• Materials containing certain etiologic agents' means 'material known to contain or reasonably believed (by the shipper) to contain' an etiologic agent from a list included in the regulation. (cdc.gov)
  • Transcriptional regulation information for a gene, including any predicted DNA binding site motifs ( YeTFaSCo ) for the gene's protein product, as well as any of its targets (genes it regulates) or regulators (genes that regulate it), based on experimental evidence. (yeastgenome.org)
  • We later revised the regulation to reflect that the DDP applies to all new renal dialysis drugs and biological products. (cms.gov)
  • Under our current regulation, an "oral-only drug" is a drug or biological product with no injectable equivalent or other form of administration other than an oral form. (cms.gov)
  • Biomedical materials that are known to contain, or could contain, etiologic agents are divided into two groups: 'diagnostic specimens and biological products' on the one hand and 'materials containing certain etiologic agents' on the other. (cdc.gov)
  • Infectious substances can include patient specimens, biological cultures, medical or clinical wastes and/or biological products such as vaccines. (csun.edu)
  • Use this microscope for observing biological specimens, samples from nature, small parts, fabric samples, and many other possibilities. (khanscope.com)
  • This session was recorded as part of FDLI's Introduction to Biological Products, Including Vaccines, Biosimilars, Cell and Gene Therapies, and Other Advanced Therapies Course in October 2023. (fdli.org)
  • Biological product' means a product prepared in accordance with regulations that govern the manufacture of vaccines, reagents, etc. (cdc.gov)
  • According to the European Union (EU) legislation, these products can be currently categorized into different regulatory statuses, depending, for vaccines, on their target (infectious disease or not) and, for other drugs, on how they are obtained (chemically or biologically). (frontiersin.org)
  • While the first mRNA vaccines against an infectious disease have reached the market ( 1 , 2 ), many other medicinal products with RNA as an active substance (see Table 1 ), either vaccines against non-infectious diseases or non-vaccine drugs, are under development ( 3 - 18 ) or even approved ( 19 - 25 ). (frontiersin.org)
  • Sino Biological, Inc. (SZSE: 301047) has recently deposited reagents for the Omicron variant, including recombinant proteins to Spike and Nucleocapsid, and antibody products to BEI Resources, a central repository for reagents to support infectious disease research. (the-scientist.com)
  • Sino Biological is an international biological reagent supplier and service provider. (the-scientist.com)
  • Sino Biological is dedicated to virology and infectious disease research. (the-scientist.com)
  • Sino Biological assumes no obligation to update these forward-looking statements and do not intend to do so. (the-scientist.com)
  • Sino Biological is the researchers' one-stop technical services shop for the advanced technology platforms they need to make advancements. (labx.com)
  • In addition, Sino Biological offer pharmaceutical companies and biotechnology firms pre-clinical production technology services for hundreds of monoclonal antibody drug candidates. (labx.com)
  • Relationship between pyrogenicity and bacterial endotoxin contamination on latex products was demonstrated by chemical analysis and biological assays. (nih.gov)
  • ATCC will support analytical assays, product characterization, and biopharmaceutical development activities. (atcc.org)
  • With this contract, ATCC, as a member in the NIAID selected service provider pool, will support NIAID's Preclinical Services for Biopharmaceutical Product Development in two main areas: the development and validation of analytical assays for product characterization and process development and formulation. (atcc.org)
  • The approval was based on "comprehensive review of scientific evidence," including "comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data," the FDA said. (medscape.com)
  • To date, eleven biosimilars have been approved in the United States, but nearly 70 more are in the development pipeline," said Leah Christl, Ph.D., director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in FDA's Office of New Drugs, noting that the patents on some widely used biological drugs will expire in the coming years. (haihengpharma.com)
  • Today's approval exemplifies the FDA's longstanding commitment to support a competitive marketplace for biological products," Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars in the FDA's Center for Drug Evaluation and Research, said in a statement . (medscape.com)
  • If a contract company is handling the waste, requirements in OSHA standards, including Bloodborne Pathogens (29 CFR 1910.1030) may also apply. (cdc.gov)
