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Spectroscopic analytical techniques are pivotal in the pharmaceutical and biopharmaceutical industries, facilitating the classification and quantification of processes and products. This review highlights very recent advancements in several key spectroscopic methods, including atomic, vibrational, molecular, electronic, and diffraction techniques. The applications of these analytical techniques in drug development, process monitoring, and quality control are discussed, showcasing their integral roles in advancing pharmaceutical sciences. [ABSTRACT FROM AUTHOR]

The article discusses gene and cell therapies and potential drug targets for retinitis pigmentosa (RP) as of May 2024. Topics covered include limited treatment candidates for voretigene neparvovec which give positive results, and therapies under development like viral vectors, clustered regularly interspaced palindromic repeat (CRISPR/CRISPR-associated nuclease 9 (Cas9) gene editing system, and ribonucleic acid (RNA) replacement. Also noted are stem cell therapies, and optogenetics.

The article discusses findings from the CHAMP phase 3 study which showed that NVK002 atropine 0.01% from Vyluma, Inc. meaningfully slowed myopia progression in pediatric patients with myopia, presented by Dr. Rupa K. Wong at the 49th Annual Meeting of the American Association for Pediatric Ophthalmology and Strabismus. Topics include advantages of the formulation of low-dose atropine, explanation by Wong about the treatment of myopia with low-dose atropine in the U.S., and results of the study.

The article enumerates the things that one should know about presbyopia, farsightedness that is affecting nearly all aging individuals due to age-related decline in lens accommodation. Topics include topline data that support approval of the first pharmacologic therapy for presbyopia, investigational miotics that are in various stages of development, and the need for appropriate patient evaluation prior to miotic therapy.

The article focuses on treatment options being evaluated and developed for geographic atrophy, which is an end stage of age-related macular degeneration. Topics discussed include the use of the complement pathway therapy to treat geographic atrophy, a clinical trial of Gildeuretinol from Alkeus Pharmaceuticals, and a study of antigen-binding fragment ANX007 from Annexon Inc.

Bispecific antibodies open new opportunities in drug development and have become a desirable drug format in cancer immunotherapy. In this type of application, one arm of the bispecific antibody binds to a cancer-specific receptor, while the other arm binds to a T-cell specific receptor to induce cancer cell elimination. Because up to four different polypeptide chains are involved in the assembly of a full-length bispecific antibody, many strategies have been developed to maximize the yield of the desired product (heterodimer) and facilitate the removal of undesired variants, such as homodimers. The successful adaptation of each strategy requires the development of suitable analytical methods to detect and measure the levels of undesired variants. Because the physicochemical properties of the undesired variants can be very similar to those of the desired heterodimer, it is paramount to magnify the minor differences as part of method development. In addition, given that the facilitation of heterodimerization of bispecific antibodies often relies on specific mutations that may impact the physicochemical properties, additional method assessments may need to be considered to ensure their suitability, such as interference from desired product to undesired variants. In the first half of this article, a summary of the common strategies employed in the production of full-length bispecific antibodies is provided. Then two case studies are presented in the second half. In the first case study, the proof-of-concept results are shared for a novel analytical method for variant detection using hinge-specific proteases that cleave at defined sites above or below the disulfide bonds in the hinge region. In the second case study, the method qualification experiments are described for a homodimer quantitation method to address the potential charge-charge interaction between a homodimer and the desired heterodimer. [ABSTRACT FROM AUTHOR]

The article reports that YP-P10, a novel, patented synthetic peptide from Yuyu Pharma, is being evaluated for safety, tolerability and efficacy for the treatment of patients diagnosed with dry eye diseases in the phase 2 clinical trial ICECAP 1, as of May 2023. Topics covered include growth in peptide research, the challenges of developing dry eye therapeutics and the results of studies conducted in animal models of dry eye.

