Aesica Pharmaceuticals has established a new Quality Assurance team focused on delivering a range of QP services across oral, topical, inhalable and parenteral dosage forms in Investigational Medicinal Products (IMP) clinical trial release, combined with the capability to assess other alternative formats as well.
The move is set to further enhance the QP service offering provided by Aesica through its growing network of qualified European QPs who routinely release clinical trial supplies into the clinic. Moreover, it is set to bolster the company’s QP EU release service offering for clinical trial products manufactured in non-EU countries, including in the US. QP services at Aesica include full specification testing, carried out at the company’s GMP analytical laboratories, thereby enabling products manufactured in the US to be used in EU based clinical trials. Furthermore, Aesica handles importation licenses as an additional service to customers.
The company has today announced the appointment of Gareth Adlam as Quality Assurance Director at its Nottingham based formulation development site. As an experienced Qualified Person (QP), Gareth brings with him a wealth of pharmaceutical expertise extending over 15 years, with six years acquired in practice as a QP professional. Prior to qualifying as a QP, Adlam worked as a pharmacist, before taking on roles in scale up, product development and R&D compliance.
Aesica now has 15 QPs in operation across its Zwickau, Nottingham, Queenborough, Pianezza and Monheim sites, further enhancing its international offering to customers. The company performs full release of commercial products to the market, providing this service for the bulk of products that it currently manufactures.
Adlam and his team will work across any type of IMP clinical trial. This provides a significant advantage for Aesica with its ability to manufacture and QP release clinical trial products to international markets around the globe, in a multiplicity of dosage forms, including tablets capsules, liquids, creams, injectables, powders, patches and inhalers. Moreover, the flexibility to change and QP release different dosage forms from those initially envisaged, meets a key industry challenge head on. If difficulties are experienced during the formulation development phase, with a new product form and route of administration proves necessary, Aesica can adapt quickly, manufacture the new form to the capacity required whilst ensuring that the product is QP certified in line with specified regulations.
In his new role, Adlam’s main goal is to drive batch certifying procedures and to bring high quality, best practice expertise to bear in QP services, applying his knowledge and success gained from his previous QP role to both small scale capabilities, as is the case at Nottingham, through to the larger commercial scale IMP sites in place within the Aesica Group.
Prior to joining Aesica, Gareth held multiple positions at 3M Healthcare including Value Stream QP with responsibility for certifying Commercial and IMP batches of product, reviewing and approving deviations and coaching and mentoring personnel regarding quality.
Commenting on his appointment, Gareth Adlam remarked: “I am delighted to be joining Aesica at such an exciting time with the continued expansion of its QP release services. Indeed, our international network of experienced QP professionals and services means that we can bring significant benefits to customers, not least saving them significant resources in cost and time that they would otherwise incur if they endured the responsibility of taking the products into clinical trials themselves. The benefits to our US clients are especially strong as we can effectively enable trial products produced outside of the EU to reach, and be utilised in, the EU’s own drug development market.”
He continued: “Aesica stands out in the market for the sheer volume of different dosage forms to which it offers experienced QP release. Products that Aesica are currently developing include high-potency cytotoxic drugs and steriles. The Nottingham site has a SafeBridge® Category 3 licence to work with high-potency drugs, which are a growth area within the industry and renowned for poor solubility and being difficult to formulate.”
Adlam added: “I am bringing fresh ideas into Aesica which will undoubtedly add value to our client-services, particularly now that we have the added capability to deliver QP services across multiple dosage forms. Indeed, what marks Aesica out is not just this capability to manufacture and QP release such a wide range of formats during the formulation development phase, but the flexibility that comes with this to adapt and change product forms during clinical trials”.
He added: “This combined with our ability to take a product from API process development through scale up to formulation development right the way through to commercial manufacture, operating for the entire product lifecycle, gives Aesica a serious competitive edge.”
Gareth has been a qualified QP since 2005, having undergone extensive training at the University of Strathclyde and David Begg Associates. Lean Six Sigma trained to green belt level, he will be representing the CDMO as QP predominantly for IMP products in the Phase I and Phase II clinical trial stages.