Life Science Industry Research Articles

Data Reliability Controls in Life Science Industries

Data Reliability Controls in Life Science Industries

Happy 25th Anniversary, EurJOC!

Happy 25th Anniversary, EurJOC!

SP-3: PRECISION MEDICINE

Precision Medicine is one of the most impactful global opportunities in healthcare. We can debate the name, whether it is precision, stratified or personal but at the highest strategic level, we all share a common goal to enable a world where healthcare is informed by each person unique clinical, molecular and lifestyle information. Precision Medicine will spur a revolution in healthcare, bringing the prospects of earlier, pre-symptomatic diagnosis, more effective treatment, significant cost savings for the NHS and all the above combined with better patient outcomes. Moreover, Precision Medicine will reach the global market value of £134 billion by 2025 thus contributing to unprecedented developments in Life Sciences industry, including new jobs creation, and a significant economic growth. The UK is in a prime position to lead on Precision Medicine globally due to the NHS facilitating advanced health data management, excellent genomics and other omics, new imaging modalities and major advances in the artificial intelligence applied to diagnostics. All the above is supported by the triple helix approach, which involves close collaborations among academic researchers, the NHS and industry. The Covid-19 pandemic has made a major contribution to the UK molecular diagnostic capability. This legacy includes very high throughput laboratories, which should become key building blocks for the UK cutting edge Precision Medicine strategy for the next decade and beyond.

CiteAb for researchers and suppliers: How identifying product citations from publications can help accelerate science

The monumental waste of time and money when the incorrect reagent is purchased is a prevalent problem in life science research. CiteAb is an innovative technology company that has developed unique data collection technology to identify product citations from the scientific literature in order to solve this problem. Citation data powers a search engine which ranks products by citation count. This provides researchers with a simple, unbiased and reliable method to identify the best reagent for their experiment. CiteAb then saw an opportunity to provide citation-based data products to reagent suppliers and financial companies to maximise their business performance, reach and impact. CiteAb technology is estimated to have saved the life science industry $10 billion, ultimately helping accelerate science. This success has driven sustained revenue growth with no external investment. This article will give an overview of CiteAb’s technology, products, impact and future directions, including the potential for partnerships with publishers.

Collaboration to develop modular facility proof-of-concept for multi-modal bioprocessing activities

Watch the video or read the poster to learn about:Why modular, multimodal bioprocessing is an important future trendThe specific design and timelines for the proof-of-concept facility designHow this modular facility approach can be leveraged for your specific requirementsA roadmap for the future, including improved sustainability and greater automationJerome Dalin, Senior Consultant– EMEA Traditional Modalities, Bioprocessing Strategy Operationalization, Merck. Jerome started his career at Sanofi Pasteur 20 years ago in vaccine process development in France before joining Merck in 2013 to manage bioprocessing sales with vaccine project coordination at a global level. In his current role, Jerome is leading strategic initiatives and supporting go-to-market strategies with a special focus on traditional modalities.Thomas Hauser, Business Development Manager, EMEA, G-CON. Thomas is working for G-CON Manufacturing in the EMEA region in a drive to bring forward the pharmaceutical facility of the future concept. He is also supporting companies in the life science segment in expansion strategies, strategic facility implementation, start-up support, and pharmaceutical packaging supply and technologies. Before 2020, Thomas worked in business development, strategic implementation, and sales in the pharmaceutical packaging field. He has more than 25 years of experience working with the global life science industry.

Wood lignocellulosic stabilizers: effect of their characteristics on stability and rheological properties of emulsions

Lignocellulosic materials from the forest industry have shown potential to be used as sustainable hydrocolloids to stabilize emulsions for many applications in life science and chemical industries. However, the effect of wood species and recovery method on the product’s properties and ability to stabilize emulsions of isolated lignocellulosic compounds is not well understood. Hemicelluloses, abundant lignocellulosic side stream, exhibit differences in their water solubility, anionic character, lignin content, and degree of acetylation. Here, we explored stability and rheological properties of model emulsions (5% hexadecane and 1% stabilizer, w/w) stabilized by different grades of sprucewood galactoglucomannan (GGM) and birchwood glucuronoxylan (GX) hemicelluloses. The results were compared to known soluble, insoluble, charged, and non-charged cellulosic stabilizers, namely methyl cellulose (MC), carboxymethyl cellulose (CMC), anionic- and nonionic-cellulose nanocrystals (aCNC and dCNC). The results showed that GX emulsions were highly stable compared to GGM emulsions, and that deacetylation and lignin removal markedly reduced emulsion stability of GGM. Carboxymethylation to increase anionic characters enhanced the emulsion stabilization capacity of GGM, but not that of GX. Investigating flow behaviors of emulsions indicated that hemicelluloses primarily stabilize emulsions by adsorption of insoluble particles, as their flow behaviors were similar to those of cellulose nanocrystals rather than those of soluble celluloses. Understanding the impact of the variations in composition and properties of hemicellulose stabilizers to stabilize emulsions allows tailoring of their recovery processes to obtain desirable hydrocolloids for different applications.

