PROCESS DEVELOPMENT
Industry challenges in non-GMP manufacture
Michael Wilkins of Almac explains how the company is helping to meet pharma industry challenges by offering customers greater flexibility and speed when assessing the feasibility of technical concepts and formulations, and creating streamlined progression from clinical-stage to commercial manufacturing.
Almac is a leading drug development and commercialisation organisation formed by the late Sir Allen McClay in 2001 from five divisions bought out from his first venture, Galen Holdings Plc. The organisation has seen more than 30 years of continual growth and now partners with more than 600 companies worldwide, including all the market leaders. Almac now employs more than 3,000 people within facilities in the UK and the USA and offers a broad range of drug development services from research through pharmaceutical and clinical development to commercialisation of product. The company is expanding its
pharmaceutical development offering through the addition of new non-GMP services at its Craigavon, UK headquarters facility for the development and scale-up of solid oral dose drug products. “Any pharmaceutical drug product for human consumption has to be manufactured under GMP conditions, irrespective of whether it is used in a clinical trial setting or as a commercially available medicine” explains Dr Michael Wilkins, head of formulation & process development at Almac.
“GMP is concerned with the production and quality control of the product, and carries a significant burden of paperwork and record- keeping that is not required in its entirety for development activities, where the product is not going forward for human consumption. Therefore, conducting development activities in a dedicated non-GMP environment allows for speed and flexibility within the development process, and is equally applicable to work on potent and non-potent materials. “The expansion in Almac’s pharmaceutical development offering is, quite simply, due to increased client demand,” he says. “We have established ourselves as a development partner of choice for many of our clients. Additionally, our clients are facing increasing pressure to bring their clinical candidates through their pipeline, faster, more efficiently and at a lower cost. The new non-GMP development facility will offer clients greater flexibility and speed when assessing the feasibility of technical concepts and formulations, creating a streamlined progression from development to clinic to scale-up to commercialisation.
“Complementing this our integrated CMC service bridges the gap between drug substance and drug product development. As an established provider of both drug substance and drug product development services and by offering these
Non-GMP and GMP contained processing of high-potent compounds with OELs as low as 0.03 µg/m3
24 sp2 Inter-Active July/August 2012
within an integrated package, our
clients are assured
of scientific continuity from a dedicated project team, on a single site, resulting in significant savings in both time and costs. Integrated teams within Chemical and Pharmaceutical Development work closely to fully understand the physicochemical properties of the API to ensure the optimum chemical entity is available for the manufacture of clinical supplies.”
Innovative technologies Whether client requirements are for First in Human supplies or later-phase development, manufacture or registration batches, Almac has access to a wide range of innovative technologies for solid oral dose products. For early-phase, First in Human supplies, the company offers a range of solutions from manual filling of capsules / capsule boards to automated technology such as the Xcelodose® 600S precision powder micro- dosing system to accelerate the manufacture of clinical supplies, reducing API waste whilst ensuring quality.
Aiding scale-up from non-GMP formulation design to Phase 1 clinical trials and subsequently through to Phase 2 and 3, the company’s formulation scientists utilise statistically designed experimental programmes for process optimisation and process validation. Conducting risk assessments, ranking critical quality factors and parameters and using design software such as SAS JMP and Design Expert, Almac can develop an optimum Design Space for drug products. Evaluation of material variability in relation to the formulation can be integrated into development to support QbD regulatory submissions.
Supporting late-phase clinical supplies, Almac has the capacity to scale to batch sizes up to 100kg and can then
commercialise up to tonne(s) scale to ensure a smooth transition between development and commercialisation.
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