Therapeutics CDMO Solutions

Therapeutics CDMO Solutions — MycoVista

From IND math to GMP reality — faster, smarter, and inspection-ready.

Introduction: Why Therapeutics Need a Different Class of CDMO

At MycoVista Therapeutics CDMO Solutions, we recognize that therapeutic development is not just about making molecules — it is about transforming abstract designs into clinical reality with precision, reproducibility, and speed. The therapeutic landscape has evolved beyond traditional monoclonal antibodies into a wide spectrum of mRNA payloads, engineered proteins, bispecifics, subunit vaccines, and viral vectors. Each of these modalities brings unique upstream and downstream challenges, regulatory pathways, and scalability concerns.

Unlike generalized CDMOs that offer a patchwork of services, MycoVista Therapeutics CDMO Solutions builds every program on the same foundation: Design → Data → Decision → GMP. From the earliest QTPP to the last PPQ run, every decision is tied back to manufacturability, regulatory inspection, and patient delivery.

Our dual hubs in San Diego and Montréal operate under a unified digital QMS (ALCOA+), giving you mirrored capacity, resilience, and continuity. Whether you are developing a rare disease therapeutic for a small patient population or scaling an oncology biologic for multi-center trials, MycoVista provides a phase-appropriate, analytics-first, GMP-ready pathway without detours.

MycoVista Biotech, Innovative Monoclonal Antibody Research and Development

Modalities We Support

Therapeutics now span a broad set of modalities. MycoVista Therapeutics CDMO Solutions is uniquely positioned to deliver all of them under one roof, harmonized by the same regulatory-grade quality system.

mRNA and saRNA Payloads + LNP Formulation

  • In vitro transcription (IVT) using validated templates.
  • Enzymatic capping and cleanup workflows with phase-appropriate QC.
  • Microfluidic lipid nanoparticle (LNP) formulation with tight control of size, PDI, and encapsulation efficiency.
  • In-line analytics to ensure spec compliance early in development.
  • Release assays validated ahead of clinical deadlines.

Protein Biologics: Fragments, Bispecifics, Fusions, Cytokines

  • E. coli and Pichia pastoris expression systems for antibody fragments and bispecifics.
  • Refolding and secretion strategies to optimize yield, lower endotoxin, and reduce COGs.
  • Fc fusions and recombinant cytokines engineered for potency, glycosylation fidelity, and manufacturability.
  • Intensified downstream processing (DSP) for rare-disease proteins, ensuring endotoxin and bioburden control are in place from day one.

Baculovirus Expression Vector System (BEVS)

  • Sf9, Sf21, High Five cell lines for subunit vaccines and glycoproteins.
  • Baculovirus vector design, expansion, and expression optimization.
  • DSP polishing to lock in glycan and charge profiles.
  • Consistency across lots to safeguard potency, comparability, and regulatory approval.

AAV & Plasmids

  • Rational design of AAV capsids, promoters, and payloads for optimized vector performance.
  • Scalable rAAV process development and GMP manufacturing.
  • Plasmid DNA production from RUO through GMP, with validated endotoxin and residual DNA removal.
  • Comprehensive QC: vg titer by ddPCR, full/empty capsid ratio by AUC/EM, potency assays, and residuals control.

What You Get with MycoVista Therapeutics CDMO Solutions

  • IND-Enabling Packages: DoE-derived CPPs, QTPP→CQA mapping, and risk-based control strategies.
  • Robust USP/DSP: Processes that survive tech transfer, scale-up, and inspection.
  • Analytics-First Approach: Phase-appropriate characterization including potency, HCP/DNA residuals, glycan profiling, charge heterogeneity, size, and purity.
  • CMC Authoring Support: IND/IMPD/BLA submissions backed by inspection-grade documentation.
  • Audit-Ready Data Spine: Every decision captured in ALCOA+ digital systems, harmonized across hubs.

