OUTSOURCING ARTICLES
-
![PCR machine Thermocycler for DNA or RNA quantification-GettyImages-1227432556]( "A Flexible Mindset For Bridging Between Cell-Based Assay Groups")
A Flexible Mindset For Bridging Between Cell-Based Assay GroupsTransferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.
-
![Tariffs-GettyImages-2203818660]( "The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical Trials")
The Potential Impact Of U.S. Tariffs On The Biotech Sector: Manufacturing, Funding, And Clinical TrialsSyner-G Biopharma Group's Raymond Forslund, Ph.D., MBA explores how U.S. tariffs might affect biotech manufacturing, funding, and clinical research.
-
![US Tariffs-GettyImages-2197351521]( "Navigating Tariffs: Implications And Strategies For Pharmaceuticals Manufacturers")
Navigating Tariffs: Implications And Strategies For Pharmaceuticals ManufacturersThe U.S. tariffs on trading partners bring a whole new set of challenges, but there are tactics and strategies companies can deploy to help offset the cost and operational impacts.
-
![Teamwork, cooperation, partnership-GettyImages-2156102274]( "Implement Creative And Collaborative Strategies to Optimize Your mRNA Development And Manufacture")
Implement Creative And Collaborative Strategies to Optimize Your mRNA Development And ManufactureNo matter how you approach it, mRNA manufacturing is expensive. The raw materials, technologies, and educated labor force require immense investment. To avoid incurring extra costs and to ensure your strategy is precise and risk averse, identify an experienced partner that prioritizes communication and first-time-right manufacturing.
-
![Genie lamp-GettyImages-1188901837]( "The mRNA Industry's Three Wishes: Can CDMOs Play The \"Genie?\"")
The mRNA Industry's Three Wishes: Can CDMOs Play The "Genie?"During the panel discussion last November, three CDMO execs shared the biggest scientific, regulatory, and technological complexities barring a “magical” solution to each biotech’s wishes. However, as each of the AMM panelists pointed out, there are short- and long-term technological innovations in the works that will be essential in advancing the manufacturing infrastructure for mRNA therapeutics in all their shapes, forms, and scales.
-
![Artificial Intelligence, AI-GettyImages-2178269161]( "Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides?")
Is Your CDMO Using These AI-Driven Solutions In CMC For Oligos And Peptides?Oligonucleotides and peptides require precise, scalable, and compliant production. CDMOs are integrating AI-driven technologies to answer the call. Many of these technologies are notable for specific needs.
OUTSOURCING VIDEOS
In part two of this webinar series, presenters focus on avoiding potential risks, such as unexpected budget changes and unplanned change orders, that could jeopardize the success of a clinical trial.
Having worked on both the innovator and CDMO sides of the industry, Advancing RNA LIVE panelist Khaled Yamout outlines where he sees the greatest weaknesses in these critical sponsor-CDMO partnerships and offers guidance.
Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.
TFF Pharmaceuticals’ Kayla Hannon and University of Sheffield’s Dr. Zoltán Kis discuss the cost and capacity implications of therapeutic demand surges in this Surge Manufacturing for Biopharma Resilience segment.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![Lipid Nanoparticle mRNA Vaccine GettyImages-1418152448]( "A New Centre For Continuous mRNA Manufacturing")
Explore how a partnership between academia, regulatory agencies, and manufacturing organizations has the potential to reshape the way we produce and distribute mRNA-based therapies.
-
![GettyImages-1751848523-meeting-evaluation-charts-table]( "What Is The Role Of CROs In Drug Development?")
CROs are not just facilitators but strategic innovators essential for delivering new therapies to patients efficiently and safely.
-
![GettyImages-1869998960 patient, doctor, clincial trial]( "Phase IIb Trial: Evaluating A Novel Treatment For Locally Advanced Or Metastatic Breast Cancer")
This case study highlights a successful Phase IIb clinical trial conducted by an Indian biotech company evaluating a novel treatment for Locally Advanced or Metastatic Breast Cancer.
-
![GettyImages-1355122387 RNA]( "Improvement Of Self-Amplifying RNA Quality And Potency With IVT Optimization")
Explore our study on optimizing In-Vitro Transcription (IVT) conditions for self-amplifying RNAs to achieve high yields, low residual dsRNA, and improved potency, and learn how these advancements can enhance RNA-based therapies.
-
![deep freezing cryopreservation GettyImages-952307842]( "Pioneering The Future Of Pharmaceutical Supply Chains")
Drive the efficiency and resiliency of supply chains by integrating automation, AI, and effective communication, ensuring the successful distribution of lifesaving medicinal products.
-
![RNA abbreviation of ribonucleic acid-GettyImages-1453953422]( "Navigating Challenges In Progressing Breakthrough RNA Therapeutics")
RNA therapeutics hold immense promise for precision treatment, but their development faces challenges. A CDMO with adaptable platforms and flexible timelines can help reduce time and costs.
-
![iStock-879831370-plasmid-lab-cell]( "Pre-Banking And Avoiding Manufacturing Challenges For GMP Plasmids Containing Unstable Sequence Regions")
Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.
