Scale-up Studies Research Articles

Two-year scale-up dissemination study of a multi-strategic community-wide intervention promoting physical activity: a single-arm pre-post hybrid effectiveness-implementation trial

BackgroundIntervention trials that have demonstrated significant effects may not always replicate those effects when scaled up. This study aimed to test whether scaling-up a successful cluster randomized trial (the COMMUNICATE study, 9 intervention communities), which promoted population-level physical activity (PA), could promote PA in a broader citywide setting (29 communities) after two years, as a mid-term evaluation of the six-year scaled-up trial.MethodsThis is a single-arm, pre-post comparison of a multi-strategic community-wide intervention covering the entire Unnan City, Japan. The intervention for middle-aged and older people consisted of three components: information delivery, education, and support delivery. The intervention method followed the COMMUNICATE study but adapted and introduced new initiatives tailored to local resources. A baseline survey (n = 3,718) among randomly selected residents aged 40–79 years in 2016 and a follow-up survey with the same respondents two years later were conducted. The primary outcome was the change in the percentage of people who practiced the recommended levels of PA, analyzed with a generalized linear mixed model to account for clusters at individual and community levels. Additionally, we examined the dose–response relation of the effect based on the intervention doses in each community. The RE-AIM framework assessed intervention dissemination and implementation.ResultsThe two-year intervention was implemented in all communities, reaching and involving various groups. The rate of people engaged in PA significantly increased in two years (adjusted change: + 8.0 percentage points [95% confidence interval: 6.1, 10.0]). Based on the type of PA, only muscle-strengthening activity showed a significant increase (+ 11.5% points [9.6, 13.5]), whereas walking (-1.8% points [-3.6, 0.1]) and flexibility activities (+ 0.3% points [-1.5, 2.0]) did not. The increase in PA in higher-dose areas was not significantly different but slightly larger than that in lower-dose areas (+ 8.4% points vs. + 7.6% points, adjusted difference in change: 0.8% points [-3.8, 5.5]).ConclusionThe scaled-up citywide intervention promoted PA, especially muscle-strengthening activity. Collaboration with diverse organizations in different settings is crucial for multi-faceted interventions and requires balancing uncertainty in its implementation quality and quantity owing to collaborative decision-making.Trial registrationUMIN-CTR, UMIN000024682. Registered 02 November 2016, https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000028377

Strengthening policy engagement when scaling up interventions targeting non-communicable diseases: insights from a qualitative study across 20 countries.

Policy engagement is an essential component of implementation research for scaling up interventions targeting non-communicable diseases (NCDs). It refers to the many ways that research team members, implementers and policymakers, who represent government decision-making, connect and interact to explore common interests. Well-conducted engagement activities foster co-production, local contextualization and assist in the successful translation of research evidence into policy and practice. We aimed to identify the challenges and facilitators to policy engagement during the early implementation phase of scale-up research studies. This qualitative study was focused on the research projects that were funded through the Global Alliance for Chronic Diseases in the 2019 round. Nineteen project teams opted to participate, with these studies implemented in 20 countries. Forty-three semi-structured stakeholder interviews, representing research, implementation and government were undertaken between August 2020 and July 2021. Transcripts were open-coded using thematic analysis to extract 63 codes which generated 15 themes reflecting both challenges and facilitators to undertaking policy engagement. Knowledge of the local government structures and trusting relationships provided the foundation for successful engagement and were strengthened by the research. Four cross-cutting concepts for engagement were identified and included: (1) the importance of understanding the policy landscape; (2) facilitating a network of suitable policy champions, (3) providing an environment for policy leaders to genuinely contribute to co-creation and (4) promoting two-way learning during researcher-policymaker engagement. We recommend undertaking formative policy analysis to gain a strategic understanding of the policy landscape and develop targeted engagement plans. Through engagement, researchers must facilitate cohesive vision and build a team of policy champions to advocate NCD research within their networks and spheres of influence. Ensuring equitable partnerships is essential for enabling local ownership and leadership. Further, engagement efforts must create a synergistic policymaker-researcher lens to promote the uptake of evidence into policy.

