Pharma News & Events
Piramal’s healthcare vertical invests USD $2.5 million to further expand commercial ADC capacity
Piramal | Healthcare was the first contract supplier of ADCs globally
PPDS, Ahmedabad facility gets State GMP & GLP Certificate
Piramal Pharmaceutical Development Services Pvt. Ltd, Ahmedabad gets State GMP & GLP Certificate
PPDS, Ahmedabad facility gets EU GMP Certificate
Piramal Pharmaceutical Development Services Pvt. Ltd, Ahmedabad gets EU GMP Certificate
Liquid Formulation Development Facility begins at PPDS, Ahmedabad
Liquid Formulation Development Facility at Piramal Pharmaceutical Development Services (PPDS) Pvt. Ltd, Ahmedabad
Successful CPhI 2012 for Pharma Solutions
This year's CPhI was held in Madrid from the 9th to the 11th of October. The show was a great success for Piramal Pharma Solutions, with hosting 3 days of meetings involving new and existing customers, Pharma Solutions hosted an on-stand wine tasting event and an evening of fine dining and Flamenco Show at Casa Patas an authentic Spanish Restaurant. 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 Frankfurt at CPhI 2013!
Piramal: M&A shopping for strategic fit and value:
Piramal Healthcare Chief Operating Officer Vijay Shah will be thinking about shopping during his stay in Madrid for CPhI 2012 - but mainly for companies. He heads a dedicated M&A team looking to grow the Piramal CRAMS business (Stand 4F16) to get inside the world top five within the next five years.
“One side of the CRAMS coin shows a bright and shiny picture of continuing steady growth in the outsourcing market, but the other side is much more complicated”, he says.
“The market remains fragmented, and with big pharma customers looking to focus on just a few CRAMS partners, consolidation across surplus capacity will accompany the trend of overall growth”.
Piramal has clear ideas about candidate additions to its family. Capabilities and strategic fit to its business model are much more critical than discounted company valuations in the current buyer’s market.
“Scale-up via organic growth and acquisition must continually reflect the crucial combination to the customer of technical distinction, value and partner reliability”, Mr. Shah notes.
Piramal is especially interested to add technology platforms from large multinationals, formulation technologies for early-phase and R&D work and more capacity to provide contract manufacturing for leading brands.
Since the last CPhI Worldwide in Frankfurt, Piramal has looked closely at six contract manufacturers in Europe and the US, which qualified for attention based on their niche products and/or technical capabilities. Shah confirms that some opportunities have been discounted, while various other conversations: “remain live and active”.
Piramal is of course no stranger to growth via acquisition.
Its widening global presence in the CMO space essentially began with the 2005 acquisition of Avecia Pharmaceuticals, bringing key production facilities in the UK – notably at Morpeth and Grangemouth – and in North America.
At last year’s CPhI Worldwide it announced the re-branding to Piramal Discovery Solutions of the discovery chemistry and services business 02h, which joined the Piramal family in early 2011.
Reflecting expansion upstream into the discovery segment, the business logically complements Pharma Solutions three primary business units – Formulation Services, API Services and API Generics.
In the UK, Piramal marked the formal opening earlier this year of its upgraded antibody drug conjugate (ADC) development and production facility at Grangemeouth. The site gained FDA approval in June 2011 – becoming the world’s first contract supplier of ADCs at commercial scale.
With a quickening development pace in ADC-based anti-cancer drugs, Piramal is planning to expand capacity at Grangemouth.
Piramal and Fujifilm Diosynth announce strategic alliance for ADCs
Piramal Healthcare UK has announced it has entered into a strategic alliance with Fujifilm Diosynth Biotechnologies. The companies will offer seamless contract development and manufacture of antibody drug conjugates (ADCs), a growing niche in the development of biopharmaceuticals.
The deal will allow customers to benefit from the experience and assets of both organisations, while simplifying supply chain and vendor management relationships, leading to shorter time to clinic.
Through its Grangemouth UK facility, Piramal is a global leader in antibody drug conjugation, while Fujifilm Diosynth Biotechnologies is one of the world’s leading providers of contract development and manufacturing services for biopharmaceuticals.
