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Biologics, especially protein drugs, are often produced in cultured cells. Those cultured cells, called host cells, synthesize the target proteins along with the proteins coded by the cell genome for [...]

As the saying goes, 'the only constant in life is change,' and in today's life sciences industry, that's undoubtedly the case, as the widespread adoption of digital technologies for enhanced [...]

Chewable tablets are a widely used dosage form for the delivery of pharmaceutical, nutraceutical, and veterinary active substances. Some examples of marketed products are listed in Table I (1-10). Chewable [...]

Soft gelatin (softgel) capsules can be a means of achieving bioavailability of highly lipophilic drugs that are practically water insolle. The API is generally dissolved in edible oil. Typl oils [...]

The accuracy and ease of use provided by electronic batch records (EBR) contributed to their adoption by large pharmaceutical companies. While the cost of transitioning from paper to EBR may [...]

The article discusses the challenges of detecting host cell proteins (HCPs) in biologics manufacturing, and provides recommendations on what can be done in-house and when outsourcing is a better option. It mentions that the most common method for HCP detection is enzyme-linked immunosorbent assay (ELISA), but coverage assessment of HCP antibodies can be challenging, making outsourcing to experienced labs a viable option.

In this paper, the authors introduce a method that combines ion exchange chromatography with a easier-to-perform, simpler one-step post-column derivatization that is selective to nitrite and visible spectrophotometric detection to allow high sample loading volumes without affecting resolution. The method introduced here can be broadly applied to multiple polymeric excipient types. Ion-exchange chromatography post-column derivatization is used to determine ultra-low levels of nitrite in three excipients. [ABSTRACT FROM AUTHOR]

The article focuses on EMA's promotion of real-world data (RWD) in non-interventional studies for generating real-world evidence (RWE), addressing methodological aspects, governance, and data quality, aligning closely with FDA guidance but highlighting differences in NIS definitions, aiming to enhance regulatory decision-making and scientific rigor while improving transparency and reliability of industry-generated RWD.

Stability data of samples of pharmaceuticals are often generated as replicate test results, typically as duplicates. A statistical analysis for determination of an expiration date can then be applied on either the replicates or their corresponding averages in line with the methodology suggested in ICH Q1A(R2) and Q1E guides. This paper aims at clarifying when a shelf-life derived from all replicates or averages is justified and correct. When replicate stability data represent preparations of the same sample, this is a case of pseudoreplication, and, therefore, the statistically derived shelf-life should be based on the averages of the replicates. However, when these replicate data represent independently and randomly selected and tested samples at each time point, a statistically derived shelf-life based on all replicate data is justifiable. [ABSTRACT FROM AUTHOR]

The article focuses on the annual survey on inspections and audits has revealed opportunities to use more flexible approaches to optimize processes. Topics discussed include this paper presents the most recent results from the European Federation of Pharmaceutical Industries and Associations (EFPIA) annual survey and their conclusions; and the year 2020 demonstrated the ability of pharmaceutical industry and regulators to be agile whilst maintaining the same high standards as previous years.

The article explores unreliable data leads to unreliable validation execution. Quality teams, however, are still managing validation projects using paper-based processes that drive information silos, poor tracking, and fragmented data. This leads to higher operational costs and increased risk of non-compliance, which can significantly impact the bottom line: poor data quality is responsible for an average of US$15 million.

The article focuses on sustainable secondary packaging trends in the pharmaceutical industry. Topics include the emphasis on sustainability driven by consumer preferences, innovations in coding and marking technologies to ensure product security, and the growing demand for smart packaging with features like child-resistance and serialization.

The article focuses on the application of the "Quality Quartets" concept to achieve knowledge-driven, risk-based approaches to commissioning and qualification in the pharmaceutical industry, particularly in line with the revised ICH Q9(R1) guidelines. The topics discussed are the role of subjectivity in Quality Risk Management (QRM), the concept of formality in QRM, and the benefits of using Quality Quartets to facilitate risk-based decision-making and knowledge management.