  • With our expertise and resources, NIAID is better able to more quickly diagnose infectious disease-causing pathogens and toxins, and then strive to develop therapeutic products to treat them. (atcc.org)
  • Objective 1: Discover new efficacious natural products, including fire ant-specific pathogens, for Integrated Pest Management (IPM) of invasive ant species. (usda.gov)
  • All of Sino Biological's products are independently developed and produced, including recombinant proteins, antibodies and cDNA clones. (labx.com)
  • Although monoclonal antibodies were known for their discriminatory ability to damage targeted cells, Idec's scientists employed a plan-B strategy in treating non-Hodgkin's B-cell lymphomas, working on a product to reduce total B cell levels, thereby eliminating a patient's normal and malignant B cells. (encyclopedia.com)
  • ISO 11138-5:2006 provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent. (iso.org)
  • Specifies general production, labeling and performance requirements for the manufacture of biological indicators and suspensions intended for use in the validation and monitoring of sterilization cycles. (ansi.org)
  • ATCC, the world's premier biological materials management and standards organization, today announced that it has been awarded an Indefinite Delivery/Indefinite Quantity (IDIQ) contract 75N93023D00009 by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). (atcc.org)
  • Aqueous liquids are water-based liquids with a pH between 5.0-9.0, such as saline and buffer solutions or washings from radioactive contaminated laboratory glassware, and weak acids and bases that contain no biological, pathogenic, or infectious materials. (uh.edu)
  • Microorganisms, which include bacteria, can be classified into four infectious groups, and the degreaser manufacturers claim that their products are harmless (Risk Group 1). (irsst.qc.ca)
  • Montréal, November 7, 2019 - To clean oily or greasy parts in mechanical maintenance shops, workers use biowashers or biological degreasing stations. (irsst.qc.ca)
  • ATCC provides clinical and epidemiological study support including collection supplies, sample receipt and storage, biospecimen processing, and distribution. (atcc.org)
  • In 1993, Idec began Phase I clinical trials with a monoclonal antibody product it had given the temporary name IDEC-C2B8. (encyclopedia.com)
  • Many of the drugs currently in clinical use originate from natural products. (lu.se)
  • The 3M™ Attest™ Rapid Ethylene Oxide Biological Indicator, 1294-S, Green Cap, is designed for development, validation and routine monitoring of ethylene oxide (EO, EtO) sterilization processes used in the manufacturing of medical related products. (3m.com)
  • The ISO 11138-1:2017 and ISO 11138-2:2017 compliant 3M™ Attest™ Rapid Ethylene Oxide Biological Indicator, 1294-S, is appropriate for use in industrial (Life Sciences) ethylene oxide (EO, EtO) sterilization applications when verified by the end user. (3m.com)
  • Improve patient outcomes with diagnostic products and continuing education. (fishersci.com)
  • Because aldehydes have the tendency to react with biological molecules to form various products, including Schiff base protein adducts, free aldehydes released into the headspace of biological samples from the Schiff base protein adducts at low pH (~3) are analyzed. (cdc.gov)
  • Dust hazards included exposures to wood dust, mold and bagasse dusts and fibrogenic dusts. (cdc.gov)
  • Another example of a workplace process potentially leading to worker exposure is machining of polymer and plastic products generating dusts [7, 9]. (cdc.gov)
  • The MT-60 is a Binocular Compound Biological Brightfield Microscope with 4X, 10X, 40X and 100X oil, Infinity Corrected Microscope system with state-of-the-art features that have been specifically designed for Life Sciences and Biomedical Sciences. (meijitechno.com)
  • The Celestron Labs CB1000CF Compound Binocular microscope offers all the essential features you need in a lab-ready Biological microscope at an economical price. (khanscope.com)
  • This Celestron Labs CB1000CF Compound Binocular microscope is especially great for doing biological examination, because it includes an Abbe type Substage Condenser with Iris Adjustment. (khanscope.com)
  • This CB1000CF Compound Binocular Biological microscope from Celestron has an excellent focusing mechanism with coarse and fine focus control knobs, on separate knobs for precise focus control. (khanscope.com)
  • ATCC's assistance with analytical assay development for product characterization and process development and formulation will be part of the suite of services included in the contract commonly associated with the preclinical development of biopharmaceutical products. (atcc.org)
