J Occup Environ Hyg

Powered air-purifying respirators (PAPRs) that offer protection from particulates are deployed in different workplace environments. Usage of PAPRs by healthcare workers is rapidly increasing; these respirators are often considered the best option in healthcare settings, particularly during public health emergency situations, such as outbreaks of pandemic diseases. At the same time, lack of user training and certain vigorous work activities may lead to a decrease in a respirator's performance. There is a critical need for real-time performance monitoring of respiratory protective devices, including PAPRs. In this effort, a new robust and low-cost real-time performance monitor (RePM) capable of evaluating the protection offered by a PAPR against aerosol particles at a workplace was developed. The new device was evaluated on a manikin and on human subjects against a pair of condensation nuclei counters (P-Trak) used as the reference protection measurement system. The outcome was expressed as a manikin-based protection factor (mPF) and a Simulated Workplace Protection Factor (SWPF) determined while testing on subjects. For the manikin-based testing, the data points collected by the two methods were plotted against each other; a near-perfect correlation was observed with a correlation coefficient of 0.997. This high correlation is particularly remarkable since RePM and condensation particle counter (CPC) measure in different particle size ranges. The data variability increased with increasing mPF. The evaluation on human subjects demonstrated that RePM prototype provided an excellent Sensitivity (96.3% measured on human subjects at a response time of 60\u2009sec) and a Specificity of 100%. The device is believed to be the first of its kind to quantitatively monitor PAPR performance while the wearer is working; it is small, lightweight, and does not interfere with job functions.CC999999/ImCDC/Intramural CDC HHSUnited States

Guide to industrial respiratory protection

"A guide was presented for providing users of respiratory protective equipment with a single source of pertinent information. Selection, use, and maintenance of respiratory protective devices available in 1987 were covered. Topics included types of respirators (respiratory inlet coverings, air purifying respirators, and atmosphere supplying respirators); respirator selection (based on regulatory requirements, general selection information, NIOSH respirator decision logic, and NIOSH Certified Equipment List); use of respirators according to Federal regulatory requirements; responsibility of employer and employee in a respiratory protection program; elements of a program (administration and components of the total program); respirator use under special conditions (facial hair, eye glasses, contact lenses, facial deformation, communication, dangerous atmospheres, low and high temperatures, and physiological response to respirator use); and new developments at NIOSH concerning respiratory physiology, filtration mechanics, sorption technology, quantitative respirator efficiency testing, certification of new types of respirators, and NIOSH respirator problem investigation. Appendices provided a sample respirator program, fit testing procedures, selected NIOSH respirator user notices, sample Mine Safety and Health Administration/NIOSH approval labels, respirator decision logic, and breathing air systems for use with pressure demand supplied air respirators in asbestos (1332214) removal." - NIOSHTIC-2Spine title: Guide to industrial respiratory protection.At head of title: A NIOSH technical guide...Author of previous edition: John A. Pritchard. Shipping list no.: 88-5-P."September 1, 1987"Also available via the World Wide Web.Bibliography: p. 131-133

Diesel aerosols and gases in underground mines: guide to exposure assessment and control

"Diesel engines are a major contributor to concentrations of submicron aerosols, CO, CO2, NOX, SO2 and hydrocarbons (HC) in underground coal and metal/nonmetal mines. The extensive use of diesel-powered equipment in underground mines makes it challenging to control workers' exposure to submicron aerosols and noxious gases emitted by those engines. In order to protect workers, mines need to establish a comprehensive program based on a multifaceted and integrated approach. Many of the technologies and strategies available to the coal and metal/nonmetal underground mining industries to control exposures of underground miners to diesel pollutants are similar. The effort to reduce the exposure of underground miners to diesel pollutants requires the involvement of several key departments of mining companies, including those responsible for health and safety, engine/vehicle/exhaust aftertreatment maintenance, mine ventilation, and production, as well as the departments responsible for acquiring vehicles, engines, exhaust aftertreatment systems, fuel, and lubricating oil." - NIOSHTIC-21. Introduction -- 2. Source control of diesel particulate matter (DPM) and gases -- 3. Control of exposure to airborne diesel pollutants -- 4. Monitoring of diesel particulate matter and gases -- 5. Administrative controls and practices -- 6. Referencesby Aleksandar D. Bugarski, Samuel J. Janisko, Emanuele G. Cauda, James D. Noll, and Steven E. Mischler.Includes bibliographical references (p. 111-149)

