2 viral particle samples and clinical nasopharyngeal swab samples. OIL-TAS showed a 93% positive predictive agreement (n = 57) and 100% negative predictive agreement (n = 10) with clinical SARS-CoV-2 qPCR assays in testing clinical samples, highlighting its potential to be a faster, cheaper, and easier-to-deploy alternative for infectious disease testing.

How SARS-CoV-2 Transformed the Clinical Laboratory: Challenges and Lessons Learned

The COVID-19 pandemic has made a devastating impact on global health and continues to challenge healthcare infrastructure and delivery. The clinical laboratories were no exception as they are responsible for diagnostic testing that dictates many clinical, infection control and public health decisions. Information technology and laboratory management tools are critical assets for maintaining and adapting operations in response to crises and when utilized effectively, promote the integration between the clinical laboratory specialties (e.g., chemistry, hematology, microbiology, and molecular pathology). During the COVID-19 pandemic, our systems and processes were strained due to high testing volumes, demand for rapid turnaround times, supply chain constraints, and constantly evolving testing algorithms and result interpretations as our knowledge of the virus and of diagnostics increased over time. In this report, we describe those challenges and subsequent adaptations made by each clinical laboratory section. We hope these details help provide potential solutions and approaches for other hospitals facing COVID-19 surges or other future pandemics.

Optimal deterministic and robust selection of electricity contracts

We address the Electricity Contract Selection Problem (ECSP), of finding best parameters of an electricity contract for a client based on his/her past records of electricity consumption over a fixed time period. The objective is to optimize the electricity bill composed by some fixed cost, the cost of the subscription of the electricity contract and penalties due to overpowering when consumption exceeds subscribed power. The ECSP can be formulated as a convex separable optimization problem subject to total order constraints. Due to this special structure, ECSP is a special case of two well known classes of convex separable optimization problems, namely the minimum network flow under convex separable cost and minimizing convex separable functions under chain constraints. Both classes are well treated in the litterature and can be solved in polynomial time (Ahuja and Orlin in Oper Res 49(5):784–789, 2001; Ahuja et al. in Manag Sci 49(7):950–964, 2003; Best et al. in SIAM J Optim 10:658–672, 2000; Karzanov and McCormick in SIAM J Comput 26(4):1245–1275, 1997; Minoux in Eur J Oper Res 18(3):377–387, 1984; Minoux, in Gallo and Sandi (eds) Netflow at pisa, mathematical programming studies, Springer, Berlin, 1986). In particular, the algorithm in Ahuja and Orlin (2001) achieves the best theoretical time complexity assuming that computing the objective function value at one specific point can be done in constant time. However, when we work on a big amount of historic data as in ECSP, the time required for evaluating the objective function cannot be assumed to be O(1) anymore. In this paper, we propose a new algorithm for ECSP which is specially designed to reduce the computational effort over large scale historical data. We present numerical results showing that our algorithm outperforms the algorithm in Ahuja and Orlin (2001) when applied to consumption data of various types of clients. A robust version of ECSP based on a Seasonal and Trend decomposition approach for modelling consumption uncertainty is also investigated. The resulting worst-case cost minimization problem is shown to be efficiently solvable using the same algorithm as for deterministic ECSP.

Should countries switch to using five- or ten-dose rotavirus vaccines now that they are available?

IntroductionSingle-dose rotavirus vaccines, which are used by a majority of countries, are some of the largest-sized vaccines in immunization programs, and have been shown to constrain supply chains and cause bottlenecks. Efforts have been made to reduce the size of the single-dose vaccines; however, with two-dose, five-dose and ten-dose options available, the question then is whether using multi-dose instead of single-dose rotavirus vaccines will improve vaccine availability. MethodsWe used HERMES-generated simulation models of the vaccine supply chains of the Republic of Benin, Mozambique, and Bihar, a state in India, to evaluate the operational and economic impact of implementing each of the nine different rotavirus vaccine presentations. ResultsAmong single-dose rotavirus vaccines, using Rotarix RV1 MMP (multi-monodose presentation) led to the highest rotavirus vaccine availability (49–80%) and total vaccine availability (56–79%), and decreased total costs per dose administered ($0.02-$0.10) compared to using any other single-dose rotavirus vaccine. Using two-dose ROTASIIL decreased rotavirus vaccine availability by 3–6% across each supply chain compared to Rotarix RV1 MMP, the smallest single-dose vaccine. Using a five-dose rotavirus vaccine improved rotavirus vaccine availability (52–92%) and total vaccine availability (60–85%) compared to single-dose and two-dose vaccines. Further, using the ten-dose vaccine led to the highest rotavirus vaccine availability compared to all other rotavirus vaccines in both Benin and Bihar. ConclusionOur results show that countries that implement five-dose or ten-dose rotavirus vaccines consistently reduce cold chain constraints and achieve higher rotavirus and total vaccine availability compared to using either single-dose or two-dose rotavirus vaccines.