The companies’ combined experience covers work on more than 150 biopharmaceuticals and over 300 batches of ADCs spanning over more than 30 different NCEs, including the world’s only FDA-approved ADC.
Aidan Walker, President Formulations Services for Piramal said: “We are delighted to combine with Fujifilm Diosynth Biotechnologies to offer a seamless service to customers for the production of antibody conjugates. Fujifilm Diosynth Biotechnologies has a long track-record in delivering successful biologics programmes, and this alliance will combine strengths from both companies for the benefit of our customers, and ultimately patients”.
Stephen Taylor, Commercial Vice President of Fujifilm Diosynth Biotechnologies said: “This strategic alliance with Piramal is an important step for us in bringing a new, high-technology offering to the market place. Our customers will benefit from high quality, consistent material, rapid service and shorter logistical chains, saving time on the critical path of drug development. Piramal is a recognised world-leader in this area and we are delighted to be partnering with them”.
For Fujifilm Diosynth Biotechnologies, this is part of an ongoing programme to expand its offering in mammalian-based biopharmaceuticals. The company recently announced an expansion of its cGMP manufacturing facilities at both its RTP, USA and Billingham, UK sites.
The alliance was announced to coincide with late October’s ADC World Summit in San Francisco. The sector’s leading annual technology event, the Summit was attended by both Piramal and Fujifilm Diosynth.
FDA and MHRA approvals spur ADC growth agenda for Piramal Grangemouth…
Since 2011’s CPhI Worldwide, Piramal Healthcare (Stand 4F16) at Grangemouth have had an eventful and hugely successful year.
The site gained FDA approval for its Antibody Drug Conjugation (ADC) facility in June 2011 - meaning that the site was the first ADC CMO to host a successful FDA Inspection, becoming the world’s first contract supplier at commercial scale for ADCs.
This was on the back of an upgrade programme – started in 2006 - that saw the company invest US $400k. on an upgraded QC laboratory and a total of US $800k. on ADC manufacturing facilities since 2008.
The immediate outcome from the inspection was that Piramal’s client were able to gain BLA approval from the FDA two weeks ahead of schedule and were immediately approved to supply commercial scale ADCs for onward fill/finishing.
After recruiting an EU Qualified Person into the site Head of Quality position, Grangemouth then submitted Manufacturing Licence applications to MHRA and - following a successful MHRA inspection in May 2012 - the site was also approved for EU commercial scale supply.
These key milestones have generated significant interest in the ADC sector as they demonstrate Piramal’s ability to meet internationally recognised cGMPs and be ready for inspection.
Grangemouth continues to build on 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.
“These achievements represent how effective the Grangemouth team have been in analysing and interpreting the needs of clients and putting in place GMP processes that are reliable, predictable and appropriately designed to meet cGMPs” said John Johnson, Piramal Healthcare UK’s Quality Director.
Terry Cooke, Grangemouth’s Site Leader added: “We are very proud to be seen as an extension of our customer’s organisations and are continually exploring new ways to differentiate our offering to clients. The quality and experience within our team means that we can offer unparalleled advice, partnership in project management, technical support and predictable delivery to key milestones”.
Piramal Healthcare have already seen a favourable increase in client enquiries as the ADC sector begins to move into late phase development and commercialisation of novel molecules.
Following a visit earlier this year by Scotland’s Deputy First Minister Nicola Sturgeon MSP - centrepiece of the formal opening of the upgraded manufacturing suite and QC laboratory - the site is now prepared for long term sustainable growth and increased collaborations with the world’s leading ADC companies.
Already in the global top 10 of CMOs, Piramal Healthcare is targeting to be world number three by 2016/17, driven by organic growth and the benefit from any strategic acquisitions in the space.
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:
Piramal Pharma Solutions Exhibiting:
- Informex, Anaheim, CA, USA, 19-22 February 2013
Piramal Pharma Solutions Attending:
- World ADC Frankfurt, 26-28 February 2013
- DCAT Week, New York, 11-14 March 2012
- euroPLX 51, Limassol, Cyprus, 4-5 March 2013