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Increasing production capacity may necessitate the facility to cater for higher hazardous area category (e.g., H-Occupancy) design features, such as specialized building construction and potential blast zones. [...]an assessment should cover: * Quantification of flammable material use for production steps, including buffer preparation and LNP storage * Equipment and facility cleaning strategies that contribute to the facility flammable materials inventory * Impact of HVAC design to avoid hazardous atmospheres (e.g., full fresh air), use of local exhaust ventilation (LEV) or fume hoods * Solvent distribution methods (e.g., closed solvent delivery and waste removal systems) * Location of solvent bulk storage outside of the processing area/ facility, and piping in what is necessary plus removing spent solvent in a timely manner (e.g., piped transfer to a waste tank for removal by a specialist contractor). At present, the process cannot be fully single-use, so thought needs to be put into the cleaning and sterilization processes, plus the analytical support infrastructure needed for reusable product-contact surfaces. [...]it is recommended that for each mRNA project, consideration is given to the following aspects to determine the link between the equipment available and the facility design: * Need for custom/proprietary equipment * Independent production rooms with "through-wall" buffer transfer through iris ports in from logistics corridor (Buffer Prep/Hold) * Room electrical classification needs versus process step. * Equipment selection versus electrical and fire code requirements * Benefits and limitations of implementing single-use technologies, given that the process will be hybrid (with stainless steel). [...]the limited capacity for outsourcing of supporting functions, such as facility environmental monitoring or product sterility testing, should be considered during concept design.
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Among the challenges of a pandemic is the need to scale up to billions of doses, at a larger scale than typically needed for vaccines, from raw materials all the way through to the materials for the containers for fill/finish. Having adequate raw materials, building and staffing the facilities, and tech transfer are all keys to success. [...]we can plug into existing infrastructure, including services (gas, water, waste, etc.) as well as analytics and quality labs." Emergent BioSolutions says that its flexible CDMO capacity deployment model can respond quickly to demand fluctuations. The company's facilities in France, Switzerland, and the US are working on the project;at CordenPharma Colorado, unique high-pressure chromatography systems usually used for manufacturing peptides have been reallocated for purifying lipids.
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Conducting virtual audits, conducting effective virtual training, and enhancing communications with suppliers to ensure an uninterrupted supply chain are among the changes implemented to maintain operations, stay compliant, and continue manufacturing medically necessary products. The necessity for virtual audits was to allow companies and regulators to continue to evaluate the compliance stature of manufacturers while respecting stay-at-home and social distancing requirements that prevented in-person site audits. Some of these venues are free, and some require a registration fee. supply chain quality Enhanced communication with suppliers to ensure an uninterrupted supply chain has also become a priority during the pandemic.
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The guidance states, "These preventative measures can include steps to prepare personnel such as: * "Educating employees on topics such as, in the case of a pandemic, personal hygiene (hand washing and coughing and sneezing etiquette), social distancing, and appropriate use of sick leave * "Encouraging employees to get immunized as appropriate by providing information on local vaccination services or by offering on-site vaccination services, if reasonable * "Providing information for and encouraging employees to develop family emergency preparedness plans * "Reviewing CGMP [current good manufacturing practice] regulations regarding appropriate sanitation practices and restriction of ill or sick employees from production areas (see 21 CFR [Code of Federal Regulations] 211.28)" (2). Examples include: * "Production equipment routine maintenance * "Utility system performance checks and maintenance (e.g., air temperature, lighting, compressed air) * "Environmental monitoring of facilities such as cell culture, harvesting, and purification rooms during production * "Stability testing for certain drug products and components * "Periodic examinations of data and of reserve samples" (2). EMA, Guidance on the Format of the Risk Management Plan (RMP) in the EU-in Integrated Format, EMA/164014/2018 Rev.2.0.1 accompanying GVP Module V Rev.2 Human Medicines Evaluation (EMA, 31 October 2018).