  • Few regulatory studies are available to assist in the regulatory categorization of RNA-based medicinal products. (frontiersin.org)
  • The site conformed to both Steiner Biodynamics and Permaculture principles, with zoning strategies accommodating food and medicinal herb production surrounding a central core of living accommodations and commerce, which included a commercial nursery, and facility for the manufacture of herbal-nutritional formulations. (oneradionetwork.com)
  • Terpenes are natural products derived from plants that have medicinal properties and biological activity. (medscape.com)
  • ATCC is a premier global biological materials and information resource and standards organization and the leading developer and supplier of authenticated cell lines, microorganisms, and associated data for academia, industry, and government. (atcc.org)
  • These recommendations list effective disinfectant products and procedures, guidance for contract companies to follow in dealing with contaminated wastes, and guidance on how to use personal protective equipment (PPE). (cdc.gov)
  • The CSUN Institutional Biosafety Committee (IBC) must review and approve of all activities involving the use of regulated biological materials via the Biological Use Authorizations (BUA) application and approval process. (csun.edu)
  • Biological contaminants can come from both outside and inside the home. (healthlinkbc.ca)
  • Biological contaminants can cause allergic symptoms. (healthlinkbc.ca)
  • For more information, see HealthLinkBC File #65b Indoor Air Quality: Mould and Other Biological Contaminants . (healthlinkbc.ca)
  • In addition, some intermediates were also included in the biological evaluation. (lu.se)
  • The consortium will work with other collaborators including Beth Israel Deaconess Medical Center, Boston Children's Hospital, Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital, and MilliporeSigma. (fujifilm.com)
  • Sixteen natural products were obtained from collaborators, including 9 botanical extracts, 6 ant extracts and one synthetic naturally occurring compound. (usda.gov)
  • The manufacturing facility is planning for eight cleanrooms, with a configuration that will produce both cell and viral vector products within its physical space. (fujifilm.com)
  • Its newly launched ProVir™ collection is the world's largest viral antigen bank, carrying over 1,000 viral products from 350 strains of viruses. (the-scientist.com)
  • and Viral inactivation of equine or other viruses in biological products. (who.int)
  • 2. To subsequently consider the results of independent laboratory analysis of antivenom products, and the outcomes of Good Manufacturing Practice (GMP) inspections. (who.int)
  • With the addition of the Omicron products to previously deposited array of SARS-CoV-2 reagents, researchers can readily get access to them by registering with BEI Resources. (the-scientist.com)
  • Learn the statutory definitions of a biological product as well as recognize the distinctions that drive jurisdiction and regulatory pathways. (fdli.org)
  • Discover more with lab, safety, and production products and services. (fishersci.com)
  • The various hazards present in the many steps used in the production of products from pulp and paper mills were reviewed and discussed. (cdc.gov)
  • and insufficient human and financial resources for research and production of traditional medicine products. (who.int)
  • Weak partnerships between the private and public sectors and research communities have militated against large-scale production of traditional medicine products. (who.int)
  • In commercially available latex products' surveillance, water extracts prepared from one surgical glove and two silicone elastomer-coated Foley catheters sterilized by gamma-irradiation were obviously pyrogenic in rabbits. (nih.gov)
  • The study protocol included a questionnaire, assessment of styrene and noise exposures, and an extensive audiologic battery. (cdc.gov)
  • The experienced, multidisciplinary team includes researchers from academia and SMEs. (europa.eu)
  • To address this lack of data, the researchers monitored five biological degreasing stations for a year, taking 50 mL samples of degreasing fluid every two months and, for comparison purposes, an initial sample of unused degreaser from each station. (irsst.qc.ca)
  • These products are broadly antiviral and capable of inactivating both enveloped and nonenveloped viruses, including ebolaviruses. (cdc.gov)
  • We identified a new virus associated with equine serum hepatitis and confirmed its pathogenicity and transmissibility through contaminated biological products. (cdc.gov)
