US CMO Catalent has added potent product handling capacity at its manufacturing and packaging facility in Schorndorf, Germany.
Part of the expansion is a potent compound handling area, specifically dedicated to working with high-potency drug products in complex dosage forms. Catalent has also installed over-encapsulation capacity in line with growing demand for trial materials.
The move is very much in keeping with a wider trend that has seen many contract manufacturing organisations (CMO) bolster compound capacity in response to the growing number of potent pharmaceuticals entering clinical trial phase development.
This growth in market demand was acknowledge as a key motivation for the expansion by Schorndorf site manager Eric Schmidhaeuser in a press statement accompanying the news.
He said the “addition of this new potent handling and over-encapsulation area will help to meet the needs of our customers, both global and local,” and added that the investment builds on work already completed at the plant.
The Schorndorf facility, which has operated since 1973, conducts formulation development work as well as clinical and commercial-scale manufacturing for tablets, capsule, powders and a variety of other dosage forms.
The plant has undergone a number of expansions over the last few years since, with work primarily being focused on boosting its capacity for the production of clinical trial supplies.
More recently the capacity expansions have focused more on the commercial supply side of Catlent’s manufacturing business.
For example, in October last year the facility was cleared by the US Food and Drug Administration (FDA) to undertake the contract production of two new drugs for the US market, building on the approvals it already held from regulators in Germany, Brazil and Taiwan.