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COVID-19 research for children image
Tech & Analysis
COVID-19 research for children
Emmes, a global, full-service Clinical Research Organization dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced its role as a Data Coordinating Center on a team whose work has accelerated pediatric COVID-19 research through the Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POP02). The team, led by the Pediatric Trials Network at Duke University, also includes the Gabriella Miller Kids First Data Resource Center (DRC) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). POP02 is one of several cohort studies within the Collaboration to Assess Risk and Identify LoNG-term outcomes for Children with COVID, known as CARING for Children with COVID. The National Institutes of Health (NIH) initiated the CARING for Children with COVID program to collect clinical data and samples that would advance the understanding of SARS-CoV-2 infections in children. The program seeks to provide information to help healthcare providers and parents make informed decisions when caring for children infected with either COVID-19 (acute coronavirus disease) or who have MIS-C (multisystem inflammatory syndrome). Data from the POP02 study was used to develop and pilot tools leveraging the Health Level Seven International® (HL7®) Fast Healthcare Interoperability Resources (FHIR®) standard. These are new tools and resources that will advance and accelerate the rapid release and accessibility of pediatric COVID-19 clinical data. The first batch of POP02 data (representing 57 participants) has been released using a newly launched FHIR Application Program Interface (API), in cooperation with the Kids First DRC. A second batch of data will be released in the coming weeks. According to Emmes’ Vice President of Maternal and Child Health, Ravinder Anand, Ph.D., “The FHIR API is the first-of-its-kind implementation for near real-time, secure release of pediatric COVID-19 data. Before our partnership with Kids First DRC, Emmes had developed FHIR APIs across multiple cloud platforms to easily accommodate the addition of ongoing semantic information. The Kids First cooperative effort required mapping the data collected in the POP02 study case report forms to existing FHIR resources and incorporating additional terms from a variety of health sources, such as SNOMED Clinical Terms.” Valerie Cotton, deputy director of the Office of Data Science and Sharing at NICHD, said, “Rapidly sharing pediatric COVID data using interoperability standards accelerates research that will help understand the impact of the pandemic on children and design interventions. This effort is a model for how groups can collaborate to respond to public health needs.” Emmes’ work to support the POP02 and its participation in the CARING for Children with COVID project grew out of its existing role as the Data Coordinating Center for studies conducted under the Best Pharmaceuticals for Children Act (BPCA). Results from these clinical trials have contributed directly to improved drug labeling for a range of products used in treating infants and children. “Our role as Data Coordination Center for the Best Pharmaceuticals for Children Act dates back to 2009,” noted Emmes Chief Executive Officer, Dr. Christine Dingivan. “Now, with this newer work, we’ve widened our focus from supporting the safe drug development in children to the international priority on how to combat pediatric COVID-19.”
Emmes launches Advantage eClinical as a standalone cloud native clinical technology platform
The cloud platform will empower biotech companies and CROs with an integrated solution for clinical data management and is supported by Emmes specialist data management teams Rockville, MD, May 11th, 2022: Emmes – a global, full-service Contract Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, announces that it will introduce to market its third generation version of Advantage eClinical at Society for Clinical Trials (SCT) in San Diego, May 15th – 18th. The cloud platform of Advantage eClinical will be available as a standalone software product after undergoing more than two years of development. The system has been specifically designed to provide fast study builds, greater flexibility, and insights to clinical trial sponsors of all sizes. Advantage eClinical provides a fully integrated suite of data management applications backed by decades of domain expertise. The cloud platform includes apps for study design, electronic data capture (EDC), randomization and trial supply management (RTSM), patient-reported outcomes (ePRO), safety data and reporting, risk-based monitoring, source data verification, and specimen/shipment tracking. It will be offered as part of combined packages with data consultation services, or simply as a standalone software product. “One of the challenges many smaller biotechs face in the market is they don’t have access to an integrated technology platform for their trials. Options are incredibly limited and expensive, and they are often inflexible and lack support. This is exactly what we have set out to address with our third-generation Advantage eClinical platform,” commented Hemang Maniar, Chief Information Officer at Emmes. Advantage eClinical was developed by clinicians for clinicians and provides one of the most cost competitive and resource rich options available to sponsors. It delivers robust features