Contract Research and Manufacturing Services in Recombinant Proteins
Member of Farmavita.Net have formed a biopharmaceutical CRAMS division that will
look into offering biotech services to global clients in Recombinant Proteins area
and have begun working consciously in this direction.
The
services currently offered are process R&D, scale-up, analytical
methods development and validation, protein characterization, contract
Manufacturing, fill and finish packaging.
Member of Farmavita.Net is the Biopharmaceutical subunit of pharmaceutical company which has the distinction of being amongst the fastest
growing pharmaceutical companies in India
(CAGR of about 40% since last 5 years as per IMS) and currently ranked amongst
the top 20 pharma companies in India.
Company currently markets its indigenously developed biopharmaceutical products in
India.
Notable among the products are a recombinant Human Granulocyte Colony
Stimulating Factor, Erythropoietin and Interferon Alfa 2b. It also have the unique distinction of having completely developed
the first PEGylated rHu product (from India)
and taken it through development, successfully completed clinical trials and now preparing for the market launch in India. Currently we have 12
projects ongoing at various stages and we have a very robust R&D team and
activity.
Company has a very rich biopharmaceutical product development pipeline, positioned
to launch 2 products every year. It is noteworthy here that one of the products
has entered clinical trials in Europe. Company is
working on fermentation and cell culture based technology platforms to derive
biopharmaceutical recombinant proteins. It has set up a manufacturing plant
for bulk and finished formulation (in pre filled syringe) meeting stringent
cGMP norms. It is also noteworthy here that the facility has received the EMEA
approval in April 2007. These accomplishments of the company, places it as one
of the front-runners in the biopharmaceutical sector in India. The
services currently offered are as below
· Process R&D (Development and / or Improvement)
· Scale-up (step wise upto 50L)
· Analytical Methods Development / validation / Protein characterization
· Contract Manufacturing
· Fill and finish packaging (PFS and Vials – liq and Lyo)
Company also provides full fledged Regulatory assistance and / or CMC development
during the entire development process.
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