Biopharmaceutical Process – Contract Development Organization: Startup

Due to their high specificity and the wide range of treatments they can provide, monoclonal antibodies (MAbs) from mammalian cell cultures have gained increasing popularity in therapeutics. As a result, treatments have become cheaper and easier to manufacture while maintaining their natural effectiveness, further increasing their appeal. Building MAb manufacturing facilities can be costly for biopharmaceutical companies, especially smaller biotech firms, and current production capacities are limited. As a result, there is an everincreasing demand for contract development organizations (CDOs). The CDO being proposed targets demand within this regime specific to MAbs entering clinical trials. It has the capability to screen clones, grow MAb-producing cells up to a 2500 L culture, and purify the MAb to clinical standards. By employing the newest technology available, the facilities will provide flexibility necessary for producing a myriad of different MAb therapeutics in Chinese Hamster Ovary (CHO) cells. Microbioreactors can screen dozens of clones at the millileter scale, saving time and money. Disposable bioreactors in the upstream process allow for variance in the production capacity due to the range of sizes they are available in. Finally, the purification process has been designed to allow for flexibility depending on the size and needs of every client’s product to maximize value to the costumer as well as the company. The current market for MAb production has an astounding worldwide value of approximately $27.5 billion and continues to expand as the number of MAbs entering clinical trials increases (Cowen 2006). It is estimated that within the next four years that the worldwide market value will reach$50 billion (“Preclinical Development”, 2010). The profitability of this proposal is based on running 39 batches a year at 4.326 kg MAb/batch or 168.71 kg MAb/year. By charging a reasonable average of $1,125,000/kg MAb, a profitability profile can be created. Assuming a 70$111,907,800 and 52.96% respectively. However, using a 70% production capacity also leaves room for even higher profit margins. The plant design also has space allotted for future expansion within the mammalian suite as well as room for a future microbial suite

Dust control handbook for industrial minerals mining and processing

"This handbook was written by a task force of safety and health specialists, industrial hygienists, and engineers to provide information on proven and effective control technologies that lower workers' dust exposures during all stages of mineral processing. The handbook describes both dust-generating processes and the control strategies necessary to enable mine operators to reduce worker dust exposure. Implementation of the engineering controls discussed can assist operators, health specialists, and workers in reaching the ultimate goal of eliminating pneumoconiosis and other occupational diseases caused by dust exposure in the mining industry. Designed primarily for use by industrial minerals producers, this handbook contains detailed information on control technologies to address all stages of the minerals handling process, including drilling, crushing, screening, conveyance, bagging, loadout, and transport. The handbook's aim is to empower minerals industry personnel to apply state-of-the-art dust control technology to help reduce or eliminate mine and mill worker exposure to hazardous dust concentrations - a critical component in ensuring the health of our nation's mine workers." - NIOSHTIC-2NIOSHTIC no. 20055113Suggested citation: NIOSH [2019]. Dust control handbook for industrial minerals mining and processing. Second edition. By Cecala AB, O\u2019Brien AD, Schall J, Colinet JF, Franta RJ, Schultz MJ, Haas EJ, Robinson J, Patts J, Holen BM, Stein R, Weber J, Strebel M, Wilson L, and Ellis M. Pittsburgh PA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2019\u2013124, RI 9701. https://doi.org/10.26616/NIOSHPUB2019124201910.26616/NIOSHPUB2019124606

Monoclonal Antibody Production and Purification

Monoclonal antibody (mAb) therapy is a form of immunotherapy that uses mAbs to bind mono-specifically to certain cells or proteins. This may then stimulate the patient\u27s immune system to attack those cells. MAbs are currently used to treat medical conditions such as cancer, diabetes, arthritis, psoriasis, and Crohn’s Disease, but have the potential to treat countless diseases and disorders. In 2015, the mAb market was valued at $85.4 billion, and is expected to reach$138.6 billion by 2024.1 In manufacturing, mAbs are typically produced in suspension in a series of fed-batch bioreactors using genetically engineered cells originally obtained from Chinese Hamster Ovaries (CHO).2 In this proposal, two upstream bioreactor designs were analyzed for economic comparison given an annual production goal of 100 kg of mAb, with the first design culminating in a 20,000 L volume at low mAb titer and the second design culminating with a 2,000 L volume at high mAb titer. Following upstream mAb production, the protein was purified to meet clinical FDA standards using a series of downstream purification techniques, including centrifugation, filtration, and chromatography. The two designs can be modeled for both an on-patent and off-patent mAb in order to ensure long-term economic viability. In this project, the drug was modeled based on Ocrevus (ocrelizumab), a humanized therapeutic mAb brought to market in 2017 that targets a CD20-positive B cell to treat the symptoms of both primary progressive and relapsing Multiple Sclerosis.3 For an off-patent drug, it is recommended that the mAb be priced at $35,000 per 1200 mg annual treatment in order to earn a 15$65,000 per 1200 mg treatment should be used to recover the R&D costs of developing a new drug and sunk cost of past unsuccessful drugs. After analyzing both designs, it was concluded that the second, smaller design scheme is more scalable, less risky, and more cost effective for the production of both the on- and off-patent drugs

