juk production site.pdf
TRANSCRIPT
production site
• sheep plasma• animal plasma• animal sera• gmp unit• contract manufacturing• equine hemin• equine tendons• product list
production site
Kraeber & Co. GmbH is registered according to regulation (EC 1069/2009) for Animal By Products.
We are ISO 9001:2008 and GMP certified.Our facility is in the North of Germany.
KRAEBER & CO GMBHpharmaceutical and cosmetic substances
Waldhofstraße 14D-25474 Ellerbek, Germany
Phone: +49-4101-3053-0Fax: +49-4101-3053-90Free call: 0800-KRAEBERE-mail: [email protected]: www.kraeber.de
KRAEBER (UK) Ltd.
16 The StreetSaxon StreetNr. Newmarket CB8 9RUUnited Kingdom
Phone: +44-1638-731 297Fax: +44-1638-731 291E-mail: [email protected]
© 2014-05 KRAEBER & Co. GmbH
Kraeber offers cosmetic and pharmaceutical substances since 1980.
The company was founded by Jens Uwe Kraeber, JUK, who is still not retired and assists with his wealth of experience. Since 2009 Kraeber & Co.GmbH is led by his niece, Franziska Faber, a long standing and experienced member of Kraebers team.
Based on a GMP related quality system, Kraebers raw materials for the cosmetic industry are produced in their own production facilities in Hamburg/Germany or from ex-clusive, mainly German partners. We are also realizing custom manufacturing additionally to our own production and are focussing on niche products.
As a family owned company, Kraeber looks back on more than 30 years of experience in the special field of cosmetic and pharma- ceutical raw materials.
juk-kraebermore than 30 years
In the early 80´s, Kraeber was the pioneer in producing standardized Sheep Plasma. Today we are the main supplier of Sheep Plasma for the determination of Heparin activity.
Sheep Plasma for the determination of Heparin activities
Taking into account the various pharmacopoeia standards, Kraeber today provides the tem-perature sensitive products in the following qualities:
sheep plasma
Quality Bottle SizesSheep Plasma, USP frozen 100 ml
frozen 50 mlSheep Plasma, lyophilized 50 mlPlasma Substrate R1, Ph. Eur. frozen 10 ml
frozen 30 mlPlasma Substrate R1, lyophilized 30 ml
As a special service we are able to supply plasma with defined clotting times.
Our plasmas of various animal origin are espe-cially suitable as components of bioassays, immunoassays or enzyme assays. The plasma provides a broad spectrum of macromolecules, attachment and spreading factors, carrier pro-teins for lipoid substances and trace elements, low molecular weight nutrients and hormones.
Made in Germany
Consequently they are used for the isolation of blood clotting factors and single proteins such as fibronectin and thrombin. We are able to manufacture customized materials with, for example, various stabilizers.
animal plasma
Plasma Available Qualities OriginBovine Plasma Regarding customers specification e.g.:
• various stabilizers• various anticoagulants and other
additives• non-sterile• sterile filtered• defibrinated• gamma irradiated
GermanyEurope*Chicken Plasma*
Equine Plasma*Porcine PlasmaRabbit PlasmaSheep PlasmaOther categories on request
Standard bottle sizes are: 1.000 ml and 500 ml or upon customers request.
Shipping in dry ice or temperature-controlled deep frozen.
Our sera are of various animal origin, especially suitable for pharmaceutical and diagnostic uses:
• immune histochemistry• immunoblotting• immunofluorescence
Other important areas of applications are:
• cell culture• stem cell culture• proliferate growth of mycoplasma• virus culture
Kraebers scientists are involved in all stages from collection to filling, entirely documented.
animal sera
Sera Available Qualities QualityBovine Serum
• non-sterile• pre-filtered• sterile filtered 0.2 or 0.1 µm• heat inactivated• gamma irradiated
(as per customer specifications)
• Serum from male or female animals (bovine, equine)
• low hemoglobin• lipid removed• delipidated
Chicken SerumGoat SerumEquine SerumPorcine SerumRabbit SerumSheep Serum
Standard bottle sizes are: 1.000 ml and 500 ml or upon customers request.
Shipping in dry ice or temperature-controlled deep frozen.
• Heparin Sodium, Ph. Eur.
Kraeber has traditionally delivered Heparin to the laboratory industry. Since we obtained GMP status we have also been able to supply customers who need pharmaceutical grades.
Customized filling sizes, stockholding andjust-in-time deliveries are part of our service.
Taking into account the different project requi-rements of our customers, we decided to applyfor the GMP certification for the following products:
• Glucosamine NaCl• Glucosamine HCl• Glucosamine KCl
As well as the manufacturing license Kraeber has permission to import according to AMG § 13 and § 72/72a.
Kraeber has its own German GMP unit for storage, filling and labeling of:
gmp unit
The scientists of Kraeber, as the cornerstone of the production team, have their core compe-tence in filtration- and separation technology expanded and optimized in more than 25 years.
Experimental series, cleanrooms with various ISO classifications and state of the art equipment combined with competent employees characterize the quality of our work.
