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Crystallization Process Development

Scalable, QbD-Driven Process Engineering

Transforming a newly discovered crystal form into a scalable manufacturing process requires a blend of deep theoretical understanding and strict process control. We design processes that consistently yield your target crystal form while optimizing API particle properties, overall yield, and production costs.

Process Design and Control
Quality by Design (QbD)
Critical process parameters and quality attributes are identified to define the design space and establish robust control strategies for reproducible manufacturing.
Metastable Polymorph Control
Specialized strategies are applied to control metastable forms, which are often challenging to scale due to their tendency to convert to more stable forms. Process conditions are optimized to ensure stability and reproducibility at scale.
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Scaling Peptide Crystallization: From Feasibility Studies to Robust Process Control
Small Molecule
First-Time-Right 3-STEP Approach Developability Assessment API Form and Solid-State Research Crystallization Development Services Pre-formulation Studies Analytical Research and Quality Control First-Time-Right Formulation Development Clinical and Commercial Manufacturing Clinical Supply
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DNA Synthesis RNA Synthesis LNP Formulation Services Analytical & Characterization Services Early-Phase Manufacturing Catalogue Products
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Solid-State, Crystallization & Preformulation Technical Platforms for Oral Dosage Forms
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bd_global@crystalpharmatech.com (925) 558-5040
U.S
NJ Sites: Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey, USA 08512

2005 Eastpark Blvd, Cranbury, New Jersey, USA 08512

CA Site: 7133 Koll Center Parkway, Suite 200, Pleasanton, California, USA 94566
Canada
6800 Kitimat Rd, Unit 1, Mississauga, Ontario, Canada L5N 5M1
China
No. 288, Jiangyun Road, Suzhou Industrial Park, Suzhou, China 215123

Floor 1, Bldg. 3, 68 Chunpu Road, Suzhou Industrial Park, Suzhou, China 215123
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Small Molecule
First-Time-Right 3-STEP Approach Developability Assessment API Form and Solid-State Research Crystallization Development Services Pre-formulation Studies Analytical Research and Quality Control First-Time-Right Formulation Development Clinical and Commercial Manufacturing Clinical Supply
Crystal Bio Solutions
Biologics Characterization and CMC Analytics Bioanalytical and Biomarker Services Quantitative Clinical Pharmacology (QCP)
Platforms
Quick Links
About Us Events
NJ Sites: Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey, USA 08512

2005 Eastpark Blvd, Cranbury, New Jersey, USA 08512

CA Site: 7133 Koll Center Parkway, Suite 200, Pleasanton, California, USA 94566
bd_global@crystalpharmatech.com (925) 558-5040
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