A quick-look guide to everything MycoVista can do for you

Welcome. This page is your high-signal, crawl-friendly overview of MycoVista’s Platforms & Modalities and our cross-cutting Solutions. Each subsection gives a concise orientation plus a “what you get” snapshot and a suggested deep-link target. The through-line across everything we do is simple and consistent:

• QbD as an operating system: we map QTPP → CQAs → CPPs first, then build the process, analytics, and documents you will actually run and defend.
• Digital by default: eBMR/eBR + LIMS/ELN + unified digital QMS (ALCOA+) across both hubs.
• Operator-holdable ranges: we lock NOR/PAR with real guardbands and interlocks, not slideware.
• Evidence over optimism: orthogonal analytics; comparability that’s prespecified; validation that reflects real risk.

If you’re skimming, jump to Program Onboarding (first 30 days) and FAQs at the end, then come back and dive into the specific platform or solution you need.

How we work (the spine that keeps everything straight)

Quality by Design (QbD), for real. We start each program by declaring what must be true at dose and in the dossier. That becomes a one-page QTPP, a defendable CQA list, and a short list of CPPs/CMAs that actually govern risk. Focused DoE quantifies effects and interactions; edge-of-failure exercises set guardbands; and the resulting control strategy is written directly into batch records with alarms and interlocks.

One digital truth across two hubs. San Diego and Montréal run the same SOPs, method versions, recipes, and escalation rules in a unified digital QMS (ALCOA+). LIMS/ELN and eBMR/eBR give you traceability from raw signal to CoA, plus review-by-exception that keeps QA focused on deltas.

Phase-appropriate analytics and validation. Methods move development → transfer → qualification/validation, sized to what the decision requires at that phase. Validation (filtration, viral safety, holds, cleaning, media fills, dsRNA/empty-full/topology where relevant) is designed to the product and the risk—not to tradition.

Comparability planned up front. Site/scale/material changes run on prespecified protocols with acceptance windows and orthogonal confirmation for high-impact attributes. The goal is to make changes predictable and file-able, not improvisational.

Platforms & Modalities

Microbial Fermentation

Scope: E. coli, Bacillus, Corynebacterium, Lactococcus; yeasts (Pichia, Saccharomyces, Kluyveromyces); Aspergillus for secreted enzymes; bench → pilot → 50,000 L stainless (qualified programs).
Why us: We build manufacturability by default—oxygen transfer and carbon uptake that close at 10,000–50,000 L, impurity maps that behave in real buffers, and documentation that passes inspection.

We run: recombinant proteins & enzymes (intracellular/periplasmic/secreted), plasmid DNA (RUO→GMP), probiotics and animal-health biologics, select metabolites/small molecules. Refold programs treated as first-class unit ops (kinetics, mixing, activity as the scoreboard).

What you get: a strain that scales, a USP recipe with headroom, a DSP train sized on real harvests, endotoxin control engineered in, and a digital record spine your auditors will actually enjoy reading.
Link: /platforms-and-modalities/microbial-fermentation/

Cell Culture (Mammalian & Insect)

Scope: CHO/HEK & hybridoma for mAbs, fragments, Fc-fusions, complex proteins; BEVS (Sf9/Sf21/High Five) for subunits and glycoproteins; adherent→suspension conversions and microcarrier perfusion for true anchorage-dependent lines.

Why us: Manufacturability by default. We won’t “win” a hero titer that collapses Protein A, tightens polishing windows, or bricks viral filtration. We design headroom, tune glycan/charge windows by feed/temperature/residence time, and prove filtration/lyo reality early.

What you get: CLD with documented clonality and stability, USP fed-batch/perfusion options sized to your CQAs, DSP that runs on real harvests, and phase-appropriate DP (liquid/high-conc/lyo) that filters or runs aseptically with media-fill proof.
Link: /platforms-and-modalities/cell-culture/

Monoclonal Antibodies & Advanced Biologics

Scope: IgG1/IgG4, bispecifics (IgG-like & fragment-based), Fc-fusions, complex proteins; Protein A or alternative captures; orthogonal polishing; viral safety; high-concentration SC or lyo DP.

