MAR / APR 2022
Olon HPAPI milestone
Italian CDMO Olon has completed a large-scale high containment production line ( OEL < 1 mg / m 3 ) at its Rodano site , at a cost of about € 10 million . The new line , which is already operative , enables Olon to produce HPAPIs in batches of 30-250 kg . This is part of a planned € 27 million it will roll out over 2022-3 that is fully allocated to the expansion of internal expertise and high containment production capacity .
“ Now we are one of the few CDMO companies to offer the range of specific integrated capabilities necessary to support the customer from the first clinical phase up to industrialisation , regardless of the quantity of product needed and batch size required , and regardless of the ongoing molecule development phase ,” said CEO Paolo Tubertini .
This expansion is also in line with a long-term business strategy of expanding internal technology platforms , focusing on HPAPIs and on biotech . In the latter field , Olon recently concluded a long-term strategic partnership for the manufacturing of the protein-based biocontrol products of Belgium ’ s Biotalys .
This , the companies said , will secure the global supply of Biotalys ’ first product , Evoca , a biofungicide planned for market introduction in the US in 2H . Evoca controls diseases such as Botrytis and powdery mildew in fruit and vegetables . As well as reducing dependency on chemical pesticides that might lead to residues in harvested produce , Biotalys said that it offers “ a distinctive new tool to manage pathogen resistance development ”.
Olon will produce the active at its sites in Capua and Settimo Torinese , which both have many years of experience in microbial fermentation . They have respective capacities of 35 m 3 in bioreactors and batches of up to 112 m 3 , far above what has so far been reached with Biotalys ’ products .
Biotalys submitted Evoca for registration to the US EPA in December 2020 . It passed both the provided completeness check and the preliminary technical screening . Separately , it was submitted for approval in California , which performs its own in-depth review , in April 2021 . In the EU , EFSA and the College for Approval of Crop Protection Products & Biocides have confirmed that that the registration dossier submitted for the active substance in March 2021 is admissible for review .
The new Science & Lab Solutions business unit will combine the Research Solutions and Applied Solutions units into one to “ provide a more seamless experience to customers in the pharma and biotech , industrial and testing , academic and government , as well as diagnostics sectors ”. Jean-Charles Wirth , currently head of Applied Solutions , will lead it . Integrated Supply Chain & Operations , to be headed by Ivan Donzelot after Christos Ross ’ s retirement at the end of March , will absorb the parts of the CDMO and Contract Testing businesses related to supply chain . Process Solutions will continue to offer products for pharmaceutical development and manufacturing , with Andrew Bulpin remaining at the helm .
IN BRIEF
Flamma buys site
Italian CDMO Flamma has reached an agreement in principle to acquire the Bulciago site at Lecco , Italy , from Teva Group subsidiary Sicor . CEO Dr Gian Paolo Negrisoli said that the firm ’ s goal “ is to be able to produce more APIs in Italy , which is in line with the European pharmaceutical strategy that aims to have a more robust and resilient supply chain ... not totally dependent on Asia ”.
New 2-ME plant
BASF has started production at a new plant for the intermediate 2-mercaptoethanol ( 2-ME ) at Ludwigshafen , following a trial run of several months . The facility , which has 10,000 tonnes / year of capacity , replaces an older one at the site , which closed after over 40 years of operation . 2-ME is used in crop protection products , oilfield chemicals , plastics and coatings .
Chelate expansion
Nouryon has completed a chelates facility at Herkenbosch , Netherlands . This should open in Q2 and will double the company ’ s Dissolvine green chelates capacity by supplying Dissolvine M or MGDA ( methylglycine N , N-diacetic trisodium salt ), Dissolvine GL or GLDA ( glutamic acid , N , N- diacetic tetrasodium salt ) and other ingredients for uses in consumer cleaning .
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