  • Theiler's disease has been described in horses in many areas of the world after treatment with a variety of equine serum products, including tetanus antitoxin ( 3 - 8 ), botulinum antitoxin ( 9 ), antiserum against Streptococcus equi ( 4 , 10 ), pregnant mare's serum ( 4 ), and equine plasma ( 1 , 2 , 5 , 11 ). (cdc.gov)
  • Under these user fee programs FDA has dramatically reduced the review time for new products, without compromising the Agency's high standards for demonstration of safety, efficacy, and quality of new drug products prior to approval. (fda.gov)
  • FDA met or exceeded all GDUFA review goals to date, including goals for original Abbreviated New Drug Applications (ANDAs), ANDA amendments, Prior Approval Supplements (PAS), and controlled correspondence. (fda.gov)
  • Patient confidence that generic drugs will work the same as brand products, and can be freely substituted, is the foundation for trillions of dollars in savings that generics produce for the healthcare system. (fda.gov)
  • The company's portfolio of approved drugs includes Rituxan and Zevalin, both of which treat B-cell non-Hodgkin's lymphoma. (encyclopedia.com)
  • The ESRD PPS includes specific functional categories, which CMS has used since 2011 to identify drugs and biological products that are renal dialysis services paid for under the ESRD PPS. (cms.gov)
  • An ESRD PPS functional category is a distinct grouping of drugs or biological products, as determined by CMS, whose end action effect is the treatment or management of a condition or conditions associated with ESRD. (cms.gov)
  • To add new renal dialysis drugs and biological products to the ESRD PPS bundled payment, CMS uses a drug designation process (DDP) that is based on the ESRD PPS functional categories. (cms.gov)
  • In general, drugs and biological products are considered included in the ESRD PPS base rate if they fit within one of the ESRD PPS functional categories, which are listed in the table below. (cms.gov)
  • In the CY 2016 ESRD PPS final rule , we implemented this provision and finalized a DDP based on our longstanding process for identifying renal dialysis service drugs and biological products that fit into ESRD PPS functional categories. (cms.gov)
  • Other appropriate applications include work with antineoplastic drugs, genetic material, asbestos and additional substances that generate hazardous airborne particulates. (labconco.com)
  • The label includes a chemical process indicator. (3m.com)
  • The biological effects of 43 chemical, physical and dust hazards were detailed in this report. (cdc.gov)
  • In those five decades, NIOSH helped with establishing methods to characterize aerosols including particle size and shape distribution, concentration, and chemical composition and to minimize exposure to them. (cdc.gov)
  • Exposure to topical products that contain camphor can cause serious toxicity in young chlidren. (medscape.com)
  • Degradation of carpets and other synthetic fiber products can produce airborne fibers considered NMPPs [14] with potential for exposure among office/teleworkers and custodial staff. (cdc.gov)
  • For example, the NIOSH Nanotechnology Center demonstrated that existing exposure mitigation techniques such as local exhaust ventilation and High Efficiency Particulate Air filters effectively reduce concentration of airborne particles including those in the nanoscale [13]. (cdc.gov)
  • The questionnaire included questions on work history, non-occupational solvent and noise exposure, and medical history. (cdc.gov)
  • Exposure assessment included gathering data from interviews and company records, and site measurements of noise levels for different work tasks. (cdc.gov)
  • Formaldehyde and other volatile organic compounds (VOCs) are chemicals found in materials such as plywood and particleboard, in furnishings such as furniture, drapes and carpets, and in personal care products. (healthlinkbc.ca)
  • Inflammation could be compounded by adverse biological response to chemicals and metals also in the particles (the "Trojan horse" mechanism). (cdc.gov)
  • Collection of domains associated with the protein based on various sources, including the protein coordinates for the domain, a domain Description, a Source and corresponding accession ID, and the number of S. cerevisiae genes that share the same domain. (yeastgenome.org)
  • Brief summaries describing the function of each gene's product are of great value to the research community, especially when interpreting genome-wide studies that reveal changes to hundreds of genes. (stanford.edu)
  • Includes AC power / DC module with four AC adapter plugs. (khanscope.com)
  • It comes with full optical glass elements, metal framework, 360° rotatable monocular head, and the LED illumination system that uses either wall-power (adapter included) or three AA batteries (or re-chargeable batteries). (primelabmed.com)
  • Is your Labconco product functioning properly? (labconco.com)