Physician–Medical Manufacturing Industry Relationships: Perceptions of Malaysians

The relations between physicians and the medical manufacturing industry(MMI) which includes pharmaceutical, medical device or implants or life science industry, etc., are well known. To promote better physician–patient relationship and to safeguard patients’ interest, it has been proposed to make physician–industry financial relations transparent and accessible to public. This study aimed to explore Malaysian public’s perceptions towards these relationships. A survey questionnaire was specifically prepared to meet the objective of the study after a review of the existing literature. Statements describing various types of physician–industry financial interactions were formulated based on previous research. The participants were instructed to mark their response to each statement based on a 5-point Likert scale ranging from strongly disagree to strongly agree. More than half (57.1%) of the participants were aware of the relationships between physicians and MMI and online database was noted to be the most preferred type of disclosure. Age, gender, race, education status, annual income and subjective health influenced the perceptions. Since consumers (patients) are the key stakeholders of the healthcare industry, their opinions are important. It is hoped that disclosing the financial relationships will help them to make a better-informed decision while choosing their healthcare provider.

Tales, tips & teachable moments from applications support veterans

Charlotte Barker, Editor, BioInsights speaks to three Field Application Scientist Managers at Corning Life Sciences: Chris Suarez, Catherine Siler & Austin Mogen Dr Chris Suarez is the Manager of the Field Application Scientist team at Corning Life Sciences. He received his PhD in Medicinal Chemistry and Molecular Pharmacology from Purdue University working on viral production, cell line engineering, and cancer biology. Dr Suarez has held positions in academia focusing on translational research to overcome mechanisms of therapeutic resistance in breast and prostate cancer using 3D tumor organoid models. Dr Suarez works extensively with process development groups, optimizing production capabilities and cellular scale-up conditions from viral production to cellular therapeutics. In addition, he focuses on collaborations utilizing 3D technology like the Corning spheroid and Elplasia® microplates, Transwell® inserts and extracellular matrices to provide more predictive models for therapeutic response.Dr Catherine Siler is an accomplished Field Application Scientist for Corning Life Sciences, with a PhD in Biology from Johns Hopkins University. Dr Siler enables scientists and researchers in the life science industry to overcome challenges with cell culture and scale-up for clinical manufacturing of advanced therapies. She also utilizes her research and teaching experience to drive the adoption of an industry-leading global product portfolio of innovative single-use consumables for research, process development and bioprocessing applications.Dr Austin Mogen is a Field Application Scientist Manager for Western United States and Latin America at Corning Life Sciences. He received his doctorate from the University of Florida and gained industry experience as a Senior Scientist of upstream process development and manufacturing supervisor for viral vector manufacturing. In this position he focused on bioprocess development, closed system solutions for cell culture scale-up, and viral vector production. Since joining Corning Dr Mogen works extensively with academic researchers and process development groups, optimizing cell culture assays and cellular scale-up conditions for viral production, cellular therapeutics, and biologics.

Learning from pediatric CAR-T development: insights from manufacturing unique patient doses

Chris Brown is the Director of GMP Manufacturing within the Therapeutic Cell Production Core, Seattle Children’s Therapeutics’ GMP cell manufacturing facility. He leads the facility’s manufacturing/process development team and played a key role in initial design, stand-up, and ongoing development of the TCPC facilities, team, and manufacturing methodologies. He has more than 20 years’ experience in the manufacturing of cellular products for Phase 1 and 2 clinical trials, with a focus in translating cutting-edge research into first-in-human cellular therapeutics. He joined Seattle Children’s Research Institute from the Fred Hutchinson Cancer Research Center in 2010, where he led the manufacturing team within the Cellular Production Facility cleanroom. He holds a BA in Biology from Carleton College in Northfield, Minnesota.Sean Werner is the Chief Technology Officer – Cell Processing at BioLife Solutions, a leading provider of bioproduction tools and services to the cell and gene therapy and broader biopharma markets. BioLife acquired Sexton Biotechnologies in 2021 where Sean was President of the company known for providing processing and handling solutions for the CGT industry. Sean received his PhD from Purdue University in Biology followed by post-doctoral positions at the Indiana University School of Medicine and Eli Lilly. Sean has previous experience filling various roles in the global regulatory and general management functions supporting medical devices, autologous cell therapy, and single use disposable development programs. In his 15 years working in the life science industry, he has guided pre-clinical and clinical testing and submission strategies leading to global commercialization of multiple medical devices and bioprocessing tools.

