Column chromatography is a powerful separation tool for biopharmaceutical research and industry, with applications ranging from laboratory bench-scale purification to process development and commercial-scale manufacturing of biotherapeutics. Ensuring the highest quality of separations depends on many factors, including the technique used for packing the chromatography column. Well-packed columns provide for the best chromatographic separations. Successful column packing ensures proper mobile-phase distribution and resin contact. Scaling up to large columns can introduce many challenges. Manufacturers of chromatography media provide best-practice advice…
Monday, December 5, 2022 Daily Archives
Leading Biopharma Uses Linkit® AX: Here are the Results
A Leading Biopharma was looking for a way to speed up their CAR-T media preparation. Their manual aliquoting process was time intensive, had a high risk of error and inaccuracy, and lacked a strategy for scaleup to a GMP environment. Sartorius developed a semi-automated media blending and aliquoting solution – the Linkit® AX Aliquoting Solution – that has been implemented and is now part of a GMP CAR-T manufacturing process. Read about how they used Linkit® AX to achieve 10x…
Full-service offering protecting CDMO biz from variable demand, says Thermo
“I have never seen customers pulling forward demand because they don’t want excess inventory of finished products,” says Thermo Fisher’s CEO. Like other contract development and manufacturing organizations (CDMOs), Thermo Fisher firm stepped up during the pandemic and supported many of the vaccine and therapeutic projects, but – unlike some of its peers – the company remains confident it is in a good place to manage a post-pandemic demand drop, also known as the COVID cliff. “The business is having…
Lilly: Internal capacity increases and CDMOs to support Mounjaro scale-up
Eli Lilly expects “a substantial expansion” of capacity for its type 2 diabetes drug Mounjaro (tirzepatide) to come online around 2025 through internal investments and third-party support. Mounjaro, a once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor, received US Food and Drug Administration (FDA) in May this year. The product is a first in a new class of type 2 diabetes medication and is expected to become a blockbuster for Eli Lilly, and sales in its first full…
Pfizer ups EU CAPEX spend to $2.5bn with Belgium expansion
A day after announcing plans to expand a biomanufacturing site in Ireland, Pfizer has committed a second €1.2 ($1.25) billion for its Puurs, Belgium facilities. The site in Puurs, Belgium became central in Pfizer’s COVID-19 vaccine network, and underwent an expansion during the pandemic to install additional manufacturing and filling lines. Now the Big Pharma firm has committed a further €1.2 billion to the site, located 20km north of Brussels, over the next three years to expand production capacity, cold…
Full-Life to acquire peptide firm Focus-X for $245m
Full-Life Technologies, a year-old Brussels-Shanghai radiotherapeutics company, will acquire New Jersey’s Focus-X Therapeutics for up to $245 million. Using its proprietary peptide engineering technology. Focus-X has built a portfolio of eight radiopharmaceuticals targeting various cancers. Its lead assets are a prostate specific membrane antigen (PMSA)-targeted peptide for advanced prostate cancer and a neurotensin receptor type 1 (NTSR1)-targeted peptide for pancreatic cancer. Focus-X shareholders will receive an upfront payment, up to $245 million in milestones plus royalties on sales. Founded in 2020,…