Timely access to information in a streamlined, synthesized, and comprehensive format is critical to the success of the transformative programs and learning health systems that characterize Vanderbilt University Medical Center (VUMC). To meet this need, highly-trained information professionals created an infrastructure support framework, based on years of successful evidence interventions, that helps move discoveries from bench to bedside. As clinical programs and practices are regularly evaluated at the institutional level, a team of information experts, each participating actively in projects throughout the medical center, helps document institutional decisions and supports them with both internal and external research data. An archival system supports the maintenance and scalability of this effort through intelligent reminders and, when feasible, work assignments. With the drive to achieve precision medicine-based care, defined by the National Institutes of Health as an approach accounting for individual genetic, environmental, and lifestyle factors, information professionals need to continually enhance their cadre of skills and competencies. At VUMC, information scientists are engaged in efforts to advance healthcare research; these efforts span from drug repurposing projects that require applying advanced, ever-changing subject knowledge to mine data from genetic, protein, and structural resources, to population health initiatives that necessitate understanding of public health, epidemiology, social determinants of health, and healthcare disparities. The institution's commitment to discovery is coupled with the need to contain costs while improving care. Information scientists ensure resources are properly channeled to current effective care practices by regularly appending and substantiating evidence to decisions undergoing process review. Data is collected on an ongoing basis for formal and informal evaluations, both for purposes of process refinement and for effective communication to leadership on return on investment. [ABSTRACT FROM AUTHOR]

A defining requirement in biopharmaceutical development, formulation, and manufacturing is to elucidate and maintain the structure of the drug entity. That work relies on relevant protein characterization, a task complicated by how samples evolve through the drug development lifecycle. The requirement to change techniques to cope with progressively more concentrated, and complex, multicomponent formulations is a major issue when it comes to comparing datasets and safeguarding structural parity. In this article, we discuss a new infrared spectroscopy technique, microfluidic modulation spectroscopy (MMS), that delivers reproducible protein characterization over close to four orders of magnitude in protein concentration, from 0.1 to 200 mg/mL. This technique can transition with the sample from the earliest stages of development through to manufacture, and present experimental data demonstrating the concentration-independent data that can be generated. [ABSTRACT FROM AUTHOR]

The article discusses latest research and drug development on eye care for patients. Topics include need of medical eye care to prevent sight loss; Vascular endothelial growth factor (VEGF) which is important factor in the development of both diabetic macular edema (DME) and proliferative diabetic retinopathy (PDR); and Intensive lifestyle which focused on weight reduction and increased activity levels.

The article discusses the systemic lupus erythematosus (SLE) which is a chronic inflammatory autoimmune disorder that predominantly affects women of child-bearing age with a ~9:1 female-to-male ratio. It states that patients with SLE will suffer an impaired health-related quality of life and will experience fatigue and pain as major problems.

There are now >30 antiretroviral medications available for the treatment of HIV. These drugs have distinct sites of action in the HIV life cycle, and unique pharmacological properties that dictate how they can be used safely in the treatment of HIV. Drugedrug interactions (DDIs) can occur because of alterations to several pharmacodynamic processes, including absorption and drug transport, but hepatic metabolism is clinically the most important. Co-administration of antiretrovirals with other, more commonly used drugs is becoming commonplace, and clinicians must be aware of potentially serious interactions that can lead to treatment failure and toxicity. [ABSTRACT FROM AUTHOR]

The article discusses the continue drug development, with patients a disservice, with drawing on the treatment philosophy in glaucoma specialty practice. Topics include medical treatment of glaucoma are adherence issues, patient burden and ocular surface side effects; and the introduction of sustained-release device that can relieve treatment burden from patients.

The program would aim to incentivize competition in small molecule generics markets, which currently have limited competition. Because of a lack of competition in some generic drug markets, experts have proposed a new priority review voucher program to incentivize competition in small molecule generics products that currently have few competitors. To address this, the authors proposed that companies that develop and market generic drugs in markets with limited or no competition would receive a transferrable priority review voucher (PRV) with no expiration date. [Extracted from the article]

The article provides insights into biosimilars, overcoming barriers to biosimilar uptake, and the impact of biosimilars on retinal eye disorders. Topics include difference between biosimilars and reference drugs, the use biosimilars in ophthalmology, and practical implications of increased biosimilars use.

