Avantor to begin cGMP production of J.T.Baker high purity low endotoxin sugars in Panoli, India
Avantor is unique in offering cGMP manufacturing capabilities in the US, Europe and India
Avantor, the global leader in ultra-high-purity materials for the life sciences and advanced technology markets, has begun production at a new cGMP manufacturing area at its Panoli, India, facility.
The ISO 9001:2008 certified and Indian FDA-approved manufacturing facility makes Avantor unique in offering cGMP capabilities in the US, Europe and India. The India-based cGMP manufacturing area produces Avantor’s J.T.Baker brand high purity low endotoxin (HPLE) sugars using the same Avantor cGMP quality systems that are in place at the company’s US and European facilities.
Avantor’s proven global quality systems include a robust management of change programme, fully traceable supply chain, globally accepted documentation support and ISO 9001-compliant quality management systems.
'Avantor’s global cGMP manufacturing footprint offers strategic advantages for our life sciences customers,' said Devashish Ohri, Executive Vice President, APAC, for Avantor. 'Biopharmaceutical manufacturers can confidently expand into new markets with the security of knowing that J.T.Baker brand materials, which meet the highest regulatory specifications, as well as Avantor’s applications specialists, are readily available.'
In addition to J.T.Baker HPLE sugars, the Panoli, India, facility produces Macron Fine Chemicals brand products under cGMP conditions that comply with India Pharmacopoeia (IP), US Pharmacopeia (USP), National Formulary (NF), European Pharmacopoeia (EP), Japanese Pharmacopeia (JP) and British Pharmacopoeia (BP). Various pack sizes are available to support formulation development from discovery to full-scale production.
'The cGMP facility in Panoli, India, is equivalent in every way to Avantor’s cGMP facilities in the US and Europe, and shares the same quality systems and capabilities that our customers have come to expect,' said Ohri. 'The facility provides Avantor with a cGMP manufacturing hub in Asia, allowing us to provide the best service to our life sciences customers, regardless of their locations.'
J.T.Baker HPLE sugars can increase the efficacy of active pharmaceutical ingredients and improve cell culture yield for biopharmaceutical manufacturers, and may enhance patient safety in formulations.
Features and benefits of J.T.Baker HPLE sugars include
- same proprietary purification process used in US and India
- delivers endotoxin levels below regulatory requirements (as defined by USP, EP and JP)
- high-purity nutrients proven to increase cell culture yield
- reduces adverse reaction risk to enhance patient safety
- low endotoxins reduce API degradation in parenteral formulations
- industry leading low metal contaminant levels
- sets industry standards for lot-to-lot consistency
- available as beet sucrose, cane sucrose, galactose and trehalose dehydrate.