Solvias AG
Solvias AG
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Cell & Gene Therapies - Center of Excellence at RTP with Christopher McGee
With the 2026 compliance deadline for USP quickly approaching, it's crucial for drug developers to stay ahead of the curve. We sat down with Christopher J. McGee, Ph.D., Principal Scientist, Global Extractables & Leachables Services, and the author of Solvias' latest white paper on USP, to discuss the key aspects of this chapter and its implications for single-use systems (SUS).
มุมมอง: 8

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Cell & Gene Therapies - Center of Excellence at RTP with Tami Conley1:34Cell & Gene Therapies - Center of Excellence at RTP with Tami Conley
Cell & Gene Therapies - Center of Excellence at RTP with Tami Conley
มุมมอง 5วันที่ผ่านมา
In this interview, Tami shares how the new Solvias US site at research Triangle Park is equipped to support innovative solutions in biologics and cell & gene therapies.
Cell and Gene Therapies - Center of Excellence at RTP with Anamica Sriram Muruganandham1:28Cell and Gene Therapies - Center of Excellence at RTP with Anamica Sriram Muruganandham
Cell and Gene Therapies - Center of Excellence at RTP with Anamica Sriram Muruganandham
มุมมอง 5วันที่ผ่านมา
Anamica Sriram Muruganandham highlights how Solvias' advanced integrated LIMS (Laboratory Information Management System) and ELN (Electronic Lab Notebook) streamline laboratory operations, improve data management, and elevate the overall quality of our services. For more on Solvias or our RTP facility, visit us at www.solvias.com/about-us/centers-of-excellence/
Navigating Complexity: Tailoring Cell Based Bioassays for Advanced Therapeutics1:06:02Navigating Complexity: Tailoring Cell Based Bioassays for Advanced Therapeutics
Navigating Complexity: Tailoring Cell Based Bioassays for Advanced Therapeutics
มุมมอง 71หลายเดือนก่อน
Cell-based bioassays (CBBAs) are an essential tool for drug development, from preclinical through commercialization and are crucial for monitoring drug manufacturing processes and ensuring the safety, efficacy and potency of pharmaceutical products. These products, particularly cell and gene therapeutics and advanced biologics, are inherently complex. Therefore, CBBAs must be tailored to suit e...
Navigating Cell and Gene Therapy: Podcast with Daniel Galbraith, CSO of Solvias17:34Navigating Cell and Gene Therapy: Podcast with Daniel Galbraith, CSO of Solvias
Navigating Cell and Gene Therapy: Podcast with Daniel Galbraith, CSO of Solvias
มุมมอง 473 หลายเดือนก่อน
Daniel shares insights from the forefront of drug development, including the complexities of development and commercialization, the financial dynamics of new therapies and changing regulatory landscapes. What you will learn: • Regulatory landscape for cell and gene therapy development and release • Complexities and (financial) challenges of cell and gene therapy • The potential of emerging tech...
Solvias Cell & Gene Therapy Center of Excellence at Research Triangle Park2:21Solvias Cell & Gene Therapy Center of Excellence at Research Triangle Park
Solvias Cell & Gene Therapy Center of Excellence at Research Triangle Park
มุมมอง 503 หลายเดือนก่อน
Steve Smith, U.S. General Manager for Solvias AG, discusses the significance of our new 50,000-square-foot facility at RTP, the advanced technologies we’re implementing, and how this new center will enhance our ability to support the development of advanced therapies.
De-Risking and Accelerating Small Molecule Development, From Whiteboard to First In-Human49:56De-Risking and Accelerating Small Molecule Development, From Whiteboard to First In-Human
De-Risking and Accelerating Small Molecule Development, From Whiteboard to First In-Human
มุมมอง 304 หลายเดือนก่อน
Every delay in early phase development programs can result in loss of time, shrinking of resources, and missing milestones. This, in turn, pushes a potential cure further out of reach for patients desperately in need. Reducing handoffs between diverse scientific teams minimizes risks and expedites timelines. Our integrated approach offers a comprehensive suite of customized solutions tailored t...