Vitreous tissue cryopreservation using a blood vessel model and cryomacroscopy for scale-up studies: Observations and mathematical modeling

Successful long-term cryobanking of multicellular tissues and organs at deep subzero temperatures calls for the avoidance of ice cryoinjury by reliance upon ice-free cryopreservation techniques. However, the quality of the cryopreserved material is the direct result of its ability to survive a host of harmful mechanisms, chief among which is overcoming the trifecta effects of ice crystallization, toxicity, and mechanical stress. This study aims at exploring improved conditions to scale-up ice-free cryopreservation by combining DP6 as a base cryoprotective agent (CPA) solution with an array of synthetic ice modulators (SIMs). This study is conducted by integrating cryomacroscopy techniques, thermal modeling, solid mechanics analysis, and viability and contractility investigation to correlate physical effects, thermal outcomes, and cryobiology results. As an extension of previous work, this study aims at scale-up of established baseline blood vessel models, while comparing the relative toxicity and vitreous stability of 4 ml and 10 ml samples of DP6 containing either sucrose as a SIM, or the commercial synthetic ice blockers (X1000 and Z1000). Using that established protocol, the addition and removal of DP6+0.6M sucrose and DP6 + 1% X1000 + 1% Z1000 were both well tolerated in rabbit carotid and pig femoral artery models, when assessed for metabolic recovery and contractility. Using cryomacroscopy, it was demonstrated that DP6 + 0.6M sucrose provided a stable vitrification medium under marginal cooling and warming conditions that resulted in >50% survival rate. By contrast, DP6 + 1% X1000 + 1% Z1000 was subject to visible ice formation during cooling under the same thermal conditions, resulting in a significantly lower recovery of ∼20%. Thermal modeling is used in this study to verify the actual cooling and rewarming rates in the specimens, while thermomechanics analysis is used to explain why fractures were observed using cryomacroscopy when the specimens were contained in glass vials but not in plastic vials.

Uncovering pathway and mechanism of simultaneous thiocyanate detoxicity and nitrate removal through anammox and denitrification

Thiocyanate (SCN−) exists in various industries and is detrimental to the ecosystem, necessitating cost-effective and environmentally benign treatment. In response to alleviate the bacterial toxicity of SCN−, this study developed a two-stage coupled system by tandem of anammox in reactor 1 (R1) and SCN−-driven autotrophic denitrification in reactor 2 (R2), achieving simultaneous removal of SCN− and nitrogen. The total nitrogen removal efficiency of the coupled system was 92.42 ± 1.98%, with nearly 100% of SCN− elimination. Thiobacillus was responsible for SCN− degradation. The deduced degradation pathway of SCN− was via the cyanate pathway before coupling, followed by the co-action of cyanate pathway and carbonyl sulfide pathway after coupling. Although scaling-up study is needed to validate its applicability in real-world applications, this study contributes to the advancement of sustainable and cost-effective wastewater treatment technologies, being an attractive path for low-carbon nitrogen removal and greenhouse gas emission-free technology.

A novel temperature-controlled media milling device to produce drug nanocrystals at the laboratory scale

Poor aqueous solubility of preexisting and emerging drug molecules is a common issue faced in the field of pharmaceutics. To address this, particle size reduction techniques, including drug micro- and nanonisation have been widely employed. Nanocrystals (NCs), drug particles with particle sizes below 1 µm, offer high drug content, improved dissolution, and long-acting capabilities. Media milling is the most used method to prepare NCs using of-the-shelf machinery, both at the laboratory and industrial scales. However, early NCs development, especially when limited amounts of the active are available, require the use of milligram-scale media milling. This study introduces a novel mini-scale milling device (Mini-mill) that incorporates temperature control through a water-cooled jacket. The device was used to produce NCs of three model hydrophobic drugs, itraconazole, ivermectin and curcumin, with lowest particle sizes of 162.5 ± 0.4 nm, 178 ± 2 nm, and 116.7 ± 0.7 nm, respectively. Precise control of milling temperature was achieved at 15, 45, and 75°C, with drug dependent particle size reduction trends, with no adverse effects on the milling materials or polymorphic changes in the NCs, as confirmed by calorimetric analysis. Finally, a scale-up feasibility study was carried out in a lab-scale NanoDisp®, confirming that the novel Mini-mills are a material-efficient tool for early formulation development, with potential for scale-up to commercial mills.