Why us: We map QTPP → CQAs → CPPs on day one and keep analytics orthogonal (SEC-MALS + CE-SDS + icIEF; released ± site-specific glycans; potency aligned to MoA). We guard the DP physics (viscosity, filtration recovery, residual moisture & reconstitution) before PPQ.

What you get: a process description that mirrors the floor, validation plans that mirror the dossier, and lots that behave from engineering through PPQ.
Deep link: /platforms-and-modalities/monoclonal-antibodies/

Vector & Plasmid (AAV & pDNA)

Scope: Capsid/promoter/payload design; adherent, suspension, fixed-bed production; empty/full separation engineered as a production operation; pDNA supply RUO→GMP with topology (SC/OC/L) safeguarded and endotoxin controlled.

Why us: A vector is more than a titer—it’s a specific genome in a specific capsid with a defined empty/full distribution, delivered in a buffer that preserves function and safety. We constrain decisions early, tune charge-based separation for lot-to-lot stability, and pair primary methods with orthogonal confirmations by phase.

What you get: architectural sanity, operator-holdable upstream and downstream, residual controls that stand up, and an analytics stack reviewers recognize.
Link: /platforms-and-modalities/vectors-and-plasmids/

Nanoparticles (mRNA/siRNA/DNA)

Scope: LNPs for mRNA/siRNA/DNA (hybrid/polymeric only when data warrant); formulation design; microfluidic mixing scale-up; TFF for solvent removal/buffer exchange; sterile filtration feasibility or aseptic isolators; stability and DP.

Why us: We treat assembly as physics + biochemistry, not magic. We tune FRR/TFR, N:P, temperature, solvent fraction to hold size/PDI/Enc%, and we instrument shear/TMP so TFF protects potency. dsRNA is a first-class attribute for mRNA; topology is watched for DNA.

What you get: a filterable size window when possible—or validated aseptic when not—plus Enc% and potency that stay in family from development to GMP.
Link: /platforms-and-modalities/nanoparticles/

Microbial Proteins & Enzymes

Scope: Therapeutic and diagnostic enzymes/proteins from microbial/yeast/fungal hosts; inclusion-body/refold or secretion routes; activity-first analytics; endotoxin control end-to-end.

Why us: Microbes win when timelines are tight and cost must behave. We design oxygen/carbon/time to scale, build refold like an engineered unit op when it pays, and keep activity as the primary potency signal.

What you get: activity that holds, impurity maps that clear, buffer/lyo formats that travel, and a file that reads like what the plant actually runs.
Link: /platforms-and-modalities/microbial-proteins-enzymes/

Specialty Programs

Scope: Bispecifics & multi-specifics, Fc engineering & glyco-tuning; site-specific conjugation & conjugated biologics under defined OELs; high-concentration SC; membrane/secretory “difficult proteins”; ERT with glycan windows; cell-free (select); continuous USP/DSP when validation is clean.

Why us: Specialty work fails when attributes fight each other. We align MoA-critical CQAs (pairing fidelity, DAR distribution, glycan windows, viscosity/filtration) with direct levers and orthogonal analytics—and we keep settings operator-holdable.

What you get: constraints turned into recipes—plus containment/cleaning validation where chemistry demands it.
Link: /platforms-and-modalities/specialty/

AAV & Plasmids

This modality page reflects a straightforward approach: define the product, control the physics, measure what matters, and document each link. AAV vectors and plasmids produced under this discipline are consistent at scale and defensible at inspection. 
Link: /platforms-and-modalities/AAV-Plasmids

Food & Synthetic Biology

Scope: Precision-fermented proteins (caseins, whey, collagen), functional enzymes/flavors, biopolymer precursors; TEA/OPEX-COGs models; bench→pilot→50,000 L.

Why us: We bring GMP-grade discipline to food & synbio: PAT-driven ferments, analytics-first QC, and investor-ready techno-economic dashboards.
Link: /solutions/food-synthetic-biology/

Diagnostics CDMO

Scope: Bst polymerases, RTs, RNase inhibitors; recombinant antigens; antibody fragments for LFA/ELISA; ISO-aligned QC and batch documentation; fast RUO→IVD pathways.