Clinical staff, including nurses, have played a crucial role in caring for and supporting patients with COVID-19. [ABSTRACT FROM AUTHOR]

The article describes the use of microfluidic modulation spectroscopy (MMS) in determining the characterization and measurement of the secondary structure of proteins. Topics discussed include the measurement of protein structures in drug formulation, development and manufacture, the use of vibrational spectroscopy, and the series of experiments on the dynamic range, sensitivity and repeatability of MMS.

The article focuses on the biomimetic chromatographic profiling and measurement of nonspecific binding to proteins and lipids to accelerate drug discovery process. It explains the high performance liquid chromatography (HPLC)-based measurements of lipophilicity and biomimetic properties of albumin, glycoprotein, and phospholipid binding of drug discovery compounds. It also explains the in vivo distribution models derived from the measured data of drug discovery compounds.

The article presents a study which profiles various nonionic ethoxylated surfactants applied in pharmaceutical formulations using comprehensive two-dimensional liquid chromatography (LC) with evaporative lightscattering detection (ELSD) and mass chromatography (MS). The study used an Agilent 1290 Infinity 2D-LC Solution system and analyzed products such as alcohol ethoxylate, polysorbate, and polyethoxylated castor oil. Results of the study are offered.

The article discusses the importance of mass spectrometry in the discovery and development of biopharmaceutical drugs. It mentions that high resolution mass spectrometers (HRMS) especifically quadrupole time-of-flight mass spectrometers (QTOFs), are well-established for biopharmaceutical characterization in drug discovery and development including the determination of high fidelity rate that allows accurate glycosylation profiling.

The article focuses on the U.S. Food & Drug Administration (FDA) approval of two cancer treatments and asthma drug made by the drug company AstraZeneca. It discusses the introduction of oncology drugs in the breakthrough therapy designation (BTD) and how the shortening of the time frame for the oncology drug should have reduced the research and development (R&D) costs, which is not happening.

The article discusses the role of G protein-coupled receptor (GPCR) structures in drug development and design. Topics include the use of point mutations for stabilizing GPCRs without disrupting protein conformations and functions, discovery of high-resolution GPCR crystal structures, and the use of structure-based design by GPCR company Receptos to identify the GPCR-targeted drug candidate RPC1063 (ozanimod).

The article explores technological innovations in cataract surgery for 2017. Topics mentioned include the use of Tecnis Symfony Extended Range of Vision intraocular lenses (IOL) for presbyopia correction, the benefits offered by the Zepto Capsulotomy System from Mynosys, and the importance of Bausch + Lomb's enVista IOL MX60E for the achievement of predicting outcomes using a toric model.

The article informs that chemist Matthew Disney is planning and designing of small-molecule drugs that can target RNA. It mentions proteins use pockets in their complex three-dimensional structure to respond to, construct, or break down molecules. it also mentions academic chemists are increasingly making RNA drug discovery more mainstream.

The complexity of next-generation drug modalities and delivery systems requires new and integrated analytical approaches. A progressive design of chromatographic instrumentation, stationary phases, flexible data systems, and integrated control are needed for chromatography to remain a leading relevant characterization tool. This paper provides an overview of some current and emerging physicochemical analytical challenges associated with these sophisticated drug systems and some of the technical advances needed in chromatographic systems to enable their design, development, and manufacture. [ABSTRACT FROM AUTHOR]

The article reports on the growing demand for chemists and specialized instruments in the U.S. The trend is attributed to the rising number of new products developed by manufacturers. The Food and Drug Administration (FDA) has approved several products introduced by drug companies. Other companies are developing pharmaceutical-grade cannabis-based products.

The article reports that Jiangsu Hengrui Medicine Co. Ltd., one of China's largest generic drug makers, has launched two of its own drugs in China and licensed rights to another to a U.S. firm. It is said that Hengrui and other Chinese firms launching their own drugs at home is an indication that an innovative drug industry is taking root.

