Solutions — MycoVista Biotech
What “Solutions” Means at MycoVista
At MycoVista CDMO Solutions, our approach is not defined by a static menu of services, but by the creation of manufacturable, inspection-ready pathways designed to take programs from early concept to compliant production. Every engagement begins with a clearly articulated Target Product Profile (QTPP), mapped carefully to Critical Quality Attributes (CQAs) and translated into locked Critical Process Parameters (CPPs). Each decision is documented with the rigor expected in a regulatory audit, ensuring that clients move seamlessly from bench to bioreactor to GMP execution with minimal handoffs, reduced uncertainties, and accelerated learning cycles.
Our methodology is rooted in the principle that manufacturability must be the default outcome—not a secondary consideration. We deliver processes that scale reliably, release on schedule, and withstand the scrutiny of global regulatory authorities. From the earliest design stages, analytics serve as the cornerstone: phase-appropriate characterization, process analytical technologies (PAT), and data-driven control strategies are embedded to guide decision-making. With fully harmonized ALCOA+ digital records in San Diego, every program benefits from a unified quality framework that is transparent, reproducible, and inspection-ready at all times.
Equally important, MycoVista offers breadth without sacrificing depth. We operate as a single partner across all major modalities—mammalian and microbial systems, fungal fermentation, baculovirus expression (BEVS), adeno-associated virus (AAV) vectors and plasmids, lipid nanoparticles (LNPs), and selected small molecules. This versatility enables us to meet clients at the point of their greatest need and advance programs efficiently, regardless of platform or therapeutic area.
We serve a diverse global client base spanning Therapeutics, Diagnostics, Food and Synthetic Biology, Veterinary Biologics, and Research Tools. Each sector is supported by the same robust foundation of Quality by Design (QbD), analytics-first decision making, and a unified quality system, customized to align with the regulatory and commercial realities of the market. In every case, MycoVista CDMO Solutions provides the same outcome: reliable execution, transparent data, and a direct path from Design → Data → Decision → GMP.
Sector Solutions
1) Therapeutics
From IND math to GMP reality — faster.
Modalities we run
- mRNA/saRNA payloads + LNP formulation
- Protein biologics: mAb fragments, bispecifics, Fc fusions, cytokines
- BEVS: subunit vaccines & complex glycoproteins (Sf9/Sf21/High Five)
- AAV & plasmids: design-to-MFG with rational capsid/promoter/payload selection
What you get
- IND-enabling PD packages with DoE-derived CPPs
- Robust USP/DSP that survives tech transfer and scale
- Phase-appropriate analytics (potency, HCP/DNA, glycan, charge, size, purity)
- CMC authoring support (IND/IMPD/BLA) with inspection-grade documentation
Typical wins
- mRNA payload + LNP: size/PDI/Enc% in spec early; release assays validated before you need them
- E. coli or Pichia fragments: refold/secretion options to de-risk yield and endotoxin
- Rare-disease proteins: intensified DSP with endotoxin & bioburden control planned on day one
2) Diagnostics
Speed, reproducibility, and a documentation spine built for RUO → IVD.
We manufacture
- Recombinant enzymes (Bst, RT, RNase inhibitors)
- Antigens & protein standards
- Antibody fragments for lateral flow and ELISA
Quality
- ISO 13485-aligned QC and batch records
- Endotoxin-controlled manufacturing for sensitive assays
- Lot-to-lot reproducibility tracked with statistical drift alerts (PAT + eBMR)
Why it works
- Diagnostic supply chains need fast turns and clean paperwork. You get both.
3) Food & Synthetic Biology
Fermentation-first solutions for the next wave of food, materials, and climate biotech.
Applications
- Precision-fermented proteins (caseins, whey, collagen)
- Flavor & functional enzymes
- Biopolymer precursors and biomaterial monomers
What we add
- Strain engineering to techno-economic modeling (OPEX/CAPEX, media costs, yield sensitivity)
- Fermentation process development → pilot → commercial scale (qualified programs up to 50,000 L stainless)
- Sustainability & cost optimization dashboards you can show to investors
4) Veterinary Biologics
Clinical-grade manufacturing for animal health—USDA, EMA, CVM in mind.
Programs we support
- Species-specific antibodies, therapeutic enzymes, and vaccines
- Oral/injectable formulations for pets, livestock, aquaculture
- Scaled supply for field trials with cross-species QC method development
Regulatory
- Dossier support (USDA/EMA/CVM) with data packages aligned to each jurisdiction
5) Research Tools & Reagents
From R&D to catalog lots without burning your cash on reinvention.
