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The article focuses on the potential for point-of-care (POC) manufacturing in the biopharmaceutical industry. Topics include the emergence of advanced manufacturing technologies and regulatory considerations, the benefits of distributed manufacturing and technological advancements for ensuring drug quality, and the relevance of POC manufacturing for cell and gene therapies.

The article discusses the challenges faced by manufacturers of cell and gene therapies (CGT) in scaling up production efficiently and meeting the increasing demand. It highlights the need for automation and standardized systems to overcome manual handling limitations and achieve higher throughput, as well as the importance of flexibility in manufacturing setups to address the diverse products in the CGT field.

The article explores how 3D printing (3DP) is revolutionizing the manufacturing of solid dosage drugs, offering new opportunities for personalized medicine and controlled release formulations. Topics include the advantages of 3DP for customized drug delivery, the development of innovative dosage forms beyond traditional tablets, and the ongoing collaborations between companies like Triastek and BioNTech to enhance drug delivery systems.

The article focuses on the growing role of 3D printing (3DP) in solid dosage drug manufacturing, offering opportunities for customization and precision. Topics include the advantages of 3DP for controlled-release and personalized medicine, the development of new drug delivery forms such as orodispersible films and long-acting implants, and advancements by companies like Aprecia and Triastek in creating innovative drug products using 3DP technologies.

The article focuses on advancements in robotic automation technologies for pharmaceutical manufacturing, highlighting innovations that improve efficiency, flexibility, and contamination control. It examines the latest developments in robotic filling systems and telemanipulation technologies, which enhance compliance with stringent regulatory requirements while minimizing manual intervention and maintaining sterility.

The article explores the shift towards decentralized or distributed manufacturing in biopharmaceutical production, focusing on the potential benefits, challenges, and emerging technologies, with a particular emphasis on point-of-care manufacturing. Topics include the regulatory landscape, advancements in quality assurance/quality control (QA/QC) methods, and the application of advanced manufacturing technologies such as machine learning (ML) and end-to-end continuous manufacturing.

The article focuses on the emergence of advanced manufacturing technology in the biopharmaceutical industry, indicating a shift toward distributed manufacturing models. Topics discussed include the U.S. Food and Drug Administration's recognition of the need for flexible manufacturing, regulatory challenges, and the potential of point-of-care (POC) manufacturing to address issues such as drug shortages and pandemic preparedness.

The article focuses on the growing applications of twin-screw extruders in pharmaceutical manufacturing, particularly in processes like hot-melt extrusion and twin-screw granulation. It highlights researchers are actively developing process analytical technology for twin-screw granulation to improve product and process development using quality by design techniques, emphasizing the importance of understanding formulation and process variables for granule quality.

The article discusses the expanding applications of twin-screw extruders in pharmaceutical manufacturing, both as standalone units and as part of continuous manufacturing lines. It highlights the use of hot-melt extrusion (HME) for producing amorphous solid dispersions, twin-screw granulation (TSG) for making granules using various techniques, and its importance in certain formulations where direct compression is not suitable.

The article highlights how process automation technologies are aiding the modernization and improvement of downstream biopharmaceutical processes, including benefits such as efficient operation of connected systems, reduced variability and error, and the use of closed systems. Topics covered include intensified purification processes, single-use system handling, and the role of process analytics in enhancing continuous measurements of critical parameters and quality attributes.

The article focuses on the challenges faced by manufacturers in meeting the growing demand for personalized cell and gene therapies (CGTs). It highlights the need for automated strategies and standardized systems to efficiently scale up production. It discusses the challenges of current manufacturing processes, including labor intensity, complexity, and the potential for errors and contamination.

The article discusses automation's role in aiding cell and gene therapy production. Manufacturers face challenges in meeting the increasing demand for personalized biopharmaceuticals. Automation and in-line sensing technologies are sought for scaling up production efficiently and reducing errors. The factory in a box concept and closed systems can address bottlenecks in production capacity and skilled workforce availability, making therapies more accessible to patients in need.