Why us: Diagnostics live and die on speed + reproducibility. We build lot-drift monitoring into the digital QMS, pair activity with stability, and ship audit-ready RUO or IVD documentation.
Link: /solutions/diagnostics/

Therapeutics CDMO (End-to-End)

Scope: mRNA/saRNA + LNP; fragments/bispecifics/fusions/cytokines (microbial + mammalian); BEVS subunits; AAV & pDNA; IND math → GMP reality with analytics and CMC authoring.

Why us: One spine from Design → Data → Decision—with dual-hub resilience and a control strategy reviewers recognize.
Link: /solutions/therapeutics/

Research Tools & Reagents

Scope: RUO proteins/enzymes, research-grade mRNA (± LNP), biosensor scaffolds; pilot lots in weeks; catalog scaling; RUO docs built to step toward IVD.

Why us: We make reproducibility the product: activity/stability panels, drift analysis per lot, and ALCOA+ artifacts even for RUO.
Link: /solutions/research-tools/

Veterinary Biologics

Scope: Multi-species antibodies/enzymes/vaccines for canine/feline/equine/bovine/ovine/caprine/swine/poultry/aquaculture/camelids/exotics; USDA-CVB, EMA-CVMP, CVM pathways; field-realistic formulations (multi-dose, spray/in-water, immersion).

Why us: We start at the point of care (barn, hatchery, deck, clinic), then design process, formulation, packaging, and documentation backward to inspection.
Link: /solutions/veterinary-biologics/

Select Small Molecules & Process Chemistry

Scope: Route scouting, hazard/safety, process dev (batch/intensified/flow), solid-form/PSD, kilo-lab → GMP API, impurity control, cleaning validation, stability.

Why us: Simple beats clever. We pick the route you can run at 3 a.m., make the impurities so we can remove them, lock form before scale, and write specs from data.
Link: /platforms-and-modalities/small-molecules/

Solutions

Analytical Characterization & Assays

Position: Analytics is our OS. We design the control strategy first, then build methods with system suitability, orthogonality where it lowers risk, and data integrity by configuration. Release/in-process, method lifecycle, comparability, stability, and regulatory authorship live in one digital spine.
Link: /platforms-and-modalities/analytical-characterization/

Downstream Processing & Purification

Position: We size clarification → capture → polish → viral safety → UF/DF on real harvests, not buffer fantasies. Ion exchange/HIC/mixed-mode by impurity map; viral filtration pressure-time modeling; mass balance & recovery trended every run.
Link: /platforms-and-modalities/downstream-processing/

Method Validation & Stability

Position: Yardsticks that detect real failure + stability that mirrors logistics. ICH Q2(R2)/Q14, Q1A/B/Q5C; stability-indicating methods, regression-based shelf life, in-use and transport simulations that reflect your lanes.
Link: /method-validation-stability/

PPQ & Process Validation

Position: Stage 1 → Stage 2 → Stage 3 alignment. PPQ protocols with sampling & stats sized to decisions, boundary/worst-case confirmation before report, unit-op validations (filtration/viral/holds/cleaning/media fills), and CPV dashboards live at handoff.
Link: /platforms-and-modalities/ppq-validation/

Tech Transfer & CMC Rescue

Position: Stabilize → Optimize → Re-lock. We triage documents and physics (kLa/OUR, pressure/flux, Enc%/dsRNA, empty/full, topology), set interim guardrails, run targeted DoE on true drivers, and re-establish a control strategy with comparability for any change.
Link: /platforms-and-modalities/tech-transfer-rescue/

Regulatory Support (IND/IMPD/BLA)

Position: CMC that matches the plant. We write to the process you will run, justify specs with development distributions and clinical context, and build clean eCTD sequences with trace tables. PAI playbooks included.
Link: /regulatory/

Digital QMS (ALCOA+)

Position: One electronic spine: document control, training, deviation/CAPA, change, supplier quality, equipment lifecycle, eBMR/eBR, LIMS/ELN, stability, CPV. Part 11/Annex 11, CSA/GAMP5 validation, cyber & continuity engineered in.
Link: /platforms-and-modalities/digital-qms/

Cleanrooms & Controlled Environments

Position: Annex-1-grade CCS across hubs; pressure cascades and non-viable continuous monitoring with alarms; qualified viable plans; disinfectant rotation validated on your surfaces and in-house isolates; VHP cycles where justified.
Link: /cleanrooms/

Bioreactor & Fermentor Fleet (to 50,000 L)