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Objectives: To evaluate how payers utilize Institute for Clinical and Economic Review (ICER) assessments to inform coverage or formulary decisions. Method(s): Double-blinded, web-based survey was fielded through Xcenda's research panel, the Managed Care Network, from June to July 2022. Result(s): A total of 51 payers from health plans (n=27), integrated delivery networks (n=12), and pharmacy benefit managers (n=12) participated in the survey. When assessing the usefulness of ICER's value assessment framework (VAF) to inform formulary decisions within their organizations, 57% of payers indicated it was extremely/very useful, 33% indicated somewhat useful, and 10% indicated not at all/not very useful. Most respondents (73%) agreed that ICER assessments are aligned with their organization's internal assessment. Utilization of ICER's VAF was most prevalent in high-cost drug or disease states (78%), rare/orphan disease states (71%), and oncology/hematology disease states (67%). Payers reported less use in primary care disease states (29%), COVID-19 (8%), and digital therapeutics (4%). In the last 24 months, 20% of payers reported ICER's recommendations often influenced coverage decisions, 59% indicated occasional influence, and 22% indicated no influence. In the last 24 months, payers indicated the top 5 ICER assessments that influenced their coverage decisions included high cholesterol (38%), Alzheimer's disease (36%), atopic dermatitis (33%), multiple myeloma (31%), and chemotherapy-induced neutropenia (28%). ICER assessments that were less impactful included beta thalassemia (3%), digital health technologies (3%), and supervised injection facilities (3%). Payers reported using ICER assessments to inform both expanded and restricted coverage decisions. Conclusion(s): Payers find ICER's VAF useful to inform their organization's formulary decisions. ICER's assessments often align with payers' internal assessments and are most frequently utilized for high-cost drugs or disease states. Payers indicate ICER assessments have affected both expansion and restriction in their coverage policies.Copyright © 2023
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Objectives: Data showed that during the SOVID-19 pandemic the pharmacy is the first place for patient care. The purpose was to study the awareness of pharmacists about the COVID-19 for 2021-2022 in Ukraine to provide complete and quality care. Method(s): Survey was developed to determine the level of knowledge of pharmacists regarding the main symptoms, methods of diagnosis, treatment and prevention of uncomplicated forms of the COVID-19 by using Google form. The heads of pharmacies, pharmacists in eight regions of Ukraine were involved. The research period was December 2021 - December 2022. Result(s): We received, 725 completed questionnaires from 8 regions of Ukraine, of which 69.7% were pharmacy managers, 12.0% were pharmacists, and 18.3% were intern- pharmacists. Of the surveyed pharmacists, 95% called the method of airborne transmission, but 4.7% believe that the coronavirus is transmitted by the contact-household method, and 0.3% - transmissible. We found that 100% of respondents correctly named the main indicators of the condition of a patient with the COVID-19. However, only 95.4% of pharmacists correctly defined the concept of saturation, which requires improvement of information support. For the symptomatic treatment of uncomplicated forms, 91.7% of respondents correctly determined that Paracetamol, Ibuprofen are for the symptomatic treatment of uncomplicated forms, but 8.3% of pharmacists named other drugs. Assessing the need to take antibiotics, 88.5% of pharmacists gave the correct answer, but 5.5% believe that the reason for prescribing antibiotics is an increase in body temperature, and 5.4% named a decrease in saturation, 0.6% - dry a cough, that does not meet the requirements of thee national guideleines Covid-19. Conclusion(s): We found that pharmacists are 100% well-informed with the symptoms and causes of the Covid-19. However, it is necessary to improve the provision of information about the requirements for the treatment of uncomplicated forms of Covid-19 and the dispensing of antibiotics from pharmacies.Copyright © 2023
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Background It is a challenge for pharmacy courses worldwide to combine theoretical knowledge with practical skills to equip students for their future practice. Computer-based simulation offers a way of building a bridge between theory and practice. In recent years, digital simulation has expanded rapidly as a new technique of virtual learning. The digital platform ''Pharmacy Simulator'' proposes computer-based encounters with virtual patients to train clinical and communication skills in a community pharmacy setting. However, during the COVID-19 pandemic, while students were digitally resilient and endured the endless challenges of online lectures, many were dealing with Zoom and screen fatigue. Purpose To investigate pharmacy students' acceptance of Pharmacy Simulator before and during a pandemic situation. This focuses on students' self-assessment and confidence in counselling after playing the scenarios on Pharmacy Simulator. Method Two cohorts of Master of Pharmacy students at The University of Western Australia played two scenarios on Pharmacy Simulator in 2019 (anaphylaxis and salbutamol) and 2021 (anaphylaxis and vaccination). A mixed-method analysis was performed with data from (i) qualitative semi-structured interviews carried out in 2019 pertaining to participants' acceptance of Pharmacy Simulator and in 2021 (ii) a questionnaire with 25 items derived from the interviews. The interviews were transcribed verbatim into electronic format with the data management assistance MAXQDA and analyzed inductively using the Framework Method. Questionnaire responses were analyzed in Microsoft Excel using descriptive statistics. Openended questions were evaluated inductively. Findings Data were collected from 20 interviews and 31 answered questionnaires. In 2019, participants reported that Pharmacy Simulator was a fun, engaging, and straightforward learning tool and, therefore, user-friendly. They reported the feedback at the end of the session to be most valuable. The platform was perceived to fill the gap between the theory from lectures and community pharmacy practice. In 2021, participants ''agreed'' (median: 4, on a 5-point Likert scale) with seven statements about Pharmacy Simulator's usability, such as it being a helpful tool for acquiring new knowledge. Participants' confidence in counselling regarding the scenario topics improved. One participant stated, ''It taught me more through trial and error''. Conclusion Pharmacy students reported similar acceptance levels of Pharmacy Simulator before and during the COVID-19 pandemic. The use of simulation during virtual patient encounters seems to facilitate the transfer from theory to practice, independently of learning conditions that were predominantly screen-based.
