Design → GMP, without detours

Core Hub: San Diego, CA (Southern California)

At MycoVista, we treat analytics not as a milestone, but as the operating system of biomanufacturing. Our San Diego core hub serves as a dedicated Analytical Characterization & Assays CDMO, specializing in method development, transfer, qualification, validation, and release testing. Our scope spans monoclonal antibodies and biologics, microbial and fungal proteins, enzymes, AAV and plasmids, lipid nanoparticles (mRNA/siRNA/DNA), and select small molecules. From comparability studies to stability programs and custom study design, our approach builds a complete analytical framework that drives your program seamlessly from QTPP to CQAs and CPPs. Every assay, every chart, and every data point is mapped into a unified digital QMS and LIMS with full ALCOA+ compliance, ensuring audit-ready traceability.

Why Teams Trust MycoVista for Analytics

• End-to-End Ownership
  As a specialized Analytical Characterization & Assays CDMO, we offer integrated solutions covering every step—method development, transfer, qualification, validation, release, out-of-specification and out-of-trend handling, as well as regulatory writing. With two harmonized facilities, our execution is synchronized, reducing variability and ensuring your CMC package reads as one cohesive story.
• Modalities Without Silos
  Protein, vector, pDNA, and LNP programs are designed under a single analytical narrative. Each modality is tuned for its unique technical requirements, yet they integrate into one storyline for regulatory and commercial success. This eliminates fragmented data sets and supports a strong, unified submission package.
• Orthogonality by Design
  We do not over-index on one platform. Instead, we build orthogonal methods that reinforce one another, ensuring robust PPQ and minimizing regulatory risk. This multi-angle approach provides high confidence in results and reduces downstream surprises.
• Evidence Over Optimism
  Our system prioritizes data integrity and decision-making grounded in real evidence. Trend charts, control limits, and detailed failure mode analyses are embedded into your files—not just on presentation slides. If a study or method won’t survive inspection or scale, it won’t leave our labs.

At MycoVista, our decisive, technical, and audit-ready culture ensures that every unit operation and every release study ties back to methods with documented system suitability and acceptance criteria. By embedding Analytical Characterization & Assays CDMO principles at the heart of development, we deliver not just assays, but a sustainable control strategy that scales with your program and stands up to regulatory scrutiny.

What “Analytical & Assays” means at MycoVista

We cover the spectrum—from feasibility and fit-for-purpose in early development to qualified and validated methods for GMP release.

• Release & in-process testing (phase-appropriate) for all supported modalities.
• Method lifecycle: development, transfer (inter-site), qualification, validation (accuracy/precision/LOD/LOQ/specificity/linearity/range/robustness), and change control.
• Comparability & characterization for process changes, site moves, or scale transitions.
• Stability programs (real/accelerated) designed to ICH expectations, with tailored stress studies that match your distribution reality.
• Data integrity & traceability from instrument to CoA, with electronic records, audit trails, and version control.
• Regulatory authoring for IND/IMPD/BLA sections; responses to reviewer questions backed by raw data and statistics.

Core method families (by modality)

A) Proteins & mAbs (CHO/HEK, microbial, fungal)

Identity & purity

• Intact mass and peptide mapping (LC-MS).
• CE-SDS (reducing/non-reducing) for size/fragmentation; SEC-MALS for monomer/aggregate distribution.
• icIEF/IEF for charge variants; targeted assays for deamidation, oxidation, clipping.
• Glycan profiling (released and, where justified, site-specific) with comparability windows defined early.

Potency & binding

• Cell-based potency; Fc-effector (ADCC/CDC) where mechanism demands; binding kinetics.
• Enzyme activity assays for catalytic programs (microbial/fungal), linked to formulation stability and process conditions.

Process residuals & safety

• Host cell proteins (HCP); host cell DNA; Protein A ligand; detergents and processing aids; endotoxin/bioburden/sterility; mycoplasma (as applicable).

Formulation support

• pH/ionic strength/excipient screens; stress mapping (thermal, agitation, freeze–thaw, light) tied to degradation pathways.

B) AAV & other viral vectors

Titer & genome integrity

• Vector genome titer by quantitative PCR/digital PCR.
• Capsid protein quantification and identity assays.

Quality attributes

• Empty/full profiling via charge-based or density-sensitive methods; orthogonal confirmation (e.g., analytical ultracentrifugation or electron microscopy when phase-appropriate).
• Residuals: host cell DNA/protein, helper plasmids/replication components (as applicable), residual detergents/benzonase-type nucleases.
• Safety: sterility, endotoxin, mycoplasma; adventitious agent testing per phase.
• Potency: cell-based transduction/functional readouts aligned to MoA.

