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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

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.

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

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.

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.