Company Category: cGMP Manufacturing (Drug Product)

Established in 2010, Crystal Pharmatech is a global company with around 250 employees and three R&D centers located in Suzhou (China), New Jersey (USA), and Toronto (Canada). We are distinguished by our comprehensive suite of specialized services, which includes API solid-state research, crystallization, preformulation, formulation development, and manufacturing. Our scientific leadership team, averaging 15 years of experience, has successfully delivered over 100 early-phase and 19 commercialized products for worldwide pharmaceutical companies. We have catered to over 1,000 clients, aiding in the development of more than 2,000 new chemical entities. Utilizing our distinctive expertise, we collaborate with clients to design and develop the most appropriate crystal form and formulation for further development. Our principle of “getting the crystal form and formulation right the first time for Phase I” not only accelerates the progression of your molecule to IND filing and Phase I clinical trials but also minimizes the need for human PK bridging studies. This method saves time and reduces costs as your program progresses to Phase II and beyond. Crystal Pharmatech is a specialized CRO/CDMO focused on Solid State Research, Pre-Formulation, Formulation Development, and Manufacturing. Our strength lies in our concentrated expertise in these areas, and we offer the following Mol2Med™ Integrated Services: the First-Time-Right 3-STEP Approach. This method is designed to quickly advance small molecule lead compounds or preclinical candidates into Phase I and further, with unmatched efficiency and precision. The approach starts at the lead optimization/PCC stage: This innovative method ensures a robust API form and a scalable manufacturing process, leading to a First-Time-Right formulation for Phase I. By streamlining the transition to future clinical studies following Phase I success, our First-Time-Right approach lays the groundwork for optimized drug development and future success. Step 1: Developability Assessment Our method evaluates the physicochemical properties of all lead candidates to identify the most “developable” lead, benchmarking against industry standards and aiming for the highest likelihood of success in GLP Tox and FIH studies. It also aids in deciding whether a free form or salt, and either a crystalline form or an amorphous solid dispersion should be chosen for further development. Step 2: Solid Form Screening/Selection and Pre-Formulation We begin with thorough screening and selection of the optimal crystalline form for the API. We then develop an ideal preclinical formulation to support PK/PD and GLP Tox animal studies. Step 3: Formulation Development and CTM Manufacturing Our API-specific “First-time-right” strategy produces the best formulation for Phase I and subsequent clinical studies. This approach allows late-stage development to concentrate on process optimization and scale-up without significant formulation changes, thereby eliminating the need for human PK bridging studies. Service offerings: 1. Polymorph screening, salt screening, cocrystal screening, solid form screening a. Most solid drugs can exist in different solid forms (polymorph, anhydrate, hydrates, solvates, cocrystals, salts, and amorphous forms), which lead to different physicochemical properties, such as solubility, stability, particle size and others. Therefore, screening and selection of the ideal API solid forms is critical to obtain the highest standard quality, performance and a good manufactured reproducibly. 2. Solid state research a. Solid state characterization, solid state research, single crystal growth 3. Crystallization development a. The aim of a crystallization process development is to find a crystallization process which can stable produce the optimal solid form with all desired properties such as particle size, particle shape, bulk density, purity, yield, residual solvent content, etc. Experienced engineers agree that crystallization is an inherently challenging process, one that involves a blend of art and science. Even small variations in the process can have profound impact on the outcome for both the API producer and its business pharmaceutical partners, which incorporate the API into finished drug formulations. At Crystal Pharmatech, successful crystallization development is based on a fundamental understanding of physicochemical and engineering principles, implementation and development of technologies and expertise in specialized areas. 4. Pre-formulation Development a. Preformulation development, preformulation studies, amorphous solid dispersion screening, vehicle selection to support animal studies 5. Formulation Development, CTM manufacturing, spray drying, hot melt extrusion, oral solid dosage, clinical supply service, clinical trial material a. Crystal Pharmatech has rich experience in the development of new drug products during the whole life cycle. Based on the concepts of Quality by Design (QbD) and Fit-for-Purpose (FFP), a suitable formulation development strategy will be adopted in view of the characteristics and technical requirements of different kinds of products at different stages. We aim to develop a robust formulation and process for your product, to rapidly advance to different stages of clinical research. Product changes will be minimized in the subsequent clinical and marketing process to achieve comprehensive and efficient development goals by scientific bridging study design. As a professional pharma formulation company, we have top-notch equipment and instruments for formulation development and analysis, which can support the development of oral solid dosage forms at all stages from early clinical to commercialization. The first-time success of GMP production of clinical samples can be effectively guaranteed and thus saving the development cost and shortening the development cycle by taking the following strategies: compaction and mathematical simulation technologies, similar critical equipment between GMP and R&D, and the same personnel responsible for R&D and GMP production of clinical samples. 