C) Plasmid DNA (research → GMP)

• Topology distribution (supercoiled/open circular/linear); residual RNA and genomic DNA; host proteins; endotoxin.
• Identity via restriction/enzyme mapping and/or sequencing confirmation appropriate to phase.
• Purity & potency: A260/280 context checked against more discriminating orthogonal assays to avoid false comfort.

D) Nanoparticles (LNPs for mRNA/siRNA/DNA)

• Particle size & PDI (dynamic light scattering or equivalent); encapsulation efficiency (fluorometric nucleic acid assays).
• Osmolality, pH, residual solvent, and buffer composition aligned to clinical presentation.
• mRNA integrity (length/cap structure where required), dsRNA detection by appropriate immunoassay/analytical techniques.
• Sterile filtration feasibility and post-filter potency recovery established early.

E) Utilities, environment, and materials (program safety net)

• Environmental monitoring trending for classified spaces (viable/non-viable).
• Utilities QC: HPW/clean steam/compressed air point-of-use testing; TOC/conductivity where applicable.
• Extractables/leachables programs when contact-material risk justifies them.

Method lifecycle: how we build assays that last

1. Requirements & risk
   • Start from the control strategy: which CQAs need which readouts, how often, with what detection limits.
   • Draft acceptance criteria tied to clinical dose and safety margins—not just platform folklore.
2. Development
   • Screen techniques and conditions for specificity and ruggedness.
   • Define system suitability criteria that predict the day’s performance (e.g., resolution, tailing, %RSD) and tie to investigation triggers.
3. Transfer (dual hubs)
   • Protocolized inter-site transfer with predefined equivalence metrics; handle matrix differences and instrument class deltas explicitly.
   • Training + competency records captured in QMS; deviations during transfer become learnings, not institutional myths.
4. Qualification/Validation
   • Phase-appropriate qualification scaling to full validation for GMP release—accuracy, precision (repeatability/intermediate precision), specificity, linearity, range, LOD/LOQ, robustness.
   • Statistical plans pre-approved; outliers and re-tests governed, not improvised.
5. Lifecycle & change control
   • Versioning, periodic review, OOS/OOT handling with CAPA; comparability studies when we change columns, membranes, lots, or critical reagents.
   • Re-validation triggers defined in the procedure so nobody debates the rules mid-campaign.

Comparability (when anything changes)

Scale changes, site moves, raw-material shifts—comparability is how we keep your narrative continuous.

• Analytical similarity protocols with prespecified acceptance windows.
• Side-by-side lots and bridging designs to show sameness (or managed difference) in potency, purity, glycan/charge, vector quality, or LNP attributes.
• Regulatory language prepared up front to avoid last-minute scrambles.

Stability programs (real, accelerated, and stressed)

Stability is a design lever, not a post-hoc report.

• Program design matched to clinical and commercial storage/shipping conditions; time points selected to answer real questions (hold times, in-process waits, transport).
• Stress studies (heat, light, agitation, freeze–thaw, pH) that map degradation pathways—so formulation can counter the right failure modes.
• Trending & shelf-life assignment with defensible models; for LNPs and vectors, osmolality and potency retention hold the pen.

Digital backbone: QMS, LIMS, ELN, and data integrity

• Unified digital QMS across hubs with eBMR/eBR, deviation/CAPA, and validated computerized systems.
• LIMS & ELN integration: barcode chain of custody, instrument interfacing, and audit trails from raw data to CoA.
• ALCOA+ principles enforced by system design, not memory; access controls and review workflows prevent “quiet edits.”

Statistics & decision-making (so the data speaks)

• Control charts & trending for in-process and release parameters to catch drift before it becomes deviation.
• Acceptance limit setting grounded in development data and clinical context.
• Design of experiments (DoE) to build design spaces where CQAs respect CPP ranges.
• Risk heatmaps keep eyes on what matters: sensitivity to raw materials, lot-to-lot resin variability, and operator factors.

How analytics integrate with process (the loop that makes scale predictable)

• Upstream feeds into real-time decisionality: titer, metabolites, viability; soft sensors calibrated to analytical truth.
• Downstream performance modeled with pressure-throughput curves, breakthrough profiles, and orthogonal impurity measurements.
• Fill–finish and formulation decisions guided by aggregation/stability readouts and sterile-filter recovery studies.