Serotonin-Salt-Stress Model-Induced Cell Growth via Promoting an Antioxidant System and Secondary Metabolites in Capsicum annuum Cell Suspension Culture.

Capsicum annuum contains potential therapeutic capsaicinoids, and various stress factors influence plant productivity. Serotonin is an indoleamine involved in signaling several stress response mechanisms in plants. However, the influence of serotonin on cell growth and the accumulation of secondary metabolites, mainly capsaicinoids production, is not yet clearly defined under salt stress. In this study, we optimized chili cell suspension cultures to maximize biomass, capsaicinoids, and phenolic compounds production using response surface methodology with two variables (serotonin and NaCl) of different concentrations in culture media supplemented with 2,4-dichlorophenoxyacetic acid and Kinetin. The results revealed a significant increase in biomass (14.3 g/L FW), capsaicin (0.93 μg/g FW), and dihydrocapsaicin content (0.32 μg/g FW) in chili cell suspension cultures compared with the control. Among all the phenolic compounds, chlorogenic acid was enhanced (17.4 μg/g FW), compared to control cultures. Serotonin exhibited stress mitigation effects and boosted antioxidant potential in chili suspension cultures. The present results illustrated that the optimized conditions can be used in scale-up studies of capsaicinoids production through the bioreactor.

Phosphine-catalyzed synthesis of (Z)-N-alkenyl-2-pyridones: A dual Z-diastereoselective and N-selective approach under mild conditions

Herein, a new approach for the synthesis of (Z)-N-alkenyl-2-pyridones from 2-pyridones and propiolates using phosphine catalysis under mild conditions is reported. This dual Z-diastereoselective and N-selective reaction demonstrates excellent selectivity, yielding sole (Z)-N-alkenyl-2-pyridones. Furthermore, scale-up studies confirm its practical applicability, with consistent efficiencies observed.

Sustained release of 3D printed bupropion hydrochloride tablets bearing Braille imprints for the visually impaired

3D printing has been introduced as a novel approach for the design of personalized dosage forms and support patient groups with special needs that require additional assistance for enhanced medication adherence. In this study liquid crystal display (LCD) is introduced for the development of sustained release bupropion.HCl printed tablets. The optimization of printing hydrogel inks was combined with the display of Braille patterns on the tablet surface for blind or visually impaired patients. Due to the high printing accuracy, the Braille patterns could be verified by blind patients and provide the required information. Further characterization revealed the presence of BUP in amorphous state within the photopolymerized resins. The selection of poly(ethylene glycol) (PEG)-diacrylate (PEGDA) of different molecular weights and the presence of surfactants or solubilizers disrupted the resin photopolymerization, thus controlling the BUP dissolution rates. A small batch scale-up study demonstrated the capacity of LCD to print rapidly a notable number of tablets within 24 min.

Mathematical modeling of bioactive extraction from cashew apple: Maxwell-Stefan approach to resolve effect of internal diffusivity and external mass transfer

