MAR / APR 2023
CDMOs complete API expansions
Piramal Pharma Solutions has begun production of initial batches of APIs in new reactor suites at its facility in Riverview , Michigan . This , the company said , represent the first in a threestep process for Phase II clinical trial materials . As part of the programme , technicians are scaling up material from 10-15 kg to 75-80 kg .
The first phase of Project PRIME began in May 2021 and involved $ 38 million in equipment and construction costs . It features 10 m 3 of reactor capacity that can produce HPAPIs to OELs of > 1μg / m 3 , plus a pressure dryer filter . The facility , currently covering about 2,300 m 2 , is readily scalable to add more reactor bays as part of the second phase .
This follows on from a recently completed $ 22 million expansion at Piramal ’ s API site in Aurora , Ontario . This added over 900 m 3 of manufacturing and utility space , including two new reactor suites with additional filtration and drying capabilities . Both investments were prompted , said CEO Peter DeYoung , by “ the industry trend for onshoring of drug substance production ”.
Meanwhile , Italy ’ s Dipharma Francis has completed the second phase of expansion at its US site at Kalamazoo , also in Michigan . The new investment provides additional cGMP capacity , a QC laboratory equipped to the latest pharmaceutical quality standards , with full 21CFR Part 11 compliance for electronic data integrity , plus fully climate-controlled warehouses with more space and increased material segregation . Dipharma had opened the QC lab in 2020 , along with a cGMP kilo lab .
Also in the US , Lonza is to expand its Early Development Services offering into North America with a new ,
1,600 m 2 laboratory in Cambridge , Massachusetts . Due to begin operations in May , this will offer in silico non-GMP protein expression and in vitro immunosafety assessment services for pre-clinical stage small- to mid-sized biotechs .
Lonza has also completed the expansion of the bioconjugation facility at Visp , Switzerland . This includes two manufacturing suites and supporting infrastructure for both clinical and commercial supply . It complements recent expansions at the site in mammalian capacity , microbial development , drug product and HPAPI payload-linker capacity .
Veranova ’ s Macfarlan Smith subsidiary has completed a $ 10 million expansion of its mid-scale API manufacturing capabilities at Edinburgh , UK . The facility will be able to handle highly active APIs and intermediates for the generic opioid analgesic and anti-addiction markets , as well as having general multi-purpose capacity . A second , $ 7 million phase is now undergoing commissioning .
Meanwhile in Italy , Olon has completed an investment to expand the capacity of its pilot plant in its Rodano facility so as to scale up HPAPI production at up to 0.1-1 µ g / m 3 containment levels . The facility be integrated into other pilot plants “ for increased capacity and improved flexibility ”, the firm said .
Finally , Indian CRDMO Sai Life Sciences has similarly opened a 1,485 m 2 HPAPI facility at its cGMP API campus in Bidar . This is designed and validated to handle highly potent molecules down to < 1 µ g / m 3 . It will enable Sai , which recently opened an HPAPI development facility at Hyderabad , to handle all aspects of the product life cycle .
IN BRIEF
Solvay to recycle rMEOs Solvay is to source mixed rare earth oxides recycled from permanent magnets by Canadian cleantech start-up Cyclic Materials for use in automotive , renewable wind energy and electronics applications at its site in La Rochelle , France . The company is working to validate its products ’ compatibility with Cyclic Materials ’ separation process .
The name is Ketjen As outlined in November 2022 , Albemarle has officially launched Ketjen , a subsidiary that “ crafts tailored , advanced catalyst solutions for the petrochemical , refining and specialty chemicals industries ”. Ketjen is based in Houston under its president Raphael Crawford and the management team of Albemarle ’ s existing catalysts business .
SampleRite opens in Germany SampleRite , a 2M Group operation , has opened a new facility in Wendelstein Germany . Like its existing sites in the UK and China , it will offer sample management , stock handling , refilling and storage of dangerous and non-dangerous goods , and will also act as the point of contact for chemical manufacturers and distributors across all markets .
Brenntag buys in South Africa Brenntag has bought an additional water treatment facility in Pomona , near Johannesburg , South Africa . This will form part of the Brenntag Specialties segment and will offer expanded blending and storage capacities to regional customers , particularly in cooling and boiling water .
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