The article presents the discussion on automation and digitalization work together in the digital plant. Topics include automation and digitalization enabling online quality testing and review-by-exception; and data collected from equipment being connected through the industrial Internet of things (IIoT) and analyzed with artificial intelligence (AI).

The article discusses benefit of automation and digitalization for biopharmaceutical manufacturers in multiple fields of plant operation. Topics discussed included equipment like "industrial internet of things (IIoT)" and "artificial intelligence (AI)" allow control system to know when a process is out of specification, digital biopharmaceutical manufacturing plan is "facility to future," and discussing the obstacle with automation is difficulty to calculate return on investment of a project.

The article offers information on the increasing use of automation and digitization in the biopharmaceutical manufacturing. It mentions the views of the Heather Coglaiti, global industry strategy and marketing lead for life sciences, Rockwell Automation on how automation leads to improved product quality and compliance, reduced risk, and improved productivity.

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 important role played by precompetitive consortiums in cell and gene therapy (CGT) manufacturing in the biopharmaceutical industry. According to National Institute for Innovation in Manufacturing Biopharmaceuticals' (NIIMBL) Chris Yochim, a consortia-based approach facilitates technology adoption and the creation of standardized tools to address industry-wide challenges. Also cited are some consortiums like the Bio-Process System Alliance (BPSA).

The article discusses the digital transformation in life sciences manufacturing in the U.S. It mentions that digital transformation is being accelerated by the need for more supply chain agility, remote work, and the tight labor market. It also mentions that digitalization is a new way of thinking and working, but misconceptions and limited knowledge remain a barrier for some.

The article pays attention to the significance of process analytical technology (PAT) for process control and real-time release in continuous manufacturing of solid-dosage drugs. Topics discussed include use of in-line PAT instruments for real-time measurement in continuous manufacturing (CM) of oral solid dosage (OSD) drugs, importance of physically integrating the PAT probe into the process for accurate measurement and using PAT to predict tablet dissolution.

The article discusses the use of in-line PAT (process analytical technology) instruments for real-time measurement in continuous manufacturing (CM) of oral solid dosage (OSD) drugs. It focuses on the advances in PAT, including near-infrared (NIR) spectroscopy and Raman spectroscopy, that are enabling increased use of these tools for real-time quality control in OSD CM. It also covers the adoption of Raman within CM and improvements in sample interface technology.

The article discusses pharmaceutical manufacturing is inching towards implementing more efficient and sustainable processes, including continuous manufacturing (CM) of solid-dosage drugs. Advantages of CM include the potential for faster development, easier technical transfer, and more efficient and flexible commercial production with tighter process control.

The article presents the discussion on collaboration and new tools aid efforts in small-molecule drug product manufacturing. Topics include pharmaceutical manufacturing moving towards implementing more efficient and sustainable processes containing continuous manufacturing (CM) of solid-dosage drugs; and industry being concerned about the risks to development costs and speed-to-market.

The article offers information about the development of Additive manufacturing, which is commonly called three-dimensional printing (3DP). It mentions that 3DP offers the potential for manufacturing specialty dosage forms and personalized medicine in either a centralized, industrial environment or in distributed, point-of-care supply.

The article explores the potential of three-dimensional printing (3DP) for manufacturing specialty dosage forms and personalized medicine in either a centralized, industrial environment or in distributed, point-of-care supply. Topics covered include possibility of portable and flexible point-of-care manufacturing offered by good manufacturing practice (GMP) 3D printers, and how new materials designed for 3DP could help advance the adoption of 3DP technology.

The article explores an ongoing engineering challenge for aseptic drug manufacturing is to reduce the risk of contamination as much as possible. As it is well known that human operators are the biggest source of contamination in a cleanroom, a growing consensus is that automated systems that eliminate human intervention are the future of aseptic processing.

The article reports on the efforts to automate aseptic manufacturing to reduce risk of contamination in the pharmaceutical industry. Also cited are the growing use of robotic technology in drug compounding and gloveless isolators, the benefits of robotic automation technology like the ability to handle multiple formats like vials and syringes, and the comment of Syntegon Pharma Technology's Laura Moody on the automation technologies.