Every year 2.2 giga-tons of cashew apples are produced and 80 % (unutilized fruit) of them are wasted and contain useful bioactives such as polyphenols and tannins (high molecular weight polyphenols). These bioactives can be separated using extraction: the nutraceutical value of which is of the order of 1 billion USD/year. However, extraction kinetics are normally fitted to simple phenomenological models. These models fail to establish the effect of shrinkage, temperature, thermodynamic parameters, and internal resistances on diffusion of solute. Hence, the objective of this study was to develop a Maxwell-Stefan model that can overcome the above shortcomings and optimize the extraction process of bioactives from cashew apples. The optimized parameters for the extraction process obtained were − solid:solvent ratio- 1:6, particle size (of solid) 125–250 μm, and the extraction temperature as 30 °C. The non-random two liquid (NRTL) activity coefficient model was first used to capture the thermodynamics of extraction effectively, followed by its utilization in the development of Maxwell-Stefan model to resolve the effect of internal diffusivity and external mass transfer coefficient. The model gave a good fit (R2 > 0.90) for all the parameters and could thus predict the extraction data greatly for all operating parameters including temperature, particle size, and solid:solvent ratio. This makes it eminently suitable for scale-up studies.

Assessing the potential of a genetically modified Parachlorella kessleri-I with low CO2 inducible proteins for enhanced biomass and biofuel productivity

The biological process is one of the promising approaches for CO2 capture and storage. Recently, biological sequestration using microalgae has gained much interest due to its capability to utilize CO2 as a carbon source to generate valorizable biomass. This algal biomass further can be used as a feedstock for bioenergy and different value-added products. Here, we have heterogeneously overexpressed the low CO2 inducible proteins (LCIA & LCIB) from Chlamydomonas reinhardtii in the marine alga Parachlorella kessleri-I. Incorporation of these two genes boosted the endogenous CCM leading to a hybrid system and improved overall carbon acquisition. The combination of these CCM proteins enhanced the supply of inorganic carbon to RuBisCO with positive effects on growth and biomass productivity. Biochemical analyses revealed that the hybrid CCM in P. kessleri-I was characterised by 2- fold higher carbonic anhydrase activity, increased starch, and 2X more lipid yield in comparison to wild type (WT) strain. Moreover, the semi-continuous cultivation of GM strain with supply of 1 % CO2 led to around 60 % rise in the overall biomass productivity. These traits also persisted in scale-up studies leading to 2X more biomass productivity in the GM strain than WT in 100 L PBR. A comparative life-cycle assessment underlines the sustainability of the process of carbon capture and both biofuel and biochar production from P. kessleri-I with a hybrid CCM.

Scale-up of Global Child and Youth Mental Health Services: A Scoping Review

Numerous influential policy and scientific bodies are calling for more rapid advances in the scale-up of child and youth mental health services (CYMHS). A number of CYMHS innovations hold promise for advancing scale-up but little is known about how real-world efforts are progressing. We conducted a scoping review to identify promising approaches to CYMHS scale-up across the globe. Searches were completed in six databases (Academic Search Complete, CINAHL, MEDLINE, PsychInfo, PubMed, and Web of Science). Article selection and synthesis were conducted in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews (PRISMA-ScR) checklist. A second search focused on low-and-middle-income countries (LMIC) was conducted based on the Cochrane Library recommended search filters of the World Bank listed LMIC countries. Authors used a double coding strategy during the title/abstract and full-text review. Twenty-eight articles meeting the eligibility criteria were identified that described 22 initiatives (in 11 different countries). Our review found the majority of published scale-up studies in CYMHS were not informed by scale-up frameworks in design or reporting. The methods and outcomes used in the identified articles were highly variable and limited our ability to draw conclusions about comparative effectiveness although promising approaches emerged. Successes and failures identified in our review largely reflect consensus in the broader literature regarding the need for strategies to better navigate the complexities of system and policy implementation while ensuring CYMHS interventions fit local contexts.