Adeno-associated virus has emerged as a leading platform for gene delivery for treating various diseases due to its excellent safety profile and efficient transduction to various target tissues. However, the large-scale production and long- term storage of viral vectors are not efficient, resulting in lower yields, moderate purity, and shorter shelf-life compared to recombinant protein therapeutics. Cell lysis is one of the key downstream unit operations, where the outer boundary or cell membrane is broken down or destroyed to release viral vector from the host cell. During cell lysis and separation of viral vector from cell debris, viral vectors are exposed to harsh shear stress that aggregates, unfolds, and precipitates virus. In this paper, the authors discuss a novel cell lysis solution that is efficient and generates low foam, making it easy to use. The novel solution also protects the viral vector from shear-induced damage during the manufacturing process, resulting in an improved viral vector titer. [ABSTRACT FROM AUTHOR]

This paper demonstrates how assay data sets of a formulated liquid product, drug substance, and an impurity, obtained from combined accuracy-precision studies, are evaluated to calculate statistical intervals (prediction and tolerance intervals) and to graphically display the total analytical error (TAE) to account for the systematic and random errors. Inclusion of either the statistical intervals or the TAE within the allowed accuracy limits is an indication of a successful validation of the accuracy and precision method characteristics. This paper subsequently evaluates the capability of common procedures of pharmaceutical analysis to accommodate acceptable TAE and statistical intervals. While considering typical values of standard deviations (0.5-2.5% relative standard deviation) of chromatographic tests and typical specifications ([+ or -]2, [+ or -]5, or [+ or -]10%) of pharmaceuticals, it is shown that a substantial portion of specification tolerance is taken up by either the statistical intervals or by the TAE, particularly in cases of narrow specif ications and imprecise procedures., Two new draft International Council for Harmonisation (ICH) guides, one dedicated to development of analytical procedures for pharmaceuticals (1) and the other to their validation (2), introduced for the first [...]

The article focuses on demystifying risk-based decision making (RBDM) in pharmaceutical quality systems, especially in the context of the ICH Q9(R1) guidelines. Topics include the differences between RBDM and other decision-making processes; the importance of RBDM in enhancing quality risk management (QRM) effectiveness for patient benefit; and recommendations for improving RBDM like deciding the appropriate level of formality and providing the best available knowledge.

An interview with Nathalie Batoux, the product manager for Research Innovation at IDBS is presented. She discusses the significance of data in the biopharma industry and the measures taken to protect data integrity. She explains how the digital transformation and the rise of artificial intelligence (AI) and machine learning (ML) have made historical data crucial for repurposing existing drugs and driving research initiatives.

The article offers information on cold-chain packaging protects biologics and other temperature-sensitive drugs. Topics include optimizing the design, materials, and components to minimize overall size and weight of the shipping solutions; and quality demands increase as more sensitive products bring logistics complexity and greatly expanded risk.

The article focuses on the UK's re-entry into the Horizon Europe research programme, highlighting the significance for the scientific community and addressing challenges such as rebuilding research relationships and navigating regulatory divergences with the EU. Topics include the impact on UK science due to limited funding opportunities, the collaborative benefits of the programme, and the need to address issues arising from regulatory differences between the UK and EU.

The article presents an Excel spreadsheet approach for statistically testing the poolability of stability data involving more than three batches, following the International Council for Harmonisation (ICH) guidelines. Topics include the application of different models, such as common intercept common slope (CICS), separate intercept separate slope (SISS), and separate intercept common slope (SICS), to analyze stability data, aiming to determine the most suitable model for shelf-life estimation.

The article focuses on precompetitive consortiums create a space for both manufacturers and equipment and technology suppliers to find solutions to manufacturing challenges that affect the whole industry. It mentions increasing the industry's capacity to make and supply viral vectors has been of high importance, as demand for these starting materials in cell and gene therapy production has outpaced supply. It also mentions topics including scalability, standardization, and change management.

The article discusses the benefits of active and intelligent packaging in the pharmaceutical supply chain. Topics include the expected increase in global demand for smart packaging by 2021, the incorporation of intelligent packaging technology in caps, labels and flexible packaging materials and the improvement in patient compliance and handling of drugs with smart packaging solutions.

The article provides information and guidance on performing statistical analysis for in-vitro permeation test (IVPT) data using MS Excel. It emphasizes the importance of IVPT studies in evaluating topical drug products, particularly for generic drugs. It is reported that the IVPT data analysis involves calculating parameters such as maximum flux (Jmax) and total cumulative amount of drug permeated (AMT) for the test and reference products.