that improve data quality, ease oversight of clinical trial operations, and reduce trial timelines and costs. The cloud platform builds on Advantage eClinical’s long history of supporting over 1,000 clinical trials, including several high-profile adaptive COVID-19 trials, and leverages these prior study designs as clone templates to empower customers with an expedited set-up. Maniar added, “as a cloud-based multi-tenant system it is easier to ensure scalability, security and release updates quickly. What’s more, out of the box CDASH CRF libraries allow us to get studies up and running in only a few weeks. This addresses a major concern from sponsors who need to start collecting data ASAP to avoid any delays on trials. What we are also providing is tremendous flexibility, and the client can choose to build their modules alone or engage our experienced data teams to provide guidance. The combination of an integrated system built by experienced clinicians, flexible support, and cost-effective scale is unique in the current marketplace.” Advantage eClinical has supported over 1,000 trials, for nearly one million patients in over 70 countries, spanning more than 31,000 clinical trial sites. -ENDS- Notes to editors About Emmes Founded in 1977, Emmes is a global, full-service clinical research organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. The company’s clients include numerous agencies and institutes of the U.S. federal government and a wide range of biotechnology, pharmaceutical, and medical device companies throughout the world. To learn more about how our research is making a positive impact on human health, go to the Emmes website at www.emmes.com. For media enquiries, please contact: Alex Heeley or Nidhi Narain De Facto Communications T: +44 (0) 203 735 8165 M : +44 (0) 7769015043 E: a.heeley@defacto.co.uk / n.narain@defacto.co.uk
'Comprehensive Solutions for GPCR Expression' image
R&D
Comprehensive Solutions for GPCR Expression
CD BioSciences, a leading customer-focused biotechnology company based in New York, recently introduces comprehensive solutions for GPCR expression based on various strategies and technique platforms to facilitate customers’ cutting-edge programs. G protein-coupled receptors (GPCRs) are the largest family of cell surface receptors, which play key roles in signal transduction and are involved in a variety of physiological regulatory mechanisms in the human body. They regulate adaptations in homeostasis, metabolism, sensory perception and neurotransmission. As one of the largest pharmacological therapeutic targets, the detailed structural and functional knowledge of GPCRs is important for understanding drug-target interactions. Most GPCRs are naturally present in very small amounts. The inherent structural flexibility and dynamic properties of GPCRs are also major obstacles. Therefore, a robust, efficient, and reliable expression system must be established to obtain stable GPCRs in sufficient quantities for various downstream applications such as basic functional studies, structural studies, antibody development, and drug discovery. Highly expressed GPCRs also have great potential in developing new treatments for a variety of diseases. CD BioSciences now provides its customers with comprehensive solutions for GPCR expression to facilitate their cutting-edge programs. Its experienced scientific team can select the most suitable expression system and provide customized services tailored to specific requirements of customers. CD BioSciences offers various expression systems for researchers to choose from, like stable expression system, bacterial expression system, yeast expression system, plant expression system, and wheat germ expression system. Customers now can choose any solutions for GPCR expression to facilitate their cutting-edge programs, such as Cell-based Expression System that allows for high levels of protein production and is suitable for many different types of proteins; Cell-free Expression System that is a robust, highly efficient and controllable approach, suitable for complex, toxic, unstable or easily degradable proteins and is easy for purification; and Mammalian Cell Expression System, which is more efficient and proper protein folding and post-translational modification, and is suitable for large proteins. CD BioSciences provides comprehensive and professional protein-based solutions for GPCR research and drug development to help its global customers facilitate their cutting-edge projects. It offers customized services based on a complete set of protein assays. Its scientific team has years of experience and can provide customized services and one-stop solutions in its fully equipped laboratory. If you are interested in GPCR expression services or have any specific needs, please visit its site at https://www.progpcr.com. About CD BioSciences CD BioSciences is a leading customer-focused biotechnology company founded in New York. With unparalleled expertise in manufacturing, CD BioSciences focuses on biological and chemical products, and strives for solutions that can improve research outcomes and dramatically increase the speed of success. CD BioSciences is committed to providing universities, research institutions, biotechnology companies and pharmaceutical companies with a wide range of high quality and reliable products and comprehensive service packages of GPCRs to enable advancement of basic science and drug development.