Re-use of COVID-19 waste facemasks for modification of Nigeria’s naturally occurring bitumen for road construction

Nigeria currently imports bitumen for road construction despite the presence of a significant amount of naturally occurring bitumen (NOB) in Ondo state. The use of facemasks during the COVID-19 pandemic has led to environmental challenges due to their non-biodegradable and harmful nature. This study explores the potential of utilising waste facemasks in modifying NOB for road paving in Nigeria. The physiochemical properties of NOB were determined, and tests were conducted to assess its suitability for road construction. The results showed that the neat NOB had high penetration, low softening point, and high viscosity, making it unsuitable for road construction in Nigeria’s tropical region. However, the modified NOB, when blended with waste facemasks, exhibited reduced penetration and increased softening point, aligning with the AC-10 grade bitumen requirements. Further testing using the Dynamic Shear Rheometer (DSR) is recommended to determine the rheological properties of the modified NOB. This study is the first of its kind to explore the use of waste facemasks in modifying naturally occurring bitumen for road construction. It proposes a novel solution that not only addresses the environmental issues associated with waste facemasks but also offers a sustainable alternative to imported bitumen. Future works include long-term performance studies, comparative evaluations, environmental impact assessments, and scaling-up studies to assess the feasibility and practicality of implementing this approach on a larger scale.

CH4 Adsorption in Wet Metal-Organic Frameworks under Gas Hydrate Formation Conditions Using A Large Reactor

Nanoporous materials, such as metal-organic frameworks (MOFs), are renowned for their high selectivity as gas adsorbents due to their specific surface area, nanoporosity, and active surface chemistry. A significant challenge for their widespread application is reduced gas uptake in wet conditions, attributed to competitive adsorption between gas and water. Recent studies of gas adsorption in wet materials have typically used small amounts of powdered porous materials (in the milligram range) within very small reactors (1–5 mL). This leaves a gap in knowledge about gas adsorption behaviors in larger reactors and with increased MOF sample sizes (to the gram scale). Additionally, there has been a notable absence of experimental research on MOFs heavily saturated with water. In this study, we aimed to fill the gaps in our understanding of gas adsorption in wet conditions by measuring CH4 adsorption in MOFs. To do this, we used larger MOF samples (in grams) and a large-volume reactor. Our selection of commercially available MOFs, including HKUST-1, ZIF-8, MOF-303, and activated carbon, was based on their widespread application, available previous research, and differences in hydrophobicity. Using a volumetric approach, we measured high-pressure isotherms (at T = 274.15 K) to compare the moles of gas adsorbed under both dry and wet conditions across different MOFs and weights. The experimental results indicate that water decreases total CH4 adsorption in MOFs, with a more pronounced decrease in hydrophilic MOFs compared to hydrophobic ones at lower pressures. However, hydrophilic MOFs exhibited stepped isotherms at higher pressures, suggesting water converts to hydrate, positively impacting total gas uptake. In contrast, the hydrophobic ZIF-8 did not promote hydrate formation due to particle aggregation in the presence of water, leading to a loss of surface area and surface charge. This study highlights the additional challenges associated with hydrate-MOF synergy when experiments are scaled up and larger sample sizes are used. Future studies should consider using monolith or pellet forms of MOFs to address the limitations of powdered MOFs in scale-up studies.

Optimization of biotransformation processes of Camarosporium laburnicola to improve production yields of potent telomerase activators

BackgroundTelomerase activators are promising agents for the healthy aging process and the treatment/prevention of short telomere-related and age-related diseases. The discovery of new telomerase activators and later optimizing their activities through chemical and biological transformations are crucial for the pharmaceutical sector. In our previous studies, several potent telomerase activators were discovered via fungal biotransformation, which in turn necessitated optimization of their production. It is practical to improve the production processes by implementing the design of experiment (DoE) strategy, leading to increased yield and productivity. In this study, we focused on optimizing biotransformation conditions utilizing Camarosporium laburnicola, a recently discovered filamentous fungus, to afford the target telomerase activators (E-CG-01, E-AG-01, and E-AG-02).ResultsDoE approaches were used to optimize the microbial biotransformation processes of C. laburnicola. Nine parameters were screened by Plackett-Burman Design, and three significant parameters (biotransformation time, temperature, shaking speed) were optimized using Central Composite Design. After conducting validation experiments, we were able to further enhance the production yield of target metabolites through scale-up studies in shake flasks (55.3-fold for E-AG-01, 13-fold for E-AG-02, and 1.96-fold for E-CG-01).ConclusionFollowing a process optimization study using C. laburnicola, a significant increase was achieved in the production yields. Thus, the present study demonstrates a promising methodology to increase the production yield of potent telomerase activators. Furthermore, C. laburnicola is identified as a potential biocatalyst for further industrial utilization.