The article focuses on the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK issuing detailed guidance on the new International Recognition Procedure (IRP) for medicines manufacturers. It mentions that it aims of bringing cutting-edge medicines faster to UK patients by leveraging the expertise of trusted regulators in various countries, and replacing the current European Commission Decision Reliance Procedure with the new process starting from January 1, 2024.

The article focuses on the recent amendments to Germany's Medical Research Act (MFG) by the Bundestag, which streamline clinical trial processes and revise drug pricing regulations. Topics include the reorganization of regulatory agencies and ethics committees, new rules for confidential drug pricing, and the potential impact on pharmaceutical companies' pricing strategies and market dynamics.

The article focuses on the recent Nobel Prize in Physiology or Medicine awarded to Katalin Karikó and Drew Weissman for their research on RNA, highlighting the advancements in genetic medicine, challenges in non-viral delivery systems, and the importance of collaboration and investment in manufacturing to realize the potential of novel genetic therapies.

The article discusses the importance of hand hygiene and proposes supplementary handwashing techniques to improve handwashing efficacy. The authors used a fluorescence test method to visually evaluate handwashing efficacy and identified difficult-to-clean areas on the skin. It mentions specific washing techniques to address problem areas and suggested that incorporating these techniques into established handwashing procedures could enhance hand hygiene efficacy.

The article discusses that Machine and material innovations yield more efficient, sustainable processes for pharmaceutical packaging, including vaccine vials. It mentions that labelling equipment and materials continue to evolve with onboard serialization and inspection capabilities, adoption of radio frequency identification (RFID) technology, ever-improving performance and speed, and higher levels of connectivity.

The article presents an interview Joerg Zimmermann, vice-president of Vetter Pharma-Fertigung GmbH & Co. KG., exploring information related to technology transfer process. Topics discussed include manufacturing processes that should be evaluated in technology transfer and the difference between in-company transfers and sponsor/contract facility transfers.

The article offers information on how pharmaceutical companies set goals and adopt more sustainable alternatives. It mentions that incorporating post-consumer recycled (PCR) content in packaging as viewed as highly desirable by the industry and consumers, but can pose challenges due to supply chain and quality issues.

The article focuses on the efforts of pharmaceutical manufacturers & suppliers to integrate sustainable practices into their packaging and operations. It discusses the growing market for sustainable pharmaceutical packaging, the drivers behind the interest in sustainability, and the challenges in adopting more environmentally friendly packaging materials and designs. It also highlights specific initiatives among pharmaceutical companies and suppliers to reduce the industry's carbon footprint.

The article offers information on the impact on pharma companies from no-deal Brexit. Topics discussed include information on need to prepare for the potential new relationship between Great Britain and European Union (EU;) importance of collaboration on EU pharmacovigilance systems and databases; and need for preparations like stockpiling and putting transportation arrangements.

The article discusses the efforts put in by European Union (EU) in handling the problem of drug shortages. It is mentioned that the EU established a task force in December 2016 with European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) to offer solution for disruptions to drug supplies. The article also talks about effect of Brexit on the issue, serialization or barcode identification regulation, and challenges faced in keeping medicines available.

Simple deviations can be completed in a short time frame, but more involved deviations will take longer to complete. A. The overuse of human error as a root cause to a deviation represents lost opportunities to reduce future issues by masking the identity of the true root cause. 50 Pharmaceutical Technology Europe APRIL 2021 PharmTech.com ask the expert LEIGH PRATHER- STOCK.ADOBE.COM Q. What is a deviation, and do all deviations need to be investigated?. [Extracted from the article]

The article explores how Blow-fill-seal (BFS) technology can help maintain sterility during the biologics manufacturing process. Topics include technology enhances the ability to form the container and closure during the packaging process, which allows for a more custom design of the container; and use of BFS technology limits human involvement, which further improves the level of sterility assurance by removing a significant contamination factor from the drug making process.

The article discusses the importance of maintaining required levels of cleanliness in the biopharmaceutical industry. It highlights the significance of cleaning validation for equipment and the growing demand for it as drug products become more complex and sensitive to potential contaminants. It further explores the importance of a risk assessment, identifying and removing residues, and validating cleaning processes for effectiveness and reproducibility.

