OUTSOURCING ARTICLES
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![Outsourcing-GettyImages-467648692]( "Contract Manufacturing Outsourcing Trends For Advanced Therapies In 2025 And Beyond")
Contract Manufacturing Outsourcing Trends For Advanced Therapies In 2025 And BeyondContract manufacturing continues to emerge as the widely adopted model for bringing cell therapies, gene therapies, RNA therapeutics, and oligonucleotides to patients worldwide.
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![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.
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![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.
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![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.
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![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.
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![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.
OUTSOURCING VIDEOS
Gain insight from several clinical operations experts into the significance of meticulous contract examination when choosing an outsourcing partner.
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.
Gain the insight and strategic flexibility needed to confidently navigate the unique scientific, regulatory, and documentation challenges of gene therapy development.
Discover how our advanced capabilities in Hopkinton, MA, are overcoming the challenges of large-scale RNA therapeutic manufacturing, enabling the efficient production of complex srRNA and mRNA therapies.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![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.
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![GettyImages-1295693748-mRNA]( "Addressing Challenges In mRNA Drug Development And Manufacturing")
mRNA-based drug products serve as an ideal platform for use in infectious disease, protein replacement, and immuno-oncology applications due to the simplicity of manufacturing and robust immune response.
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![GettyImages-946264472-test-tube-lab]( "Improving Toxicology Testing For Inhalation Products")
By embracing new approach methods, regulatory agencies can revolutionize toxicology testing. These methods can be adapted for various medications, including inhalers and nasal-administered drugs.
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![GettyImages-1284529278-syringe-pre-filled-PFS]( "New Perspectives On Accelerating Genetic Nanomedicines Through The Regulatory Pathway")
Discover how regulatory bodies are adopting a risk-based approach to address the unique challenges of genetic nanomedicines, and stakeholder engagement is essential.
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Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here, we explore this from a biopharma process development and manufacturing perspective.
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![GettyImages-1483104506 Document Digitization Concept]( "A Sustainable, Efficient Approach To Enhance Equipment Qualification")
Explore compelling reasons to digitize your qualification documents and the benefits of a sustainable and efficient approach that utilizes digital tools to enhance your equipment qualification process.
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![GettyImages-1387090964 cell and gene therapy]( "Gene And Cell Therapy: Planning For Manufacturing Success Early")
As gene therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations, explore how to optimize plasmid production and reach patients with efficiency.
