Supplier News: Lonza, Euroapi, Catalent & MilliporeSigmaBy
The latest from CDMOs, CMOs, and suppliers featuring Lonza, Euroapi, Catalent, MilliporeSigma and Purolite.
Chemicals/Chemical API Manufacturing
* Lonza Beings Commercial Ops of Mid-Scale API Expansion in China
* Euroapi Temporarily Suspends Prostaglandin Production at Budapest Site
* Purolite Opens Ion-Exchange Resin Mfg Facility
* Catalent Opens Cell-Therapy Mfg Facility
* MilliporeSigma Acquires Bioreactor Platform Company Erbi Biosystems
Chemicals/Chemical API Manufacturing
Lonza Beings Commercial Ops of Mid-Scale API Expansion in China
Lonza’s has started commercial operations of new mid-scale manufacturing assets at its active pharmaceutical ingredient (API) manufacturing center in Nansha, China. The expansion was part of a CHF 20 million ($21.3 million) investment announced in June 2021.
The expansion includes six 1,000-L reactors, four 1,500-L reactors, and isolation equipment to provide mid-scale capacity to bridge between early-phase and late-phase production. The expansion created about 70 new position to increase the total numbers of employee at the site to about 330.
Euroapi Temporarily Suspends Prostaglandin Production at Budapest Site
Euroapi, a Paris-headquartered CDMO of small-molecule active pharmaceutical ingredients and intermediates, spun off from Sanofi earlier this year (2022), has temporarily suspended prostaglandin production activities at its site in Budapest, Hungary following a routine internal assessment in which the company identified some GMP deficiencies related to documentation management.
The GMP deficiencies are associated with production records for certain prostaglandin products that are manufactured in a segregated production unit at its Budapest site. Upon identification, and out of an abundance of caution, the company says it decided on November 30, 2022, to pause batch release and as a second step to temporarily suspend prostaglandin production.
The company says it is still finalizing the assessment and is building an action plan to remedy the situation at its Budapest unit and has informed relevant health authorities. The company says it does not anticipate any impact on the other activities of its Budapest site, including CDMO activities. Based on the company’s internal assessment, it says that considers that the prostaglandin products on the market are within specification and are suitable for their intended use.
The temporary and targeted pause of production will affect the company’s business activities and financial performance. It now (as of December 7, 2022) anticipates net sales of approximately EUR 980 million ($1.03 billion) and a core EBITDA margin between 12%–13% in 2022, due to loss of sales, related provisions, and remediation costs. The company estimates that prostaglandin production could remain suspended for a few weeks (as reported on December 7, 2022).
Purolite Opens Ion-Exchange Resin Mfg Facility
Purolite, a King of Prussia, Pennsylvania-based supplier of resin-based separation, purification, and extraction technologies, has opened a new 74,000-square-foot ion-exchange manufacturing facility for use in active pharmaceutical ingredient (API) manufacturing. The company’s ion-exchange resins are used in drug formulations as APIs or excipients. The facility has two new cleanrooms to manufacture APIs, which will increase the company’s production of APIs by 67%. The company manufacturers APIs such as cholestyramine and sodium polystyrene sulfonate. The new plant is the company’s fifth manufacturing facility globally.
Catalent Opens Cell-Therapy Mfg Facility
Catalent has opened a new commercial-scale cell-therapy manufacturing facility at its European Center of Excellence for Cell Therapies, in Gosselies, Belgium.
The facility has 60,000 square feet of dedicated cell-therapy manufacturing space housing multi-product, segregated suites designed to support autologous and allogeneic cell-therapy manufacturing through to late-stage clinical and commercial-scale supply. It also has Grade B and C suites to support high-throughput processes and accommodate bioreactor-scale cell- therapy manufacturing as well as on-site quality control laboratories and warehousing.
The newly completed facility is the latest addition to Catalent’s Gosselies campus, which includes a 67,000-square-foot clinical manufacturing facility. The Gosselies campus also includes separate plasmid DNA development and manufacturing facilities.
MilliporeSigma Acquires Bioreactor Platform Company Erbi Biosystems
MilliporeSigma, the life-science business of Merck KGaA, has acquired Erbi Biosystems, a Burlington, Massachusetts-based developer of micro-bioreactor platform technology.
The acquisition expands the upstream portfolio of MilliporeSigma’s BioContinuum Platform, which includes cell culture, cell retention, and bioreactor solutions for continuous bioprocessing, to include scalable cell-based perfusion bioreactor processes from 2 mL to 2,000 L with lab-scale process development. It also offers future development opportunities in novel modality applications, including cell therapies. Financial terms were not disclosed.