Canadian firm BioVectra is a CDMO in both large and small molecules and has similarly been addressing demand for integrated DS-DP capabilities in both fields . It has also expanded into fields adjacent to its core competencies , such as microbial fermentation to develop metabolites for oncology drugs .
The company had moved into recombinant proteins 15 months before to supply mRNA-based COVID vaccines . Now said , chief science officer Dr Marc Sauer , it is adding to its capabilities now by taking a licence to Acuitas ’ lipid nanoparticle technology for these therapeutics , and is preparing to enter C & GT too .
Meanwhile , Quotient Sciences has invested in sterile fill-finish at its facility in Alnwick , UK , “ to meet increasing industry demand for fully integrated drug development programmes ”. The company had earlier rolled out a new kilo lab at the site , taking it into Phase II and GMP batch sizes of up to 8 kg .
“ Clients talk increasingly about integrating DS programmes into
DP programmes . The integration of DS and DP development in parallel is vital ,” said Paul Quigley , principal research fellow , drug substance . “ We are also seeing new therapeutic modalities and more complex molecules being introduced to the market .
“ My strong belief is that there is a convergence between chemistry and biology ,” said Luzeau of Seqens . RNA vaccines are a prime example . Most new drugs , he added , are combinations of one kind or another , increasingly using less API and being more targeted at the area where they are needed , which itself requires real innovative capabilities from CDMOs .
Continued acquisition
In addition to organic growth , CDMOs continue to buy to diversify and broaden their offer . Minakem , for instance , has strengthened its generics portfolio and invested € 35 million to add a new workshop at Beuvry-la-Forêt in northern France for mid-volume APIs . Most significantly , it gained a base in North America for the first time in July with the acquisition of
Montréal-based Delmar , brining in 174 m 3 of reaction capacity , plus R & D and scale-up resources .
Since GHO Capital acquired it in 2019 , Sterling has made an acquisition each year to add to both capacity and capabilities . In September , it bought NewChem Technologies , a UK supplier of contract services focused on complex organic process chemistry , which will work “ synergistically ” with its early-phase development centre at Cary , North Carolina .
In October , SK Pharmteco took a controlling interest in Center for Breakthrough Medicines ( CBN ), having invested $ 350 million in it two years ago . Based in King of Prussia , Pennsylvania , CN is focused on CG & T that complements the capabilities of SK ’ s European portfolio operation Ypsokesi .
Shore thing
The industry has been talking about ‘ onshoring ’ and ‘ reshoring ’ of production from Asia back to the West for a decade and more in response first to the hidden costs of production in China and quality
Biologics still booming
The latest CPHI Annual Report predicts that demand for biologics will grow by 11.5 %/ year from 2,500 KL in 2022 to 4,400 by 2027 , while capacity will increase from 6,500 KL in 2023 to 8,400 in 2027 .
There has been a major push to outsource manufacturing in the last decade , said Dan Stanton , editor of BioProcess Insider , at the CPHI press conference . Fewer than 30 % of facilities do all their bioprocessing in-house , according to Contract Pharma ’ s 20th Annual Report & Survey of Biopharmaceutical Manufacturing . This has basically halved since 2006 .
Demand for COVID vaccines gave the trend further impetus . Revenues in outsourced mAbs and biologics manufacturing were just under $ 16.9 billion , with the top four of Lonza , WuXi Biologics , Catalent and Samsung Biologics accounting for nearly half . Lonza and WuXi Biologics enjoyed 17 % and 32 % revenue growth in this field respectively in 2022 .
Biological CDMOs are continuing to make huge investments , Stanton noted . Fujifilm Diosynth is engaged in $ 1 billion + projects in Denmark and North Carolina that will come online in the next two years ; Samsung Biologics have opened a fourth ‘ superplant ’ in South Korea , with plans for three more at the same site ; WuXi Biologics has huge amounts of capacity to come online in China , Singapore Massachusetts and Ireland .
By 2027 , the big CDMOs are expected to have half of the world ’ s mammalian biologics capacity . “ I ’ m a tad surprised that there is no more capacity available to industry but , when you look at the vast legacy sites of Roche or J & J and their continued need to secure inhouse capacity , I guess it makes sense ,” Stanton said . “ However , this shift to CDMO capacity that is coming online will bring more flexibility for the industry to use .”
By contrast , CPHI ’ s expert panel suggests that enough CMO capacity should be accessible for most biotechs in the year ahead , but that “ demand could be constrained in the future as more and more biologics commercialise ”. This will depend on approvals for new blockbusters in such fields as Alzheimer ’ s and diabetes .
20 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981