Repligen ups disposable chromatography column capacity
The expansion includes a production suite that more than doubles capacity for the company’s line of pre-packed chromatography columns, known as Opus, as well as new cleanrooms.
Repligen spokeswoman Sondra Newman told BioPharma-Reporter.com, “The manufacturing expansion is due to customer demand and market expectations as well as our commitment to bioprocessing R&D.”
In addition to the Opus-focused area, she said there is another area that is Protein A fermentation focused and will aim “to improve our Protein A ligand yield internally, also to conduct R&D for life sciences customers who, for example, may want to develop a new Protein A media and come to us for our expertise.”
Regarding Opus specifically, the new suite is designed to satisfy customer need by providing “direct contact with the media that is packed into the ‘disposable’ Opus columns, versus the biopharmaceutical customer packing their ‘permanent’ columns in house.”
The pre-packed columns can help biopharma companies improve their downstream processes.
In addition, there is demand from customers for the Opus columns “for late stage clinical and/or commercial products. Thus, the Company's cleanrooms need to be of a quality standard equivalent to our customers…[and] are appropriately controlled to satisfy the GMP standards,” Newman said.
The columns are configurable for any resin, application or standard size and column diameters with bed heights range from 5 to 40 cm.
The facility expansion also triples Repligen’s warehouse space.
“Business continuity is another important reason for the expansion,” Newman added, noting the company now has additional, redundant warehouse space with two warehouses in Waltham, Mass., and one in Lund, Sweden to ensure customer security.
The company may also further expand as 17,000 square feet is reserved for future expansion of the same facility should demand pick up more. The company will report its Q3 financial results on Thursday.