The article discusses the importance of streamlining equipment quality and flexibility in pharmaceutical and biopharmaceutical manufacturing. It explores the views of Michalle Adkins, director of life sciences consulting at Emerson, on using cloud-based FAT (factory acceptance testing) tools to remotely connect to equipment at the supplier, run tests using the actual system configuration, and generate documentation.

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 explores how to analyzing extractables and leachables in single-use systems for any product-contact material to determine the risk of leachable compounds contaminating a drug product . Topics include container-closure systems, which contact the drug product during longterm storage; and polymer single-use systems (SUS) are increasingly being used in biopharmaceutical manufacturing throughout the supply chain.

The article discusses the ways to run downstream processes more efficiently by biopharmaceutical manufacturers. Topics include the Intensified processes rely on process analytical technology (PAT) to collect real-time data; downstream processing of monoclonal antibodies (mAbs) traditionally uses chromatography, and automation to interconnect all the downstream unit operations.

The article offers information on the 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 discusses that Consortiums move through development toward commercialization, collaborative efforts can help speed the solution of problems that arise when trying to manufacture efficiently at commercial scale.

Small-scale end-to-end systems Innovators are prototyping other mobile manufacturing facilities using continuous, end-to-end manufacturing at small scales of finished drug forms for both small- and large-molecule drugs. The call for reshoring manufacturing may be answered in part by using these advanced technologies to produce APIs or to continuously manufacture drug products endto-end, beginning with basic raw materials and ending with a finished drug form. Continuous path for OSD drugs While FDA has approved one API made using continuous flow chemistry, continuous manufacturing - starting with API and excipients and ending with finished drug - is now being used to produce six FDA-approved oral solid-dosage (OSD) drugs, including some previously made in batch manufacturing as well as new drugs approved with continuous OSD processes. The commercial facility will have a capacity that is several times greater than that of the pilot line, with two end-to-end lines that will have the capacity to produce multiple APIs and drug products, including both sterile injectables and OSD drugs using a "multi-suite" design. [Extracted from the article]

Small-scale end-to-end systems Innovators are prototyping other mobile manufacturing facilities using continuous, end-to-end manufacturing at small scales of finished drug forms for both small- and large-molecule drugs. The call for reshoring manufacturing - coming perhaps most loudly from the United States but also a concern in other countries - may be answered in part by using these advanced technologies to produce APIs or to continuously manufacture drug products end-to-end, beginning with basic raw materials and ending with a finished drug form. Continuous path for OSD drugs While FDA has approved one API made using continuous flow chemistry, continuous manufacturing - starting with API and excipients and ending with finished drug - is now being used to produce six FDA-approved oral solid-dosage (OSD) drugs, including some previously made in batch manufacturing as well as new drugs approved with continuous OSD processes. 16 Pharmaceutical Technology APRIL 2021 PharmTech.com Cover Story: Manufacturing Advances SERGEY NIVENS- STOCK.ADOBE.COM Advanced Manufacturing Technologies Shift Outside the Box Jennifer Markarian Intensified and distributed manufacturing approaches create flexible, local capacity. [Extracted from the article]

The article discusses Blow-fill-seal (BFS) equipment has been widely used for many years in aseptic fill/finish of small-molecule and biologic liquid formulations, including nebulizer solutions for respiratory delivery and ophthalmic sterile solutions packaged as unit-doses. A key advantage of the process is that it is a closed, automated system—a plastic container is formed within the equipment, filled with sterile solution, and closed, with limited human intervention.

The article presents the discussion on aseptic fill/finish process finding use in vaccines and biologic drugs. Topics include nebulizer solutions for respiratory delivery and ophthalmic sterile solutions packaged as unit-doses; and showing concerns about process temperatures causing hesitancy with some manufacturers of temperature-sensitive biologic drug products.

The article discusses that the United States Pharmacopeial Convention, a nonprofit organization known for developing standards for quality, is actively involved in facilitating the implementation of continuous manufacturing in the biopharmaceutical industry. It mentions that the International Council for Harmonisation published draft guidance on continuous manufacturing in July 2021 that was beneficial for small-molecule drug manufacturing and biologic drug manufacturing.

