OUTSOURCING ARTICLES
-
![cars driving on a bridge-GettyImages-1167795076]( "The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic Future")
The RNA Synthesis Spectrum: Between Solid-Phase Roots & A Hybrid Enzymatic FutureThere were two additional takeaways I had following my conversation with Kuchimanchi, each of which depicts where there still exists quite a bit of dynamism for an industry which can claim an “established” manufacturing paradigm.
-
![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.
OUTSOURCING VIDEOS
Together, Omega’s Jeff Atkinson & Sail Biomedicines’ Jim Nolan share their perspectives on the health of the linear mRNA and circRNA outsourcing sector.
Gain insight from several clinical operations experts into the significance of meticulous contract examination when choosing an outsourcing partner.
Stay ahead in mRNA therapeutic development by mastering the essential quality systems, process controls, and analytical methods required for robust GMP production and efficient manufacturing.
While the speed of production and flexibility of mRNA are appealing, several industry challenges must still be addressed to realize the full potential and further expand its use.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
-
![Developing mRNA Vaccines GettyImages-1307593959]( "Improving Pre-Clinical Study Efficiency With mRNA-LNP Technology")
Uncover how Repair Biotechnologies, in collaboration with Vernal Biosciences, helped to pave the way for the next generation of breakthrough treatments for cholesterol and aging-related diseases.
-
![GettyImages-1313742092 tech partner]( "The Execution Stage Of Technology Transfer")
What are the key elements in the readiness stage of a technology transfer that are critical to your success? Explore Process Performance Qualification (PPQ) and the execution stage of PDA TR-65.
-
![Scientist, laboratory, microscope analysis-GettyImages-1530246394]( "Expression Analysis Of CTLA-4, PD-1, And PD-L1")
Advance personalized immunotherapy in NSCLC by leveraging qPCR-based analysis of CTLA-4, PD-1, and PD-L1 expression to identify predictive biomarkers and guide more effective treatment strategies.
-
![GettyImages-597935610 cell and gene]( "The Sponsor's Clinical Development Handbook For Gene Therapy Trials")
Gene therapy has existed for decades, but the field is not as mature as it may seem. Here, the author provides essential insights and strategies for overcoming gene therapy development challenges.
-
![GettyImages-1354171846-lab-research-development]( "Identifying Sustainable Pathways Toward Oligonucleotide Therapeutics")
What sustainable manufacturing processes best address Oligonucleotide environmental impact while maintaining scalability?
-
![scientist laboratory microscope-GettyImages-1253518521]( "Cell And Virus Banking In OV Development And Manufacturing")
Delve into the exciting potential of OVs, including the critical role of cell and virus seed banks, and discover key considerations for establishing cell and virus banks for OV production.
-
![GettyImages-1387090964 cell and gene therapy]( "Moving CGTx Clinical Development Forward In 2023")
Gain insights on cell and gene therapy (CGTx) clinical trial design and commercialization strategies as a panel of industry experts share their considerations.