6. Biologics analytical services a. Typical CMC-related analysis of primary and higher order structure, product and process purity, and forced degradation with correlation bioactivity with MS identity for potential critical quality attributes. Additional modalities such as traditional types of ADC & novel conjugated combinations, mRNA & lipid nanoparticles in combination with a strategic partner. Sample pretreatment strategy combined with LC-MS to complement assays used in various bioassays and cell/ gene analysis to support structure/ function elucidation. Analysis of protein expression from cell, tissue, or blood matrix. Bioactivity, effector functional (ADCC& ADCP), and ligand binding analysis for potency and mechanism of action. PK/PD for investigational & preclinical analysis, and extendable to clinical analysis as needed. | x | Established in 2010, Crystal Pharmatech is a global CRO/CDMO with around 300 employees and four R&D centers located in Suzhou, New Jersey, California, and Toronto. We provide integrated development support across small molecules, biologics, and nucleic acid therapeutics. Our core capabilities include API solid-state research, crystallization development, preformulation, formulation development, analytical support, and manufacturing. Through Crystal Bio Solutions, we also offer biologics characterization and CMC analytical services, Bioanalysis and Biomarker (BABM) services, and Quantitative Clinical Pharmacology (QCP). Through Crystal NAX, we extend our platform into nucleic acid therapeutics with DNA synthesis, RNA synthesis, LNP formulation, analytical and characterization services, and early-phase manufacturing. Our scientific leadership team, averaging 15 years of experience, has successfully supported over 100 early-phase and 19 commercialized products for pharmaceutical companies worldwide. We have served more than 1,000 clients and contributed to the development of over 2,000 new chemical entities. Utilizing our specialized expertise, we collaborate with clients to design and develop the most appropriate crystal form, formulation, and development strategy for further advancement. Our Mol2Med™ First-Time-Right approach is designed to establish a robust API form and scalable manufacturing process early, helping accelerate programs toward IND filing and Phase I while reducing later-stage development risk. Service offerings: 1. Polymorph screening, salt screening, cocrystal screening, and solid form screening • Many drug substances can exist in different solid forms, including polymorphs, anhydrates, hydrates, solvates, cocrystals, salts, and amorphous forms. These forms can significantly affect solubility, stability, particle size, manufacturability, and overall performance. Screening and selecting the right solid form is therefore critical for successful development. 2. Solid-state research • Solid-state characterization, solid-state research, absolute structure determination, crystal identification, and related analytical support for API form understanding and selection. 3. Crystallization development • Crystallization process development is aimed at establishing a robust and reproducible process that consistently delivers the target solid form with desired properties such as particle size, particle shape, bulk density, purity, yield, and residual solvent profile. Crystal Pharmatech approaches crystallization development through a combination of physicochemical understanding, process expertise, and practical engineering considerations. 4. Preformulation development • Preformulation studies, developability evaluation, amorphous solid dispersion screening, vehicle selection, and related work to support PK/PD and GLP tox studies, while clarifying the most suitable path forward for formulation and clinical development. 5. Formulation development, analytical development, CTM manufacturing, spray drying, hot melt extrusion, oral solid dosage, and clinical supply • Crystal Pharmatech provides integrated formulation development and manufacturing support for oral drug products from early clinical stage through commercial readiness. The First-Time-Right strategy is designed to develop robust formulations and scalable processes early, so later development can focus on optimization and scale-up with fewer major formulation changes. Capabilities include analytical research and quality control, clinical and commercial GMP manufacturing, and clinical supply support. 6. Biologics characterization and CMC analytical services • Product quality analysis, including identity, purity, potency, and safety testing using orthogonal biochemical and biophysical methods. • High-resolution mass spectrometry for intact mass analysis, peptide mapping, PTM and glycan profiling, sequence coverage, and charge variant assessment. • Impurity characterization, including host cell proteins, residual DNA, residual Protein A, detergents, endotoxin, and bioburden analysis. • Bioactivity and potency assays, including cell-based potency, reporter, and binding assays. • Developability assessment and preformulation studies, including stress studies, forced degradation, excipient compatibility, and stability risk evaluation. • Advanced analytical support for complex modalities such as ADCs, peptides, ASO, siRNA, mRNA, LNP, and AAV. 7. Bioanalysis and Biomarker (BABM) services • Immunoassays using ELISA, MSD, Gyrolab, Luminex, SPX, and related platforms for proteins, antibodies, oligonucleotides, and biomarker quantification. • LC-MS and LC-MS/MS support for ADCs, oligonucleotides, peptides, small molecules, and endogenous biomarkers. • Cell-based assays for potency, mechanism of action, neutralizing antibody assessment, and functional pharmacology endpoints. • Flow cytometry for immunophenotyping, receptor occupancy, and biomarker strategy support. • ELISpot assays for cell-mediated immune response evaluation. • Molecular biology capabilities including qPCR, ddPCR, RNA-Seq, NanoString, and NGS workflows. • Additional support for immunogenicity strategy, ADA/NAb assessment, PK/PD analysis, exploratory and clinical biomarkers, central lab logistics, and eCTD-ready data packages. 8. Quantitative Clinical Pharmacology (QCP) services • Noncompartmental PK/TK analysis and reporting. • Statistical programming with SAS and CDISC-compliant deliverables, including SEND, SDTM, ADaM, tables, listings, figures, define.xml, and reviewer guides. • Translational modeling and simulation to support first-in-human dose projection, clinical PK/PD understanding, and study design decisions. • Pharmacometrics, including population PK/PD modeling and exposure-response analysis for dose selection and trial optimization. • Quantitative systems pharmacology and model-informed drug development support for indication selection, biomarker strategy, and regulatory decision-making. 9. Nucleic acid therapeutics services • DNA synthesis • RNA synthesis • LNP formulation services • Analytical and characterization services • Early-phase manufacturing