Position: Mixing, mass transfer, and control you can audit. Mammalian SU (50 L & 250 L GMP; perfusion-ready), vector fixed-bed options, stainless microbial trains to 10,000 & 50,000 L. Recipes carry kLa/P/V, enrichment caps, shear envelopes, and PAT hooks.
Link: /bioreactor-fleet/

Quality by Design (QbD)

‘Position: From program architecture to PPQ: QTPP/CQA/CPP mapping, FMEA/HAZOP, focused DoE, edge-of-failure guardbands, NOR/PAR/design space, CPV, and comparability templates—embedded into eBMR/eBR and the QMS.
Link: /qbd/

Facilities & Scale

• Mammalian single-use suites: development through 50 L & 250 L GMP; perfusion footprints to multi-thousand liters for late-stage/registration-intent programs (via partners where noted).
• Vectors: adherent, suspension, and fixed-bed production; perfusion where it wins; closed processing where risk justifies.
• Microbial & fungal: bench and pilot through 10,000 L and 50,000 L stainless (qualified) with validated CIP/SIP and O₂ enrichment; ATEX-aware methanol envelopes for Pichia.
• DSP suites: chromatography/TFF skids (pilot→GMP), viral filtration capability, in-line conditioning options, recipe-controlled diafiltration.
• DP: vial/PFS in isolators/RABS; lyophilizers with shelf mapping; CCIT platforms; automated/manual inspection.
• Cleanrooms: ISO 8/7 with positive cascades, unidirectional flows; BSL-2 where required; validated HPW/clean steam/compressed air, continuous EM trending.
• Digital systems: validated CDS, LIMS/ELN, eBMR/eBR; audit trails, access control, versioned methods; mirrored across hubs.

Program Onboarding (first 30 days)

• Day 0–5 — Control strategy stub: We map QTPP → CQAs and propose CPPs, acceptance criteria, and orthogonality. You see the first draft of the analytical plan and validation/qualification scope by phase.
• Day 6–15 — DoE & validation plan: Focused DoE protocols for the two–three levers that govern risk; filtration/viral/hold/cleaning or dsRNA/empty-full/topology plans where relevant; stability protocol outline matched to route & chain.
• Day 16–30 — Digital scaffolding & schedule: LIMS templates, method files, eBMR recipes with NOR/PAR/interlocks, EM/utilities hooks (if DP), and a Gantt + FMEA with decision gates to IND/registration or PPQ.
  Deliverable: a signed, inspection-grade 30-day package (control strategy, DoE/validation/stability plans, comparability skeleton, calendar).

CDMO Capabilities FAQ

Perfusion or fed-batch for my mAb?
Whichever meets CQAs with the least complexity. If quality or cadence demands perfusion, we implement residence-time and retention controls with guardbands and validate viral safety/UF-DF accordingly.

Can you actually separate AAV empty/full at production scale?
Yes—charge-based primary separation tuned for lot-to-lot stability, paired with an orthogonal confirmation method appropriate to phase. Acceptance windows are prespecified and trended.

Our LNP doesn’t filter—now what?
Two paths: (1) redesign to a filterable size/composition window and prove recovery, or (2) run validated aseptic processing in isolators with media fills and strong EM performance. We document the choice and the controls.

Can you hold plasmid supercoiled (SC) content through TFF?
We tune TMP/cross-flow/diavols and pre-conditioning; validate membranes on real intermediates; and trend SC/OC/L with acceptance criteria before lock.

Do you take on inclusion-body refolds?
Yes—when economics and activity support it. We treat refold like a unit operation with denaturation/redox screens, mixing kinetics, and refold-aware DSP. Activity, not apparent “solubility,” is the scoreboard.

How many PPQ lots?
Risk-based—often three, justified by Stage-1 maturity, process complexity, and market scope. Boundary/worst-case evidence is produced before the PPQ report.

How do you prevent method drift between hubs?
Mirrored SOPs and transfer protocols with predefined equivalence metrics (bias, precision, linearity, specificity), shared reference standards, and cross-site CPV overlays with convergence rules.

Do you write the CMC?
Yes—Module 2/3 text that matches the plant, plus eCTD publishing, lifecycle management, and PAI playbooks. Query/clock-stop responses include tables, statistics plans, and raw-data references.