One-pot, easy and scalable synthesis of large-size short wave length IR emitting PbS quantum dots.

This study presents a versatile and efficient method to synthesize large-size lead sulfide (PbS) quantum dots (QDs) that display emission in the short-wave infrared (SWIR) region, using accessible and stable diethylammonium diethyldithiocarbamate (C2)2DTCA and octylammonium octyldithiocarbamate (C8DTCA) as sulfur sources. As these sulfur sources enable the formation of well-dispersed, large-size PbS QDs in a very convenient way, this method can further be taken up for scale-up studies. Importantly, this approach allows precise control over QD sizes, thereby enhancing their SWIR optical properties. By adjusting the hot injection temperatures and sulfur source concentrations, different synthesis routes are explored, providing flexibility for the desired QD characteristics. The results presented here offer a promising opportunity to leverage the synthesized PbS QDs in applications such as optoelectronics, sensors, and imaging technology.

Updated review on current approaches and challenges for poly- and perfluoroalkyl substances removal using activated carbon-based adsorbents

Per- and polyfluoroalkyl substances (PFAS) are persistent and toxic to the environment and human health. Activated carbon (AC) has been extensively investigated for the removal of PFAS and has shown promising candidates for PFAS removal. Up to date, a remarkable advancement has been achieved in PFAS removal using AC, still, the application remains challenging. The main objective of this article is to summarize the recent advancement in PFAS removal from water using activated carbon-based adsorbents. The dominant PFAS removal mechanisms using AC are electrostatic interaction, hydrophobic interaction, and ion-exchange. Additionally, this review highlighted the critical factors that influence PFAS removal using AC, including AC's properties, solution pH, ionic strength, and natural organic matter effects. Notably, the presence of natural organic matter significantly impacts PFAS adsorption performance using AC. Moreover, the review also discussed the current trend in regeneration techniques of spent AC for PFAS adsorption and the economic assessment for PFAS removal using AC from scale-up studies to establish cost-effective strategies for scaling up the process. Finally, the challenge and new perspective of AC for PFAS removal were discussed for future research advancement. This review presented the devising practical and environmentally approaches to tackle the challenges encountered by ACs in eliminating PFAS from water.

Xylitol biosynthesis and process scale-up from wheat straw hemicellulosic hydrolysate using Candida tropicalis

Due to growing applications of xylitol in pharma and food industries, process development for xylitol biosynthesis from lignocellulosic biomass seems to be a promising strategy. The present study focuses on the process development for facilitating efficient xylose to xylitol bioconversion from wheat straw hemicellulosic hydrolysate using Candida tropicalis ATCC 13803. A methodical attempt to scale up the fermentation bioprocess is demonstrated by maintaining a constant volumetric mass transfer coefficient (kLa) in bioreactors of various scales. Xylitol productivity of 1.47 and 0.58 g/Lh and yield of 1.58 and 0.74 g/g, respectively, were achieved from xylose-rich hydrolysate (41.49 g/L xylose) and synthetic xylose (40.69 g/L) in a 0.5 L bioreactor at an optimum kLa of 0.74 min-1 and 0.68 min-1, respectively. Further, scale-up in 1 L bioreactor using optimum kLa resulted in xylitol productivity (g/Lh) and yield (g/g) of 1.49 & 0.58; 1.57 & 0.74, respectively, from hydrolysate and synthetic xylose. Moreover, scale-up in a 5 L bioreactor using optimum kLa resulted in xylitol yield and productivity of 0.74 g/g and 1.55 g/Lh from synthetic xylose. The successful bioprocess scale-up studies highlight the relevance of lignocellulosic biomass’s valorization to high-valued xylitol.

