Pharma News & Events
Successful CPhI for Pharma Solutions
This year's CPhI was held in Frankfurt from the 25th to the 27th October. The show was a great success for Piramal Pharma Solutions. As well as hosting 3 days of meetings with new and existing customers, Pharma Solutions hosted an on-stand wine tasting event and an evening of fine dining and a tour of the cellars at Schloss Reinhartshausen, the oldest privately owned Wine Estate in Germany.
We would like to thank all our customers for their attendance at CPhI, and extend a warm welcome the new clients we met at the show.
See you in Madrid at CPhI 2012!
Piramal Offers Commercial Scale ADC Manufacture
Based on an expanded and FDA-approved manufacturing suite at its Grangemouth, Scotland facility, Piramal Healthcare has begun commercial scale ADC (antibody drug conjugate) manufacturing for leading players in the anti-cancer drug space.
Piramal Healthcare is one of the few contract manufacturers operating in ADCs and the first contract supplier of commercial ADCs anywhere in the world. Expanded last year, Piramal’s dedicated ADC process development and GMP production facility is one of three ADC production suites at the site. Following inspection, US FDA approval for manufacturing was confirmed earlier this year. The company works with 11 of the top 16 global ADC clients.
ADCs are targeted therapies designed to deliver a drug payload to cancer cells while minimising the adverse effects on normal healthy cells. Several ADC-based therapies are in late-phase trials, with about a dozen in Phase I and 20+ at the pre-clinical stage. Grangemouth has a notable track record in both ADC development and scale-up production. Piramal’s facility is one of only a handful in the contract manufacturing sector to offer the needed combination of expertise in handling highly potent compounds, conventional pharma synthesis and bioprocessing multi-scale capabilities at a single, fully integrated production site.
To date, Grangemouth has made over 300 ADC batches from 2g – 500g scales, across a range of over 30 different ADC NCEs (new chemical entities). “Commercial scale manufacture is another exciting ADC milestone and the culmination of over a decade of ADC experience at our Grangemouth facility”, commented Nicole Tingley, Director of Business Development for Antibody Drug Conjugates. “As an increasing number of these drugs move through clinical phases we’re confident that the range and depth of our manufacturing development experience will continue to add value to both existing customer partnerships and advancement of new ADC candidates”, she added.
As part of a continuing upgrade programme to support its ADC portfolio, Piramal opened a new US $400k. Quality Control lab suite at Grangemouth earlier this year. The development combines a number of previously separate capabilities into a single suite. The latest upgrade spend is additional to direct investment in ADC facilities of more than US $800k. over the last four years.
Piramal present on Oral Dispersible Technologies at the World Drug Delivery Conference
Vipan Dhall, Head of R&D for Piramal Pharma Solutions recently spoke at the World Drug Delivery Conference in Singapore. Vipan discussed the unique advantages of Orodispersible Tablets (ODT) over traditional dosage formulations. They are preferred due to the ease of swallowing without the use of water in paediatrics and geriatrics patient populations. Besides, this technology also offers advantages to patients suffering from dysphagia and in situations, like mouth or oro-pharyngeal cancer, where the swallowing of medication is a challenge
In spite of the simplicity of the dosage form, the technology itself has several challenges related to fast dispersion time, taste, mouth feel, and robust tablets with appropriate hardness to handle. With so many drugs having bitter taste, masking the taste of the APIs is another critical parameter in the success of the ODT. There are several different techniques that can be utilized to achieve the taste-masking, like the use of flavours and sweeteners; barrier coatings; hydrophobic materials and use of complexation techniques.
The success of the ODT as technology is evident by over a dozen drugs that have been formulated and launched successfully. The different technologies utilized for development of ODT include lyophilisation, which is the most commonly used; compressed tablets; molded tablets and floss. The lyophilisation offers the fastest dispersion time of around 5 seconds, but tablets are weak to handle and the process long and expensive. Realizing these challenges, Piramal Pharma Solutions have developed compressed tablets that can offer fast dissolution / dispersion time of less than 30 seconds while maintaining the strength of the tablets.
Ahmedabad Achieve 2 International Accreditations
Pharma Solutions Ahmedabad site have been awarded two International Accreditations from Bureau Veritas Certification. The first, ISO14001, is the international standard for Environmental Management Systems, and the second OSHAS18001, is the International standard forSafety Management Systems. The attainment of these accreditations is part of Pharma Solutions 4-fold approach to it's Environemental, Health and Safety commitments - Continuous Improvement, Sustainability, Process Safety and Certification.
Pharma Solution's Director Speaks at BioPharma india
Gerhard Klement, Director - Piramal Pharma Solutions will be speaking at the 9th Annual BioPharma India Convention which will be held at the Grand Hyatt, Mumbai on the 6-7 December 2011.
Gerhard, will be speaking about ‘The evolving roles of CRAMS - What is now expected from them’. He will discuss comparisons between India's home-grown CMOs and International CMOs, Due Diligence in selecting the right CMO partners and his views on delivering global competitiveness: Understanding big pharmas' requirements on contract manufacturers.
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Events & Exhibitions come and see us at:
Pharma Solutions will be exhibiting at:
- APV Outsourcing Conference, Berlin Germany 25-26 January 2012
- Informex, New Orleans USA, 14-17 February 2012
Pharma Solutions representitives will also be attending:
- ProcureCon Pharma, Zurich Switzerland, 28-29 February 2012
- Clinical Trials Supply Europe, London UK, 21-22 February 2012