Which Data Analytics Tool Should We Use to Evaluate Risk in Upstream Drug Supply Chains?

Drug shortages are a persistent and serious problem in the United States, affecting patient care and health care costs. This article canvasses factors that contribute to drug shortages, such as manufacturing complexity, price, and quality inspection records. This article further proposes an early warning system and payment, contracting, and pricing innovations to mitigate drug shortages and offers data-driven recommendations to stakeholders looking to protect the supply of quality medicines.

Complejo Farmaceútico del Estado Venezolano

Ente adscrito al Ministerio del Poder Popular para la Salud. Empresa sin fines de lucro, dedicada a la elaboración y comercialización de hemoderivados y otros productos químicos y biológicos de alta calidad. Cuenta con una Planta Productora de Derivados Sanguíneos (PPDS), cuya materia prima fundamental es el plasma humano, y una Planta Productora de Fármacos Recombinantes (PPFR), con instalaciones en un área de más de 5.000 metros cuadrados.

Empresa Socialista Productora de Medicamentos, C.A.

Ente Adscrito al Ministerio del Poder Popular para la Salud dedicada a la elaboración de productos biológicos como vacunas, interleukinas y anticuerpos; igualmente, especialidades farmacéuticas como tabletas, cápsulas y granulados, para ofrecer a nuestro país una solución de carácter social viable y eficiente a la creciente demanda en el sector de la salud.

Assessing biologic/toxicologic effects of extractables from plastic contact materials for advanced therapy manufacturing using cell painting assay and cytotoxicity screening.

Plastic components are essential in the pharmaceutical industry, encompassing container closure systems, laboratory handling equipment, and single-use systems. As part of their material qualification process, studies on interactions between plastic contact materials and process solutions or drug products are conducted. The assessment of single-use systems includes their potential impact on patient safety, product quality, and process performance. This is particularly crucial in cell and gene therapy applications since interactions with the plastic contact material may result in an adverse effect on the isolated therapeutic human cells. We utilized the cell painting assay (CPA), a non-targeted method, for profiling the morphological characteristics of U2OS human osteosarcoma cells in contact with chemicals related to plastic contact materials. Specifically, we conducted a comprehensive analysis of 45 common plastic extractables, and two extracts from single-use systems. Results of the CPA are compared with a standard cytotoxicity assay, an osteogenesis differentiation assay, and in silico toxicity predictions. The findings of this feasibility study demonstrate that the device extracts and most of the tested compounds do not evoke any measurable biological changes on the cells (induction ≤ 5%) among the 579 cell features measured at concentrations ≤ 50 µM. CPA can serve as an important assay to reveal unique information not accessible through quantitative structure-activity relationship analysis and vice versa. The results highlight the need for a combination of in vitro and in silico methods in a comprehensive assessment of single-use equipment utilized in advanced therapy medicinal products manufacturing.

Identification and quantification techniques of polymorphic forms - A review.

In the pharmaceutical industry, the unexpected appearance of crystalline forms could impact the therapeutic efficacy of an Active Pharmaceutical Ingredient (API). For quality control, a thorough qualitative and quantitative monitoring of pharmaceutical solid forms is essential to ensure the detection and the quantification of crystalline forms, wither different or with the same chemical composition (polymorphs) at a low detection level. The purpose of this paper was to review and highlight the importance of choosing adequate solid-state techniques for detection and quantification APIs that present polymorphism - based on limits of detection (LOD) and quantification (LOQ), pharmacopeias specifications, international guidelines and studies reported in the literature. To this study, the powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), Infrared and Raman spectroscopies and solid-state nuclear magnetic resonance (NMR) were the solid-state techniques analyzed. Additionally, the Argentine, Brazilian, British, European, International, Japanese, Mexican and the United States of America pharmacopeias were reviewed. Based on the analysis performed, the advantages and disadvantages of these techniques, as well as the LOD and LOQ values of APIs were reported. In comparison to these solid-state techniques, reference material used for identification analyses should be previously identified with the corresponding polymorph. Without this previous procedure, the patterns, the spectra, and DSC curves of the reference material can only be used to confirm the mixture of solid forms, not being able to specify which polymorphs are contained in the sample. A major advantage of PXRD is the use of the calculated diffraction patterns obtained from the Crystallographic Information Frameworks (CIFs) files which could be used as a reference pattern without any other information, assistance technique, or physical standards. Regarding the quantification aspect, different pharmacopeias suggest various methods such as the PXRD combining with Rietveld method, which can be used to obtain lower LOD values for minority phases in the mixture of different substances without the need for a calibration curve. Raman spectroscopy can detect polymorphs in small particles and solid-state NMR spectroscopy is a powerful technique for quantification not only crystalline but also crystalline-amorphous mixtures. Finally, this review intends to be a useful tool to control, with efficiency and accuracy, the polymorphism of APIs in pharmaceutical compounds.