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"The ongoing journey to standardization on more aspects of submission and data exchange will continue to have an impact," he notes. lan Crone, business unit director Europe-fme Life Sciences, which provides business and technology services, points out that the web-based human variations electronic application form (eAF) for centrally authorized products (CAPs) has been available for use since 4 Nov. 2022 on the European Medicines Agency's (EMA's) new product lifecycle management (PLM) portal. Renato Rjavec, Amplexor Life Sciences "Many biopharmaceutical functions have spent the last decade modernizing their base technologies, most often in a cloud/software as a service environment platform that brings foundational benefit to individual functions," states Steve Gens managing partner. Internal productivity and external regulatory requirements are both driving this data connectivity within industry, he adds, which "requires a clear cross functional digitization strategy and focus on cross-functional data governance, master data management, and ensuring all data from these various authoritative systems [are] at the same high level. " "Many biopharmaceutical functions have spent the last decade modernizing their base technologies, most often in a cloud/ software as a service environment platform that brings foundational benefit to individual functions." -
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[...]best-in-class pharma companies are focusing on reliability and resilience in the supply chain-if they can't make a product or deliver a product on time, a patient is not served, and no sale is made. People can scale to a certain degree but scaling by a factor of 100 is not possible with people in a short period of time and does not deliver on economies of scale. Pharma companies are also issuing 'green bonds' where investors can expect the contribution of capital to improve the company's sustainability.
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According to research, for example, the bio/pharmaceutical manufacturing market should witness compound annual growth in the region of 11% between 2022 and 2027 (2), thanks in part to advancing manufacturing technologies. "Most recently, biopharmaceutical manufacturing has been impacted by pressures on supply chain," specifies Antonio Crincoli, vice president of Engineering, Pharma and Consumer Health, Catalent. [...]there is a focus on quality management systems that ensure data integrity and governance, and that digitization occurs with appropriate validation, also, where necessary, that there is segregation of operating systems to eliminate risk of corruption." Antonio Crincoli, Catalent "PAT and an emphasis on process understanding have been embraced by the majority of pharmaceutical manufacturers, and there are several case studies where both artificial intelligence (Al) and machine learning (ML) have led to improved quality or increased yield, even in good manufacturing practice (GMP) facilities," adds Byrd.
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According to the Association of the British Pharmaceutical Industry (ABPI) there has been a significant decline in the number of industry clinical trials nitiated in the UK. "The COVID-19 pandemic has accelerated the decline in ate-stage industry clinical research in the UK, compared to its global peers," said Richard Torbett, chief executive of the ABPI in a press release (3). Findings from an ABPI report into the state of clinical trials in the UK has shown that consistently slow and variable set up times for clinical trials encountered in the NHS are causing some pharmaceutical companies to look elsewhere for clinical research (4). [...]a close relationship is needed between government and the life sciences sector now more than ever to ensure the country does not fall too far behind its global competitors.