The article explores the importance of selecting the correct thickening and suspending agents to ensure stabilized formulations, as well as adding the right blend of polymers to achieve optimal suspension viscosity and stability. The paper presents a study that evaluates the colloidal microcrystalline cellulose (cMCC) suspending agent by using a representative pharmaceutical-grade commercial version of cMCC.

Pharmaceutical and nutritional package integrity is often studied by incidental contamination, via immersion or aerosol microbiological challenge tests. Aerosol tests rely upon microorganisms settling from the atmosphere onto critical surfaces. Maintenance of a contaminated atmosphere is necessary to create the conditions that will cause a constant settling rate of the test microorganisms. Both parameters--maintenance of bioburden and duration of exposure--have to be monitored and controlled. It is important to understand the limitations of aerosol tests where the microbial contamination conditions are not maintained over the duration of the test. The following study describes a methodology to establish, control, and characterize an aerosolized bioburden within a test chamber and determine the settling rate of the bioburden. The intention of this paper is to stimulate the necessary discussion for the establishment of the standard criteria for all aerosol tests to generate comparable and reproducible data. [ABSTRACT FROM AUTHOR]

The article offers information on Good Manufacturing Practice (GMP) inspections have been performed virtually or remotely during COVID‑19, appeared to have been seen as such a success among pharmaceutical companies that they want it to become a permanent alternative. Topic include the European Medicines Agency (EMA), Heads of Medicines Agencies (HMA), representing national authorities, together with the European Commission have introduced a system during the pandemic.

This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases. More and more countries acknowledge the limited value of in-country testing compared to the benefit of full or partial testing waivers. Analyzing the changing testing requirements, the authors find that a predominant trend is waiver schemes based on unilateral reliance on reference countries with a mature regulatory system. [ABSTRACT FROM AUTHOR]

The article informs about analyzing extractables and leachables in single-use systems with standardized risk assessment and analysis protocols facilitate the comparison of processing equipment components. Topics include polymer single-use systems (SUS) are increasingly being used in biopharmaceutical manufacturing; and SUS suppliers can use the protocol to measure the extractables in representative components of bioproduction.

The article reports that according to the U.S. Food and Drug Administration (FDA) data integrity plays an important role in compliance of Current Good Manufacturing Practice (CGMP) for drugs. Topics discussed include issuing of warning letters and product seizures after coming across of data integrity problems, publishing of guide on good data management by the World Health Organization (WHO) and review of critical data points in data integrity programme.

The article explores the European Union (EU) good manufacturing practice (GMP) and the US Food and Drug Administration (FDA) regulatory documents (2) require manufacturers to monitor pharmaceutical and biopharmaceutical product quality to ensure that a "state of control" is maintained throughout the lifecycle of new and legacy products during the third process validation stage called "continued process verification (CPV)" (2) or "ongoing process verification (OPV)"

The article presents an interview with recent trends in dissolution testing leading to increased use of data integrity solutions. Topics include recent innovations, ongoing trends, and the future of the dissolutions testing industry; and requiring a shift for using inline process analytical technologies based on correlation modelling with traditional destructive offline physical tests.

The article discusses the annual survey conducted by the European Federation of Pharmaceutical Industries and Associations (EFPIA) involving research-based pharmaceutical firms. Topics discussed include the use of resources, the outcome of inspection practices for the oversight of good manufacturing practice (GMP) and good distribution practice (GDP) by domestic and foreign regulatory authorities.

The article talks about therapeutic recombinant proteins, including monoclonal antibodies (mAbs), bispecifics, and biosimilar molecules, that are among the most common biologics developed for therapeutic applications. Mentions top priorities when selecting a cell line development partner including: scientific expertise; regulatory expertise. Presents four components for a successful cell line development project: host cell line; process design; expression vector; and media.

The article focuses on UK's National Artificial intelligence (AI) Strategy for enhancing the country's digital ecosystem, with the help of health and life sciences sectors. It mentions aim to experience significant growth in the number and type of AI systems discovered in the UK; and also mentions international technical standards as a mechanism for governing AI.