Solvias

Achim L., Field Development Manager, will take the stage as a panelist at one of the industry’s most influential digital transformation events — AUTOMA+ by BGS Pharmaceutical Events 📅 25 November 2025, 13:50 📍 Session Hall 3 🎤 Panel: Driving Digital Excellence in CMC: What FDA CRLs Tell Us About Analytical Gaps AUTOMA+ brings together pioneers from across the pharma landscape to accelerate digital maturity, strengthen transformation strategies, and spark innovation through high-value knowledge exchange and unlimited networking opportunities. Don’t miss Achim’s insights on how digital excellence can close analytical gaps, reduce regulatory risk, and empower better, faster decision-making in drug development. See you in Austria!

Today, on International Journalist Day, we want to thank the journalists and editors who shared Solvias’ voice throughout 2025. Your dedication to clear, accurate, and meaningful reporting makes a real difference, and we’re grateful for every conversation, interview, and article that brought our work to a broader audience. Thank you! Biocompare: https://lnkd.in/gc72fRqH https://lnkd.in/eu9mapjE MedCity News: https://lnkd.in/dcr3HKmQ Contract Pharma: https://lnkd.in/egjCyTc7 https://lnkd.in/eiPtqQxB Samedan Ltd (International Clinical Trials): https://lnkd.in/emX9xSnN Manufacturing Chemist: https://lnkd.in/eV5xr2fS https://lnkd.in/e6kvXRNt https://lnkd.in/esMHYmnR European Biopharmaceutical Review (EBR): https://lnkd.in/eRhg_b7s The Pharma Navigator: https://lnkd.in/eU4mH96j Drug Target Review: https://lnkd.in/eXC_NUEV Discover Pharma: https://lnkd.in/eDhpc62Z https://lnkd.in/eQxFk6k2 PharmaSource: https://lnkd.in/gGv4Ps-7 Lab Design News: https://lnkd.in/eug-Rt-s Triangle Business Journal: https://lnkd.in/etQdJ4Bb Smart Biotech Scientist: https://lnkd.in/exJ-M_3e https://lnkd.in/edxmcr7a

Tomorrow’s the day! Don’t miss Donna McMutrie and Arnoud Boot as they explore the scientific and regulatory shifts driving wider adoption of NGS in quality and safety testing. Register now: https://lnkd.in/eacMTr5N What you will learn: ✅ Key drivers accelerating regulatory acceptance and standardization ✅ Case studies and lessons learned from early adopters ✅ Strategic implications for manufacturers of biologics and advanced therapies #NGS #viralsafety

We’re proud to see Donna McMutrie, our Head of Strategy for Large Molecules, featured in the latest issue of International Clinical Trials, by Samedan Ltd Pharmaceutical Publishing. https://lnkd.in/emX9xSnN With nearly three decades in molecular biology and strategic leadership, Donna reflects on the evolution of biopharma, the growing role of women in STEM, and how empathy and adaptability continue to shape innovation across the industry. Donna will also be sharing more of her insights during our upcoming webinar on Tuesday, November 18, 10 am EST — a great opportunity to hear her perspective on how advances in validation, data interpretation, and regulatory guidance are accelerating NGS adoption for ensuring viral safety in biological medicinal products. 👉 Register here: https://lnkd.in/eacMTr5N

Lunchtime Networking — Analyzing FDA CRLs: A Conversation Regarding Recent Publications for CMC Challenges The recent publication of FDA Complete Response Letters (CRLs) has shed light on persistent Chemistry, Manufacturing, and Controls (CMC) challenges that continue to hinder regulatory approval. Join us for this complimentary event that brings together experts to dissect recent CRLs, clarify the key themes regulators are emphasizing, and discuss strategies for proactively closing compliance gaps. Through candid conversations and peer exchange, you'll gain practical insights into how to interpret regulatory feedback, strengthen CMC submissions, and minimize the risk of costly delays. Register here: https://lnkd.in/eWYiWRTA 📅 Programme ✔️ 11.15 – 11.30 Guest arrival, registration & networking ✔️ 11.30 – 11:40 Welcome & Introduction to Solvias ✔️ 11:40 – 11:45 Introduction to panellists and topic ✔️ 11:45 – 12:15 Panel Discussion: Analyzing FDA CRLs: A Conversation Regarding Recent Publications for CMC Challenges ✔️ 12.15 – 12:30 Audience Q&A ✔️ 12:30 – 13.30 Networking buffet lunch ✔️ 13:30 - 15:00 1-1 meetings in breakout room (or guests free to depart)

