Crystal Bio Solutions, a member of Crystal Pharmatech

When studying oligonucleotide pharmacokinetics, one of the biggest hurdles is sample recovery. Even small losses during preparation can compromise accuracy, especially in early-phase studies where every datapoint matters. Our strategy? - Protein Precipitation (PPT): simple, effective sample prep that minimizes matrix effects - Ion-Pair Buffers (HFIP/TEA): improve retention and reduce non-specific binding - Validated Workflow: achieve high accuracy -/+7.0%, and precision < 8.8% This workflow achieves 76.3% recovery, with regulator-ready accuracy and precision. 📥 Read our case study: https://lnkd.in/dEbaabac #LCMS #Bioanalysis #Oligonucleotides #CrystalBioSolutions 

🔹 𝗖𝗣𝗛𝗜 𝗙𝗿𝗮𝗻𝗸𝗳𝘂𝗿𝘁 | 𝗢𝗰𝘁 𝟮𝟴–𝟯𝟬 | 𝗕𝗼𝗼𝘁𝗵 #𝟰.𝟭 𝗖𝟲𝟮 In a world where 𝘁𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆, 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻𝘀, 𝗮𝗻𝗱 𝘁𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰 𝗺𝗼𝗱𝗮𝗹𝗶𝘁𝗶𝗲𝘀 evolve by the month, how do biotech teams stay ahead? We’re here to help. Meet our leadership in Frankfurt: • 𝗔𝗹𝗲𝘅 𝗖𝗵𝗲𝗻, 𝗣𝗵𝗗 — 𝗚𝗿𝗼𝘂𝗽 𝗖𝗘𝗢 • Yongqiang Li, PhD — 𝗖𝗘𝗢, 𝗖𝗮𝗻𝗮𝗱𝗶𝗮𝗻 𝗖𝗗𝗠𝗢 From 𝘀𝗺𝗮𝗹𝗹 𝗺𝗼𝗹𝗲𝗰𝘂𝗹𝗲𝘀 to 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 and 𝗻𝘂𝗰𝗹𝗲𝗶𝗰 𝗮𝗰𝗶𝗱 𝘁𝗵𝗲𝗿𝗮𝗽𝗲𝘂𝘁𝗶𝗰𝘀, Crystal Pharmatech supports phase-appropriate 𝗖𝗠𝗖 𝘀𝘁𝗿𝗮𝘁𝗲𝗴𝘆, integrated 𝗮𝗻𝗮𝗹𝘆𝘁𝗶𝗰𝗮𝗹/𝗯𝗶𝗼𝗮𝗻𝗮𝗹𝘆𝘁𝗶𝗰𝗮𝗹 𝘀𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀, and scalable development pathways that keep programs moving toward First-in-Human and beyond—with speed, quality, and clarity. Heading to Messe Frankfurt? Let’s compare notes on your next milestone and map a smarter route to clinic. 📩 𝗕𝗼𝗼𝗸 𝗮 𝗺𝗲𝗲𝘁𝗶𝗻𝗴: Contact@crystalpharmatech.com #CPHI #CPHIFrankfurt #Biotech #CMC #SmallMolecule #Biologics #NucleicAcids #DrugDevelopment #FirstInHuman #CDMO #CRO #CrystalPharmatech

Receptor Occupancy can be used for interpreting drug activity, ADA effects, and clinical pharmacodynamics, but changes in receptor expression during treatment can bias receptor occupancy results. At Crystal Bio Solutions, our dual-measurement workflow combines: - Occupied receptor measurement → shows therapeutic binding - Total receptor measurement → controls baseline variability This approach ensures trustworthy RO data for smooth FDA/EMA submissions. 🔗 Read the full case study: https://lnkd.in/dZbyAEz8

Oligonucleotide therapeutics are a powerful new class of drugs, with applications ranging from genetic disorders to cancer treatment. Their promise is huge, but measuring them accurately in clinical studies is far from simple. Unlike small molecules or proteins, oligonucleotides have unique chemical properties that make them challenging to analyze with traditional LC-MS/MS methods. These hurdles can compromise pharmacokinetic (PK) data, delay regulatory timelines, and increase costs if not addressed with the right strategy. Why? - Retention issues on standard columns due to high hydrophilicity - Poor peak shape and carryover problems - Low MS response with increasing molecular weight - Strong matrix interference reducing recovery - Non-specific binding causing sample loss Overcoming them requires specialized chemistry, optimized methods, and experience in PK bioanalysis 🌐 Read more on our website: https://lnkd.in/dPUeu5WS #DrugDiscovery #Oligonucleotides #LCMS #ClinicalTrials

Every lab has a protocol but only a few deliver comparable data Consistency is critical when preparing clinical trials across different sites. At Crystal Bio Solutions, we ensure your PK data stays reliable worldwide with: - Standardized protocols tailored for oligonucleotides - Isotopically labeled internal standards for maximum selectivity - Proven stability through freeze–thaw cycles and long-term storage From first patient to regulatory submission, we deliver assays you can trust. 📩 Talk to us: https://lnkd.in/dsmSXAMK #CrystalBioSolutions #LCMS #Oligonucleotides #ClinicalTrials #Bioanalysis #CMC #DrugDevelopment

Proving that a therapeutic antibody hits its target requires functional biomarkers. Our PD-1 receptor occupancy assay delivers: - Clear, cell-level insights with a flow cytometry–based workflow - More reliable readouts through normalization with total receptor levels - Confident decision-making thanks to linearity across drug concentrations - Regulatory-ready precision validated at HQC, MQC, and LQC levels Our assay now supports clinical pharmacodynamic evaluations, advancing PD-1 therapies. 🔗 Read the full case study (link in comments) #PD1 #FlowCytometry #ClinicalPharmacology #CrystalBioSolutions