Studying footfall vibration criteria in a changing market and the effects on structural design

Design parameters for vibration criteria and tolerances from footfall induced vibration have long been categorized by general use with a focus on human comfort, with guidelines for offices, residential uses and hospital patient rooms. More stringent criteria required for sensitive laboratory and research equipment has typically been limited to select locations within projects. As the life science industry continues to expand, there is a growing trend to provide a leasable core & shell space that is already suitable for these more stringent equipment requirements while maintaining flexibility within the building. This paper reviews how 3D modelling can be utilized to demonstrate the expected vibration in large structures and study various iterations to determine how steel depth, steel weight, and composite structures can reduce vibration levels across the floorplate. Also discussed will be the implications of changing the structural design goals, with project examples of how other design considerations such as ceiling height, cost, and project schedules are impacted.

As Data Flows Surge Data Infrastructure Groans

As Data Flows Surge Data Infrastructure Groans

Industrial Organic Synthesis in Life Sciences – Today and Tomorrow

The Life Science sector is currently undergoing a revolutionary transformation – powered by the convergence of biology, technology and data-driven insights. The important enabling role of synthetic organic chemistry in this transformation is sometimes overlooked. In this Guest Editorial, a perspective on the current and future role of synthetic organic chemistry in the Life Science Industry is provided.

Why deep pockets make great borrowers: an empirical analysis of venture loans

Startups typically have no positive cash flow, little collateral to offer, and high bankruptcy rates. As a result, they seem to be poor loan candidates. However, venture loans as hybrid form financing that include a loan and a warrant are used in practice. We focus on this distinct form of venture debt and identify characteristics of startups and their financing history that are related to their probability of receiving a venture loan. We use an unbalanced panel data sample of 13,540 companies that have conducted 27,577 financing rounds. Our key finding is that venture loans are associated with strongly committed existing investors, which stimulates the requirements of venture lenders and is signaled through large invested capital amounts per investor in previous rounds. Furthermore, we find that venture loans are associated with rather mature startups and offer empirical indication that the medical, health, and life science industry with clear milestones provides good conditions for venture loans.

Afterword

For a professor of law who teaches and writes on intellectual property and health, this collection is both fascinating and immensely useful. This is especially so given my work on the history of the life science industries and, going back to the 1992 Earth Summit in Rio de Janeiro, my work on

Making billions (of cells) with adherent cell cultures

<h3>Watch the video or read the poster to learn about:</h3> <ul><li>Adherent platform options to fit the needs of your process and facility</li><li>Seed train considerations </li><li>Understanding of process parameters, cross-platform applicability and platforms that facilitate process characterization/control</li><li>Implementing automation for process consistency</li></ul><div class="authors authors-lg"><div class="author"><div class="author-img"><img src="https://cdn.insights.bio/uploads/Cat Siler Headshot copy.jpg" data-image="1"></div><div class="author-det"> <b>Catherine Siler</b> is an accomplished Field Application Scientist for Corning Life Sciences, with a PhD in Biology from Johns Hopkins University. Dr Siler enables scientists and researchers in the life science industry to overcome challenges with cell culture and scale-up for clinical manufacturing of advanced therapies, and utilizes her research and teaching experience to drive the adoption of an industry-leading global product portfolio of innovative single-use consumables for research, process development and bioprocessing applications. </div></div></div>

The world has a unique opportunity: Accelerating technology transfer and vaccine production through partnerships

The global roll-out of vaccines is crucial to defeating the pandemic, but the lack of technical know-how and manufacturing infrastructure for production are constraining the speedy provision of vaccines globally. This will remain true even if the intellectual property rights of COVID-19 vaccines are waived temporarily. To accelerate technology transfer and global vaccine production, this article calls for the promotion of joint ventures between global COVID-19 vaccine manufacturers and local pharmaceutical companies so as to create regional manufacturing hubs. These joint ventures must be supported financially by global North countries, international organisations, and host-country governments. This approach will incentivize pharmaceutical companies to share not only their patents but also tacit production knowledge because the risk and cost of setting up new facilities will be shared. In this paper, we show how the joint venture approach will have benefits for all the actors involve and generate positive impact on Sub-Saharan Africa and other regions over the long run. Following these policy proposals will not only help protect the global community from COVID-19 but will also present a rare window of opportunity to stimulate the life science industry in the global South, supporting sustainable economic and technological development.