Strategies for Determining Critical Quality Attributes of Nucleic Acid Therapeutics & Their Carriers59:32Strategies for Determining Critical Quality Attributes of Nucleic Acid Therapeutics & Their Carriers
Strategies for Determining Critical Quality Attributes of Nucleic Acid Therapeutics & Their Carriers
มุมมอง 554 หลายเดือนก่อน
Determining the critical quality attributes (CQAs) of emerging, more complex nucleic acid (NA) therapeutics and their carrier systems poses a new challenge for biopharmaceutical companies. Low molecular weight NA therapeutics, such as antisense oligonucleotides or small interfering RNA, can be fully characterized using CQAs like identity or purity using many different analytical tools. However,...
Untargeted Screening Methods in the 21st Century: Metabolomics vs Extractable Leachable18:50Untargeted Screening Methods in the 21st Century: Metabolomics vs Extractable Leachable
Untargeted Screening Methods in the 21st Century: Metabolomics vs Extractable Leachable
มุมมอง 55 หลายเดือนก่อน
In the last decades, data evaluation of untargeted screening studies was done by evaluating the peaks visible in the chromatogram. Nowadays, automated peak-picking algorithms have been around for more than 10 years, and they are used widely in metabolomic studies. Several software tools (planform based, multi-platform or open access) are now available to evaluate untargeted screenings with LC/M...
Update Your Biosafety Testing of Biologics13:53Update Your Biosafety Testing of Biologics
Update Your Biosafety Testing of Biologics
มุมมอง 325 หลายเดือนก่อน
From the Solvias Scientific Symposium: Biosafety testing has historically centered around a collection of classical in-vitro and in-vivo assays that address the risks of contamination present in raw materials, and in the manufacturing process. Historically, the requirements for in-vivo testing of cell banks and for long duration in vitro assays has impacted release times for raw materials and p...
Untargeted Screening Methods in the 21st Century: Metabolomics vs Extractable Leachable18:50Untargeted Screening Methods in the 21st Century: Metabolomics vs Extractable Leachable
Untargeted Screening Methods in the 21st Century: Metabolomics vs Extractable Leachable
มุมมอง 75 หลายเดือนก่อน
From the Solvias Scientific Symposium: In the last decades, data evaluation of untargeted screening studies was done by evaluating the peaks visible in the chromatogram. Nowadays, automated peak-picking algorithms have been around for more than 10 years, and they are used widely in metabolomic studies. Several software tools (planform based, multi-platform or open access) are now available to e...
Why Size Matters for Particulates.12:43Why Size Matters for Particulates.
Why Size Matters for Particulates.
มุมมอง 145 หลายเดือนก่อน
From the Solvias Scientific Symposium: This talk will illustrate manifold aspects in the development of an asymmetric hydrogenation applied on industrial scale. Process related parameters for the hydrogenation and scale-up of a new Ir-Crabtree/Pfaltz type catalyst will also be discussed. The combination of a diversified catalyst library with an expertized high throughput screening (HTS) approac...
Quality Matters: How to determine CQAs of nucleic acid therapeutics and their carriers?17:04Quality Matters: How to determine CQAs of nucleic acid therapeutics and their carriers?
Quality Matters: How to determine CQAs of nucleic acid therapeutics and their carriers?
มุมมอง 295 หลายเดือนก่อน
From the Solvias Scientific Symposium: After several decades of protein analytics in its focus, the biopharma community is now challenged to determine critical quality attributes (CQAs) of emerging, more complex nucleic acid (NA) therapeutics and their carrier systems. Low molecular weight NA therapeutics, such as antisense oligonucleotides or small interfering RNA, can be fully characterized r...