Paul Berg and the origins of recombinant DNA.

In fall 1972, Paul Berg's laboratory published articles in PNAS describing two methods for constructing recombinant DNAs in vitro. He received half of the 1980 Nobel Prize in Chemistry for this landmark accomplishment. Here, we describe how this discovery came about, revolutionizing both biological research and the pharmaceutical industry.

Beliefs and practices of physicians in Lebanon regarding promotional gifts and interactions with pharmaceutical companies.

Background: Pharmaceutical companies invest greatly in promotional gifts to influence prescription of medications by physicians, yet there is limited published information evaluating its impact on healthcare. Aim: This study aimed to assess the beliefs and practices of physicians in Lebanon regarding promotional gifts and their interactions with representatives of pharmaceutical companies. Methods: This cross-sectional study was conducted between December 2019 and January 2020 through an email-based questionnaire sent to 5936 physicians of different specialties registered in the Lebanese Order of Physicians. Assessment was done using a validated tool and data analysis was conducted using SPSS version 26.0. Results: Of the 268 respondents, 188 (70.4%) reported that physicians in Lebanon accepted gifts from representatives of pharmaceutical companies. Most of the physicians (31.7%) interacted with company representatives more than once a week. Medication samples (251 respondents) and stationary items (222 respondents) were the most common gifts accepted by physicians who admitted accepting gifts. Overall, 225 (84.9%) respondents believed that prescriptions by physicians in Lebanon were influenced by the gifts. Only 74 (40.0%) of those who accepted gifts from pharmaceutical companies believed that it was unethical, and around half did not know if the Lebanese Code of Medical Ethics allowed them to accept gifts from pharmaceutical companies. Conclusion: Although physicians in Lebanon were aware of the effect that gifts from pharmaceutical companies could have on their prescription behaviours, many of them still accepted the gifts. This study provides evidence to policymakers for decision-making regarding ethical guidance on interactions between physicians and pharmaceutical companies in Lebanon.

[The Applications of qNMR in Drug Quality Control].

NMR is well known as one of the most important methods for elucidating the structure of organic compounds. Furthermore, it has recently been recognized as a powerful tool for quantitative analysis. The quantitative NMR (qNMR) has become an official analytical method described in detail in the Japanese Pharmacopoeia. And today, it is widely applied in drug development. The qNMR method offers many new advantages over traditional and conventional quantitative analysis methods. For example, this method requires only a few milligrams of the analyte and allows absolute quantitation of the analyte without using a qualified reference standard as a control sample. Then, it can be easily applied to most chemicals without expending significant time and resources on method development. In addition, residual solvent can be determined using qNMR methods. The peak area of an NMR spectrum is directly proportional to the number of protons contributing to the resonance. Based on this principle, the residual solvent can be determined by counting the signal corresponding to the residual solvent in the sample solution. We have applied qNMR as an alternative to GC. Thus, qNMR is an innovative and promising analytical technique that is expected to make significant progress in the future. Recently, the analytical research and quality control departments have been working together to expand this technology to a wide range of areas in the pharmaceutical industry.

Industry updates from the field of stem cell research and regenerative medicine in November 2023.

Latest developments in the field of stem cell research and regenerative medicine compiled from publicly available information and press releases from non-academic institutions in November 2023.

Industry updates from the field of stem cell research and regenerative medicine in October 2023.

Latest developments in the field of stem cell research and regenerative medicine compiled from publicly available information and press releases from non-academic institutions in October 2023.

Patents on Risk Evaluation and Mitigation Strategies for Prescription Drugs and Generic Competition.

This cross-sectional study identifies the prevalence of patents on risk evaluation and mitigation strategies and their association with delaying generic competition.

Industry updates from the field of stem cell research and regenerative medicine in December 2023.

Latest developments in the field of stem cell research and regenerative medicine compiled from publicly available information and press releases from non-academic institutions in December 2023.

Direct-to-Consumer Drug Company Pharmacies.

The recent launch of direct-to-consumer pharmacy LillyDirect prompts the author of this Viewpoint to consider why it was created and also to raise concerns about allowing manufacturers to sell their drugs directly to patients.