What we run
- Recombinant proteins with tag optimization
- Research-grade mRNA and biosensor components
- Custom fermentation for pilot and scale lots
Why developers pick us
- Fast-turnaround pilots, stable yield, and RUO documentation that won’t fall apart when demand spikes
How we work
0 → 30 Days: Onboarding Deliverables
- Survey & CDA → scope locked, IP protected
- QTPP → CQA map with risk ranking
- Draft control strategy (CPPs, ranges, in-process controls)
- DoE plan for USP/DSP/analytics (pre-approved protocols)
- Program Gantt + FMEA with decision gates to IND/registration
- Sample plan & materials readiness (sourcing, audits, CoAs)
- QA alignment: deviations/CAPA flow, change control, data integrity plan (ALCOA+)
Our platform capabilities
Upstream
- Mammalian (CHO/HEK; perfusion, fed-batch), hybridoma; microcarriers at very high densities
- Microbial & fungal (E. coli, Pichia, Bacillus, Corynebacterium, Aspergillus, Saccharomyces, Kluyveromyces)
- Insect (BEVS) (Sf9/Sf21/High Five; polyhedrin control)
- AAV & Plasmids (rAAV PD/MFG; plasmid DNA RUO → GMP)
Nanoparticles
- LNPs for mRNA/siRNA/DNA; microfluidic scale-up with tight size/PDI/Enc%
- In-line analytics and reference methods qualified to your phase
Downstream
- Clarification; TFF (UF/DF); Protein A; IEX/HIC/MM; viral filtration
- Continuous DSP where it actually lowers COGs or risk
Analytics
- 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 where appropriate
Select Small Molecules
- Route scouting, intensification, impurity control, crystallization/polymorph
- Kilo-lab → GMP API
Facilities & scale
Microbial & Fungal
- Bench → pilot → up to 50,000 L stainless (qualified programs)
Mammalian
- 50 L / 250 L single-use suites → multi-thousand-liter perfusion
BEVS
- Rapid virus expansion + production, mg → kg-class outputs
Vectors & LNPs
- Closed, scalable systems with in-line analytics
Controlled environments
- ISO 8/7 cleanrooms, positive-pressure, unidirectional flows, validated utilities
- Continuous EM; HPW, clean steam, compressed air monitoring
- Segregated suites for potency, sterility, and particle control
Quality & Regulatory
QbD & Control Strategy
- QTPP → CQAs → CPPs (ranges defined via risk-based DoE)
- Process knowledge captured in control strategy documents you can file
Digital QMS (ALCOA+)
- eBMR/eBR, deviation/CAPA, change control; validated computerized systems
- Mirrored across San Diego and Montréal for business continuity
Regulatory
- IND/IMPD/BLA authoring support
- Method qualification/validation; PPQ; ICH stability
- GLP/GMP reporting and QA audits welcomed
Solution Tiles
| Sector | Core Outputs | Typical Scale | Key Docs |
|---|---|---|---|
| Therapeutics | mRNA+LNP, Fc-fusions, fragments, cytokines | 50 L → multi-kL | IND CMC, control strategy |
| Diagnostics | Enzymes, antigens, fragments | Pilot → commercial | ISO-aligned batch/QC |
| Food & SynBio | Precision-fermented proteins, enzymes, biomaterials | Pilot → 50,000 L | TEA, cost models |
| Veterinary | Vaccines, species-specific biologics | Field-trial → clinical | USDA/EMA/CVM packages |
| Research Tools | RUO proteins, mRNA, biosensors | Pilot → catalog | RUO CoAs, methods |
Example solution paths
mRNAExample Solution Paths at MycoVista
At MycoVista CDMO Solutions, our work is defined by reproducibility, regulatory readiness, and manufacturability. Below are representative program paths that demonstrate how we translate complex science into scalable, inspection-grade processes across multiple platforms.
Vaccine Payloads
For mRNA and saRNA vaccine programs, MycoVista CDMO Solutions provides end-to-end support from template design → in vitro transcription (IVT) → capping/cleanup → lipid nanoparticle (LNP) formulation via microfluidics → full QC release testing (particle size, PDI, encapsulation efficiency). By embedding reference methods at the earliest stages, we ensure that programs achieve spec compliance early and that validated analytics are ready to transfer seamlessly into clinical and commercial scale operations. This structured approach reduces program risk and accelerates time-to-IND.
E. coli Protein Fragments
Microbial expression projects benefit from MycoVista CDMO Solutions’ dual-path evaluation strategy: inclusion body refolding versus periplasmic secretion. Design of Experiments (DoE) guides the selection of the most cost-efficient, high-yield strategy that also meets strict endotoxin control specifications. The outcome is a validated purification process that balances yield, cost, and regulatory compliance—delivering proteins that are manufacturable at commercial scale without compromising quality attributes.
BEVS Subunit Vaccines
Using baculovirus expression systems (BEVS), MycoVista CDMO Solutions supports vaccine developers with rapid baculovirus vectoring, Sf9/Sf21 expression, and downstream polishing (DSP). The focus is not only on yield but also on maintaining consistent glycan and charge profiles across production lots. This ensures that potency remains stable from early research batches through Phase I/II and beyond, de-risking scale-up while meeting regulatory expectations for comparability and reproducibility.
Enzymes for IVD Applications
For diagnostic clients, MycoVista CDMO Solutions runs fermentation and purification workflows designed for speed and reproducibility. Enzymes such as polymerases, reverse transcriptases, and RNase inhibitors undergo activity and stability screening to guarantee fitness-for-purpose. The result is the reliable production of RUO (research-use only) enzyme lots with clean Certificates of Analysis (CoAs) and controlled lot-to-lot reproducibility—critical factors in diagnostic supply chains where consistency and rapid turnaround are paramount.
Program Flow at MycoVista
MycoVista CDMO Solutions applies a structured, transparent program flow that aligns with regulatory expectations while maintaining speed and flexibility:
- Technical Deep-Dive – Define goals, CQAs, and risks through onsite or virtual collaboration.
- Proposal – Deliver a detailed scope, cost model, and timeline, iterating until precisely aligned.
- QA Access – Optional pre-award audits with full transparency into our quality systems.
- Onboarding (First 30 Days) – QTPP/CQA mapping, DoE plan, draft control strategy, and integrated Gantt+FMEA for risk management.
- Design → Data – Execute DoE studies, apply PAT-driven decisions, and issue weekly variance reports.
- Decision Gate – Advance only if the process can scale and withstand inspection; if not, we redesign until it can.
Why Teams Select MycoVista CDMO Solutions
Manufacturability by Default: Every experiment asks the question—will this scale, release clean, and pass inspection?
Design-to-GMP: A true end-to-end pathway supported by a single, auditable data spine.
Analytics First: Phase-appropriate characterization and process truths established early.
Ready to move from Design → GMP?
Email: our team at: info@mycovistabiotech.com