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Process Development
& Manufacturing

A connected path from route evaluation and process understanding through gram-to-kilogram scale-up, technology transfer, analytical control and manufacturing execution for deuterated and non-deuterated programs.

Discuss your programExplore capabilities
225 kLPublished manufacturing capacity
350+Scientists across the organization
100+Process chemists supporting development

Overview

Clearsynth brings process chemistry, analytical science, scale-up planning, quality systems and manufacturing coordination into one program framework. Equipment selection and operating strategy are matched to the molecule, target scale, safety assessment and required product profile.

Process and Equipment Planning

Programs begin with route, raw-material, process, analytical and product-quality requirements. Technical teams then evaluate how the chemistry can progress from laboratory work through engineering runs and controlled manufacture.

  • Route and process evaluation
  • Safety, scalability and equipment-fit assessment
  • Isolation, purification and solid-form planning
  • Analytical methods and control-strategy alignment
Clearsynth process and utilities building
Clearsynth process and utilities building.
Deuterium chemistry

Route selection, isotope incorporation, exchange behaviour and analytical verification.

Deuterated intermediates

Labelled building blocks and intermediates for multi-step synthetic routes.

Deuterated APIs

Drug-substance development, isotope control, scale-up and manufacturing.

Development and Manufacturing Capabilities

Clearsynth supports the main stages of process development, scale-up, manufacturing, isolation, quality control and environmental management.

01

Process Development

Route scouting, reaction evaluation, process optimization, safety review and analytical support.

02

Small Scale

Laboratory evaluation and gram-to-kilogram development for early project requirements.

03

Pilot Scale

Engineering runs and equipment-fit review before production transfer.

04

Production

Manufacturing planning within the published 225 kL platform.

05

Isolation

Purification, filtration, chromatography and crystallization planning.

06

Drying

Drying requirements based on residual solvent, stability and material properties.

07

Quality Control

Analytical methods, impurity characterization, stability support and testing.

08

Recycling & Waste

Environmental management, waste considerations and controlled handling practices.

Process Development

Clearsynth supports technology transfer and laboratory-scale process evaluation through optimization, purification development, salt screening, safety and scalability analysis, analytical support and engineering-run preparation.

Process Evaluation and Development

Development teams evaluate the chemistry against yield, selectivity, impurity formation, raw-material availability, operational practicality and the intended manufacturing scale.

Work is planned to reduce technical uncertainty and create a clearer transfer package for the next stage.

  • Technology-transfer evaluation
  • Process optimization
  • Impurity isolation and analysis
  • Salt and solid-form screening
  • Calorimetry and safety review
  • Flow chemistry or specialized purification when appropriate
Clearsynth reactor hall used for process work
Process equipment at the Clearsynth facility.

Reaction development

Condition screening, parameter optimization, repeatability studies and definition of practical operating ranges.

Process safety

Assessment of reaction behavior, material hazards, operating constraints and controls appropriate to scale progression.

Impurity understanding

Identification, isolation and analytical characterization supporting fate, purge and control decisions.

Purification strategy

Workup, crystallization, chromatography and other fit-for-purpose approaches assessed for product quality and recovery.

Analytical alignment

Methods and sampling plans developed alongside the process so decisions are supported by suitable data.

Transfer readiness

Process description, risk knowledge, raw-material requirements and analytical expectations assembled for the receiving team.

Small-Scale Development

Small-scale work supports route confirmation, impurity preparation, reference materials, process learning and the first controlled progression from gram to kilogram quantities.

01

Laboratory evaluation

Feasibility, route assessment and initial reaction understanding.

02

Gram scale

Reproducibility, impurity profile and isolation behavior.

03

Kilogram scale

Scale-sensitive parameters, handling and equipment-fit learning.

04

Transfer package

Defined instructions, controls and analytical expectations for the next stage.

Responsive project sizing

Work scope is matched to the quantity, purpose and maturity of the program.

Complex chemistry support

Deuterium, lithiation, Grignard and other demanding synthetic work are evaluated program by program.

High-potency assessment

Suitability, containment and handling requirements are confirmed during technical feasibility review.

Pilot Scale

Pilot and engineering work tests the process under more representative mixing, heat-transfer, addition, workup and isolation conditions before larger-scale execution.