Industrial-Scale Manufacture of Oleosin 30G for Use as Contrast Agent in Echocardiography

In ultrasound sonography, microbubbles are used as contrasting agents to improve the effectiveness of ultrasound imaging. Monodisperse microbubbles are required to achieve the optimal image quality. In order to achieve a uniform size distribution, microbubbles are stabilized with surfactant molecules. One such molecule is Oleosin, an amphiphilic structural protein found in vascular plant oil bodies that contains one hydrophobic and two hydrophilic sections. Controlling the functionalization of microbubbles is a comprehensive and versatile process using recombinant technology to produce a genetically engineered form of Oleosin called Oleosin 30G. With the control of a microfluidic device, uniformly-sized and resonant microbubbles can be readily produced and stored in stable conditions up to one month. Currently, Oleosin microbubbles are limited to the lab-scale; however, through development of an integrated batch bioprocessing model, the overall product yield of Oleosin 30G can be increased to 7.39 kg/year to meet needs on the industrial-scale. An Oleosin-stabilized microbubble suspension as a contrast agent is in a strong position to take a competitive share of the current market, capitalizing on needs unmet by current market leader, Definity®. Based on market dynamics and process logistics, scaled-up production of Oleosin 30G for use as a contrast agent is expected to be both a useful and profitable venture

Wildfire smoke : a guide for public health officials

5/28/20 This information was developed before the COVID-19 health emergency. Please supplement this information with the latest advice from state, local, Tribal and federal agencies, including the EPA website https://www.epa.gov/coronavirus and CDC webpage https://www.cdc.gov/coronavirus/2019-ncov/index.htmlwildfire-smoke-guide-revised-2019_0.pdf2019928

Stem Cell Therapy for Spinal Cord Injuries

Stem cell-based therapies are an emerging branch of medicine with the purpose of restoring tissue function for patients with serious injuries, such as a spinal cord injury. As a result, scientists and engineers are increasing research efforts in the field of regenerative medicine. Due to the delicate nature of stem cells, producing the large quantity required for a successful therapy has proved challenging. In recent years, research has shown the potential of stem cell-based therapies, and thus there is a need for the commercialization of these treatments. The proposed facility targets the demand for spinal cord injury treatments and can support production for both clinical trials and a commercial release. Bioreactors designed specifically for the culture and growth of stem cells have flexibility in their ability to support different stem cell lines for various therapies. Small reactors in parallel can easily adapt to changes in production size. This process also takes advantage of the best options currently available for purification and preservation to maximize the product yield. Due to the strict regulations set in place by the FDA and lack of adequate funding, there is an untapped market for stem cell therapies for spinal cord injuries. Approximately 250,000 people in the United States suffer from spinal cord injuries, varying in severity, and this patient base increases at a rate of 12,000 new injuries every year (“Spinal Cord Injury Facts and Figures”, 2009). Future markets include expansion into Europe and Asia. There are two steps to this proposal: the upstream process and the downstream process. The upstream process includes the scale-up, differentiation, and purification of human embryonic stem cells; the downstream process consists of the scale-up of neurons for injection. The upstream process will be built initially and yield enough cells for clinical trials, without incurring the capital costs of building the entire plant. Upon success of the clinical trials, the downstream process will be built for maximum production. The profitability of this proposal is based on running 26 batches a year at 1.02x1010 cells per batch or 2.66x1011 cells per year. By targeting 5,000 patients, two percent of the current market, and charging $45,000 per dose, a profitable profile can be created. Assuming 50$961,892,600, and 242.81% respectively. Using a 50% production capacity allows for higher profit margins upon expansion. The proposed plan will meet the need of this growing market