What if a raw material changes (resin, lipid, nuclease)?
We run a prespecified comparability protocol with acceptance windows and orthogonal checks. Where risk dictates, we include targeted re-validation or limited PPQ.

How fast can we get to “first lot that behaves”?
Typically within weeks for stabilization scenarios using interim guardrails; new builds follow the onboarding calendar above. We publish gates and pass criteria; biology and physics set the pace.

What you actually get (Deliverables) — and why MycoVista is the best CDMO for getting them

At MycoVista, the deliverable isn’t a slide deck — it’s a process you can run, inspect, and scale. Our dual hubs (San Diego & Montréal) operate on one digital spine (ALCOA+), so every artifact below is mirrored, traceable, and inspection-grade by default.

Control Strategy (QTPP → CQAs → CPPs).

You receive a written, phase-appropriate control strategy with acceptance criteria, IPCs, interlocks/alarms, and investigation trees that tie every CQA to a controllable lever. It’s the difference between “platform folklore” and a recipe operators can hold on a night shift.

Process Description that mirrors the floor.
Complete with NOR/PAR and edge-of-failure guardbands, plus executable eBMR/eBR recipes (setpoints, ranges, alarms). No best-day settings — only headroom you can live in during campaigns.

Analytics Package that reads the truth.
Method URS → development → transfer → qualification/validation, system suitability that predicts bad days, OOS/OOT governance, orthogonality where it reduces risk (e.g., SEC-MALS + CE-SDS + icIEF; dsRNA; empty/full; pDNA topology), and trending that makes drift obvious.

Validation Dossiers sized to real risk.
Sterilizing filtration feasibility & integrity, viral safety (low-pH kinetics, filter pressure-time), hold-time, cleaning validation (MACO/PDE), and media fills for aseptic paths — all protocolized, executed, and summarized for submission and PAI.

Stability Protocols & Reports that match logistics.
Stability-indicating methods, real/accelerated/in-use/transport studies, regression-based shelf life with confidence bounds, filter recovery (where applicable), and clear time-out-of-refrigeration rules your team can follow without debate.

Comparability, planned — not improvised.
Pre-filed comparability protocols and executed reports for site/scale/raw-material changes, with equivalence windows and orthogonal confirmations for high-impact attributes. Changes become predictable and file-able.

Regulatory Text that matches the plant.
Author-ready IND/IMPD/BLA CMC (Modules 2/3), clean eCTD sequences, and PAI binders & floor routes that map your process, validation, training, EM/utilities and CPV — so reviewers see exactly what QA will show onsite.

CPV Dashboards (Stage 3).
Cross-site control charts and capability indices for key CQAs/CPPs (titer, aggregates, charge, glycans, vg titer, empty/full, Enc%, dsRNA, topology, endotoxin, etc.), linked to deviation/CAPA cadence — San Diego ↔ Montréal by default.

Plus, the differentiators that make us the best choice:

• Design → Data → Decision, without detours. We publish guardbands and edge-of-failure before PPQ, so PPQ feels like execution — not a stunt.
• Operator-holdable reality. We refuse fragile settings. Recipes include interlocks and alarms that prevent heroics and make review-by-exception work.
• Dual-hub resilience. Same SOPs, same methods, same batch logic, same dashboards — mirrored quality with business continuity built in.
• Rescue-grade discipline. If you arrive mid-story, we Stabilize → Optimize → Re-lock, then backfill documentation so regulators stay comfortable.
• Digital QMS (ALCOA+). eBMR/eBR + LIMS/ELN + validated CDS ensure traceability from raw signal to CoA; audit trails and time sync are enforced by design.
• Pragmatic innovation. Continuous/perfusion, fixed-bed, or hybrid trains only when validation is clean and operations can hold them; otherwise, robust batch wins.
• Regulatory fluency. We write specs from development distributions and clinical context, not wishful numbers — and we stand in front of them at audit.

Bottom line: with MycoVista you don’t just get documents — you get defensible ranges, reproducible lots, and a dossier that reads like your plant actually runs. That’s why teams that need speed and inspection-grade quality choose us to carry them from concept to PPQ to commercial reality.

Contact us today

Email info@mycovistabiotech.com with your modality, route, dose goals, target presentation, and current timeline.