'Very accurate dosing in accordance with GMP' image
Automation
Very accurate dosing in accordance with GMP
Less waste of APIs An important player in the pharmaceutical industry had long been familiar with the application of the highly accurate and pulsation-free micropumps of HNP Mikrosysteme on a laboratory scale. In the course of time, people came up with more and more far-reaching questions and demands. For the very accurate dosing of 2 products, 2 micro dosing systems in accordance with GMP were eventually requested. But HNPM's systems are not standardized on GMP. GMP (Good Manufacturing Practices) To comply with GMP, quite a few requirements are set. Both to the materials used and the roughness of the surface and to the cleanability of the dosing system. Because contamination is undesirable and not even allowed. The ultimate goal of GMP is to always guarantee the same high quality product, without risk of cross-contamination by residual product in one of the components of the process equipment. GMP provides for several procedures and guidelines. The purpose of the procedures is to make each component traceable. All batches must be validated. This means that these are recorded with certificates. For laboratories, this means that DIN is used as a guideline. This is a European directive. This also immediately complies with CE. Only a carefully recorded and controlled production process ensures the quality of a medicine. HNPM's standard micro dosing systems do not comply with GMP. To achieve this, adjustments had to be made. OUR SOLUTION To prevent remaining material in the dosing system and not using an unnecessary amount of API, the standard system has been adapted on several fronts. A special flow meter was also selected that complies with GMP. * Surface roughness The standard material roughness of HNPM micropumps is Ra 0.8 μm. The customer asked for a surface roughness of only Ra 0.5 μm. This roughness is not possible everywhere. In the present case, a surface roughness of Ra≤0.8 was feasible for both filter and pump. An Ra 0.8 μm is actually quite exceptional and was more than sufficient for a GMP application. A roughness of 0.8 μm was therefore agreed. The best (smoothest) we could deliver at that time. * New type of filter developed with small internal volume (7ml) HNPM developed a new type of filter, the FM10, with a smaller internal volume compared to other standard filters of HNPM (FM12 = 36ml, FM10 = 7ml). The Ra of the filter, like the one for the pump, was 0.8 μm. The advantage of this new filter is that it can be easily cleaned. Both CIP and SIP! * Adjustment NPT connections (fittings) The NPT fittings have been adapted to fittings without corners and dead volume so that they can be easily cleaned and sterilized. * PEEK tubing with internal diameter of only 1.8mm! A type of tubing was used with a smaller internal diameter. The original tubing: Internal diameter 4mm, external diameter 6mm. The new tubing: Internal diameter 1.8mm, external diameter 2mm. The advantage of this is that less API has to be used (less API waste!). In addition, this gives an improved volume flow and ensures faster and more efficient rinsing. * Documentation Inspection documentation was made available for the wetted parts: 1. Pump/ filter/ flow meter 2. Tubing/ connections/ adapters/ seals 3. Hoses For the metal products, 3.1 certificates and the Declaration of compliance 2.1 (DIN EN 10204:2005) have been delivered. Summarized 1. The system has a perfect surface roughness of Ra 0.8 μm 2. Use of FDA approved materials 3. All necessary certificates are available 4. CIP and SIP cleanable 5. Accurate and pulsation-free flow, independent of differential pressure and volume flow! With the adjustments and documentation made, the dosing system now perfectly complies with GMP! An economical and safe solution, also for your process! Fully validated according to GMP. DEMANDING PROCESSES, SUSTAINABLE SOLUTIONS
'Active Pharmaceutical Ingredient Excipients' image
Tech & Analysis
Active Pharmaceutical Ingredient Excipients
Continuing to be a trust-worthy CRO company for drug formulation and development, CD Formulation recently announces the enrichment of its active pharmaceutical ingredient excipient offerings. Now a number of API excipients are readily obtainable at CD Formulation, including Cetrorelix Acetate, Fondaparinux Sodium, Calcitriol, Vitamine D3, Tirofiban Hydrochloride, Eptifibatide, Ferric Ammonium Citrate, Calcipotriol API, Calcium Orotate, Meglumine, Obeticholic Acid, Potassium Magnesium Citrate and Magnesium Oxide. Both active pharmaceutical ingredients (APIs) and excipients are the two core components by which drugs are made up. APIs refer to the biologically active ingredients of pharmaceutical products, while excipients are chemically inactive substances that help deliver the medication to people’s systems. “The main purpose of excipients is to enhance the effect of the active ingredients in the medicine, in each possible aspect. For instance, binder excipients act as a binder to bind powder, granules, and other dry ingredients together to give the product the necessary mechanical