Consulting: CMC, QTPP & TPP Strategy

Overview

Successful development begins with defining the final product. At Esco Aster, we help clients establish a comprehensive Target Product Profile (TPP) and Quality Target Product Profile (QTPP) that serve as the strategic foundation for Chemistry, Manufacturing and Controls (CMC), regulatory planning, process development, analytical development, clinical manufacturing, commercialization, quality control and testing.

Leveraging our FDA regulatory and cGMP clinical manufacturing track record especially cancer exosome biologics, we provide phase-appropriate CMC consulting that aligns scientific development with regulatory expectations from discovery through commercial production.

The QTPP defines the intended quality characteristics required to ensure product safety, identity, strength, purity, potency, efficacy, and stability. This forms the cornerstone of a Quality by Design (QbD) approach, enabling the identification of Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), and appropriate Process Analytical Technologies (PAT) to establish a robust, reproducible, and scalable manufacturing process.

By defining the desired commercial product from the outset, research, process development, analytical development, regulatory strategy, GLP Toxicology, manufacturing, and clinical development remain aligned throughout the product lifecycle. This minimizes technical risk, reduces development costs, shortens timelines, and maximizes the value of intellectual property.

Esco Aster's integrated platform combines strategic CMC planning with Manufacturing Science & Technology (MSAT), enabling the selection or development of linearly scalable manufacturing technologies that significantly reduce development time, capital expenditure, and future cost of goods.

Advanced Cell & Gene Therapies

  • Cell therapies (CAR-T, CAR-NK, NK Cells) – autologous and allogeneic; ex vivo and in vivo
  • Gene therapies, including genetically modified cell therapies using mRNA and flow electroporation
  • Mesenchymal stromal cells (MSCs) – naïve, genetically modified (viral vectors), and immortalized
  • Induced Mesenchymal Stem Cells (iMSCs)
  • Induced pluripotent stem cells (iPSCs)
  • Embryonic stem cells

Extracellular Vesicles & Cell-Derived Biologics

  • Exosome biologics
  • Cell-derived ingredients (exosomes, collagen, omega fatty acids, PDRN, mitochondria, cell-derived nanovesicles, outer membrane vesicles, etc.)
  • Plant- and biofluid-derived extracellular vesicles (milk, blood, platelet)
  • Plant cell culture for extracellular vesicle production and agrifood applications

Microbiome & Next-Generation Therapeutics

  • Microbiome therapeutics

Food Biotechnology & Cellular Agriculture

  • Clinical nutrition
  • Cell-based/cultivated fats, proteins, and meat
  • Cultivated pet food

Consumer Health, Beauty & Wellness

  • Nutraceuticals 
  • Nutricosmetics 
  • Dermocosmetics 
  • Cosmeceuticals 
  • Medicated cosmetics

Animal Health / Nutrition

  • Veterinary therapeutics
  • Veterinary cosmetics
  • Cultivated Pet Food / Nutraceuticals (Omega Fatty acids, collagen, etc.)
Why CMC, QTPP & TPP Strategy Matters

An effective CMC strategy extends far beyond regulatory documentation. It provides a strategic roadmap that aligns scientific development, manufacturing, 

regulatory submissions, investment milestones, and commercialization.

A robust strategy enables organizations to:

  • Define a clear development pathway from research through commercial manufacturing.
  • Align product development with FDA, EMA, ICH and global regulatory expectations.
  • Establish scalable manufacturing processes using Quality by Design principles.
  • Reduce technical, regulatory, manufacturing, and investment risk. 
  • Optimize development timelines and capital efficiency.
  • Preserve patent life by minimizing avoidable delays.
  • Improve investor confidence through well-defined development milestones.
  • Support grant applications with clearly defined use-of-proceeds and stage-gated development plans.
  • Ensure commercial manufacturing remains economically viable through techno-economic assessment and cost-of-goods optimization

Without a well-defined CMC strategy, organizations frequently encounter regulatory setbacks, manufacturing redesign, delayed clinical programs, increased burn rate, 

duplicated development work, reduced intellectual property value, and higher commercialization costs.

Our Offering

Strategic Gap Assessment

We evaluate existing research, laboratory protocols, manufacturing processes, analytical methods, and development plans to identify technical, regulatory, and manufacturing gaps before they become costly obstacles.

Phase-Appropriate CMC Development

We develop practical CMC strategies appropriate for every stage of development, from proof-of-concept through IND-enabling studies, GLP toxicology, clinical manufacturing, and commercial production.

Regulatory Strategy

Our CMC strategies are designed to support global regulatory submissions including:

*With 3rd party Qualified Personnel (QP)

For clinical nutrition and cell based food products, our dedicated site is certified by Singapore Food Agency (SFA) and products are the filed for FSSC 22000 and ISO 22000.

Manufacturing Scalability

Our proprietary manufacturing platforms enable true linear scalability from laboratory research through commercial production without changing the underlying manufacturing technology.

This is particularly important for exosome and cell therapies where "the process is the product." Even small process variations can alter extracellular vesicle cargo (miRNA), protein expression, potency, and biological activity.

A robust CMC strategy ensures process consistency throughout:

Cell banking

Process Development

Analytical development

IND-enabling studies

GLP toxicology manufacturing

Clinical manufacturing

Commercial production

Product Quality Strategy

We establish comprehensive quality strategies early in development by defining:

This when required, orthogonal structured approach enables progressive qualification and validation of analytical methods and manufacturing processes while reducing variability between operators, equipment, manufacturing campaigns, and production sites.

Collaborative Development

Esco Aster partners with:

  • Biotech startups
  • First-time founders
  • Academic investigators / Investigator Initiated Trials
  • Universities
  • Research institutes
  • University hospitals
  • Biopharmaceutical companies
  • Pharmaceutical companies
  • Government agencies
  • Venture investors
  • Technology transfer offices

Our objective is to develop globally investable biotech’s that are technically robust, regulatory compliant, commercially scalable, and strategically positioned for successful fundraising, partnering, licensing, acquisition and “exit”

Deliverables

Our CMC strategy engagements typically include:

Benefits to Stakeholders

A comprehensive CMC roadmap strengthens both technical execution and financing readiness.

For startups and academic innovators, it supports competitive grant applications by clearly aligning development activities with funding milestones and capital deployment.

For investors, it provides confidence that scientific, manufacturing, regulatory, and commercial risks have been systematically addressed.

For regulators, it demonstrates a structured, science-based development program built upon internationally accepted Quality by Design principles.

Our CMC strategies can also support Singapore grant-funded development through:

Cluster level:
National level:
Company level:
Complementary CMC Analytical Development Services

Our strategic roadmap is supported by comprehensive analytical development capabilities, including:

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