Prototype Preparation
(RAMP)

The Importance of Prototype Preparation - A Strategic Advantage

Early-stage drug development requires prototypes to test formulation feasibility, dosing, stability, and preclinical efficacy. Without access to small-scale, agile production, developers often face delays, high costs, and wasted API. CMC Pharma has developed a unique small-scale manufacturing process called RAMP to give drug product developers a strategic advantage. The model is affordable, flexible, and scalable for commercial and regulatory success.

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What is RAMP?

CMC Pharma’s RAMP (Rapid & Agile Manufacturing of Prototypes) provides a unique solution for drug developers seeking small-scale prototypes for in vitro and animal studies. Many CDMOs do not offer production of small-batches, leaving developers unable to test proof of concept without committing to expensive, time-consuming, and resource-intensive GMP-scale production. Our unique RAMP model effectively bridges the gap that developers face when scaling from lab bench to pre-clinical studies.

RAMP allows rapid production of oral and injectable drug product prototypes at 10 to 1,000 units per batch, accelerating development while reducing risk and cost. By combining speed, flexibility, and technical expertise, CMC Pharma provides developers with the data they need to confidently advance programs toward larger-scale manufacturing and regulatory submission.

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RAMP enables developers to

  • Validate proof of concept without large-scale commitment
  • Test multiple formulations and dosing strategies efficiently
  • Generate data for in vitro and in vivo studies
  • Reduce risk before GMP manufacturing or scale-up

This unique capability positions CMC Pharma ahead of many competitors who focus only on GMP-scale or larger batch production, providing clients with a cost-effective, low-risk, and flexible development pathway.

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RAMP Advantages

Speed & Flexibility

● Fast turnaround times: Prototypes are available in days to weeks, rather than months or years.
● Agility: Equipment accommodates a wide range of solid APIs and existing liquid formulations.
● Minimal formulation development required: Solid APIs or liquid formulations can be directly filled into capsules or vials.
● Limited process development required: Typically, only a single small pilot study is needed to establish the process.
01

Cost-Effectiveness

● Reduced investment: Less time, fewer resources, and existing equipment lower the cost of small-scale batches.
● Minimal API requirements: Ideal for programs with limited API availability.
● Ability to meet niche demands: RAMP supports specialized formulations and emerging product needs.
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Innovation & Quality

● Expert execution: RAMP production is performed by experienced scientists for maximum quality and attention to detail.
● Facilitates experimentation: Encourages testing of new ideas, doses, and formulations and helps to identify lead candidates.
● cGMP evaluation: RAMP is being assessed for potential cGMP use in Phase I clinical studies.
● Dose flexibility: Strengths can be easily adjusted as development progresses.
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Integration with CMC Pharma’s Manufacturing Enablement Services

RAMP is a critical first step in CMC Pharma’s Manufacturing Enablement suite, providing a seamless bridge from early formulation to commercial manufacturing. By generating small-scale, high-quality prototypes, RAMP informs and accelerates downstream activities, reducing risk and cost across your program.

Scale-Up & Tech Transfer

  • Small scale batches provide real-world data on formulation behavior, allowing optimization before scaling to pilot or GMP production.
  • Insights from prototype batches guide technology transfer plans, ensuring smoother, faster transitions to manufacturing partners.
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CMO Selection & Due Diligence

  • Data from RAMP prototypes help identify the best-suited CMOs for your product based on formulation complexity, dosage form, and process requirements.
  • Early prototype experience informs due diligence, reducing the risk of CMO selection errors or production delays.
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GMP Manufacturing & Oversight

  • RAMP allows preclinical evaluation without committing to full-scale GMP batches, lowering financial and operational risk.
  • Prototype results support process validation and regulatory documentation, ensuring GMP manufacturing is executed efficiently and in compliance with FDA and ICH standards.
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By connecting RAMP to Scale-Up & Tech Transfer, CMO Selection & Due Diligence, and GMP Manufacturing & Oversight, CMC Pharma delivers a fully integrated, end-to-end development pathway, giving clients de-risked programs, cost efficiency, and regulatory-ready execution from concept through commercialization.

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How RAMP Supports Early-Stage Drug Development

  • Proof-of-concept validation: Test formulations with minimal API investment.
  • Preclinical readiness: Produce batches for in vitro and animal studies efficiently.
  • Experimental flexibility: Try multiple formulations, dosing strengths, and delivery systems.
  • Seamless transition: Data generated informs downstream manufacturing, regulatory submissions, and CMO engagement.
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Why Choose CMC Pharma’s RAMP

  • Seamless Integration: Aligns with CMC Pharma’s full-service lab, analytical, and regulatory expertise.
  • De-Risked Development: Small-scale prototypes reduce the financial and operational risk of early-stage programs.
  • Cost-Effective Innovation: Enables experimentation without committing to large-scale production.
  • Regulatory Readiness: Prepares formulations for transition to GMP manufacturing and clinical trials.

RAMP embodies CMC Pharma’s commitment to accelerated, de-risked, and cost-effective drug development, giving clients the tools they need to bring innovative therapies to patients faster.

What Sets Us Apart

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    Contact Us Today and find out how CMC Pharma can help you!

    Our expert team of scientists provides exceptional pharmaceutical formulation services for a variety of dosage forms.

    Send us a message or give us a call at 440-485-1734