About MycoVista Biotech

The One Revolutionizing the Biopharmaceutical Industry
Contract Development & Manufacturing Organization (CDMO) • Design → GMP, without detours.

MycoVista, based in San Diego, California, is a distinguished CDMO and laboratory delivering end-to-end support in cGMP bio-manufacturing, process development, and analytical characterization for biotechnology and biopharmaceutical innovators worldwide. From early design through GMP execution, our teams are trusted for rapid, dependable delivery, inspection-grade data, and transparent communication. We pair phase-appropriate development with audit-ready documentation and a unified digital quality system harmonized across two synchronized facilities, ensuring consistency, traceability, and speed at every step.

The result: programs that move from design to decision with confidence—and scale smoothly when it’s time to manufacture.

Our story & mission

Born from a Southern California tradition of hands-on bioprocess innovation, MycoVista has evolved into a dual-hub, design-to-GMP organization serving preclinical through Phase I/II—and scaling to commercial for qualified programs.
Mission: foster an entrepreneurial culture—initiative, workmanship, innovation, and creativity—so every program moves from Design → Data → Decision with integrity, transparency, and speed.

• We prioritize open communication, strong work ethics, and inspection-grade outputs.
• We embrace emerging technologies and process intensification where they lower risk or cost—never for hype.

Our Services

One partner. Every mode. Any scale.

• Cell Culture & Cell Line Development: CHO/HEK (perfusion or fed-batch), hybridoma | mAb, adaptation to serum-free and suspension, high-productivity clonal selection, cell banking & storage.
• Microbial & Fungal: E. coli, Pichia, Bacillus, Corynebacterium; fungi (Aspergillus, Saccharomyces, Kluyveromyces). High-density fermentation, refold or secretion strategies.
• Insect Cell Culture (BEVS): Sf9/Sf21/High Five; rapid recombinant protein expression under polyhedrin promoter control; milligram → kilogram-class outputs for research through clinical supply.
• Vectors & Plasmids: AAV rational design (capsid, promoter, payload), scalable rAAV PD/MFG, plasmid DNA from research to GMP.
• Nanoparticles: LNP formulation for mRNA/siRNA/DNA; microfluidic scale-up; size/PDI/Enc% tightly controlled.
• Downstream & Purification: Clarification; TFF (UF/DF); Protein A capture; IEX/HIC/MM polishing; viral filtration; continuous options where value is proven.
• Analytical Characterization: SEC-MALS, LC-MS peptide mapping, CE-SDS, icIEF, glycan profiling, endotoxin/bioburden/sterility, mycoplasma, residuals (HCP/DNA/Protein A), potency (cell-based, ADCC/CDC), vg titer (ddPCR), full/empty (AUC/EM), nanoparticle size/PDI/encapsulation.
• Fill–Finish: Aseptic vialing, prefilled syringes, cartridges; isolator/RABS; visual inspection; labeling/packaging; lyophilization as appropriate.
• Select Small Molecules: Route scouting, process intensification, impurity control, crystallization/polymorph, kilo-lab to GMP API.
• Special Programs: Blood & tissue processing (including stem cell workflows), multi-species animal health (vaccines, enzymes, probiotics).

Scale & facilities

• Microbial & Fungal: bench → pilot → up to 5,000 L stainless (qualified programs).
• Mammalian: from spinner/stationary and single-use 50 L / 250 L suites to multi-thousand-liter perfusion.
• Insect (BEVS): virus expansion + production with rapid turnarounds.
• Vectors & LNPs: closed, scalable systems with in-line analytics.
• Physical plant: segregated GMP cleanrooms (ISO 8/7), positive-pressure suites with HEPA, unidirectional flows, validated utilities, continuous environmental monitoring.
• Support suites: media/solution prep, sterilization, analytical (glucose, lactate, ammonia, LDH, IgG/IgM), HPLC, PCR/ELISA, electrophoresis; liquid nitrogen storage; large vacuum autoclave; dry-heat depyrogenation.
• Materials: critical reagents (e.g., FBS) sourced from audited suppliers (U.S., New Zealand, Australia).

Following Good Manufacturing Practice (cGMP)

We operate to rigorous cGMP standards across both hubs.

• QbD & Control Strategy: QTPP → CQAs → process parameters mapped up front; risk-based DoE formalized in protocols.
• Digital QMS (ALCOA+): eBMR/eBR, deviation/CAPA, change control, validated computerized systems.
• Regulatory: IND/IMPD/BLA authoring support; method qualification/validation; PPQ; stability (ICH).
• Quality Control: cell bank testing; raw/reference materials; in-process/intermediate/release (BDS/DP); EM in classified areas; utilities monitoring (HPW, clean steam, compressed air); process & cleaning validation studies; reference standards; GLP/GMP reporting.

Process development & production specialties

• Process design: batch, fed-batch, perfusion; intensified DSP for yield, purity, endotoxin/bioburden control, and viral safety.
• Microcarrier culture: perfusion at very high cell densities; reliable long-run performance without roller-bottle inefficiencies.
• Hybridoma | mAb: refusion, clonal selection, serum-free adaptation, optimization of production, Protein A workflows, reference lots, formulation & stability.
• Insect (BEVS): gene cloning → baculovirus vectoring → expression in Sf9/Sf21/High Five; sub-unit vaccines, IVD materials, and therapeutic proteins.

How we work

1. Survey & CDA — We start with a focused intake survey and a mutual CDA to protect IP.
2. Technical deep-dive — Conference calls or site visits to align on goals, CQAs, and risks.
3. Proposal — Detailed scope, cost, and timelines; we iterate until exactly right.
4. Quality Assurance audit (optional) — We welcome QA diligence and provide full transparency.
5. Program Onboarding (first 30 days) — Phase-appropriate QTPP; draft control strategy; DoE plan for USP/DSP/analytics; Gantt + FMEA with decision gates to IND/registration.

Program management: single source of truth, weekly variance reports, and data-driven decisions. If it won’t scale or pass inspection, it doesn’t ship.

Clients & sectors we serve

Biopharma and biotech companies of all sizes, diagnostics developers, animal health firms, academic centers, and government labs.

Why MycoVista

• Design-to-GMP, end-to-end. Fewer handoffs, fewer unknowns, faster learning loops.
• Analytics first. Process truths come from data; PAT and right-sized characterization from day one.
• Manufacturability by default. Every study asks: will this run at scale with the release we need?

Contact

email our team directly at info@mycovistabiotech.com