strength. Penetration enhancer excipients help to absorb the API through the skin into the body. Stiffening agents are used primarily in topical preparations to increase the viscosity of the preparation,” says a senior scientist from CD Formulation. Among all the newly launched API excipients, cetrorelix acetate is a white powder that can be used as a component of controlled ovarian stimulation regimens. Fondaparinux sodium can be used in anti-thrombotic applications. Eptifibatide can serve as a platelet aggregation inhibitor. The ferric ammonium citrate provided is of pharmaceutical secondary standard and tirofiban hydrochloride is of medical grade. Magnesium oxide possesses a cubic crystalline structure, although the BP and PhEur describe light magnesium oxide as an amorphous powder. Meglumine is an excipient used in Telmesartan tablets. In addition to those already readily available API excipients, CD Formulation also offers tailored synthesis and manufacturing services for clients worldwide who have special requirements on the type, quality, and quantity of excipients. With concerted efforts from both sides, CD Formulation aims to bring out the best-performing excipients and ultimately make the contracted drug research project a success. Please visit https://www.formulationbio.com/custom-pharmaceutical-excipients.html to explore more. About CD Formulation As a service provider for excipient development, analysis and testing as well as drug formulation, CD Formulation feels a great honor to have successfully accomplished several drug formulation research projects for its customers. Encouraged by the persistent trust from its partners, the company decides to further enrich its business range to provide a more comprehensive service portfolio for its valued customers worldwide. Among these, drug packaging services are newly added to help developers establish a unique and easy-to-distinguish drug packaging.
'How to Select Pharmaceutical Excipients?' image
Tech & Analysis
How to Select Pharmaceutical Excipients?
Pharmaceutical excipients refer to the substances used in the production and formulation of medicines. They perform multiple functions in pharmaceutical preparations and are likely to affect the quality, safety and effectiveness of drugs. Pharmaceutical excipients can be classified into natural, semi-synthetic and fully synthetic compounds according to their sources. And based on their use, excipients can be divided into diluents, binders, disintegrants (https://www.formulationbio.com/products/disintegrant-excipients.html), lubricants, glidants and anti-caking agents, wetting agents and solubilizers. Among all varieties of excipients, how to select the most appropriate ones for a specific drug formulation project? The guidelines below should be taken into consideration. The compatibility of the main drug and the excipients should be studied. When screening and researching drugs with new chemical structures, attention should be paid to the investigation of the interaction between the main drug and the excipients. The excipients should have stable properties with no physiological activity, no influence on the content determination of the main drug and no adverse effect on the dissolution and absorption of the drug. According to the above principles, when we select excipients, we must first conduct research on the compatibility of the main drug and excipients. Through preliminary investigation, we can understand the excipient-to-excipient interaction and excipient-to-drug interaction, to avoid the selection of excipients with adverse interactions in prescription design. For lack of relevant research data, compatibility studies can be conducted. For example, for solid oral preparations, several kinds of excipients can be selected at first, and then mix the main drug and excipients with a certain proportion, and put them under strong light (4500±500Lux), high temperature (60℃) and high humidity (90±5 %) conditions for 10 days, and finally use HPLC to check whether the content and related substances changed before and after placing. When necessary, the active pharmaceutical ingredients (APIs) and excipients can be used for parallel control experiments to judge whether it is the change of the API itself or the influence of the excipients. If conditions permit, experiments such as hot plate (DTA or DSC) can be used to determine whether the main drug interacts with the excipients. The selection of excipients should be quality centric. The choice of excipients should first consider the mechanism of action of the drug. Second, the excipients chosen should meet the characteristics and requirements of the dosage form. Third, it is a must to study the effect of the excipient’s physical and chemical properties on the preparation. Changes in the excipient’s physical and chemical properties may affect the quality of the preparation in terms of viscosity, particle size and distribution, fluidity, moisture, pH, etc. For the polymer materials used in sustained and controlled release formulations, changes in molecular weight and viscosity may have a significant impact on the release behavior