Merck KGaA (Darmstadt, Germany) launched three new products to help biomanufacturers navigate the evolving biopharma landscape with increased speed, greater flexibility and enhanced quality.
These next-generation process intensification technologies were unveiled at the 2018 BioProcess International Conference & Exhibition, being held in Boston, Massachusetts.
The new biopharma products are:
- The Eshmuno® CP-FT resin, a first-of-its kind CEX chromatography resin for the flow-through removal of aggregates from mAb therapeutics.
- Two modified amino acids to simplify feeding and reduce total volume in cell culture: Phospho-L-Tyrosine Disodium Salt EMPROVE® EXPERT and L-Cysteine S-Sulfate Sodium Sesquihydrate EMPROVE® EXPERT
Merck has seen the powerful impact the new evolution of drug manufacturing has demonstrated in the marketplace. The company estimates that next-generation processing will reduce production costs by 25 percent or more and free up manufacturing capacity by as much as 65 percent.
The Eshmuno CP-FT CEX chromatography resin uses flow-through frontal chromatography to remove aggregates from mAb therapeutics, which can induce an immunogenic response in patients. By enabling loading capacities 10 times higher than traditional bind/elute CEX chromatography, Eshmuno CP-FT resin reduces costs and improves productivity. It requires less resin and less buffer volume while offering a shorter processing time.
Phospho-L-Tyrosine Disodium Salt EMPROVE® EXPERT and L-Cysteine S-Sulfate Sodium Sesquihydrate EMPROVE® EXPERT, enable high concentrations of tyrosine and cysteine in cell culture feeds. Moreover, they can be integrated into the main bioprocessing feed, simplifying fed-batch process with optimized productivity and reduced risk. The only such products that meet industry quality and GMP (per IPEC) standards, these amino acids derivatives are stable and soluble at neutral pH and room temperature.
The Merck Group, branded and commonly known as Merck, is a German multinational pharmaceutical, chemical and life sciences company headquartered in Darmstadt, with around 50,000 employees in around 70 countries. The company was founded in 1668 and is the world’s oldest operating chemical and pharmaceutical company, as well as one of the largest pharmaceutical companies in the world. In the USA and Canada Merck KGaA operates as EMD Serono in the biopharma business, as MilliporeSigma in the life science business and as EMD Performance Materials in the materials business.