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According to market research, the pharmaceutical packaging sector is expected to grow at a compound annual rate of 7.4% between 2022 and 2031, reaching an estimated USS178.8 billion (€171.8 billion) by the end of the forecast period (1). "Pharmaceutical waste continues to be a huge problem, so to eliminate non-biodegradable and single-use plastics from the supply chain, more research is taking place around bio-based PET [polyethylene terephthalate]. "By designing a product's primary and secondary packaging well from the outset (including investing ample resources into the process), manufacturers can reduce the amount of materials used and wasted, test new eco materials, ensure safety compliance and efficacy, and benefit from cheaper transportation costs," Quelch surmises. [...]pharma companies can benefit from a packaging supplier with a true global footprint," he says.
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A major driver for innovation within the bio/pharma sector has been the COVID-19 pandemic, which propelled advances such as the approval of messenger RNA (mRNA) vaccines at record-breaking speeds and led to many companies pivoting to deal with the urgent requirements for capacity and supply chain flexibility needed to overcome pandemic challenges. "Before deciding on a location, we conducted extensive market research, and it quickly became clear, just by the sheer proximity of so many biopharmaceutical companies, associations, and research centres, that the event had to be in Geneva. Organized as four half-days, they will each address a theme related to the four main areas of the supply chain present in the exhibition area: pharmaceutical packaging (primary and secondary), medical devices, pharmaceutical sub-contracting, and pharmaceutical equipment. The dream scenario, the real measure of success, is when a product comes to market that happened as a result of a meeting or discussion that took place at our event.
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The COVID-19 pandemic highlighted how vital cold chain is for the pharmaceutical industry, particularly as some vaccines needed to be produced, transported, and stored at -70 °C. Market projections for cold chain logistics of pharmaceuticals are projected to grow at a compound annual growth rate of 9.03% by 2025, which is reported to be driven by greater global demand for pharmaceuticals, increasing initiatives to promote cold chain, and more demand for reefer containers from the pharma industry (1). Gilmore (Tower Cold Chain): Putting the European success of the COVID-19 vaccine rollout to one side, the demand for effective temperature-controlled packaging solutions in the pharmaceutical supply chain has increased significantly in recent years. Today, the cold chain is grappling with additional challenges: serving a global market, driving out costs and waste, addressing capacity and resource constraints, and dealing with continually mounting regulations-all whilst handling valuable pharmaceutical cargo. Cold chain logistics providers must invest in the latest on-board equipment built into containers to track temperature and location, and to make data available to partners and customers in real time, to prevent or mitigate loss.
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[...]we've seen more companies diversifying their portfolios and investing in therapies for rare diseases so that advanced therapies, and in particular, gene therapies-which were deemed experimental and risky when I was involved with the European Medicines Agency's Committee for Advanced Therapies some 10-12 years ago-take centre stage," Schneider continues. The year's expectations were unsurprisingly centred around COVID-19 for Martin Lush, global vice president. "Many big pharma companies will continue down the path of externalising services for small molecules and/or known molecules maintenance, to keep their focus on novel molecules," she explains. [...]of this complexity, there can be much negotiation and, hence, delay in access to medicines, he explains.
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Dissolution testing is an integral part of pharmaceutical development, providing drug companies with the analytical ability to determine the efficacy, bioequivalence, and bioavailability of the active drug substance, as well as control quality, stability, and consistency of the final drug product. [...]there is also a shift in focus to more novel and personalized dosage forms that is happening within the bio/pharma industry, requiring modifications to many different areas of drug development and manufacturing, including dissolution testing, Spisak added. Novel formulations can pose challenges when using standard apparatus;nanoparticles, for example, are not necessarily sufficiently separated from the dissolution medium with standard techniques. [...]modification of the instrumentation, such as that found in Agilent's NanoDis system, is required to ensure an accurate prediction of in-vivo performance of the drug product can be made.
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Increased awareness of the carbon footprint associated with pharmaceutical products and the replacement of high global warming potential (GWP) constituents used in the final product, or within the manufacturing process, may drive further diversification of formulation approaches in the future. [...]the nose offers an opportunity to deliver drugs directly to the brain or central nervous system (CNS) via the olfactory pathway. Two relatively recent commercializations for intranasal delivery are naloxone nasal spray to treat suspected opioid overdose emergencies and diazepam nasal spray for short term rescue treatment of seizure clusters. [...]in cystic fibrosis, the overproduction of mucus and alteration of mucus properties, represents a challenge for effective drug delivery by inhalation alone.