  • Product Service is ready to help with installation questions, troubleshooting and replacement parts for your existing Labconco equipment. (labconco.com)
  • Four different paclitaxel mimetics have successfully been synthesized and tested for their biological activity in five breast-derived cell lines. (lu.se)
  • With a history of scientific contributions spanning nearly a century, ATCC offers an unmatched combination of being the world's largest and most diverse collection of biological reference materials and data, and is a mission-driven, trusted partner that supports and encourages scientific collaboration. (atcc.org)
  • Exosomes are being utilized in a variety of biomedical applications, including targeted drug delivery, gene therapy, diagnosis, and tissue regeneration. (selectbiosciences.com)
  • This comprises of all the activities in the value chain, such as the procurement of various raw materials, manufacturing and sales of the products, and their distribution. (medgadget.com)
  • Additionally, as FUJIFILM Corporation has announced previously, the company continues to invest in growing its CDMO business across several modalities including microbial and most recently, in cell culture, with a capital investment of more than 2 billion USD to build a large-scale cell culture manufacturing facility in the U.S. The new facilities will be operated by FUJIFILM Diosynth Biotechnologies. (fujifilm.com)
  • Furthermore, it provides manufacturers with independent product analysis, evaluation of Good Manufacturing Practices (GMP) and potential product recommendation. (who.int)
  • These preventive measures can include seasonal sanitation programs, water management initiatives, and other innovative techniques. (e-architect.com)
  • This research will produce innovative products and methods for managing invasive pest ants. (usda.gov)
  • This would be accomplished through the generation of new formulations of biological control agents (BCAs) based on entomopathogenic fungi and nematodes within integrated pest management strategies. (europa.eu)
  • For example, this company that provides Pest Control in Newcastle can remove vermin in commercial and domestic settings and help you deal with pests larger than insects, including birds. (e-architect.com)
  • The report also analyses the competitive structure of the biological safety cabinet industry and provides the profiles of major players operating in the market. (medgadget.com)
  • Moreover, in order to determine market attractiveness, the report analyses the biological safety cabinet industry along the parameters of the porter's five forces model. (medgadget.com)
  • 4. Based on the findings of the product dossier reviews, laboratory analyses and GMP inspections, to make recommendations to WHO on whether the assessed antivenoms should be listed as recommended product under the SAIL procedure, and under what conditions. (who.int)
  • There are currently several products containing RNA on the market, and many are under development, among them mRNA, antisense oligonucleotides (ASOs), small interfering RNAs (siRNAs), small activating RNAs (saRNAs), micro-RNAs (mi-RNAs), RNA aptamers and RNA guides. (frontiersin.org)
  • Biological factors include different forms of disease organisms in food and water, and those that can be transmitted by insects and animals, and person-to-person contact. (cdc.gov)
  • By analyzing the discharge collected from the stinger apparatus (milking) and the contents of poison and Dufour's glands of little black ants, seven new compounds were found, including amines, alkaloids and terpenes. (usda.gov)
  • Some products are considered "biopesticides" and others "biostimulants. (farmprogress.com)
  • These adverse health effects were associated with the presence of nanoscale particles comprised of decomposition products, including polymers, in the fumes, which can reach deep into the lung and access the pulmonary interstitium [12]. (cdc.gov)
  • Beginning with a global overview, the report explores the dynamics that have a strong influence on the biological safety cabinet market and can also impact its future growth. (medgadget.com)
  • Sites not subject to the NIH Guidelines may choose to establish an IBC or use a committee with a similar name (e.g., site biosafety committee, institutional safety committee) to oversee research with recombinant or synthetic nucleic acids and/or biological agents. (csun.edu)
  • As an institution of research and higher education, CSUN is committed to maintaining a safe working environment in both research and teaching facilities where biological materials are used. (csun.edu)
  • BUSINESS WIRE )--Pfizer today announced a joint initiative with the Shanghai Institutes for Biological Sciences (SIBS) to support fundamental research in China. (pfizer.com)