Multi-Objective Sustainable Planning of Chemical Production Chains

Sound management of chemicals is one of key contributors for achieving of the Sustainable Development Goals. The aim of this work is developing a multi-objective planning framework on the early planning and decision-making for chemical production processes, in order to obtain the maximum economic benefits, minimize the risk of possible chemical accidents to people, and minimize the environmental risk of production routes. GM (1, 1) model was established to predict the price trend and demand change of chemical products from 2020 to 2030. Combining three objective functions with the production chain constraints, a mixed integer linear programming model is developed. Polyvinyl Chloride production chains are taken as an example.

Initial determination of COVID-19 seroprevalence among outpatients and healthcare workers in Minnesota using a novel SARS-CoV-2 total antibody ELISA

ObjectivesTo avoid the significant risks posed by the use of COVID-19 serology tests with supply chain constraints or poor performance characteristics, we developed an in-house SARS-CoV-2 total antibody test. Our test was compared with three commercial methods, and was used to determine COVID-19 seroprevalence among healthcare workers and outpatients in Minnesota. MethodsSeventy-nine plasma and serum samples from 50 patients 4–69 days after symptom onset who tested positive by a SARS-CoV-2 PCR method using a nasopharyngeal (NP) swab were used to evaluate our test’s clinical performance. Seropositive samples were analyzed for IgG titers in a follow-up assay. Thirty plasma and serum from 12 patients who tested negative by a SARS-CoV-2 PCR method using a nasopharyngeal (NP) swab and 210 negative pre-pandemic serum samples were also analyzed. Among samples from patients > 14 days after symptom onset, the assay had 100% clinical sensitivity and 100% clinical specificity, 100% positive predictive value and 100% negative predictive value. Analytical specificity was 99.8%, indicating minimal cross-reactivity. A screening study was conducted to ascertain COVID-19 seroprevalence among healthcare workers and outpatients in Minnesota. ResultsAnalysis of serum collected between April 13 and May 21, 2020 indicated a COVID-19 seroprevalence of 2.96% among 1,282 healthcare workers and 4.46% among 2,379 outpatients. ConclusionsOur in-house SARS-CoV-2 total antibody test can be used to conduct reliable epidemiological studies to inform public health decisions during the COVID-19 pandemic.

Making a Difference: Adaptation of the Clinical Laboratory in Response to the Rapidly Evolving COVID-19 Pandemic

The COVID-19 pandemic, caused by severe acute respiratory syndrome coronavirus 2, led to unprecedented demands assigned to clinical diagnostic laboratories worldwide, forcing them to make significant changes to their regular workflow as they adapted to new diagnostic tests and sample volumes. Herein, we summarize the modifications/adaptation the laboratory had to exercise to cope with rapidly evolving situations in the current pandemic. In the first phase of the pandemic, the laboratory validated 2 reverse transcription polymerase chain reaction–based assays to test ∼1000 samples/day and rapidly modified procedures and validated various preanalytical and analytical steps to overcome the supply chain constraints that would have otherwise derailed testing efforts. Further, the pooling strategy was validated for wide-scale population screening using nasopharyngeal swab samples and saliva samples. The translational research arm of the laboratory pursued several initiatives to understand the variable clinical manifestations that this virus presented in the population. The phylogenetic evolution of the virus was investigated using next-generation sequencing technology. The laboratory has initiated the formation of a consortium that includes groups investigating genomes at the level of large structural variants, using genome optical mapping via this collaborative global effort. This article summarizes our journey as the laboratory has sought to adapt and continue to positively contribute to the unprecedented demands and challenges of this rapidly evolving pandemic.