Scale-Up and Engineering Runs

The team reviews critical parameters, material inputs, sampling, equipment interfaces, hold points and failure modes. Observations from engineering runs are converted into updated instructions and controls.

  • Equipment and material compatibility
  • Mixing and heat-transfer considerations
  • Addition and temperature controls
  • Workup and phase-separation behavior
  • Isolation and drying approach
  • Analytical method transfer
Panoramic view of the Clearsynth reactor hall
Pilot and scale-up equipment.

Production

Clearsynth’s published manufacturing platform provides 225 kL of capacity, supported by scientific, process, analytical and quality teams. Each production plan remains subject to chemistry, safety, equipment-fit, containment and scheduling review.

Clearsynth production facility
Clearsynth production facility.
225 kL manufacturing capacity

Published manufacturing capacity supporting API development and production programs.

Scale-up and technology transfer

Process knowledge, risk controls, analytical methods and documentation move together into manufacturing.

Clinical and commercial support

Program scope and manufacturing stage are aligned with the molecule, intended market and quality requirements.

Cross-functional execution

Process chemists, analytical scientists, quality specialists and manufacturing teams work to a common project plan.

Material Storage

Dedicated facility areas support the storage and organization of drums and packaged materials.

Raw material storage area at the Clearsynth facility
Raw Material Storage Area
Finished goods storage at the Clearsynth facility
Finished Goods

Isolation and Drying

Isolation is developed as part of the process—not treated as a final afterthought. Purity, recovery, physical form, handling and downstream use guide the selected approach.

Purification

Workup and purification options are evaluated for impurity removal, recovery and scalability.

Crystallization & salts

Salt screening, crystallization behavior and solid-form decisions are aligned with the product requirement.

Chromatography

Specialized chromatographic purification may be used where it is technically appropriate for the program.

Filtration strategy

Solid-liquid separation requirements are evaluated against particle behavior, scale and product handling.

Drying strategy

Residual solvent, thermal sensitivity, stability and physical properties inform the drying approach.

Containment review

Potency, hazard and exposure considerations are assessed before equipment and operating arrangements are confirmed.

Program-specific confirmation: Installed equipment, construction materials, working volumes, filtration and drying suitability, containment requirements and scheduling are confirmed during technical feasibility review.

Quality Control

Analytical support spans method setup and development, impurity characterization, in-process understanding, stability work, qualification planning and testing aligned with the program stage.

LC-MS equipment in the Clearsynth quality control laboratory
LC-MS equipment in the quality control laboratory.
Clearsynth scientist preparing a quality control sample
Quality control sample preparation.

Analytical Methods and Equipment

HPLCUPLCPreparative HPLCLC-MSLC-MS/MSGC-MSGC-HS/MSNMRBio NMRICP-MSIRUV/VISAASTGACoulometryFlash chromatography
  • Method development and fit-for-purpose setup
  • Impurity identification and characterization
  • Stability and release-support testing
  • Analytical transfer and qualification planning
  • Controlled data review and reporting
Published Clearsynth analytical instrument inventory
InstrumentBrandQuantity
600 MHz Bio NMRBruker1
ICP-MSPerkinElmer1
GC-HS/MSThermo1
LC-MSAB Sciex and Shimadzu2
TGAPerkinElmer1
Preparative HPLCShimadzu2
HPLCWaters3
HPLCDionex1
HPLCThermo6
Flash systemSepaBean1
CoulometerMetrohm1
IRShimadzu1

Recycling and Waste Management

Clearsynth’s ISO 14001:2015 environmental management system supports controlled environmental practices across operations.

Environmental and utility equipment at the Clearsynth facility
Environmental and utility equipment.

Process and Waste Considerations

Route and process assessment can consider solvent use, raw-material efficiency, process economics, waste generation and practical improvements in responsible chemistry. Site-specific handling and disposal arrangements are confirmed through the applicable operating and compliance systems.

  • ISO 14001:2015 environmental management system
  • Waste and solvent considerations during process optimization
  • Hazard assessment and controlled handling procedures
  • Program- and site-specific disposal verification

Quality Certifications

Access the current certificates and accreditation documents published by Clearsynth.

Research Recognition

DSIR Recognition

Recognition of the in-house research and development unit.

View certificate

Discuss Your Project

Share your chemistry, development stage, target quantity, quality requirements and timeline with the Clearsynth d-CDMO team.

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