GMP Manufacturing

Process development

GMP certification

Regulatory supporting

data

Analytical development

Your innovation

 

 

 

 

 

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Process Development

 

Principles that guide us in our Process Development programs:

 

Select a solid form (salt or neutral) of the target substance that offers the desired solubility, stability and solid state properties early on. Such a selection process involves a salt and a solid state screen of selected salt/neutral.

Prioritize the development of the final process stages early on. Later process stages are more likely to impact heavily on the products impurity profile and other critical quality attributes (CQA), such as solid state properties.

Identify impurities found in the target substance and trace these back to their points of origin. This information provides guidance in the process development work, which is aimed at controlling and reducing these critical impurities (early part of QbD). In later stages of the development program these critical process parameters are formally identified and acceptable process ranges are set. This is the basis for Quality by Design (QbD).

Often speed of delivery is a priority in the beginning of the development program. Producing the early clinical supply using a first manufacturing process and later on a switching to a more effective manufacturing process is often a preferred strategy. When such a switch is planned for it is important to avoid changes in the target substance qualified impurity profile and solid state properties. Changes in the earlier parts of the process are often possible without affecting the CQA’s of the product (se bullet 2).

 

 

 

 

 

 

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Analytical development

 

Principles that guide us in our Analytical Development programs:

 

Assign assay (strength) of a well characterized reference standard.  Use 1H NMR assay determination for comparison of assigned (calculated) assay.

 

Early on, develop and validate a suitable analytical method for quantifying related substances and determination of assay.

Work closely with the process chemist and identify impurities in target product and track these to their origin.

Identify critical impurities in key raw materials that may carry to target product such as homologues and isomers and set relevant specifications limits.

A forced degradation study provides pathways for degradation of the target product. This information is used in the development of analytical methods as well as gives important clues to likely process impurities in the target product.  Also the information is useful in the development of suitable packaging methods for the target product.

 

 

 

HPLCs

 

  • Systems – Dionex Ultimate 3000         Detectors – DAD, CAD, LSD, MS          Software – Chromeleon 7.2

 

GCs

 

  • Systems – Agilent                             Headspace sampler                          Detector – FID, MS                             Software – Chromeleon 7.2

 

LC-MSs

 

  • System – Agilent                                Detector –Time of flight MS 6210              Interface – ESI

 

FT-IR ATR

 

  • System – Bruker ALPHA (ATR)               Software - Opus

 

Coulometric Karl-Fischer Titrator

 

  • System – Mettler Toledo             Autosampler- Stromboli oven sampler changer

NMR

 

  • System - Varian Mercury Plus                Magnet – Oxford Instrument AS 400 (400 MHz)
    Autosampler – 50 position
    Software – Varian VNMR-J

 

Semi-Preparative LCs

 

  • System – Shimadzu LC-8A gradient pump               Detector – SPD-10A UV-Vis
    Fraction collector – Shimadzu FRC-10A
    Software – CLASS-VP



  • System – Merck-Knauer K-1800
    Detector – Merck-Knauer L-2501
    Software – EZChrom Elite

 

Climatic chambers

 

  • System – Binder

 

 

Analytical Equipment

Phone: +46 8 554 422 50

email: info@syntagon.se

 

 

Sweden

 

Postal address

Syntagon AB

Box 2073

SE-151 02 Södertälje

Sweden

 

Visiting & Delivery address

Tallvägen 6

SE-151 38 Södertälje

Sweden

Latvia

 

Phone: +371 67 490 881

email: info@syntagon.se

 

 

Postal and Visiting address

Syntagon Baltic SIA

Vecpagrabs Pinki Babites pagasts

LV-2107 Babites novads

Latvia