of drugs. Therefore, according to the characteristics of the preparation and the route of administration of the drug, the physicochemical properties of the excipients in the prescription that may affect the quality of the preparation should be analyzed. If necessary, the corresponding quality control standards should be formulated, and attention should be paid to the selection of appropriate sources of supply to ensure the stability of the quality of excipients. It should be noted that although some excipients pass the short-term compatibility test without problems, new degradation impurities may appear after 3-6 months of accelerated test. On the contrary, sometimes the compatibility study is first problematic, everything gets fine after adjusting the ratio. For instance, captopril (captopril) and magnesium stearate are incompatible, but the tablet with high drug content (100mg) and magnesium stearate are stable, while tablets with low drug content (2 mg) showed significant incompatibility. Therefore, the results of the compatibility test between raw materials and excipients cannot fully represent the stability under real conditions. CD Formulation is a leading manufacturer of a large variety of excipients. Driven by the latest science and technology, it has grown to be a reliable source for the pharmaceutical industry, offering not only rich collection excipients but also a wide range of preformulation, formulation, analytical and custom pharmaceutical excipients services. Always at the forefront of innovation, CD Formulation aims to address the challenges arising from pharmaceutical formulation, and in a much broader sense, hopes to advance the global medical business.

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'Cannabis vs. Coffee: The science behind the ultimate extraction' image
Quality
Branded
Cannabis vs. Coffee: The science behind the ultimate extraction
Regardless of the particular coffee roast or cannabis strain, there is a science to extraction that underlies the true essence of these plants and their extracted products. Your favourite coffee or expresso. The warm balance of the roast. The sweet and fruity notes. The robust and toasty finish. These traits come from a balance of oils, fruit acids, sugars, and aromatics, something you may have pondered after a sipping a cup or two. Chances are you’ve given less thought about where these qualities originate and how they find their way into your cup. Extraction is the process that provides access to these qualities and compounds, through grinding the coffee bean, solubilizing in water, and separating the extract. Whether filtered coffee, French press, or espresso, all methods for brewing involve the central process of extraction. Each brewing method requires a consistent and ideal size of grind, ranging from coarse to super fine, and each extraction method calls for uniform coffee particles in order to deliver the unique characteristics of the brew. One could think of cannabis or hemp concentrates in a similar light. Whether ethanol, butane, or supercritical CO2 extraction, the goals of these extraction techniques are the same – to gain access and harvest compounds and qualities of the plant. Each biomass processing method demands an ideal grind or milling output. And the success of each extraction method depends on controlled particle size, which translates to the value of the product for both the producer and the consumer. Regardless of the particular coffee roast or the specific cannabis strain, there is a science to extraction that underlies the true essence of these plants and their extracted products. Dr. Markus Roggen, in collaboration with FRITSCH MILLING & SIZING, INC, recently explored the parameters behind cannabis extraction, with particular focus on the impact of milling performance on yield, consistency, and overall quality. The Science of Extraction: Yield, Consistency, Quality Yield, the percentage of material that is harvested from the source, is an important component of extraction. The “strength” of coffee relates to the percentage of dissolved compounds in the extract. The strength and consistency of a brew has everything to do with achieving the appropriate yield and maintaining this ability in subsequent attempts. Failure to do so can result in product that is either too thin and weak or shows unwanted variability from one batch to the next. Cannabis and hemp processors strive to maximize extraction yields and harvest as much soluble material as possible for subsequent processing. If the yield of the cannabis extract is too low, potency of cannabinoids, terpenes, and other desirable compounds is diminished. If batch consistency is low, the quality and the value of the extracted product is compromised. The Impact of Milling on Cannabinoid and Terpene Recovery In their work, Dr. Roggen, Blake Grauerholz, and colleagues first set out to study the impact of particle size and consistency of the starting material on recovery yields of cannabinoids and terpenes. In a first set of experiments, a homogenous mixture of whole plant material was ground into multiple samples ranging from 1 mm to 