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Pharmaceutical News and Events
Iwan Thomas, PhD BPharm - Head of Pharmaceutical Development for Piramal Healthcare spoke at the recent BIO Europe Spring Conference held in Barcelona 8 to 10 March 2010. Iwan was presenting his vision of an Integrated Approach to Pharma Services. For a copy of Iwan's presentation.
Piramal starts work at state-of-the Art Formulations Development Centre in Ahmedabad, India . January 2009
Pharma Solutions is proud to offer to our customers our state-of -the Art Solid dose Formulations Development Centre at Ahmedabad in India. Set up over 50,000 square feet of space, the centre is located in the Pharma Special Economic Zone (SEZ) in the industrial state of Gujarat.
Focussing on solid dose development, the centre in its first phase will be staffed by 85 Scientists including 40 formulators and 45 analysts. Piramal expect the staffing levels to increase to 150 scientists by Q4 of 2009. Scientists will work in two shift operations at the development centre and be able to reduce project execution timelines and also be accessible to our customers across different time zones. While development work has already started, GMP operations are expected to start from March 2009.
The centre provides a suite of services such as:
Formulations development and supply of GMP Clinical Trials Material
- Granules, Pellets
- Immediate release Tablets and Capsules
- Controlled release tablets, pellets, capsules
Analytical Services
- Method development and validation
- Stability services
Packaging and Labeling for Phase I or First in Human Dose requirements
The centre has been equipped with the latest equipment to support formulation development, robustness studies and GMP supply to support upto Phase II trials
- Glatt Fluid Bed Granulators (GPCG 2.0, GPCG 30)
- Fitzpatrick IR220A Roller Compactor with micro change parts
- Korsch instrumented tabletting press
- Diosna type High Shear Granulators
- Automated Capsule filler for filling Granules and Pellets
- Extruder and Spheronisers
- Aqueous Coating
- Blenders upto 100L capacity
The Centre has 10 GMP suites with dedicated Air Handling Units and has the capacity to add another 10 suites in a short time span . Additional features include a dedicated High potency suite capable of handling substances upto 1 .g/m3 exposure levels and a dedicated Low Humidity rooms with < 20% RH for development of effervescent products and hygroscopic API handling
Being part of the Pharma Special Economic Zone (SEZ) in Ahmedabad provides the centre tax incentives and waiver of import duty for materials and equipment, thereby ensuring long term competitiveness. The Ahmedabad operations also perfectly dovetail with Piramal.s capabilities for Preformulations studies at Mumbai and scale up and commercial supply from FDA approved site of Pithampur
Piramal Healthcare launches clinical trials services from UK facility as part of Pharma Solutions business – Aug 2008
Piramal Healthcare has launched Clinical Trials Services from the Morpeth, UK site staring Aug 2008.
The newly equipped 13,000 sq. ft. Clinical Trials Packaging and Distribution facility has the capability for primary packaging solid dosage forms – including multi-dose blistering and walleting. Secondary packaging booths are set up for the labelling and assembly of various dosage forms. Further flexibility exists within the current footprint for future doubling of primary and secondary packaging capacity.
Piramal offer a full range of CTS services including Comparator Drug Procurement, Label Design and Printing, Primary Packaging for Solid Dose, Assembly and Labelling for all dosage forms, Product Blinding, Global Storage and Distribution and Drug Destruction services from this new initiative.
Project tracking will be facilitated by Piramal’s in-house developed tracking system “TrakPack” in conjunction with IVRS providers. TrakPack features bar-coding of patient kits across labelling, assembly and distribution. Customers can track real time project status via a fully integrated web enabled system from project initiation, packaging, inventory control and distribution – thereby reducing time and uncertainty in tracking exact status.
Piramal Healthcare also has preferential relationships in-house with CROs based in Romania and India and can provide ready access to customers to these clinical trial centres.
Dr. R. Ananthanarayanan President, API and Formulations for the Pharma Solutions business unit, commented: “This expansion into Clinical Trial Supplies adds to our significant existing capabilities in Clinical Trials manufacturing. It adds a further service layer to our all-phase offer, with the benefit of Morpeth’s proven track record”.
Ian Morgan, who recently joined from Fisher Clinical Services to head the Clinical Trials Services initiative, added: “Morpeth is a flagship site, where we can build further on its deep experience in Customer Service. Alongside drug product development and clinical trials manufacture, Morpeth offers customers connected capabilities with benefits in time, cost and reduced customer intervention”.
Pharma Solutions setting up Commercial Injectables capacity in India – April 2008
Pharma Solutions is setting up a new sterile injectables site at Bangalore in India. The group acquired privately owned Healthline Pharma’s injectables unit in January 2008 and facility upgrades to confirm to full GMP levels are in progress. The site is expected to be commissioned by Q3 2009 and will have capacity to do 2ml – 20 ml vial filling operations.
The site will have the flexibility to manufacture both ampoules and vials and also has aseptic filling as well as terminal sterilisation capabilities. The site will have two injectables lines with separate Air Handling units and will be able to supply Clinical Trial Material (CTM) from one line and commercial from the other high speed Bosch filling line Batch sizes range from 100 litres to 1400 litres.
Pharma Solutions sets up Phase III/Launch Antibody Drug Conjugate capacity in UK – April 2008
Pharma Solutions carried out plant expansion at the Grangemouth site to set up their 5th GMP suite for manufacturing of Antibody Drug Conjugates.(ADCs) The new suite set up with an investment of over $350,000 would be able to supply ADCs from batch sizes of 200g – 1000g and support Phase III/Product Launch programs in the area. The newly refurbished suite maintains Class 10,000 in general processing area to minimise the risk of bioburden build up during bioprocessing operations. Supertoxins for conjugation with the antibodies are handles at multi-gram scale levels in glove box safety systems rated to OEB 4 levels.
The site Quality system was inspected by the USFDA in 2006 for PAI for a high potency commercial API and obtained approval without any 483s. The site was audited by the UKMHRA in 2006 with no critical or major observations.
Commercial capacity in the area of cytotoxic conjugates is very limited and the Piramal site has been engaged with development and manufacture of ADCs for over 5 years and is one of the key CMOs in the sector working with leading technology platforms in the sector. The site is self sufficient in all analytical requirements associated with ADCs such as ELISA testing, CBA tests and a range of HPLC analyses.