🔹 𝗠𝗲𝗲𝘁 𝗖𝗿𝘆𝘀𝘁𝗮𝗹 𝗣𝗵𝗮𝗿𝗺𝗮𝘁𝗲𝗰𝗵 𝗮𝘁 𝗖𝗣𝗛𝗜 𝗙𝗿𝗮𝗻𝗸𝗳𝘂𝗿𝘁 — 𝗕𝗼𝗼𝘁𝗵 #𝟰.𝟭 𝗖𝟲𝟮 (𝗢𝗰𝘁 𝟮𝟴–𝟯𝟬) Bringing 𝘀𝗺𝗮𝗹𝗹 𝗺𝗼𝗹𝗲𝗰𝘂𝗹𝗲 𝗮𝗻𝗱 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 programs to clinic takes clear, phase-appropriate CMC decisions. At CPHI Frankfurt, we’re showcasing how our 𝘀𝗺𝗮𝗹𝗹 𝗺𝗼𝗹𝗲𝗰𝘂𝗹𝗲 𝗮𝗻𝗱 𝗯𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 approach helps biotech teams de-risk early development, conserve API, and stay IND/BLA-ready. What to discuss at the booth 🔹𝗦𝗺𝗮𝗹𝗹 𝗠𝗼𝗹𝗲𝗰𝘂𝗹𝗲: solid-state selection, API-sparing preformulation, PBPK-guided risk triage, scalable crystallization/PSD, and clinical-ready formulations (ASD via spray drying/HME, SEDDS, mini-tabs). 🔹𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀: HRMS-driven analytics, bioanalysis/biomarkers (LC-MS/MS, immunoassays, cell-based, flow cytometry), and 𝗾𝘂𝗮𝗻𝘁𝗶𝘁𝗮𝘁𝗶𝘃𝗲 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗹𝗼𝗴𝘆 (PopPK/PD, pharmacometrics/QSP). 🔹𝗡𝘂𝗰𝗹𝗲𝗶𝗰 𝗔𝗰𝗶𝗱𝘀: RNA/oligo and 𝗟𝗡𝗣 𝗱𝗲𝘀𝗶𝗴𝗻 & 𝗼𝗽𝘁𝗶𝗺𝗶𝘇𝗮𝘁𝗶𝗼𝗻, end-to-end analytics, and clinically ready delivery strategies. 📍 Messe Frankfurt, Frankfurt, Germany 📩 Book a meeting: Contact@crystalpharmatech.com #CPHI #CPHIFrankfurt #CMC #SmallMolecule #Biologics #Bioanalysis #QuantitativeClinicalPharmacology #LNP #ASD #HME #Formulation #SolidState #FirstInHuman #CDMO #CRO #CrystalPharmatech

Immunophenotyping not only shows how therapies 𝗿𝗲𝘀𝗵𝗮𝗽𝗲 𝘁𝗵𝗲 𝗶𝗺𝗺𝘂𝗻𝗲 𝘀𝘆𝘀𝘁𝗲𝗺. 𝗜𝘁 𝗮𝗹𝘀𝗼 𝗵𝗲𝗹𝗽𝘀 𝗶𝗱𝗲𝗻𝘁𝗶𝗳𝘆 𝗲𝗮𝗿𝗹𝘆 𝗺𝗮𝗿𝗸𝗲𝗿𝘀 𝗼𝗳 𝘁𝗿𝗲𝗮𝘁𝗺𝗲𝗻𝘁 𝗲𝗳𝗳𝗶𝗰𝗮𝗰𝘆 𝗮𝗻𝗱 𝘀𝗮𝗳𝗲𝘁𝘆. A full evaluation of drug performance goes beyond PK or PD, it requires observing immune cell dynamics. Especially in oncology and immunotherapy. However, immunophenotyping is challenging due to cell variability, sample handling, and drug interference. Our senior scientists have developed and validated a FACS assay for immune monitoring in clinical trials that: - Profiles T cell subsets (CD4/CD8, naïve, effector, memory) - Identifies five NK subpopulations - Maintains stable, reproducible results for up to 2 weeks, even in drug-exposed samples Our method enables clear, reproducible insights into 𝗽𝗵𝗮𝗿𝗺𝗮𝗰𝗼𝗱𝘆𝗻𝗮𝗺𝗶𝗰𝘀, 𝘀𝗮𝗳𝗲𝘁𝘆, 𝗮𝗻𝗱 𝗶𝗺𝗺𝘂𝗻𝗲 𝗿𝗲𝘀𝗽𝗼𝗻𝘀𝗲 𝗶𝗻 𝘀𝗼𝗹𝗶𝗱 𝘁𝘂𝗺𝗼𝗿 𝘀𝘁𝘂𝗱𝗶𝗲𝘀. 📥 Download the full case study: https://lnkd.in/dHMuYqUh #Immunotherapy #FlowCytometry #FACS #Oncology #ClinicalTrial #CrystalBioSolutions

Running oligonucleotide programs comes with high stakes. Data must be consistent, reproducible, and ready for global submission. At Crystal Bio Solutions (CBS) we help you get: ✅ Consistent results across sites:  Ensuring your PK data is comparable worldwide ✅ Regulatory confidence: Assays designed to meet FDA/EMA expectations from day one ✅ Reduced risk of rework: Proven stability and validated methods eliminate delays ✅ Streamlined development: From preclinical discovery through clinical trials, one partner for bioanalysis, biomarkers, CMC, and clinical pharmacology Move your oligonucleotide therapy from lab to patient faster. 📩 Talk to us: https://lnkd.in/difQ89Qd #CrystalBioSolutions #Oligonucleotides #Bioanalysis #ClinicalTrials #CMC #DrugDevelopment #CRO