A numerical scale-up study of annular fluidized bed reactor with high centrifugal acceleration

A rotating fluidized bed imposes a strong centrifugal force to form the dense annular bed with high interphase slip velocity for significantly enhanced gas-solids contact. The fundamental fluidization behaviors in rotating fluidized beds have been well understood in small-scale systems. The current study focuses on the scale-up of a rotating fluidized bed from lab-scale to commercial-scale through computational fluid dynamics modeling. The computational model was first validated against a lab-scale horizontal rotating fluidized bed for the general flow behavior and pressure drop. The validated computational model with a column diameter of 0.12 m was then scaled up to 0.48 m and 1.92 m to investigate the flow hydrodynamics at larger scales. By comparing the solids distribution and other flow field variables, major limitations in the stable operation of a rotating fluidized bed at large scales were identified. The challenges faced in the scale-up of an annular fluidized bed with centrifugal acceleration are discussed and ways to overcome such challenges are explored.

The longitudinal impact of an evidence-based multiple family group intervention (Amaka Amasanyufu) on family cohesion among children in Uganda: Analysis of the cluster randomized SMART Africa-Uganda scale-up study (2016-2022).

Family functioning plays a critical role in childhood disruptive behavior disorders (The Family Journal, 2003, 11(1), 33-41; Research in Nursing and Health, 2016, 39(4), 229-243). Yet, there is limited research on the impact of evidence-based family strengthening interventions on improving family cohesion as a protective factor among children experiencing behavioral challenges. To address this gap, we analyzed data (N = 636) from the SMART Africa-Uganda study (2016-2022), a cluster randomized clinical trial testing an evidence-based family-strengthening intervention called Amaka Amasanyufu (translated as "Happy Families" in the local language). Children aged 8-13 and their caregivers were recruited from 26 public primary schools that were randomized to: (1) control condition receiving generalized psychosocial literature (10 schools), (2) intervention delivered via parent peers (eight schools), and (3) intervention delivered via community healthcare workers (eight schools). Children completed the family cohesion questionnaire at baseline, 8 weeks, 16 weeks, and 6 months post-intervention completion. The intervention effectiveness was evaluated via a three-level logistic mixed effects model with pairwise comparisons across study conditions within each time point. Participants in the parent-peer intervention group had greater odds of being in the higher family cohesion group than participants in the control group at 8 weeks (OR = 3.24), 16 weeks (OR = 1.88) and 6 months (OR = 2.07). At 8 weeks, 16 weeks, and 6 months, participants in the community health worker group had 3.98, 2.08, and 1.79 times greater odds of being in the higher family cohesion group than participants in the control group, respectively. Our findings strengthen the evidence base for Amaka Amansayufu as an effective intervention that can be utilized in SSA to improve family cohesion in families with children experiencing behavioral challenges.

Characterization Data for the Establishment of Scale-Up and Process Transfer Strategies between Stainless Steel and Single-Use Bioreactors

The reliable transfer of bioprocesses from single-use bioreactors (SUBs) of different scales to conventional stainless steel stirred-tank bioreactors is of steadily growing interest. In this publication, a scale-up study for SUBs with volumes of 200 L and 2000 L and the transfer to an industrial-scale conventional stainless steel stirred-tank bioreactor with a volume of 15,000 L is presented. The scale-up and transfer are based on a comparison of mixing times and the modeling of volumetric mass transfer coefficients kLa, measured in all three reactors in aqueous PBS/Kolliphor solution. The mass transfer coefficients are compared with the widely used correlation of van’t Riet at constant stirrer tip speeds. It can be shown that a van’t Riet correlation enables a robust and reliable prediction of mass transfer coefficients on each scale for a wide range of stirrer tip speeds and aeration rates. The process transfer from single-use bioreactors to conventional stainless steel stirred-tank bioreactors is proven to be uncritical concerning mass transfer performance. This provides higher flexibility with respect to bioreactor equipment considered for specific processes.