A surfactant-based diluent was used in sample preparation for reversed-phase high performance liquid chromatography (HPLC) analysis of a drug product and its impurities in a phospholipid formulation. The use of didodecyl trimethylammonium bromide (DDAB) enabled a consistent, quantitative extraction of the analytes of interest from the lipid matrix in a much more aqueous, weaker solvent than was specified in a previously established method. Water was added as an antisolvent to precipitate the surfactant from the system to eliminate HPLC injection pressure spikes, thereby enabling large-volume injections and achieving a consistent, robust method for long-term use. This article describes both the method development and validation steps. [ABSTRACT FROM AUTHOR]

The article focuses on cryopreservation of human tissues for organ transplantation and the research in areas such as tissue engineering and drug discovery. It mentions Organ Preservation Alliance and the U.S. American Society of Mechanical Engineers (ASME) is organizing Summit on Organ Banking through Converging Technologies in Boston, Massachusetts in August 2017. It also mentions nanowarming is accomplished by infusing the tissue with magnetic nanoparticles.

The article presents the author's views regarding increasing biomedical research being conducted on male animals as compared to female ones. Topics discussed include views of Monica P. Mallampalli, vice-president at Society for Women's Health Research, regarding different responses of drugs in men and women, views of researcher Jeffrey S. Mogil regarding its for implications for drug development and views of researcher Virginia M. Miller regarding synthesis and cell signaling pathways.

Portable instrumentation for Raman spectroscopy has rapidly evolved over the last decade, where sample testing that once occurred in the laboratory is now executed in the field (for example, warehouse). Portable Raman spectroscopy is a powerful technique for the rapid identification of diversely sourced raw materials used in pharmaceutical processing. In addition to portability, reduced cost, rapid data acquisition, and ease of use make this powerful technique attractive and accessible to both expert spectroscopists and non-specialists. In most cases, the method development can be easily accomplished in the laboratory after which the instrument and methods are transferred to the field for sample analysis or warehouse areas for inspection of incoming raw material. Qualitative Raman methods for identification of raw materials typically use spectral libraries for sample-to-standard comparison. Great care is required when developing Raman spectral libraries for raw material identification and considering critical factors (for example, instrument type, Raman capability, container type, container interference, background interference, and material variability) that can potentially influence the identity of the material. This article discusses portable Raman techniques and approaches for raw material identification as well as key considerations for developing and validating Raman spectral libraries. [ABSTRACT FROM AUTHOR]

The article focuses on the approaches being used for drug development within the AstraZeneca's Safety Health and Environment (SHE) Strategy. Topics discussed include activities involved in the development of pharmaceutical products; principles behind green chemistry which involves atom economy, waste prevention and use of catalysis; and presentation of a flowchart representing methanol and tetrahydrofuran (THF) production.

The article offers new briefs on the industry responses to the incoming Donald Trump administration policies in the U.S. U.S. government agriculture advisor, Bruce Rastetter, want the incoming administration to enact laws to stop mergers of chemical and seed companies. The impact of the immigration policies of the Trump administration on the scientific community is included.

The article discusses findings of a study conducted by researchers at the Ohio State University, reveals an antibiotic-resistance gene among swine. The study examines the antibiotic resistance intends to provide prophylactic ceftiofur treatment for swine diseases. The drug research also stresses its continuing testing and experiments in treating swine disease. INSET: 8 important takeaways from the OSU antibiotic-resi.

The article looks at the several aspects of why Chinese contract research organization (CRO) are doing more of its businesses in the country. Topics discussed include the various factors affecting the outsourcing decisions of Chinese drug firms such as bioequivalency research, returnees, and private funding, the increase in the pharmaceutical research and development (R&D) in China, and the several leading CROs in the country including BioDuro, Sundia MediTech, and PepTech.

The article presents profiles for several startup chemical companies, including AgriMetis, DiCE Molecules and Inpria. Topics discussed include the intention of AgriMetis to invest in the development of crop protection chemicals, DiCE Molecules' use of the DNA-directed iterative process developed by biochemistry professor Pehr Harbury for drug discovery and the use of inorganic chemistry by Inpria to develop a photoresist for extreme ultraviolet lithography.