All Hands-On Deck and All Decks on Hand: Surmounting Supply Chain Limitations During the COVID-19 Pandemic

Testing during the COVID-19 pandemic has been crucial to public health surveillance and clinical care. Supply chain constraints—spanning limitations in testing kits, reagents, pipet tips, and swabs availability—have challenged the ability to scale COVID-19 testing. During the early months, sample collection kits shortages constrained planned testing expansions. In response, the University of Vermont Medical Center, University of Vermont College of Medicine, Vermont Department of Health Laboratory, Aspenti Health, and providers across Vermont including 16 area hospitals partnered to surmount these barriers. The primary objectives were to increase supply availability and manage utilization. Within the first month of Vermont’s stay-at-home order, the University of Vermont Medical Center laboratory partnered with College of Medicine to create in-house collection kits, producing 5000 per week. University of Vermont Medical Center reassigned 4 phlebotomists, laboratory educators, and other laboratory staff, who had reduced workloads, to participate (requiring a total of 5.3-7.6 full-time equivalent (FTE) during the period of study). By August, automation at a local commercial laboratory produced 22,000 vials of media in one week (reducing the required personnel by 1.2 FTE). A multisite, cross-institutional approach was used to manage specimen collection kit utilization across Vermont. Hospital laboratory directors, managers, and providers agreed to order only as needed to avoid supply stockpiles and supported operational constraints through ongoing validations and kit assembly. Throughout this pandemic, Vermont has ranked highly in number of tests per million people, demonstrating the value of local collaboration to surmount obstacles during disease outbreaks and the importance of creative allocation of resources to address statewide needs.

Recent Advances of Chemical Definition of Cell Culture Media and Excipients for Virus and Viral Vector Manufacturing: A Review

A vital step in the manufacturing of vaccines and viral vector-based cell and gene therapies is virus production. Historically, virus production relies heavily on undefined and highly variable raw material for cell-based platforms to be successful. Yet due to supply chain constraints, poor reproducibility, and safety concerns attributed to potential adventitious agents present in serum and serum-derived proteins, regulatory agencies have encouraged replacement of these components. Recombinant serum proteins, specifically albumin and transferrin, can successfully replace serum-derived proteins in the expansion of VERO cells and subsequent production of multiple virus types. Furthermore, recent successes have demonstrated that recombinant human serum albumin can serve as an effective excipient in final formulations for the stabilization of virus in vaccines. Collectively, chemical definition of both upstream and downstream processes provides numerous advantages and is essential given the importance of virus and viral vector production for clinical applications.

Controlled Heat and Humidity-Based Treatment for the Reuse of Personal Protective Equipment: A Pragmatic Proof-of-Concept to Address the Mass Shortage of Surgical Masks and N95/FFP2 Respirators and to Prevent the SARS-CoV2 Transmission.

Background: The coronavirus infectious disease-2019 (COVID-19) pandemic has led to an unprecedented shortage of healthcare resources, primarily personal protective equipment like surgical masks, and N95/filtering face piece type 2 (FFP2) respirators.Objective: Reuse of surgical masks and N95/FFP2 respirators may circumvent the supply chain constraints and thus overcome mass shortage. Methods, design, setting, and measurement: Herein, we tested the effects of dry- and moist-air controlled heating treatment on structure and chemical integrity, decontamination yield, and filtration performance of surgical masks and FFP2 respirators.Results: We found that treatment in a climate chamber at 70°C during 1 h with 75% humidity rate was adequate for enabling substantial decontamination of both respiratory viruses, oropharyngeal bacteria, and model animal coronaviuses, while maintaining a satisfying filtering capacity.Limitations: Further studies are now required to confirm the feasibility of the whole process during routine practice.Conclusion: Our findings provide compelling evidence for the recycling of pre-used surgical masks and N95/FFP2 respirators in case of imminent mass shortfall.