  • Royal jelly is one of the most studied bee products, but there still remains much to reveal about its biochemistry and biological activity in future research for our health and life benefit. (researchgate.net)
  • We do the research so you can find trusted products for your health and wellness. (medicalnewstoday.com)
  • These included identifying barriers to lime use, research needs, the establishment of a state acidity committee, the development of various decision support tools, various training and awareness activities with growers and agribusiness, support to various regional projects and trials, and establishing a soil acidity website with key information and tools. (grdc.com.au)
  • This project plan describes research to develop new products for managing invasive ants, particularly the imported fire ant, Solenopsis invicta, and the tawny crazy ant, Nylanderia fulva. (usda.gov)
  • By 2012, a total of 40 countries had national TM policies, 19 had national TM strategic plans and 28 national research institutes conducted research on traditional medicine products used for malaria, HIV/AIDS, sickle-cell disease, diabetes and hypertension. (who.int)
  • the Parties at he national, regional munication of Information" spels These wil include but not be and international evels in order to out a framework for research, restricted to those mandated or reduce continualy and substantialy surveilance and technical co p- recommended by the Convention. (who.int)
  • The effect of uncertainty expressed by the combination of the consequences of an event and the associated likelihood of occurrence, where biological material is the source of harm. (csun.edu)
  • This includes engineering and fundamental sciences like microbiology and biochemistry, to agriculture, environmental management and food technology and innovation. (massey.ac.nz)
  • Physical factors include elements that may influence health and well-being, such as injuries and deaths from accidents, loud and excessive noise, extreme temperatures (heat and cold), and the effects of radiation. (cdc.gov)
  • Physical hazards included high heat and humidity, and noise. (cdc.gov)
  • Reactive oxygen species (ROS) are by-products of cell aerobic respiration. (wikipedia.org)
  • The basic principle of biological phosphorus removal is to expose bacteria to alternating anaerobic and aerobic conditions to promote "luxury uptake" of phosphorus. (aqua-aerobic.com)
  • Based on the strategy of operation of the process for granulation with anaerobic feed and selective wasting, the aerobic granular sludge is an excellent system for enhanced biological phosphorus removal. (aqua-aerobic.com)
  • Interventions include but improvement. (who.int)
  • In line with Resolution AFR/RC50/R3 , Member States took steps between 2001 and 2012 to promote traditional medicine (TM) by developing national policies and regulatory frameworks for TM practice, practitioners and products and by implementing some priority interventions. (who.int)
  • As the foundation of that commitment, the University and its policies comply with all federal and state regulations & guidelines governing the use of biological materials. (csun.edu)
  • A recent opinion issued by the Enlarged Board of Appeal (EBoA) of the European Patent Office (EPO) has established that plants and plant materials are not patentable if they are exclusively obtained by means of an essentially biological process. (cooley.com)
  • Until now, however, the EPO has not adopted a settled approach as to whether plants or plant materials (such as fruits or other plant parts) that have been obtained by an unpatentable essentially biological process are themselves patentable. (cooley.com)
  • The EPO has at some points appeared to "firmly" establish that plants and plant materials that have been obtained by an unpatentable essentially biological process are patentable and at other times that they are not patentable 3 . (cooley.com)
  • Pepper endorses the EBoA's previous interpretation in Broccoli/Tomato II , and so it appears that patents and applications to which Pepper does not apply may validly claim plants or plant materials exclusively obtained by means of an essentially biological process. (cooley.com)
  • The V-ATPase that includes the subunit produced from the ATP6V1B1 gene is found in the inner ear and in nephrons, which are the functional structures within the kidneys. (medlineplus.gov)
  • Since the index case was identified in Illinois on March 3, 2018, state health departments have reported 202 cases, including five deaths, to CDC. (cdc.gov)
  • Actual results may differ materially from those included in these statements due to a variety of factors, over which Biological has no control. (the-scientist.com)
  • Tight control of pH is necessary for most biological reactions to proceed properly. (medlineplus.gov)