The article offers information on ophthalmology products and emerging therapies as of December 2018. Topics include the New Drug Applications (NDA) approvals for Latanosprostene Bunod for intraocular pressure (IOP) reduction in patients with glaucoma, and Loteprednol corticosteroid indicated for postoperative inflammation, and the Envista Toric intraocular lens (IOL) for astigmatism. Also noted is the development of a nicotine acetylcholine receptor agonist spray for natural tear stimulation.

The analysis of synthetic cannabinoids and their metabolites can be a difficult task, one that is further complicated by the ever-growing list of synthetic cannabinoids produced by illicit drugmakers. As shown here, the retention and selectivity of the Raptor Biphenyl column allows new drugs to be added to an existing method, providing labs with an important vehicle for improving efficiency and productivity. [ABSTRACT FROM AUTHOR]

The article discusses the approach in standardization of high performance liquid chromatography (HPLC) columns in pharmaceutical development laboratory. Topics include the advances of HPLC and ultrahigh-pressure liquid chromatography column technologies in silica-hybrid particles and high-purity silica, the transfer of column to contract manufacturing organizations, and the use of generic method to achieve a cost saving assessment.

The article focuses on biotechnology firm Evotec which is using a range of automated drug discovery tools in internal and customer projects. Topics include invention of partnered drug development pipeline by the firm for generating future returns, presents views of Mario Polywka, chief operating officer at Evotec, on providing encouraging environment for employees and providing better return to shareholders; and partnership of Evotec with pharmaceutical firm Roche for a drug discovery program.

The article provides an overview of potential sample preparation techniques that can be used for pharmaceutical samples. Topics covered include a table that shows samples dissolved in dimethyl sulfoxide against the same samples subjected to nitric acid digestion, issues to consider when performing direct dilution of samples, and a table that outlines recovery of spiked solutions of various catalysts based on sample preparation procedure.

This article discusses emerging trends in the design and use of spectroscopic instrumentation. It focuses on recent research using new or modified spectroscopic techniques that are advancing scientists' capability to obtain high-content, high-resolution data from ever-smaller sample sizes. To illustrate this trend, the article surveys novel approaches to complex measurement problems across a wide range of critical fields, including disease research, food safety, environmental monitoring, and drug development. [ABSTRACT FROM AUTHOR]

The article discusses the pursue of pharmaceutical contract manufacturers on quantity and quality expansion despite the faced scrutiny with regulations. Topics mentioned include the contract manufacturing organizations (CMOs) are driven by the merger and acquisitions (M&A) of pharmaceutical companies, the in demand of the sites in the U.S. and Europe, and the areas of expansion include formulation development, active pharmaceutical ingredients (API) manufacturing, and finished-drug production.

An unusual source of contamination was found in the reversed-phase liquid chromatography (LC) analysis of a 0.4% (w/w) drug product during the development stability studies at levels much greater than the 4 ppm limit of quantitation. System-related sources (mobile phase, injector carryover and contamination), formulation components (drug substance, excipients), and the sample-handling procedure were studied by a systematic approach. The evaluation of the sample-handling procedure identified extractables from the sample vial (different from that specified in the analytical method) and the rubber-lined vial cap, and incidental transfer of residue from commonly used nitrile gloves as the sources of unintended contamination in sample analysis. [ABSTRACT FROM AUTHOR]

An interview with Kathleen C.M. Campbell, an audiologist and professor at the Southern Illinois University School of Medicine, is presented. Topics include D-methionine, a drug that she is developing as of January 2016, that could prevent noise-induced hearing loss, why noise-induced hearing loss is an issue in the military, and how she arranged the study with the military.

The article focuses on the practices of quality control in the small-molecule drug development's separation science. Topics discussed include regulation of quality control by the U.S. Food and Drug Administration; quality control in the pharmaceutical industry leading to current good manufacturing practices (cGMP); and discussions over controlling the genotoxic impurities (GTIs) in pharmaceutical products.

The article provides an overview of modern practices of separation science in small molecule drug development. It mentions approaches in high performance liquid chromatography (HPLC) method development and chemical characterization to support process chemistry and control of clinical trial materials. It also highlights the role of separation scientists in analytical development and chromatographic methodology trends.