News and Events

News and Events

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 new 50000 sq ft formulations development and CTM capacity in India – April 2008

Piramal Healthcare is setting up a new state of the art formulations development and CTM Supply centre at Ahmedabad in India – the centre is expected to be operational from Dec 2008 and carry out GMP supplies from Q2 2009.

The centre is set up in Special Economic Zone in Ahmedabad and has a total footprint of 50,000 sq ft of which only half will be built out in Phase I of the project. This will comprise over 110 scientists to be staffed at the centre.

The centre will be equipped with state of the art, instrumented equipment for early phase formulations development and CTM supply – these include Glatt FBPs, Fitzpatrick Roller Compactors, Korsch compression machines for example. 10 GMP suites with dedicated Air handling units have been set up allowing the team to work on a number of projects simultaneously.

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.