Typical Wins

  • mRNA payload + LNP: Particle size, PDI, and encapsulation efficiency in spec early, with validated release assays in place before you need them.
  • E. coli or Pichia fragments: Inclusion body refolding and secretion evaluated side-by-side, enabling the lowest-cost, highest-yield path under strict endotoxin limits.
  • Rare-disease proteins: Intensified DSP and endotoxin/bioburden control embedded from day one, ensuring manufacturability at clinical scale.
  • BEVS subunit vaccine: Glycan and charge profiles held consistent across lots; potency maintained through Phase I/II scale-up.
  • AAV & plasmids: Rational vector design coupled with GMP-grade documentation that stands up to FDA/EMA review.

Program Flow

1. Technical Deep-Dive

Every program begins with a structured technical discussion — either onsite or virtual — to align on goals, CQAs, and risks. This includes a QTPP→CQA mapping session that forms the backbone of your development strategy.

2. Proposal

We prepare a detailed scope, cost model, and timeline. Iteration is expected and encouraged until the proposal is precisely aligned with your needs.

3. QA Access

Clients are invited to audit our QA systems before award. Full transparency is provided, including SOPs, deviation/CAPA handling, and digital batch records.

4. Onboarding (First 30 Days)

  • QTPP/CQA map finalized.
  • DoE plan drafted for USP/DSP and analytics.
  • Control strategy framework developed.
  • Gantt + FMEA produced to map decision gates through IND/registration.

5. Design → Data

Execution of DoE studies, with PAT-driven decisions and weekly variance reports. Data becomes the “single source of truth” shared transparently with the client.

6. Decision Gate

Projects advance only if the process can scale and pass inspection. If not, MycoVista re-engineers until it can.

Regulatory Alignment

MycoVista Therapeutics CDMO Solutions ensures that regulatory expectations are met from the very beginning. We provide:

  • CMC authoring support for IND, IMPD, and BLA submissions.
  • Method qualification and validation across all modalities.
  • PPQ and ICH stability studies.
  • GLP/GMP reporting aligned with FDA, EMA, Health Canada, and other global authorities.
  • Inspection readiness baked into every protocol and SOP.

Analytics First

Process truths come from data. Our analytics suite includes:

  • SEC-MALS for size distribution.
  • LC-MS peptide mapping for structural verification.
  • CE-SDS, icIEF for charge heterogeneity.
  • Glycan profiling for post-translational consistency.
  • Endotoxin/bioburden testing for release assurance.
  • Potency assays including ADCC/CDC.
  • Vector analytics: vg titer (ddPCR), full/empty capsid ratios (AUC/EM), nanoparticle encapsulation metrics.

Every therapeutic program benefits from phase-appropriate analytical depth without unnecessary cost.

Facilities & Scale

  • Microbial & Fungal: Bench to pilot to 50,000 L stainless for qualified programs.
  • Mammalian: 50 L / 250 L single-use suites to multi-thousand-liter perfusion.
  • BEVS: Rapid baculovirus expansion, mg to kg-class outputs.
  • Vectors & LNPs: Closed, scalable systems with in-line analytics.
  • Fill–Finish: Aseptic vialing, prefilled syringes, cartridges, lyophilization.

All cleanrooms ISO 8/7, positive-pressure, HEPA filtered, and continuously monitored. Utilities (HPW, clean steam, compressed air) are validated and logged under ALCOA+ systems.

Why Teams Pick MycoVista Therapeutics CDMO Solutions

  • Design-to-GMP: End-to-end execution under one data spine.
  • Dual-Hub Resilience: San Diego & Montréal provide mirrored methods, capacity headroom, and business continuity.
  • Analytics First: Process truths established early, reducing late-stage surprises.
  • Manufacturability by Default: Every study asks: Will this scale? Will it release clean? Will it pass inspection?

Conclusion & Call to Action

Therapeutic programs demand a CDMO that is not only technically competent but inspection-grade by default. At MycoVista Therapeutics CDMO Solutions, we integrate upstream, downstream, analytics, and regulatory into a unified framework that accelerates your path from IND to GMP reality.

If you are developing an mRNA vaccine, a rare disease biologic, a bispecific antibody, or an advanced viral vector, we can design, document, and deliver the pathway that gets you to clinic faster — with fewer unknowns and more confidence.

Contact us today at info@mycovistabiotech.com to begin your therapeutic journey. With MycoVista, the path is always Design → GMP, without detours.