Custom Made Drug Delivery Compounds



Custom Made Drug Delivery Compounds
EMD Millipore provides also custom made Drug Delivery Compounds in GMP quality to the pharmaceutical industry for use in clinical trial and commercial product applications.

Product Range
  • PEGylation Reagents
  • Specialty Lipids
  • Activated PEG Lipids
  • Linkers & Activators 
Services
  • Route Finding
  • Improvement of an existing process
  • Synthesis of By-Products
  • Development of Analytical Methods
  • Scale-Up
  • Sourcing of suitable Raw Materials
  • Process Validation
  • Validation of Analytical Methods
  • Small Scale Production
  • Process Transfer to Full Scale Production
  • Preparation of  CTD for DMF or CMC section

Analytical Services

Our services include the development and validation of analytical methods. We identify by-products and determine polymorphic product forms. ’s broad portfolio of analytical methods includes HPLC(-MS), CE, GC(-MS), FT-IR, NMR, XRD, DSC, ICP, particle size determination, and many more.

Additionally, we routinely perform microbiological tests, quantify bioburden and endotoxin contents and perform stability studies according to ICH guidelines.

Services
  • Chemical Analytical Testing
  • Development and Validation of Analytical Methods
  • Identification of By-Products
  • Determination of Polymorphic Form
  • Stability Studies according to ICH
  • Determination of Bioburden and Endotoxin Content
  • Development and Validation of Microbiological Methods

Analytical Methods
  • HPLC  (/MS)
  • CE
  • GC  (/MS)
  • UV/VIS
  • FT-IR
  • NMR
  • TG
  • DSC
  • TOC
  • XRD
  • ICP
  • Karl Fischer
  • Particle Size Determination
  • Potentiometry
  • Disintegration Test on Drug Products

Microbiological Methods
  • Bioburden
  • LAL Endotoxin Test