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First-Time-Right Formulation Development

In Crystal Pharmatech, instead of one-size-fit-all platforms or “super-placebo” or quick and rough “fit-for-purpose” formulation approaches in early development, we apply a “First-Time-Right” strategy for formulation development to accelerate your molecule to First in Human (FIH) studies and onward to commercialization at a cost-effective and time-saving way.


Crystal Pharmatech boasts a formulation development leadership team with extensive experience and deep expertise and has built a state-of-art formulation pilot plant and labs, which are equipped with world-class manufacturing equipment and R&D instruments. We strive to provide you with the best formulation development approach and become the trusted internal partners to support each step of your project to:


A well-designed formulation should have appropriate bioavailability, good physicochemical, biological and microbiological stability, and a robust manufacturing process. Biding by the molecule-material-medicine, dubbed the M3 drug product development philosophy, we design and develop a formulation tailor-made for a molecule to meet its intended clinical needs, with good bioavailability, stability, manufacturability, patient compliance and regulatory acceptance while avoiding significant formulation change from early to late development. 


MoleculeMaterialMedicine
  • Clinical info and needs

  • DMPK understanding

  • Pharmacodynamics

  • Safety info 

  • Molecular profile

  • API phase

  • API physiochemical, biopharmaceutical, mechanical properties and stability

  • Excipient functionality, physical attributes, compatibility

  • Properties of formulation tailored for process

  • Label as driver for design

  • Interaction of composition and process

  • Impact of API(s) and excipients properties and composition on CQA

  • Impact of CPP on CQA

  • Control strategy for drug product


Analytical Chemistry Services 

Crystal Pharmatech has considerable experience in analytical chemistry. We offer a comprehensive range of integrated, high-quality, efficient and effective solutions using advanced methods and instrumentation and problem-solving skills.


Benefits: 

Achieve Your Success with Our Expertise
Contact Us
bd_global@crystalpharmatech.com +1-609-604-8303
U.S
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
Canada
6800 Kitimat Rd, Unit 1, Mississauga, Ontario, Canada L5N 5M1
China
Suite B4-101, Biobay, 218 Xinghu Street, Suzhou Industrial Park, Suzhou, China, 215123
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
bd_global@crystalpharmatech.com +1-609-604-8303