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.

• Croatia - Pharmaceuticals and Biotechnology (18/10/2008)
• Monoclonal Antibodies Report (14/10/2008)
• MARKET RESEARCH OF LAXATIVES (12/09/2008)

• 200 Formulation Dossiers (04/03/2007)
• Dermatological Formulation (03/12/2006)
• Software and IT support (21/08/2006)
• Clinical Trials (20/08/2006)
• Laser technology (09/05/2006)
• Chiral Chemicals (11/01/2006)