10 mm using a FRITSCH Universal Cutting Mill PULVERISETTE 19. In parallel, a mixed particle size sample produced using a food processor as well as an un-ground sample were analyzed. The RPM of the milling system was also varied during testing, in order to determine if there was any thermal degradation of compounds resulting from increased rotor speed. Lab testing was performed on pre- and post-milled material to determine recovery yields of terpenes and cannabinoids. Results indicated that recovery yields of cannabinoids and terpenes increased as the size of the milled particles decreased. Furthermore, milling RPM of the P19 had minimal effects on decarboxylation or thermal degradation of compounds. This is consistent with the engineering and operational functionality of this device and the focus on heat load and temperature mitigation. The Impact of Milling on Extraction Efficiency The act of coffee grinding provides access to internal compounds within the cavities of the beans. The resulting exposure of increased surface area within the beans promotes extraction of the compounds. The size and the consistency of the coffee grinds, as well as the duration and precision of the process, have significant bearing on the success of extraction. Smaller size particles slow down the flow of water and increase contact time between the grinds and the water. Higher particle consistency results in better integrity of the extraction vessel, less channelling, and other effects. Whether pour over, flow, or pressurized extraction, the extraction efficiency is paramount in attaining that perfect cup of brew. A further set of experiments by Dr. Roggen’s group focused on the impacts of particle size and consistency on cannabis extraction efficiency. A select range of particle sizes (2 mm, 6 mm, and 10 mm, along with controls) were used for CO2 extraction under typical production parameters. The effects of milling were determined by analysis of cannabis oil yield and composition. Results indicated that finer, more uniform particle sizes provided better precision in extraction. Furthermore, smaller particle sizes resulted in higher quality and purity of cannabinoid fractions in the extracted product. Un-ground samples, on the other hand, offered minimal precision and demonstrated greatly reduced extraction yields compared with milled samples. Espresso beans are typically ground to a fine consistency and packed tightly for extraction. Rapid extraction with hot, pressurized water gives rise to a highly concentrated, strong “shot” of coffee. In theory a tight, uniform particle size distribution should allow more cannabis material to be packed in an extraction column. This is turn should lead to increase sin extraction yield. To test this, the output of the PULVERISETTE P19 milling system was examined, and the particle size distribution was measured using the FRITSCH Laser Particle Sizer ANALYSETTE 22 NeXT. Results showed a sharp peak at 1 mm, with minimal secondary peaks, indicative of a tight size distribution. Further investigations of milled and un-milled cannabis within the extractor vessel demonstrated that indeed the packing density has a significant effect on total recovery. The Impact of Milling on Quality Additional factors can affect the overall quality of the extracted product. These include the ability to adjust or fine-tune milling in order to achieve the most desirable extraction yield and compound profile every time. In cannabis, this ability must be coupled with maintaining the chemical profile of cannabinoids, terpenes, and other valuable compounds, regardless of the type of starting material. Extensive testing of whole flower versus the PULVERISETTE 19 milling system output, showed no significant differences in compound recovery of THCa, ∆9THC, and in repeated analyses (see chart below). These data illustrate batch to batch consistency and integrity of the chemical profile through use of this Precision Milling System. Summary Just as coffee extraction can be tuned to produce that perfect cup of brew, cannabis extraction processes can be optimized to maximize yields and ensure the integrity and quality of the product. The body of research described above can be summarized with the following conclusions: ▲ Precision milling can produce the right particle size and a tight size distribution for optimal extraction yields. ▲ Process milling with the P19 does not significantly alter the integrity of the components nor the compound profile of the cannabis material. ▲ Use of the P19 promotes extraction efficiency while preventing capture of undesirable contaminants. ▲ The ability to control multiple parameters through the use of a device such as the PULVERISETTE 19 Precision Milling System enables processing of high-quality product suitable for a range of valuable downstream applications. So there you have it. Extraction is only as efficient as the quality and consistency of the starting material. In the case of cannabis, high-performance, precision milling makes all the difference. Now, back to that enticing cup of CBD infused coffee.

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