Facilities & instrumentation (selected highlights)

• Chromatography & electrophoresis: HPLC/UPLC, LC-MS, CE-SDS, icIEF, SEC-MALS.
• Biologics & vectors: qPCR/ddPCR, analytical ultracentrifugation or EM (as phase-appropriate), DLS/osmolality, endotoxin/bioburden, sterility, mycoplasma.
• Molecular & cell assays: ELISA and cell-based potency suites with controlled cell banks and reference standards.
• Data systems: validated CDS, LIMS, and ELN with instrument connectivity and audit trails.
• Environmental & utilities: continuous EM monitoring; utilities sampling plans with trending.

cGMP, regulatory, and QMS (what you’ll feel day to day)

• QbD in practice: QTPP → CQA → CPP mapping at project start; analytic envelopes tied to process ranges.
• Phase-appropriate validation escalating to full validation for release testing; stability and hold-time studies designed to ICH expectations.
• Regulatory authoring: CMC sections ready for submission; reviewer Q&A answered with data, stats plans, and method reports—no hand-waving.
• Audit-ready artifacts: method files, validation reports, CoAs, trending, and CAPA histories—accessible and consistent across hubs.

Program Onboarding (the first 30 days)

Speed is useful only if outputs are inspection-grade. In month one you receive:

1. A phase-appropriate analytical plan mapped to your control strategy (CQAs, CPPs, acceptance criteria).
2. A method gap analysis (what exists, what transfers, what must be developed/qualified/validated).
3. A DoE & validation roadmap with sampling plans, statistics, and pass/fail criteria; plus a stability plan aligned to your supply chain.

Start: Share modality, dose goals, intended presentation, and timelines. We return a design space for analytics, transfer/validation steps, and a documented path to GMP release.

FAQ – Analytical Characterization & Assays

Will you adopt our sponsor methods as-is? If they’re fit-for-purpose and transferable, yes. If gaps exist, we document, close, and validate.

How do you handle OOS/OOT? Defined SOPs: immediate assessment, phase-appropriate lab/production checks, root-cause analysis, CAPA, documented closeout.

Can you run orthogonal methods for vector empty/full? Yes—charge-based or density-sensitive primary with orthogonal confirmation as phase requires.

Do you validate LNP assays for dsRNA and encapsulation? Yes—phase-appropriate specificity, linearity, precision; we set acceptance criteria that protect potency and safety.

Inter-site consistency? Mirrored methods, shared standards, and transfer protocols with predefined equivalence metrics.

Deliverables (what you can hold)

• Analytical control strategy aligned to QTPP/CQAs.
• Method files (SOPs), transfer reports, qualification/validation protocols and reports.
• Release & in-process CoAs, batch-linked.
• Stability protocols and data with shelf-life rationale.
• Comparability reports for changes in process, site, or scale.
• Regulatory text for IND/IMPD/BLA and reviewer responses.

A few patterns that make us different

• Orthogonal by default. One method convinces; two methods persuade; trending makes it law.
• Headroom, not hero runs. We set limits where operations can live—nights, weekends, and audits included.
• One truth, two hubs. Same method, same criteria, same data story in San Diego and Montréal.
• No brand worship. We use the technique that serves your biology and inspection—full stop.

Summary — Why MycoVista for CDMO Analytics

Because analytics is how science becomes manufacturing. At MycoVista, we believe that every therapeutic program depends on the strength of its analytical framework—the methods that read the truth of your product and process, the comparability studies that prove sameness when changes occur, and the validation packages that give regulators confidence when it matters most. Our role as an Analytical Characterization & Assays CDMO is not simply to generate data, but to embed analytics as the operating system that guides your program from design through GMP, without detours.

We design assays that do more than satisfy a checklist—they establish the control strategy that keeps your program compliant, reproducible, and defensible under inspection. Every QTPP is mapped to CQAs and CPPs, then anchored by orthogonal methods that provide resilience in the face of variability. That design philosophy ensures every release test, every in-process check, and every stability study is not just a reportable result, but a documented piece of evidence that will stand up to auditors, investors, and regulators alike.

Our strength as an Analytical Characterization & Assays CDMO is end-to-end ownership: method development, transfer, qualification, validation, OOS/OOT management, regulatory writing, and submission-ready data integrity—all harmonized across synchronized facilities. We unify protein, vector, pDNA, and LNP analytics into one coherent narrative, eliminating silos and ensuring your CMC package reads as one consistent story. That’s why our clients rely on us: because we don’t just hand over assays, we deliver analytical strategies that accelerate decision-making and sustain commercial readiness.

The result: Design → Data → Decision. From feasibility studies to GMP lot release, we ensure your program advances with clarity, confidence, and control—without detours.

MycoVista | San Diego, CA
Start Program Onboarding → Share modality, presentation, and timelines. We’ll return an analytical plan, transfer/validation steps, and a documented path to GMP release.

Contact our team today at info@mycovistabiotech.com