Elixtide is a boutique biotech consultancy based in San Diego, California, founded and led by industry veteran Jack Xu, Ph.D., who brings over 20 years of expertise in drug development.
At Elixtide, we are committed to providing strategic, phase-appropriate guidance across the entire drug lifecycle, applying risk-based approaches tailored to development needs.
Our expertise spans a broad range of molecular modalities, including peptides, oligonucleotides, small molecules, and radiopharmaceuticals, alongside extensive experience in drug product formulations for injectable and oral delivery systems.
By integrating deep knowledge in discovery chemistry and Chemistry, Manufacturing, and Controls (CMC), Elixtide provides tailored, strategic support at every stage of product development.
From early discovery to preclinical, clinical, and commercial phases, Elixtide serves as a trusted partner, equipping clients with technical proficiency, regulatory expertise, and strategic foresight to accelerate therapeutic innovation and successful market entry.
Whether you’re ...
a startup or an established organization,
navigating early-stage development or preparing for commercialization,
Elixtide is ready to support your journey.
Your success is our priority.
Dedicated to excellence, Elixtide delivers high-quality consulting services to biotech and pharmaceutical companies, CDMOs, CROs, academia, and investors, offering specialized expertise that drives innovation and business success.
Peptides and Oligonucleotides
Elixtide provides industry-leading consultancy in drug design, synthesis, analysis, and purification. Our technical capabilities include:
> Peptide/peptidomimetic synthesis (Fmoc/tBu, Boc/Bzl, Cbz strategies)
> Oligonucleotide synthesis (phosphoramidite, morpholino chemistries)
Candidate Developability
Selecting the optimal candidate for development requires more than just potency. Elixtide assists clients in identifying the most viable candidates by evaluating critical developability factors, including chemical stability, manufacturing scalability, PK/PD and ADMET considerations, and formulation strategies.
CMC Development & Manufacturing
Process Development
> Synthetic Strategies and Processes (Liquid-phase Synthesis, Solid-phase Organic Synthesis, Hybrid Synthesis)
> Downstream Processes (Preparative HPLC/IEX/SEC, UF/TFF)
> Product Isolation (Lyophilization,
Crystallization/Precipitation, Spray Drying)
> Process Scale-up and Validation Strategies
> Solid-state Development (Polymorph Screening, Salt
Selection, Particle Engineering)
> Formulation Development (I.V., Sub-Q, Oral Solutions/
Capsules/Tablets, Nano Formulations)
> Specification Development (RSMs, Intermediates, DS/API, DP)
CMC plays a critical role in guiding drug candidates from preclinical through clinical development to commercial launch. Elixtide provides phase-appropriate, risk-based CMC strategies, enabling optimized resource allocation while ensuring regulatory compliance and quality standards.
Analytical Method Development & Validation
> Raw Material and Intermediate Controls
> In-process Controls
> Reference Standard Qualifications
> Stress Studies and Stability Testing
> Product Release Testing
Manufacturing Strategy
> Preclinical & Phase 1 Stage
At the early development stages, the focus is on feasibility, scalability, and safety while maintaining flexibility for future optimization.
Elixtide offers extensive expertise in guiding clients through the early stages of therapeutic development. We specialize in selecting optimal synthetic pathways, refining purification strategies, and managing impurity controls to ensure phase-appropriate outcomes. We drive formulation development by optimizing solubility, stability, and bioavailability, tailored for toxicology studies and first-in-human (FIH) trials. Our approach to analytical method development emphasizes early characterization of potency, purity, and degradation pathways to support stability profiling.
At Elixtide, we recognize the criticality of CMC development in IND-enabling studies. As a trusted partner, we are committed to focusing on generation of IND-enabling data, minimizing regulatory burden, and prioritizing CQAs alongside process variability. Our expertise enables clients to achieve IND submissions within ambitious timelines, ensuring a streamlined and efficient pathway to early-phase clinical trials.
> Late-phase Manufacturing
As molecules enter Phase 2 and late-stage clinical development, Elixtide provides strategic support in late-phase pharmaceutical manufacturing by ensuring process robustness, scalability, and regulatory compliance. We are committed to guiding the transition from small-scale to pilot and GMP-scale production, maintaining batch-to-batch consistency and mitigating risks through QbD principles.
Our expertise in CMC bridging studies helps address process validation and formulation refinements for later-stage trials. We drive process validation, analytical qualification, and release criteria to confirm stability, potency, and impurity control per ICH, FDA, and EMA standards.
Elixtide provides risk-mitigation strategies for raw material sourcing, CPPs, and regulatory alignment to streamline NDA submissions. Our in-depth experience in technology transfer enables seamless CDMO partnerships, ensuring a successful commercial launch.
GMP & Regulatory Support
> GMP Compliance & Audits (Vendor Qualification and Supplier
Audits)
> GMP Document Support (Technical Reports, SOPs/STPs, MBRs,
Executed BPRs,
Deviation/OOS Handling, Validation Protocols & Reports)
> Regulatory Submission Support (CMC Dossier 3.2.S & 3.2.P)
> Agency Meetings (e.g., Pre-IND, Interactions with FDA, EMA)
Operations & Business
> CDMO/CRO Selection & Management
> Contract Negotiations (Quality/Supply Agreements,
MSAs)
> Facilitating CDMO Partnerships for Technology
Transfer
> Project Management & Strategic Planning
> Investment Advisory & Licensing Support
Peptides (Oral & Injectable)
> GLP-1 peptides
> Macrocyclic peptides (e.g., lactams, thioether, etc.)
> Disulfide-bridged peptides
> Nα-alkylated peptides
> Branched peptides (e.g., MAPs)
At Elixtide, we have accumulated decades of experience and in-depth knowledge in the peptide and oligonucleotide domain. Our experience includes numerous clinical developmental projects and several successful NDA/commercial launches.
Oligonucleotides (Injectable)
> Antisense oligonucleotides (ASOs)
> Phosphorodiamidate morpholino oligomers (PMOs)
> Small interfering RNAs (siRNAs)
Conjugates (Injectable)
> Peptide-drug conjugates (PDCs)
> Peptide-PEG conjugates (pegylated peptides)
> Glycopeptides
> Peptide-oligonucleotide conjugates (POCs) (e.g., PPMOs)
> Protein-carbohydrate conjugates
> Radionuclide conjugates (RDCs) (e.g., Ac-225, In-111, Lu-177)
Get in touch:
Get in touch!
Your Peptide Expert.
Elixtide provides support to biotech and pharmaceutical companies engaged in drug discovery and development.
Our consultancy services are specifically tailored to address the aspects of Chemistry, Manufacturing, and Controls (CMC), with core expertise in the peptide therapeutic modality.
Whether you’re facing challenges in R&D, preclinical, clinical or commercial stages, our expertise enables us to help you out effectively.
Jack Xu, Ph.D, Founder of Elixtide LLC, boasts an impressive 32-year career in the field of drug discovery and drug development.
His expertise spans every phase of the peptide therapeutic development lifecycle - from preclinical, clinical to commercial stages, particularly in the aspects of CMC and GMP.
Dr. Xu has a proven track record of success in product development, project management, CRO/CDMO management, and regulatory preparations & submissions.
Expertise for process development, analytical method development and validation, and manufacturing strategy.
CMC Development & Manufacturing
GMP & Regulatory Support
Experienced in on GMP audit and documentation, CMC regulatory dossier, and pre-IND meeting support.
Support your operations with CDMO partner selection and management, evaluation of RFPs, strategic planning, and contract negotiations.
Operations
