Facilities & Capacity

Aenova invests $19m to expand fill-finish capacity in Italy

The expansion addresses sustained demand particularly for fill-finish services to produce COVID-19 vaccines, says CDMO Aenova Group. German contract development manufacturing organization (CDMO) Aenova has invested more than $19 million to build a sterile production site at its 40,000 square-foot facility in Latina, Italy. The expansion will focus predominately on a fill-finish area for prefilled syringes (PFS) with high-speed filling lines and vials. The first high-speed line to be fitted has a capacity of more than 80 million vials and…

Athenex adds allogeneic assets in $70m Kuur Therapeutics deal

Athenex will leverage its manufacturing capabilities and staff to support the development of Kuur’s NKT cell therapies. Biopharma firm dedicated to developing cancer treatments Athenex has acquired Kuur Therapeutics, a developer of engineered Natural Killer T (NKT) cell therapies used to treat haematological and solid malignancies. Through the acquisition Kurr could receive up to $185 million, through a $70 million upfront payment from Athenex and $115 million in development milestones. According to Athenex, it is not just financial benefit that…

CDMO RoslinCT on board to support CGT training in UK

RoslinCT will provide advanced therapy and vaccine manufacturing training in collaboration with the Scottish Universities Life Sciences Alliance. According to Cell and Gene Therapy Catapult (CGTC), employment in the UK cell and gene therapy space will need to double to more than 6,000 by 2024 to support the number of advance therapies moving into and through the clinic. To meet this need, the Advanced Therapies Skills Training Network  (ATSTN) initiative was formed to drive the sector and create economic opportunities…

COVID-19 expansions drive confidence at Maravai

Maravai LifeSciences highlighted expansions at customers Pfizer and BioNTech as indicators that demand for mRNA capping solutions will continue to grow. Maravai attained its messenger RNA (mRNA) capping solution, called CleanCap, through the acquisition of contract development and manufacturing organization (CDMO) TriLink BioTechnologies in 2016. In its first quarter 2021, the firm reported $91 million in CleanCap revenue, an increase of 76% when compared to Q4 2020. Going forward the firm “expect continued strong demand from our existing COVID-19 CleanCap…

Richter-Helm to triple biologics capacity through €70m investment

German CDMO Richter-Helm will install both stainless-steel and single-use technologies at a new facility at its Bovenau site, increasing total biomanufacturing capacity three-fold. Self-proclaimed mid-sized contract development and manufacturing organization (CDMO) Richter-Helm has facilities in Hannover and Bovenau, Germany, with bioreactor capacities of up to 1,500 liters. But the CDMO is looking to benefit from continuous growth in demand for biomanufacturing capacity and services, and on May 5 broke ground on a new €70 million ($85 million) at the Bovenau…

BioNTech aiming to bring mRNA manufacturing to Asia

BioNTech will boost its mRNA capacity by building a facility in Singapore. Meanwhile a joint venture with Fosun Pharma looks to bring its COVID-19 vaccine to China. BioNTech’s BNT162b2 became the first messenger RNA (mRNA) COVID-19 vaccine to receive emergency use approval in December 2020. Since then, 450 million doses of the vaccine have been shipped to 91 countries from the firm’s manufacturing facilities in Germany and its partner Pfizer US and European production network. Now the firm is looking…

Allogene and Regenxbio point to inhouse CGT advantage

With facilities set to come online in California and Maryland, Allogene and Regenxbio respectively are the latest advanced therapy firms to laud the advantages of inhouse production. Allogene launched in 2018 with backing from Pfizer and has progressively been developing its AlloCAR T allogeneic, or off-the-shelf, chimeric antigen receptor (CAR) T-cell therapies. Its lead candidate is ALLO-501A looking to move into Phase II studies for Non-Hodgkin Lymphoma later this year. The company hopes to support the trial and beyond through…

Catalent bolsters pDNA biz with Promethera buy

Contract development manufacturing organization (CDMO) Catalent has acquired Promethera’s cell therapy manufacturing subsidiary, Hepatic Cell Therapy Support (HCTS). No financial details have been disclosed. Catalent gains a 32,400 square-foot plant located on in Gosselies, Belgium. The facility will be used for commercial-scale plasmid DNA (pDNA) production and is next to the Delphi Genetics building, which the firm acquired in February expanding its pDNA offering. “With this investment, Catalent will now be able to offer cell therapy and gene therapy customers…

Lonza to up mammalian bioreactor capacity by 136,000L

Lonza has invested $935 million to expand its mammalian manufacturing facilities in Visp, Switzerland and Portsmouth, US.   Swiss contract development manufacturing organization (CDMO) Lonza will construct a large-scale stainless-steel plant in Visp and a small-scale, single-use technology facility in Portsmouth to respond to customer demand for mammalian drug substance production.   “At Lonza, we are focused on supporting our customers to achieve efficient, high-throughput production processes and flexible manufacturing solutions,” said Jean-Christophe Hyvert, president, Biologics and Cell & Gene, Lonza.   He added: “Our customers’ needs range from the manufacture of small- to mid-volume…

Fill & finish investments plus pandemic drive Catalent’s biologics biz

Biologics now represent over half of Catalent’s revenues with the firm citing drug product manufacture as a major driver. For a number of years, contract development manufacturing organization (CDMO) Catalent has been tipping the balance of its business away from its small molecule and delivery technology heritage, and towards its biologics business. The biologics business pulled in around 32% of Catalent’s business mix in 2019, but in under two years the division pulled in over half of the CDMO’s net revenues…