The whole nine yards in drug delivery development
just for their drug delivery technologies but also for their
regulatory and manufacturing expertise, asking them to take their
product from early stages all the way to post-approval.
By contracting a company like Cardinal or Baxter to handle all aspects of development with a new drug delivery system, pharma companies can tap into the huge resources such firms have in the area of pharmacokinetics, clinical affairs, toxicology, regulatory affairs and quality assurance, as well as their manufacturing capacity.
In-PharmaTechnologist.com caught up with Richard Beesley, programme manager of 3M Drug Delivery Systems, at the Controlled Release Society's annual meeting in Vienna, to discuss the attraction of the total solutions a company like his company provides.
"We know our drug delivery platforms well, we know how to formulate fast and avoid mistakes, so we offer shorter development times," he said.
"Initially our customers sign up for product development and later they may ask us to move their product forward to commercialisation."
The process starts with a cross-functional team drawn from both companies, pairing specialists from each, matching engineer to engineer, quality expert to quality expert, packaging designer to packaging designer, and so on.
A pre-feasibility assessment report is then usually completed under a confidential disclosure agreement and assesses the technical compatibility of 3M's transdermal or inhalation technology with the compound and the proposed product concept.
3M then provides an opinion on the likely technical success of the compound within that drug delivery system and recommends whether or not further development should be considered.
Afterwards, feasibility is performed under confidential disclosure and determines, through laboratory formulation and analysis, the compatibility of the compound with 3M's drug delivery technology. At the end of feasibility, 3M makes a recommendation on proceeding with the project under a development agreement.
If it proceeds, 3M will formulate and develop the product, manufacture clinical supplies, complete the Chemistry, Manufacturing and Controls (CMC) section for global regulatory approval, scale-up manufacturing for phase III supplies and be prepared to launch product within the marketing timelines of the partner.
This includes product formulation and stability testing, analytical method development, process development and scale-up to production, and toxicological support of components.
Following scale-up and validation, 3M then focuses on commercialisation and the supply objectives.
Among the companies 3M serves this way is Altana - it provides it with Alvesco (ciclesonide), a novel inhaled corticosteroid (ICS) to treat asthma - and Schering - it makes Menostar (estradiol transdermal system) for its US affiliate, Berlex.
Beesley sees business increasing as pharma companies seek the agility of a drug delivery company with the resources of a major health care company.
