PHARMA SPECIAL manufacturing of small molecules. The site already offers a full range of spray-drying dispersion capacity across clinical and commercial programs. This expansion will significantly increase capacity for larger volume opportunities and be available in Q1 2029.
As Bertola noted, about 25 % of small molecules in the pipeline are poorly soluble and the total market is growing at a CAGR of 11 %. The company said it is using its 30 + years of expertise in spray drying to address such technical hurdles as protein stability, fast and reliable aseptic processing, formulation optimisation, and scalable manufacturing.
Another major CDMO active in spray drying is Hovione, which recently began GMP operations at its newly expanded facility in East Windsor, New Jersey. This doubled spray drying capacity to meet growing demand for amorphous solid dispersions( ASDs).
Further expansion could take place at East Windsor, where Hovione has acquired six hectares of land to support future expansions, as well as the site it will open at Seixal, Portugal, in 2027. The new site will begin with spray drying and has space for further expansion in small molecules.
Marco Gil( left) at the opening ceremony for Hovione’ s expansion in New Jersey
Business is very strong, according to Marco Gil, co-CEO and SVP of sales and marketing, driven by the technologies in which Hovione specialises.“ Specialisation is important. Customers want to work with the top companies in specific technologies,” he said, which is why he does not think consolidation in the CDMO sector is likely.
Recognising customers’ need to move faster towards regulatory approval, Hovione has worked to integrate drug substance and drug product with particle engineering. The aim is to enable them to operate at different scales at the same site with a single product development team.
During CPHI, Hovione revealed that it will commission the world’ s first ConsiGma CDC Flex continuous tableting line at East Windsor in late 2027. This will operate in continuous or batch modes at 1-200 kg / hour, so very small to large batches of formulations can be developed on the same equipment. The company said that the $ 35 million line“ will create an integrated pathway from ASD manufacturing via spray drying through commercial tablet production”. Users will also be able to move from formulation and particle engineering to oral solid dosage medicines at commercial scale with the same team.
Also investing recently in spray drying was Piramal Pharma Services at its peptide facility in Turbhe, India. This is engineered for small-volume, high potency batches and supports a feed rate of up to 1L / hour. The company said that the investment will enable it to meet growing demand and address the formulation challenges associated with peptides and other complex molecules.
Product placement
Shortly before CPHI, Fareva continued its long record of investing in former Big Pharma sites by acquiring Sanofi’ s site in Lüleburgaz, West of Istanbul in Turkey. Terms were not disclosed. With 72,000 m 2 of industrial buildings, Lüleburgaz can produce up to 445 million packs / year over a broad range of dosage forms.
Senior business development director Didier Combis said that the company plans to invest in spray drying, a capability it already has at its site in Normandy, which bridges chemistry and drug product services. Fareva also has a large API CDMO business and its integrated offer with drug product is a key growth driver at present, along with high potency and highly complex GMP synthesis.
During the show, Curia Global announced a strategic investment to expand its sterile API manufacturing capabilities for both steroid and nonsteroid products in Valladolid, Spain. This should be completed in Q4 2028. Combined with existing capabilities, this“ will enhance support for injectable suspensions and other complex sterile formulations”.
One of the largest, most diversified CDMOs in the world is Thermo Fisher Scientific. At CPHI it showcased new drug development, manufacturing and clinical capabilities that it said address some of the“ increasingly complex paths to commercialisation”. These included:
• A collaboration with AustinPx giving access to KinetiSol, a solvent-free technology designed to improve the bioavailability of poorly soluble small molecule drugs
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