AcceleDev Chemical L.L.C

Overview:

In connection with our custom active ingredient synthesis work, we can continue the analytical Characterization work & formulation development. We can also perform these activities in an independent set of R&D work, if we are not required to synthesize the active ingredient. R&D work is performed mainly in our partner facilities, under our close management. Our partner team led by a highly accomplished team leader & experienced group including 16 Ph.D scientists & 16 MS level scientists. Additional details can be provided on request.

General capabilities include:

Pre-formulation activities	Focus Points	Equipment Overview(partial)
1)Confirm API quality & characterize its physical and chemical properties	Chemical structure Optical orientation -Purity Impurity profile Degradants Residual solvents Solubility MP/ BP pKa LogP	HPLC-UV HPLC-ELSD GC NMR LC-MS & GC-MS UV Automatic Polarimeter Capillary electrophoresis apparatus Spectrofluorophotometer
	Determine crystal properties Particle size Shape	Hot-stage microscopy with Differential Scanning Calorimetry (Leica DMLM/ Plink SC600) ZetaMaster3000, Marlven Sizer2000, Marlven Autosurface tension DCAT21, Detaphysics Rheometer DVⅢ-Utra, Brookfield
	Powder properties (flow/compaction/ density/particle size/surface area, porosity)	Tap density tester, FT300, Sotax Surface area and porosimetry analyzer SA 3100, Beckman
2)Stability	Accelerated testing(1,3,6 month)	Climatic chambers for constant conditions,Climacell,MMM
3)Salt screening	Microscopy (morphology, particle characteristics)	Bio-Microscopes Olympus C31 Fluorescence inverted microscope Olympus I51 Ultra-low temperature freezers, Forma-86C, MMM High speed refrigerated centrifuge, CR21G,Hitachi
4)Early formulation feasibility	Compatibility The impact for formulation to the later formulation production.	Airslide disintegrating mill, Mcone, JetPharma Spray dryer, B-290, Buch Freeze dryer,Labcomco Liposome ejector,Avestin C-5; High press homogenizer, NS1001L-2k,ATS Experiment used fluidized bed Mini press IISF, Glatt Intelligent lab tablet press, Mini press IISF, Karnavati Automatic high efficiency film coating machine, Labcoat LCM, O'Hara Fluidized bed GPC-1.1, Glatt Mini-4 Reciprocating cylinder dissolution apparatus, SOTAX CE

General R&D Program, after receipt of an API candidate project:

General overview by the Project leader. This includes the data package provided by customer, & also searching literature to locate any other helpful related property data.
Receive sample & begin R&D work to fully characterize the API(all items within #1 above). Tests can be tailored towards customers needs.
Stability: subject the API candidate to heat, light & moisture, under accelerated conditions(#2 above). Normally for common formulations, they test purity, impurity profile, water, particle size, and solubility. Can perform common temp test, & destructive tests.
Salt screening: Synthesize salt forms & determine the one(s) most suitable for formulation. This work is of course carried out in parralel with #3.
Early formulation feasibility: Determine compatibility[interaction between API and its auxiliary], & the impact on a formation candidate after formulation production.
Progress reporting: R&D Progress reports are provided to customer as often as needed.
Development goal: Develop a full process, which can be easily repeated & scaled up for increased development requirements or commercial manufacture.
Final Project completion report: On conclusion of the full project, a full report is provided summarizing all the gathered information.
Production Assistance: as part of the package, we assist the customer's team to understand the results & ensure that they are able to fully use the information towards successful scale-up & production. Alternatively, we can recommend partner sites to scale up the newly developed technology.