PROCESS DEVELOPMENT
Expanded pharmaceutical development services
“Having both chemical and pharmaceutical development operations at the same site, allows for optimal communication and knowledge transfer on projects,” says Wilkins. “Our clients leverage this integrated service offering, exploiting the Almac advantage of a single-partner approach. Smoothing transition through the drug development process and ultimately commercialisation saves time, transfers and other uncertainties inherent in a multi-supplier multi-site process. “This initial expansion in our Pharmaceutical Development services with the creation of a new facility at our UK headquarters in Craigavon represents an investment of £4.5 million. Phase One of the expansion will provide a state-of-the-art, non-GMP formulation development facility for the development and scale-up of solid oral dose drug products using a broad range of technologies.”
The new non-GMP formulation development suites will complement Almac’s existing pharmaceutical development facilities and will include high levels of control over environmental conditions as well as extending current capabilities in processing high-potent compounds with OELs as low as 0.03?g/m3. The current GMP development facilities focus on drug products up to pilot scale and registration, whereas the new facility will operate at lab scale, with batch sizes for most technologies typically expected to be less than 15-kilo scale.
“Our intention is to ensure that there is a seamless transition between development and GMP phases of projects in early-stage clinical development” says Wilkins. “Additionally the scale we have chosen will support the growing area of process DoE studies for candidates in late-stage development.
“The new facilities will effectively double our current pharmaceutical development capacity, allowing us to meet the growing demand for our services, both from existing and new clients.”
Meeting industry challenges Wilkins says that as the pharmaceutical development landscape changes and a greater level of outsourcing is conducted, the CDMO is faced with multiple customers all wanting priority access to manufacturing equipment:
“Long-term partnerships are established through project delivery that adheres to quality, time and cost expectations on a regular basis,” he says. “Parallel non-GMP and GMP capacity equates to a more agile
CDMO that is more assured on delivering on the time constraints from the outsourcing pharma or biotech company. “Additionally, taking a more strategic approach to outsourcing multiple development projects and allocating fixed resources to these ‘development baskets’ allows for greater flexibility and reduction in costs, as opposed to tactical, one-time project outsourcing. Relationship build time is often replicated when one customer jumps between various CDMOs. What Almac seeks to offer is a consistent, measurable and deliverables-orientated client engagement that keeps our clients coming back to us again and again.”
Early- and late-phase partnerships The Almac Group is currently working with a significant number of European and US biopharmaceutical companies to advance their drug products through the clinical pipeline. For example, one company, via Almac’s integrated CMC services, is utilising not just the non-GMP capabilities but works with Almac’s chemical development team for solid state services including polymorph screening and salt selection. “From the non- GMP development studies, the client company selected their optimum drug presentation, an API in a capsule, and will now work with Almac, utilising our Xcelodose® 600S technology, to provide GMP supplies for their First in Human trial,” says Wilkins. “From a later-phase perspective, we have been providing drug product development and clinical supply services to a US-based speciality pharma company that have now migrated over to our API development group, such that we will support both API and drug product manufacture for both the clinical and ongoing commercial needs of the client. As this client was resource-limited, the fact that they can source both their API and drug product from one CDMO in one site location saved them significantly in terms of resource and, of course, time and cost,” he states.
Technology integration
Almac’s first priority for the non-GMP sector will be to integrate all current technologies between this sector and its GMP facility. “The endpoint of most development activities is to manufacture product for evaluation in a clinical trial, and Almac’s strategy is to duplicate most of the equipment trains such that optimised process conditions can translate automatically into clinical manufacturing batch records,” says Wilkins. “This speeds up the overall project timeline to clinic, and de-risks the clinical manufacturing
activities.
“Most processing strategies for solid oral dosage forms are already covered by Almac’s capabilities, including direct compression, dry granulation and wet granulation, and we employ them on numerous immediate-release projects and controlled-release projects. The technologies can be easily transferred to Almac’s commercial manufacturing facilities or to the client’s global manufacturing network. There are a few specific technologies that have been used for controlled-release product development that Almac is considering for the future, but these really cover niche situations. The addition of specialist technologies to provide an IP base for Almac’s pharmaceutical development group is attractive and does form part of our mid-term plans,” he says. Wilkins states that in the pharmaceutical services supply sector it is difficult to see consolidation to the extent that a service provider will cover discovery activities through to clinical services: “Such a model almost describes ‘Big Pharma’,” he says, “and these companies are divesting certain functions to deal with cost control and agility issues. There is more logic for the consolidation of development functions, so that material movement and transition from API to drug product to packaged and labelled drug product to clinical study centre can be streamlined, as provided by the Almac single ‘one-stop-shop’ for integrated CMC services offering. Nevertheless, these CMC activities can be and are still frequently outsourced as separate work packages. I think that we will continue to have a mixed portfolio of service providers, ranging from smaller companies with a single service offering to multinational companies offering a broad range of services. CDMOs need to manage internal capacity constraints as greater volumes of work are outsourced. Almac is investing in this non- GMP facility to specifically address the customer need to shorten project timelines, whilst delivering consistent performance across multiple projects and clients at the same time,” he concludes.
Further information Dr Michael Wilkins Head of Formulation & Process Development Almac 22 Seagoe Industrial Estate Craigavon BT63 5QD United Kingdom Tel: +44 28 3836 3363 Fax: +44 28 3836 3300 Email:
pharmaservices@almacgroup.com
Web:
www.almacgroup.com July/August 2012 sp2 Inter-Active 25
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