CDMO & DEVELOPMENT SERVICES

From Development Candidate to Commercialization

APS takes molecules from medicinal chemistry into development. We provide process and analytical development, CMC-aligned support, scale-up, technology transfer and commercialization support for challenging pharmaceutical programs.

Our approach is phase appropriate, risk based and focused on the final application.

DISCUSS YOUR PROGRAM
SUBMIT AN RFP

One Development Path. Multiple Points of Entry.

Engage with APS at any stage after medicinal chemistry.

From Medicinal Chemistry

Development candidate, route or problem statement.

Process Assessment

Route review, feasibility and risk identification.

Process & Analytical Development

Optimization, control strategy and impurity understanding.

Polymorph & Impurity Fate & Purge

Solid-form selection and impurity behavior through the process.

Scale-Up & Process Transfer

Scale-up, robustness and technology transfer.

CMC & Clinical Support

Phase-appropriate CMC and clinical development support.

Commercialization

Ongoing support and lifecycle management.

Integrated Development Services

Scientific support structured around the decisions that move a molecule toward a reliable, scalable and transferable process.

Process Development & Optimization

  • Route design and optimization
  • Reaction condition development
  • Work-up, isolation and purification
  • Yield, robustness and control strategy
  • Scale-up and troubleshooting
Practical, reproducible processes built with scale, safety, quality and commercial viability in mind.

Analytical Development & Support

  • Analytical method development and qualification
  • In-process control analytical methods
  • Impurity profiling and identification
  • Support for scale up, tech transfer and troubleshooting
Analytical understanding integrated throughout the development program.

Polymorph Screening & Solid-Form Selection

  • Polymorph, solvate and hydrate screening
  • Form characterization
  • Crystallization evaluation
  • Form selection for development and manufacturing
  • Stability and interconversion studies
Selecting the right solid form to support a robust, scalable process.

Impurity Fate & Purge Studies

  • Impurity identification and origin assessment
  • Fate tracking through process steps
  • Purge assessment across unit operations
  • Control strategy and specification support
  • Regulatory justification support
Understanding where impurities come from, where they go and how they are controlled.

Raw Material & Supplier Strategy

  • Supplier identification and evaluation
  • Alternative supplier assessment
  • Incoming material requirements
  • Supplier qualification support
  • Impact of raw materials on process and product quality
Building a reliable, qualified supply chain for development and beyond.

Scale-Up & Process Robustness

  • Laboratory to pilot and larger scale-up
  • Process characterization
  • Identification of critical parameters
  • Robustness and variability assessment
  • Scale-dependent issue resolution
Generating the knowledge needed for confident scale-up and transfer.

CMC & Drug Development Perspective

  • Phase-appropriate CMC strategy
  • Regulatory awareness and documentation
  • Impurity control strategy alignment
  • Support for clinical supply and filings
  • Experience across the development continuum
Development decisions informed by what matters in later-stage manufacturing and submissions.

Phase Appropriate by Design

Not every program needs the same level of development at the same time. We align the work, documentation and scientific depth with the stage of your program — while keeping the next stage in view.
Right-sized development without losing sight of commercialization.
OUR SPECIALTY

Advanced Pharmaceutical Lipids

Deep expertise for complex lipid programs

APS brings specialized expertise in lipid synthesis, purification, characterization and process development to support challenging lipid-based pharmaceutical programs.

  • Custom synthesis and route development
  • Complex purification and isolation
  • Analytical characterization and method development
  • Process optimization and scale-up
  • Impurity identification, fate and control
  • Technology transfer and manufacturing support
EXPLORE OUR LIPID CAPABILITIES
DISCUSS A LIPID PROJECT
DEVELOPMENT WITH THE FINAL APPLICATION IN VIEW

Build the science you will need later — from the start.

APS combines process chemistry, analytical strategy, CMC awareness and broader drug-development perspective to move programs forward efficiently without unnecessary complexity.
  • Phase-appropriate development
  • Risk-based decision making
  • Impurity control strategy
  • Polymorph and solid-form awareness
  • Supplier and material considerations
  • Commercial objectives in view

Scale Up & Development Supply

APS adapts the developed process to larger scale while maintaining focus on reproducibility, purity, operability and appropriate controls. Our goal is to deliver reliable, consistent performance that supports progression and supply needs.

Engineering support

Robustness assessment

Clinical supply readiness

Technology Transfer & Commercialization

When appropriate, APS transfers developed processes and analytical knowledge to qualified partner manufacturing sites suited to the required stage, scale and regulatory environment.
  • Technology transfer packages
  • Process and analytical method transfer
  • Support for manufacturing partner selection
  • Transfer meetings and scientific knowledge exchange
  • Implementation troubleshooting
  • Continued technical support through commercialization

Additional Specialized Capabilities

Advanced purification and analytical technologies​

Complex intermediates and specialty molecules

Pharmaceutical reference standards

Polymorph screening and selection

Advanced purification and analytical technologies

Wherever You Are in Development, We Can Start There.

Bring us a structure, an existing route or a process problem. We will meet the program at the stage where support is needed.
DISCUSS A PROJECT
SUBMIT AN RFP