UK-based contract manufacturer Aesica Pharmaceuticals has put together a Quality Assurance team under new recruit Gareth Adlam to deliver Qualified Person (QP) services across a broad range of dosage forms for Investigational Medicinal Products (IMPs) used in clinical trials.
The move will not only further enhance Aesica’s QP service offering through its growing network of qualified European Qualified Persons, it will also bolster the EU release offering for clinical-trial products manufactured in non-European Union countries including the US, the company noted.
QP services at Aesica include full specification testing carried out at the company’s Good Manufacturing Practice-standard analytical laboratories, “thereby enabling products manufactured in the US to be used in EU-based clinical trials”, the company said. It also handles importation licences.
Aesica now has a total of 15 QPs across its sites in Zwickau, Monheim (both Germany), Nottingham, Queenborough (both UK), and Pianezza (Italy).
The company undertakes full release of commercial products to the market, providing the service for the bulk of the pharmaceuticals it currently manufactures.
Any IMP trial
The new team under Adlam, who will operate as quality assurance director out of Aesica’s formulation-development site in Nottingham, will work across any type of IMP clinical trial, the company stressed.
Moreover, the flexibility to change and QP-release different dosage forms from those initially envisaged “meets a key industry challenge head on”, it added.
If difficulties are experienced during the formulation-development phase, Aesica can adapt quickly to a new dosage form, manufacturing it to the capacity required while ensuring the product is QP-certified in line with specified regulations, the comp0any explained.
Before joining Aesica, Adlam held multiple positions at 3M Healthcare, including value stream QP with responsibility for certifying commercial and IMP product batches, reviewing and approving deviations, and coaching and mentoring personnel on quality requirements.