We have established specialized production processes for and with our partners, which are a fundamental and important part of our activites.
• ultrafiltration• deep bed filtration• centrifugal separation
Our optimized high quality products have steadily convinced our customer base to integrate us into their new projects and new cooperations for customized products for the parmaceutical and cosmetic industry.
Recently the following projects have been introduced to the market:
• Rye serum, in cooperation with our part-ner Woresan, which is used in cosmetic applications and in the nail fungus product `Mycosan` and
• The development of separation processes and protection methods for the isolation of hemoglobin from erythrocytes
Kraeber makes your idea marketable
We are mainly specialized in
contract manufacturing
Hemin is a ferrous porphyrin applicable in
• nutraceuticals or • pharmaceutical products
for porphyria or anaemia.
Our production team has developed a defined production process for improving the quality and stability of Hemin.
Obtaining the Hemin from equine starting material enables a standard of quality which is not achievable while using other animal sources. The approved production process provides a material of the highest purity.
Decades of experience in the production of animal blood fractions have made it possible to achieve such a primary purity level for Hemin.
Kraeber has developed a primary Hemin
equine hemin
Our equine tendons are suitable for collagen based products, such as medical devices for wound healing, sutures and surgery pads.
The products for wound healing purposes areprimarily used for blood hemostasis and co-agulation, where they have been successfully applied in hip surgery. Wound healing products with specific attributes can be obtained by using tendons with different collagen structu-res which occur due to the age of the collected tendons.
Kraebers personnel accompany the whole process from the collection to the treatment of the tendons. We source only materials coming from animals which, in accordance to the guide- line 1069/2009, have passed the veterinary inspection and are fully traceable.
This product needs a specific safety mange-ment to assure the quality of the tendons andto provide them free from bacterial contamina-tion. To guarantee this quality the tendons are stored and delivered deep frozen at -20° C.
Professionally collected and prepared from different age groups
equine tendons
• Bovine Plasma • Bovine Serum • Bovine Serum Albumin Fraction V• Chicken Plasma• Chicken Serum• Donor Equine Serum• Equine Plasma• Equine Tendons• Globulin Fractions• Goat Serum • Hemin• Hemoglobin • Piglet Serum • Plasmasubstrate lyophilized
• Plasmasubstrate R1 Ph. Eur.• Plasmasubstrate R Ph. Eur.• Porcine Plasma• Porcine Serum • Rabbit Plasma• Rabbit Serum• Sheep Plasma lyophilized• Sheep Plasma frozen lyophilized• Sheep Serum• Thrombin• Thymus extract• Thyroid• Trypsin
Kraebers devision „Animal Blood Fractions“ supplies the following high quality substances:
summary
Please visit www.kraeber.de to also view the products of our devisions „biochemical substances“ and „synthetic substances“.
Deanol BitartrateDeanol PidolateDeanol-p-AcetamidobenzoateDiphenylpyralin 8-ChlortheophyllinateDiphenylpyralineDonor-Equine-Serum
EEquine PlasmaEquine SerumEquine TendonsErythruloseEthyl FerulateEvening Primrose Oil
FFSH - UrofollitrophinFetal Calf SerumFluoresceinFluorescein SodiumFucoidan
GGlucosamine / Chondroitin Sulfate BlendsGlucosamine HClGlucosamine Sulfate Sodium ChlorideGlucosamine Sulfate Potassium ChlorideGlutardialdehyde-bis-Sodium BisulfiteGoat Serum
HHCG - Human Chorionic GonadotrophinHMG - Human Menopausal GonadotrophinHeminHemoglobinHeparin AmmoniumHeparin LithiumHeparin SodiumHeparinoidHyaluronic AcidHyaluronidaseHydroquinoneHydroxypropyl Chitosan
MMethyl Sufonyl Methane
NN-Acetyl-D-GlucosamineNewborn Calf SerumNicotinyl Alcohol Tartrate
OOx Gall Stones
P Perillic Acid Piglet Serum
PiprinhydrinatePlasmasubstrate R, Ph. Eur.Plasmasubstrate R 1, Ph. Eur.Porcine PlasmaPorcine SerumProtamine Sulfate
RRabbit PlasmaRabbit SerumResorcinol MonoacetateResorcinol
SSheep Placenta, ExtractSheep Plasma USPSheep SerumSodium HyaluronateStreptokinaseStreptokinase-Streptodornase
TThrombin Thymus ExtractThyroidTrypsin
UUrokinase
AArbutin, syntheticAprotinin
BBeta Glucan Bovine PlasmaBovine Serum Albumine Fraction V, lyophilizedBovine Serum
CCarboxymethyl ChitosanChicken PlasmaChicken SerumChitinChitosan AcetateChitosan HClChitosan LactateChitosan OligomerChitosan ChlorphenesinChondroitin SulfateCollagenCyclizine HCl
D D-Galactosamin HClD-Galactose from lactose (milk)D-Galactose from and non-lactose (beech)
kraeber products in alphabetic orderOur products are available in various qualities and from various species/origins