APIS & CONTRACT MANU­FAC­TU­RING

Hydro­xy­ethyl starch (HES) with variable molecular para­me­ters

Hydroxyethylstärke

In the mid-90s Serumwerk Bernburg AG developed an entirely new pro­duc­tion method for manu­fac­tu­ring HES. For the first time, local potato starch was used instead of waxy maize starch which had been standard until then.

At the same time, company sci­en­tists worked con­stant­ly on improving this active ingre­di­ent. One product of this deve­lo­p­ment work is HES 130/0.42 in phy­sio­lo­gi­cal Ringer’s acetate as the carrier solution.

Another inno­va­ti­ve area of work is the use of the poly­glu­can matrix
as a polymeric carrier for other phar­maceu­ti­cals. Thus our company has special expe­ri­ence in the modi­fi­ca­ti­on of peptides and in the sub­se­quent puri­fi­ca­ti­on and testing processes.

Gleptof­er­ron (iron dextran-heptonic acid complex) and dextrans

Gleptoferron Logo

This special iron complex is the result of con­ti­nuous research and deve­lo­p­ment work over a period of more than 40 years. Starting from a 2% iron dextran, through constant impro­ve­ment in the quality and stability of the complex, Serumwerk Bernburg AG today has iron pre­pa­ra­ti­ons in optimized con­cen­tra­ti­ons both as active phar­maceu­ti­cal ingre­di­ent (API) and finished medicinal product for injection and for oral Admi­nis­tra­ti­on, which are used to prevent anaemia in suckling piglets. These top products are highly effective and extremely well tolerated.

Polymeric active ingre­di­ents

For decades Serumwerk Bernburg AG has had specific expe­ri­ence in the pro­duc­tion of poly­glu­can-based high-molecular sub­s­tances. On request, we will put this special research and deve­lo­p­ment expertise at the disposal of partners and customers for new original active ingre­di­ents and exci­pi­ents of this product class.

As well as hydro­xy­ethyl starches with differing sub­sti­tu­ti­on, molecular weight dis­tri­bu­ti­on and specific dextran variants (DEAE-dextran), other polymers such as poly­sucro­se are part of the reper­toire of our deve­lo­p­ment and pro­duc­tion profile.

Polymere Wirkstoffe
  • DEAE-Dextran
  • Gleptof­er­ron (iron dextran-heptonic acid complex)
  • Hydro­xy­ethyl starch (HES 130/0.42)
  • Hydro­xy­ethyl starch (HES 200/0.5)
  • Hydro­xy­ethyl starch (HES 450/0.7)
  • Poly­sucro­se

Poly­ge­li­ne

We have many years of expe­ri­ence in the pro­duc­tion of sterile solutions con­tai­ning polymers, which can be used for a wide variety of purposes (e.g. volume repla­ce­ment therapy, adjuvant in the pro­duc­tion of vaccines). In recent years, customer-specific for­mu­la­ti­ons based on gelatin have been developed. By con­trol­ling the degree of hydro­ly­sis, adapting the cross­lin­king and sub­sti­tu­ting other sub­s­tances to these molecules, it was possible to achieve the appro­pria­te molecular weight dis­tri­bu­ti­on.

We can offer the following range for contract manu­fac­tu­re:

Medicinal products for vete­ri­na­ry use:

 

  • Solid phar­maceu­ti­cal forms: powder, granules, intrau­te­ri­ne pessaries
  • Liquids: 20 ml – 5000 ml (special formats)
  • Solutions for injection (10 – 100 ml), aseptic or ter­mi­nal­ly ste­ri­li­zed
  • Solutions for infusion (poly­pro­py­le­ne bottle or bag)
  • Semi-solid for­mu­la­ti­ons (aluminium tubes, plastic jars)

Medicinal products for human use:

 

  • Liquids: 20 ml – 500 ml glass
  • Solutions for injection (10 – 100 ml), aseptic or ter­mi­nal­ly ste­ri­li­zed
  • Solutions for infusion (poly­pro­py­le­ne bottle or bag)
  • Semi-solid for­mu­la­ti­ons (aluminium tubes, plastic jars)