The Journey of a Catalyst17:54The Journey of a Catalyst
The Journey of a Catalyst
มุมมอง 385 หลายเดือนก่อน
From the Solvias Scientific Symposium: This talk will illustrate manifold aspects in the development of an asymmetric hydrogenation applied on industrial scale. Process related parameters for the hydrogenation and scale-up of a new Ir-Crabtree/Pfaltz type catalyst will also be discussed. The combination of a diversified catalyst library with an expertized high throughput screening (HTS) approac...
News from the LNP front (new approaches focusing to mRNA/LNP characterizations )18:07News from the LNP front (new approaches focusing to mRNA/LNP characterizations )
News from the LNP front (new approaches focusing to mRNA/LNP characterizations )
มุมมอง 355 หลายเดือนก่อน
From the Solvias Scientific Symposium: mRNA-based drugs have tremendous potential as clinical treatments, however, a major challenge in realizing this drug class will promise to develop methods (production and analytical tools) for safely delivering the bioactive agents with high efficiency. Delivery of naked modified mRNAs is inefficient and results in low levels of antigen protein production....
Webinar: Best Practices for Genetic Characterization and QC in Cell Line Development (Cergentis)21:32Webinar: Best Practices for Genetic Characterization and QC in Cell Line Development (Cergentis)
Webinar: Best Practices for Genetic Characterization and QC in Cell Line Development (Cergentis)
มุมมอง 219 หลายเดือนก่อน
Webinar: Best Practices for Genetic Characterization and QC in Cell Line Development (Cergentis)
Webinar: The FDA and EMA’s Unwavering Request Submitting Phase Appropriate Genetic Data (Cergentis)24:46Webinar: The FDA and EMA’s Unwavering Request Submitting Phase Appropriate Genetic Data (Cergentis)
Webinar: The FDA and EMA’s Unwavering Request Submitting Phase Appropriate Genetic Data (Cergentis)
มุมมอง 189 หลายเดือนก่อน
Webinar: The FDA and EMA’s Unwavering Request Submitting Phase Appropriate Genetic Data (Cergentis)
Webinar: Accurate Vector Copy Number VCN determination in Gene Modified Cellular Products19:39Webinar: Accurate Vector Copy Number VCN determination in Gene Modified Cellular Products
Webinar: Accurate Vector Copy Number VCN determination in Gene Modified Cellular Products
มุมมอง 1459 หลายเดือนก่อน
Webinar: Accurate Vector Copy Number VCN determination in Gene Modified Cellular Products
Webinar: The Journey of a Catalyst: Catalysis on Scale Development of a Ir Crabtree Pfa1:10:16Webinar: The Journey of a Catalyst: Catalysis on Scale Development of a Ir Crabtree Pfa
Webinar: The Journey of a Catalyst: Catalysis on Scale Development of a Ir Crabtree Pfa
มุมมอง 459 หลายเดือนก่อน
Webinar: The Journey of a Catalyst: Catalysis on Scale Development of a Ir Crabtree Pfa
Webinar: Biopharmaceuticals, Cell & Gene Therapy. Single-Use Technology and Extractable/Leachables:1:01:20Webinar: Biopharmaceuticals, Cell & Gene Therapy. Single-Use Technology and Extractable/Leachables:
Webinar: Biopharmaceuticals, Cell & Gene Therapy. Single-Use Technology and Extractable/Leachables:
มุมมอง 6710 หลายเดือนก่อน
Webinar: Biopharmaceuticals, Cell & Gene Therapy. Single-Use Technology and Extractable/Leachables:
Webinar: mg to kg Discovering Optimal Solid Forms of Drug Substances58:06Webinar: mg to kg Discovering Optimal Solid Forms of Drug Substances
Webinar: mg to kg Discovering Optimal Solid Forms of Drug Substances
มุมมอง 4110 หลายเดือนก่อน
Webinar: mg to kg Discovering Optimal Solid Forms of Drug Substances
This Is Solvias.2:37This Is Solvias.
This Is Solvias.
มุมมอง 20110 หลายเดือนก่อน
This Is Solvias.