Contract Manufacture

Kraeber is a competent partner in Contract Manufacturing.

Our main activities

Our emphasis is the development, production, marketing and sales of active pharmaceutical ingredients (API), Intermediates, and biological extracts from animal and plant origin and especially animal blood fractions of the highest purity. We serve the pharmaceutical, biotechnological, cosmetical, veterinary and both the human and animal food supplement and nutraceuticals industries.

Our Competences

We have the following permissions:

  • pharmaceutical production
  • food and feed production
  • handling of animal by-products

and the following certifications:

  • GMP, GDP, ISO, REX, and AEO.

You can read and download from our page: Download

We are specialists to extract, separate, fractionate and purificate biological substances of animal and plant origins. We have 35 years specialised experience in the fractionation of animal blood from various species.

We accept contract manufacturing also on exclusive basis.

We have:We carry out:Our Equipment:

GMP compliant

  • Clean room: class B/US 100 with a class A/US 10 area
  • Clean rooms : class B, class C, class D, air-conditioned
  • Laboratory for analytical tests
  • Storage room for deep-freezing -20 to -28 °C
  • Rooms for controlled thawing
  • Working room +2/+5 °C
  • Extraction
  • Separation
  • Fractionation
  • Purificaton
  • Prefiltration
  • Sterile filtration
  • Ultrafiltration
  • Vacuum-drying
  • Heat inactivation in large batches
  • pH-treatment
  • Gamma-radiation
  • Several filtration units for:
    • Prefiltration
    • Sterile filtration
    • Ultrafiltration
    • Suction filter
  • Autoclaves
  • Heat tank with stirrer
  • Beaker centrifuges, cooled
  • Flow centrifuges (Cepa + Carr)
  • Disc bowl centrifuges
  • Vacuum dryer
  • Clean water system
  • Steam processor
  • Various dosing pumps

Contract Filtration Services

We offer a comprehensive contract service for the filtration of serum and other liquids, such as Fetal Calf Serum, under the following conditions:

  • Strict control of incoming materials.
  • Storage of frozen materials at -20 °C. Controlled thawing according to your instructions.
  • Pooling of your material and preparation of samples to your requirements, Ph.EUR, or USP. Safe disposal of packing materials by us.
  • Sterile filtration takes place to your requirements using single, double or triple filter sets.
  • Pooling of sterile liquids upon request.
  • Preparation of your bottles and bottling of the product in a Class B clean room with a Class A area. Separation of samples. Bottles used for packaging can be provided upon request and at cost.
  • Labelling and sealing of your bottles.
  • Freezing and storage at -20 °C until charge is released.
  • Packing of bottles into cartons labeled according to your instructions.
  • Dispatch of samples to an independent laboratory for testing the sterility according to USP or Ph.EUR. Additional tests can be organised upon request. A sterilisation certificate is provided with each charge. Should any testing show non-sterility of production, then the re-working and testing will be done at our cost. We recommend to take into consideration the loss of material during a filtration process; when calculating the quantitiy of the incoming material.
  • Delivery as agreed with customers. Our liability is restricted to sterility as per USP 29 or Ph.EUR.

Heat Inactivation · pH-Reduction · Gamma-radiation

Heat Inactivation

Heat inactivation is the method of choice for many investigators to ensure that cells will not be lysed by antibody binding. It is most commonly used to destroy the complement binding capacity.

Heat inactivation of small serum quantities is normally performed in a water bath. This serum often contains flocculent materials, primarily lipoproteins, which have to be removed for some purposes.

It is more efficient to inactivate sera after sterile filtration.

Due to the high sensitivity of serum components the procedure is difficult to perform. A minimum temperature of 56 °C +-1 °C should be attained for 30 minutes.

We have installed a facility which allows us to inactivate sera in batches up to 2.000 l under controlled and reproducible conditions. The process needs max. 60 minutes for heating up to 56 °C and max. 90 minutes for cooling down to 7 °C.

We are also offering to our customers the heat inactivation service according to EU-regulations.

pH-Reduction

Inactivation of viruses by pH-reduction is possible in batch sizes up to 1.000 l.

Gamma-radiation

We have established logistics for the gamma-radiation of our products. Please ask for special information

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Design & Service by InWise® GmbH, D-25474 Ellerbek
Last modified on September, 12. 2018.