With over 10,000 Sq.m of fill finish footprint, we can support filling of a wide range of presentations – vials (liquid and lyophilized), pre-filled syringes and autoinjectors.
Our automated fill finish facility efficiently handles high-accuracy, high-viscosity, low-volume protein filing. End-to-end single-use capability enables for faster change over and assurance of cleaning validation.
Our integrated approach to quality management systems enables greater flexibility and leverage pan - organization experience in managing regulatory audits.
Fill Range and Presentation
Fill range is 0.1-100 ml, Vials: 2-100 ml, PFS and auto injector: 0.1-1 ml
Manufacturing Process Flexibility and Formulation
- Manufacturing process flexibility: peristaltic, rotary piston, end-of-end single-use system, sterile filling
- Formulation: liquid, lyophilized
Why Aurigene Pharmaceutical Services?
100+ successful regulatory audits
10+K Sq.m facility footprints
300+ tech operations professionals
Operations supported by digital infrastructure
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Hyderabad R and D Center
Bangalore R and D Center
Resources
“Bathtub Chemistry” - Necessity and Aspects of Process Research
Medicine is an essential part of our life. Since ancient time human civilization has been tirelessly engaged to understand the cause and effect of a disease. Sometimes they win and many times they lose. But the story of their curiosity and enthusiasm is a never damping process. On the contrary it increases day by day, year after year.Drug discovery is a vast and ...
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HPAPI Molecule from Development to Market
The global Highly Potent Active Pharmaceutical Ingredients (HPAPI) market is expected to reach USD 26.84 Billion by 2023 from USD 17.72 Billion in 2018, at a CAGR 8.7%....
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Biologics Manufacturing Services
Our manufacturing services cater to both GMP and non-GMP manufacturing for pre-clinical development as well as GMP operation to support clinical or commercial needs for any recombinant proteins expressed in suspension mammalian culture or E. coli. ...
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Development of quick quantification method for muscle injury recovery evaluation in thermal injury mice model
Challenges: The evaluation of Evans Blue Dye (EBD) by fluorescence measurements of cryosections of individual muscle sections, and its quantification by auto fluorescence is a laborious and time-consuming process. Study design: Both sham and thermal injury techniques were followed. The evaluation of EBD was done to assess the effectiveness of two compounds in the...
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An efficient and convenient protocol for the synthesis of tetracyclic isoindolo[1,2-a]quinazoline derivatives
2016
A convenient and one-pot synthesis of tetracyclic isoindolo [1,2-a]quinazoline derivatives via Lewis acid mediated sequential C–N bond formation reactions is reported. This protocol provides a simple and rapid strategy for the synthesis of 12-benzylidene-10,12-dihydroisoindolo[1,2-b]quinazoline derivatives. However, a variety of tetracyclo indole fused quinazol...
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A simple RP-HPLC method development and verification of the Dissolution of Bromelain-A Complex mixture of proteolytic enzymes, in delayed release tablets
2005
Bromelain is a complex natural mixture of proteolytic enzymes derived from pineapple (Ananas cosmosus), which has good therapeutic properties. Bromelain can be found in all tissues of pineapple plants, including the stem, fruit, and leaves. Bromelain plays an important role in the treatment of many diseases such as soft tissue inflammation and edema, deep derma, ...
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A sensitive and a simple RP-HPLC method development and verification for the quantitative estimation of Cholecalciferol in tablets
2005
Cholecalciferol, also known as Vitamin D3, is widely prescribed for the treatment osteomalacia and osteoporosis [1]. It also plays a key role in calcium and phosphorus homeostasis and skeletal mineralization [2]. IUPAC name of Cholecalciferol is (3β, 5Z, 7E) 9,10-secocholesta-5,7,10(19)-trien-3-ol, whose molecular weight is 384.64 g/mol and its molecular formula...
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A simple RP-HPLC method development and verification for the quantitative estimation of Sodium Butyrate in tablets
2005
Sodium butyrate is the sodium salt of butyric acid (Fig. 1), which exhibits various properties such as immune system modulator, antioxidant, and anti-inflammatory properties [1]. Furthermore, sodium butyrate is used as a promoter of growth in milk replacer formula for young calves [2]....
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