CMC Studies

A culture and R&D management system for APl business

· The route and process are well designed and developed for scaling up feasibility, cost effective and regulation friendly with elegant chemistry.

· Impurity profile studies and design space(PAR)

· Corresponding R&D management systems such as checklists, templates, trainings, etc.

Services

· Dedicated CSS team.

· mg to gram quantities.

· Multiple Prep-HPLC platforms.

· In-house LCMS and 400 MHz NMR for characterization.

· e-LNB and encryption Software.

Cooperative mode

FTE

· 40+ well coached chemists,

· Regular project reports (document and TC).

· Suitable for flexible Supporting of new drug R&D projects

FFS

· Fee For Service.

· Deliver the experimental results or compounds.

· Suitable for the synthesis of specific compounds, a series of moleculars or small libraries.

Chemical Development

We develop robust processes for manufacture of advanced intermediates and APls used in pre-clinical, clinical and commercial phase production.

· Route Scouting: for delivery of excellent route with safety, quality and cost.

· Process development: for robust process with good manufacturability, cost and quality

· Process Safety: ARC/ARSST,DAC/RC-1 with corresponding managements.

· Flow chemistry: Applying equipment from different technology solutions in production.

· Asymmetric synthesis: Apply chiral auxiliary, chiral source, asymmetric catalysis technologies according to structure of target molecular.

· Analytical Methods Development.

Services

· CMC Study for AP| (CQA, lmpurity Profile, PAR, Control Strategy, etc.)

· Support Filing (IND/NDA)

· Clinical Trial samples Production

· API CMO

Manufacturing Capabilities

· Plant managed with cGMP requirements operations in 2021.

· Located in National fine chemicals park in Daya Bay, Guangdong. Near Hong Kong and 14 miles from ourPingshan R&D Site.

· cGMP Kilo scale train (1 to 100 L).

· 8 separated trains, 200 L to 5000 L volume for diferent batch size of demands. 10000 L trains available in 2023.

· High pressure (18 bar), cryogenic and high-temp vessels.

· Class D Clean rooms.

· Industry Scale Chromatography: DAC-300 HPLC, and 2000 L Medium pressure columns.

· NMPA and EU-QP audit in 2023.

Environment,  health and Safety

· On-site waste treatment facilities. 43 Tons/day capacity for liquid waste, 200 Tons/day capacity for wastewater, and 8000 Nm3/hr of gas incineration capacity.

· Process safety lab with DSC, RC-1, ARC and corresponding managing systems.

· Chemical safety such OEB. .corrosive level. etc.

· Down flow booths with HEPA filters for materials dispensing. Fully contained solids transfer systems forcharging and enclosed sampling loops and offloading and packing areas.

Services

· Solid & liquid phase synthesis of SiRNA/ASO/PMO

· Preparation of GalNAc & phosphoramidites

· ON Process development and optimization

· Exploration and validation of analytical methods

· Quality studies

Services

We offer customized synthesis services for lipid molecules, supporting production scales rangingfrom miligrams to kilograms to meet diverse customer needs for novel LlPlD synthesis and high-purity delivery requirements.

Superiority

(1)We possess a reserve of over 200 intermediate fragments with varying carbon chairlengths

(2) Our synthetic techniques have a unigue advantage in the production of ionizable lipid molecules, with varyinghydrocarbon chain lengths, degrees of symmetry, and branching.

(3) We have extensive experience in screening and selecting conditions for the synthesis of asymmetricallysynthesized fatty amines, fatty alcohols, and acid compounds, resulting in a diverse range of lipid products

Drug discovery 

custom synthesis

Synthesis Laboratory: csS drug synthesis quality management system

- FTE/FFS for Drug discovery molecules synthesize

- ELN, electronic laboratory notebook

Comprehensive laboratory management system

- Rapid structural characterization by LCMS/NMR

- Preparative Purification Prep-HPLC with UV/ELSD

- Information platform

Research on innovative synthetic routes

Starting materials and intermediates

Process research Laboratory: CDS process research quality management system

- Starting material synthetic route and process research

- Intermediate synthetic route and process research

Chemical analysis department management system

-Purity/Assay
-Residual solvent
-HPLC/GC/LCMS/KF/ titration, etc.

- Standard qualification/structure characterization

CMC pharmaceutical research

IND/NDA registration

AP| Process Research Laboratory: CMC Pharmaceutical research management system

- Quality study of API

-IND/Phasel/1/I/NDA

Independent pharmaceutical analytic department

- Follow with FDA/EMANMPA and other global regulatory requirements

- Strictly comply with lCH Q1 to Q12

- Analytical method development
- Analytical method validation

GMP commercial production

The world top class design concept

- Fully enclosed operation (isolation feeding equipment)

- Gravity flow design
- Automation: Emerson DCS and SlS systems

GMP QCIQA

- Plant and equipment validation

- Cleaning verification
- Continuous monitoring on plant environment

- Web software with Audit TrailSystem QA/validation QA, QC QA