Contract Manufacturing

Dalton PhaRMa seRVices “Better, Faster, Cheaper …. We need all three”

BY PETER PEKOS, CEO, dalton pharma services

The customer-centric variant quoted above stands in stark contrast to the classic, time-worn, vendor-centric, cliché that runs as follows: “You can have Quality, Speed, and Low Price ....... choose two”. The new reality is part of the current business environment in which CmO’s operate. serving the drug development needs of domestic and international clients has historically required us to be nimble and precise and also to eliminate anything that slows the lead-to-market path.

dalton is geared toward speed because the industry demands it. We are constantly searching for ways to increase efficiency in each of our activities, from chemistry and analytical through to Gmp manufacturing. This applies to work flow in and between departments. We have invested heavily in staff training in order to create a company-wide project management culture.

Capital efficiency has become paramount. The value that a CrO provides increases when a full spectrum of drug development services is provided. seamless and integrated services ultimately reduce the risk of lost time. hand-offs from one vendor to another, add significantly to cost and reduce flexibility if there are delays in the supply chain.

The volume of business in contract Gmp manufacturing of finished dosages has grown substantially over the past few years. It became increasingly clear to us that if we were developing and manufacturing the ApI and then doing clinical dose production for our clients, they should not have to go to another party for formulation development.

By the fall of 2009, we found our own formulation experts and finished their training to meet all our operational expectations. Our formulation expertise covers sterile and non-sterile liquids, solids, semi-solids and lyophilized formulations for small molecules, proteins, peptides, monoclonal antibodies and high-potency actives.

It is not enough to simply create a new department. none of our departments are silos. All of our activities are genuinely integrated into our operational infrastructure to allow us to work as quickly as possible. For example, we expanded our analytical department so that all the requirements of the formulation department could be met in-house. This meant, among other things, adding particle size distribution and dissolution testing capabilities.

In all our contract work we have to worry about being blindsided by the unexpected. We have found that what makes a good CMO great is the resilience of the team. Being able to adapt to challenges and changes in priorities is absolutely essential. This is especially true in the early stages of drug development programs. part of our group leader training, which is constantly reinforced, is risk management analysis. What could go wrong? What can we do to reduce risk and/or reduce the consequences? No matter what causes them, delays in drug development are devastating even for the most financially sound companies in the industry. Their success is our livelihood. We are constantly striving to be “better, faster, cheaper”.