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2019-09-19Impressions: 2927
This week, SpeakPharma speaks to Stuart Needleman, Chief Commercial Officer, Piramal Pharma Solutions, who discusses some of the innovative products the CDMO is working on, its R&D facilities and its relationships with its clients. In particular, he tells us how the acquisition of Ash Stevens (a US-based CDMO) has enhanced Piramal Pharma Solutions’ global delivery model. Needleman also discusses the various regulatory compliance-related challenges being faced by the company, as well as the industry, and the need for autonomy in the quality organization so that the business pressures do not dictate quality standards. Excerpts:
Over the past decade, the pharmaceutical industry has seen innovation in the emerging pharma and biotech companies that lack the infrastructure, capabilities and resources necessary to support the entire drug development and commercialization cycle.
By establishing strategic partnerships with CDMOs (contract development and manufacturing organizations), both large and small companies can focus on their core competencies and leverage their capacities and expertise at no additional capital investment, while also controlling costs and rapidly accelerating programs towards commercialization of their drugs.
Smaller biotechs have certain specific needs — several biotechs work off a single asset and value personalized service and access to senior management. This shows them that we value their program as much as they do.
We have an exemplary track record of executing over 80 integrated projects and are currently working on multiple integrated projects for our customers.
Our team of over 500 researchers across our global facilities have found newer and innovative ways to make molecules and have developed technology platforms to service customer needs. Our Research & Development team continues to develop novel/non-infringing process for APIs and is supported by state-of-the-art, ‘best in class’ analytical research capabilities. The team has successfully supported customers in complex process development and formulation challenges using environment-friendly processes that are in line with the ICH guidelines.
In pharmaceutical product development, through introduction of QbD (Quality by Design), the focus now is on building quality into the drug product, rather than testing it into the end product. At Piramal Pharma Solutions (PPS), QbD elements have been strengthened in product development by inclining towards in-depth characterization of API, excipient, powder blend, granule and dosage forms of NCE as well as generic compounds.
Simultaneously, we have developed a proactive approach to identify and mitigate the challenges at very early stages in drug product development that successfully supports customers in their “mind to market’’ strategy, substantially adding efficiencies in efforts and time for development.
Our development facilities are forward integrated for tech transfer with our manufacturing facilities that are inspected by US FDA, UK MHRA, PMDA Japan among others.
In response to increasing customer demand for HPAPIs (highly potent active pharmaceutical ingredients), we acquired US-based CDMO Ash Stevens (situated in Riverview, Michigan) mainly to add HPAPI capabilities to our portfolio.
Ash Stevens has extensive experience in handling highly potent compounds and is seeing increased demands for its offerings. For a CDMO like Piramal Pharma Solutions, which did not have an in-house HPAPI capability and was seeking an opportunity to acquire one, it was imperative to carefully consider several factors. In addition to HPAPI expertise and experience, crucial factors included safety track record, quality, timely delivery, regulatory history, financial stability and the firm’s ability to support continued investments in state-of-the-art technologies.
Ash Stevens was recognized as a prospective partner that met all these prerequisites satisfactorily with an exemplary record of 14 manufacturing approvals (NCEs) in its 55 year long history.
Piramal Pharma Solutions offers end-to-end oncology solutions — manufacture of high potency APIs at the Riverview facility and fill finish at our Lexington facility. With our recent investment at Riverview, the site can now handle HPAPIs with OELs (occupational exposure limits) less than 1mcg/m³ and as low as ~20ng/m³.
We are also equipped to offer ADC (antibody-drug conjugate) customers a seamless end-to-end solution, since we can develop the HPAPI payloads and linkers in Riverview, send them to our site in Scotland for the antibody conjugation, and then get them back to our Lexington (Kentucky) site for sterile fill and finish.
North America is a key market that we now serve with our three local facilities — the Riverview and Lexington facilities in the US and the Aurora facility in Canada.
A strong governance and escalation mechanism is the foundation of our quality organization. The quality organization at Piramal Pharma Solutions is independent of the business function, and reports directly to the Board.
This autonomy in the quality organization ensures that business pressures do not dictate quality standards. We employ the concept of “Global Vision, Local Execution” which enables each site to serve their customers at their location but with the global standard of quality upheld by Piramal Pharma Solutions.
Quality intelligence is a key activity within the quality team to keep up with the rapidly evolving regulatory landscape. At Piramal Pharma Solutions, we have an internal cell that tracks all regulatory updates including 483s, observations, and new regulations in the industry on a daily basis. Existing practices can be evaluated vis-à-vis these events to identify possible deficiencies.
With a strong quality framework in place, Piramal Pharma Solutions seeks to be competitive by building a brand that stands out. Quality has been long viewed as a means limited to successful clearance of regulatory audits and obtaining product approvals. Firms must shift focus from ‘quality for compliance’ to ‘quality as a culture’ by keeping the end-patient in mind. We view quality as our identity — something which represents our DNA
Over the last few years, the industry has witnessed a stream of warning letters on data integrity issues. Globally, over 50 percent of warning letters in FY18 were related to data integrity.
Piramal Pharma Solutions gives utmost priority to data integrity, our compliance is driven by a well-structured governance and vigilance model. Our team has designed a data integrity tool — CALCULUS — to conduct gap assessments and map compliance level of our development and manufacturing sites on data integrity.
Automation is a key element in the computation of our final data integrity scores, since automation is essential to increase compliance towards data integrity requirements. These scores provide visibility to management and customers on organization-wide compliance status.
As a leading CDMO operating in the most stringent markets and working hand-in-hand with prestigious partners, our facilities are continuously audited by regulatory authorities from all around the world as well as by our customers. Over the last eight years, Piramal Pharma Solutions has cleared 176 regulatory inspections.
Piramal Pharma Solutions are pioneers in Antibody Drug Conjugation and have worked on over 190 different conjugates from 120 antibodies. We are an integrated service provider in oncology and are working on over 50 molecules for more than 45 cancer indications with our customers. We serve customers across a range of therapeutic areas including HIV, diabetes, oncology, malaria, postpartum depression, inflammation, hypercholesterolemia among others.
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