The article focuses on the consideration by biopharmaceutical manufacturers of using blow-fill-seal (BFS) as an option for fill/finish of vaccines and other biologic drug products. Topics covered include the adoption of the continuous, aseptic fill/finish process in vaccines and biologic drugs, the benefits of the BFS process, and the steps for designing the process for the product.

The article informs that biopharmaceutical industry is working at unprecedented speed to develop and manufacture vaccines for the COVID-19 pandemic. It mentions that the challenges of pandemic is the need to scale up 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. It further informs about collaborative efforts to make a safe and effective vaccine against the novel coronavirus.

The article report on the biopharmaceutical industry is working at unprecedented speed to develop and manufacture vaccines for the COVID-19 pandemic. Topics discussed include collaborative efforts to make a safe and effective vaccine against the novel coronavirus, SARS-CoV-2, are underway around the world; and the views of Andre Goerke, head of the planning and value chain management business unit at Lonza; on it.

The article discusses the biopharmaceutical industry has working at unprecedented speed to develop and manufacture vaccines for the COVID-19 pandemic. Topics include modular facility designs allow manufacturers to adapt and move quickly; and the United States, the federal government's Operation Warp Speed program a partnership for the US Department of Health and Human Services, the Department of Defense.

The article offers information on use of process analytical technology (PAT) to provide the data needed to use automated control for biopharmaceutical processes. Topics include information on PAT tools such as BioPAT Spectro, which uses Raman spectroscopy for monitoring of single-use cell-culture bioreactors; focus on standardized "plug-and-play" communication interfaces; and metabolite monitoring to develop a calibration model for real-time measurement of glucose and lactate concentrations.

The article focuses on the need for quick build times, flexibility, and production efficiency is driving trends. Topics include the views of John Noble, vice-president at Jacobs, on the most common refurbishments from mothballed facilities, flexibility being important in oral solid dosage drug (OSD) manufacturing, and the manufacturing are seeking to right size the operations has based on the product portfolios and to upgrade processes.

The article presents the interview of Keith Beattie, executive director at Energy Efficiency Consultancy EECO2. Topics include the key practices and new technologies in biopharmaceutical facility design for sustainability; use of isolators for improving sterility assurance along with single-use technology; and the biggest areas of waste is energy, especially consumption related to HVAC.

The article explores A morphous solid dispersions (ASDs) are increasingly used to address the need to enhance bioavailability of poorly soluble APIs. Contract development and manufacturing organizations (CDMOs) that have amassed knowledge and experience in this specialty area play a key role in the pharmaceutical industry by providing the capabilities of developing and manufacturing ASDs.

An interview with Stuart Tindal, product manager of separations at biopharmaceutical solutions provider Sartorius, about single-use systems (SUS) in downstream processes in biopharmaceutical manufacturing and response of Sartorius to supply chain limitations and other challenges is presented. He cites the advantages and disadvantages of using SUS. Tindal describes several Sartorius technologies for the processes. He explains the effect of supply chain constraints on the market.

The article offers information on the increasing role of digitalization in the U.S. pharmaceutical manufacturing. It mentions the need to develop, manufacture, and distribute treatments and vaccines intersected with travel restrictions, social distancing, and supply chain interruptions amid the Covid-19 pandemic.

The article discusses role of digitalization in pharma equipment and processes. It mentions views of Dirk Wollaert, Vertical Market Pharma at Siemens headquarters in Belgium, on how digital technologies were key to the success of the rapid development and rollout of the COVID-19 vaccines. It reveals transition to the cloud for software solutions and data storage.

The article presents an interview of Nick Johnson, director of biopharmaceutical product management for Colder Products Co. Topics discussed include use of disposable equipment components in small-volume aseptic biopharmaceutical manufacturing; increase in small-volume biopharmaceutical processes; and benefits of standardizing single-use systems (SUS) for small-volume processes.

The article explores Continuous manufacturing (CM) has the potential to create higher quality drug substances and drug products, with greater flexibility in batch size and with a smaller facility footprint. The definition of what pharmaceutical manufacturers and regulators consider a "continuous process" is broad. The International Council for Harmonisation (ICH) Q13 draft guidance.