Fused Deposition Modeling of Microfluidic Chips in Transparent Polystyrene.

Polystyrene (PS) is one of the most commonly used thermoplastic materials worldwide and plays a ubiquitous role in today’s biomedical and life science industry and research. The main advantage of PS lies in its facile processability, its excellent optical and mechanical properties, as well as its biocompatibility. However, PS is only rarely used in microfluidic prototyping, since the structuring of PS is mainly performed using industrial-scale replication processes. So far, microfluidic chips in PS have not been accessible to rapid prototyping via 3D printing. In this work, we present, for the first time, 3D printing of transparent PS using fused deposition modeling (FDM). We present FDM printing of transparent PS microfluidic channels with dimensions as small as 300 µm and a high transparency in the region of interest. Furthermore, we demonstrate the fabrication of functional chips such as Tesla-mixer and mixer cascades. Cell culture experiments showed a high cell viability during seven days of culturing, as well as enabling cell adhesion and proliferation. With the aid of this new PS prototyping method, the development of future biomedical microfluidic chips will be significantly accelerated, as it enables using PS from the early academic prototyping all the way to industrial-scale mass replication.

The future of biomolecular simulation in the pharmaceutical industry: what we can learn from aerodynamics modelling and weather prediction. Part 1. understanding the physical and computational complexity of in silico drug design.

The predictive power of simulation has become embedded in the infrastructure of modern economies. Computer-aided design is ubiquitous throughout industry. In aeronautical engineering, built infrastructure and materials manufacturing, simulations are routinely used to compute the performance of potential designs before construction. The ability to predict the behaviour of products is a driver of innovation by reducing the cost barrier to new designs, but also because radically novel ideas can be piloted with relatively little risk. Accurate weather forecasting is essential to guide domestic and military flight paths, and therefore the underpinning simulations are critical enough to have implications for national security. However, in the pharmaceutical and biotechnological industries, the application of computer simulations remains limited by the capabilities of the technology with respect to the complexity of molecular biology and human physiology. Over the last 30 years, molecular-modelling tools have gradually gained a degree of acceptance in the pharmaceutical industry. Drug discovery has begun to benefit from physics-based simulations. While such simulations have great potential for improved molecular design, much scepticism remains about their value. The motivations for such reservations in industry and areas where simulations show promise for efficiency gains in preclinical research are discussed. In this, the first of two complementary papers, the scientific and technical progress that needs to be made to improve the predictive power of biomolecular simulations, and how this might be achieved, is firstly discussed (Part 1). In Part2, the status of computer simulations in pharma is contrasted with aerodynamics modelling and weather forecasting, and comments are made on the cultural changes needed for equivalent computational technologies to become integrated into life-science industries.

Key considerations and risk management best practice for placenta-derived cell therapy raw materials

Ruth Goldberg joined Pluristem in 2009 and currently serves as Compliance and Methods Validation Manager. Ruth has over 14 years of experience in the biotech industry in several leadership positions. She is skilled in Biotechnology, Life Sciences, Quality Assurance, Quality System, CMC, and Pharmaceutical Industry; a strong education professional with PhD in Cell Biology and Immunology, Technion.Lior Raviv joined Pluristem in 2011 and currently serves as Vice President of Operations &amp; Development. Prior to that Mr Raviv served as Process development engineer and Projects manager and Product development Team leader at Pluristem. Prior to joining Pluristem and during the years 2010–2011, Mr Raviv held the position of R&amp;D Analytical Researcher at Teva Pharmaceutical Industries. Mr. Raviv holds a M.Med.Sec in pharmacology from the Ben Gurion University and a BSc, in Biotechnology engineering from the Ben Gurion University.

Photocatalysis in the Life Science Industry.

In the pursuit of new pharmaceuticals and agrochemicals, chemists in the life science industry require access to mild and robust synthetic methodologies to systematically modify chemical structures, explore novel chemical space, and enable efficient synthesis. In this context, photocatalysis has emerged as a powerful technology for the synthesis of complex and often highly functionalized molecules. This Review aims to summarize the published contributions to the field from the life science industry, including research from industrial-academic partnerships. An overview of the synthetic methodologies developed and strategic applications in chemical synthesis, including peptide functionalization, isotope labeling, and both DNA-encoded and traditional library synthesis, is provided, along with a summary of the state-of-the-art in photoreactor technology and the effective upscaling of photocatalytic reactions.