Partnering with companies like Fresenius Kabi that drive innovation in biopharmaceutical development is a privilege. Through our Targeted Locus Amplification (TLA) technology and deep expertise in genetic characterization, we help ensure their lead single-cell clones remain free from sequence mutations. We’re honored by their words recognizing our customer-centric approach, transparent communication, and proactive mindset, which are the values that define every collaboration at Solvias. Thank you, Fresenius Kabi, for trusting Solvias as your analytical partner. Learn more about TLA and our genetic QC services: https://lnkd.in/e5U-iHuv #Solvias #ClientSpotlight #GeneticCharacterization #TLA #CRO

Achim L. and Vania Santana are heading to TIDES: Oligonucleotides and Peptide Therapeutics in Basel, 11–13 November 2025. 📍 Stop by booth #94 and poster #A50 to meet them If you’re working on peptide or oligonucleotide programs, this is a great opportunity to connect and discuss how Solvias can help accelerate your peptide and oligo therapeutics to market. 🔗 Learn more about our peptide and oligonucleotide analytical services: https://lnkd.in/eF2d5nzi https://lnkd.in/gZshZdrW #TIDESEurope

In this episode of the CMC Conversations podcast, host David Bruehlmann talks with our Chief Scientific Officer, Daniel Galbraith, about what separates analytical CROs that merely process samples from those that become strategic partners in your success. His insights can save your program months of delays and costly missteps. 🎧 Listen now in your favorite platform: ✅ YouTube: https://lnkd.in/dpk2HzCZ ✅ Spotify: https://lnkd.in/d7tpMWEQ ✅ Apple Podcasts: https://lnkd.in/dTgmRuca 💡 Highlights include: ✔️ Why cell and gene therapies face unique challenges compared to the progression seen with monoclonal antibodies (03:04) ✔️ The analytical hurdles in characterizing cell-based products and how their inherent variability impacts development (09:46) ✔️ Approaches to analytical method requirements for autologous cell therapies, and how data is gathered iteratively in these cases (13:02) ✔️ The biggest obstacles to scaling up cell and gene therapies, and why innovative cell manipulation technologies are needed (16:06) ✔️ Current trends in therapeutic modalities: why antibody-drug conjugates stand out, and whether mRNA therapies are losing momentum (18:37) ✔️ Practical advice on choosing an analytical CRO as a strategic partner - what to look for, what questions to ask, and why enthusiasm and standardization matter (21:55)

Our proprietary Targeted Locus Amplification (TLA) platform, developed by Solvias NL (previously Cergentis), enables complete targeted gene or transgene sequencing, detecting all single nucleotide variants, structural variants, and transgene integration sites in a single experiment. When combined with ddPCR for copy number estimation and Oxford Nanopore Technology for integration site reconstruction, TLA provides a comprehensive genetic characterization of cell lines. This tailored combination of assays supports analytical quality control across the entire cell line development process — from discovery and clone selection to MCB characterization, monoclonality, and genetic stability assessment. Our colleague Irina Sergeeva had the honor of presenting this work at ddPCR World On Tour in Leiden, hosted by Bio-Rad Laboratories. A big thank you to Bio-Rad for the opportunity to connect and exchange insights with the scientific community! Learn more about our genetic QC services here: https://lnkd.in/e5U-iHuv #Solvias #BioRadWorldOnTour #TLA #ddPCR #ONT #GeneticCharacterization #CellLineDevelopment #Biologics #Innovation

Christopher Latendresse, Ph.D. and Ryan Magina are at Extractables & Leachables West 2025, by Pharma Ed Resources Events , today and tomorrow in La Jolla, California. With nearly 1 in 5 FDA Complete Response Letters published earlier this year citing E&L-related deficiencies, it’s more critical than ever to design robust, risk-based extractables and leachables studies that accelerate approval timelines and build regulatory confidence. Stop by our table to meet Chris and Ryan and learn how to do E&L the right way. 📄 Download our white paper: https://lnkd.in/eAkuyg7b #ExtractablesAndLeachables #EandL #Extractables #Leachables #CRL #Solvias