The evolution of the CDMO sector is propelled by rising manufacturing standards, the advent of groundbreaking therapies, and a shift towards personalized medicine. CHEManager asked executives and industry experts from a broad range of CDMOs to share their views on how their companies are dealing with this changing economic environment and the resulting opportunities and challenges.
The evolution of the CDMO sector is propelled by rising manufacturing standards, the advent of groundbreaking therapies, and a shift towards personalized medicine.
Novo Holdings, Novo Nordisk's parent company, is acquiring US contract development and manufacturing organization (CDMO) Catalent for $16.5 billion. The companies said that Novo Holdings will acquire all outstanding shares of Catalent for $63.50 per share in cash.
Catalent, a US-headquartered CDMO, has broken ground on a project in Schorndorf, Germany, that will add capacity for storing and handling clinical trial supply materials at controlled temperatures.
Catalent has opened a new commercial-scale cell therapy manufacturing facility at its European center of excellence for cell therapies in Gosselies, Belgium.
US-headquartered CDMO giant Catalent has completed the expansion of its clinical supply facility in the Waigaoqiao Free Trade Zone (FTZ) in Shanghai, China.
Catalent has announced a $12 million expansion program to increase biologics CGMP analytical capabilities at its flagship facility in Kansas City, Missouri.
CDMO heavyweight Catalent is acquiring compatriot Metrics Contract Services, a full-service specialty CDMO with a facility in Greenville, North Carolina, for $475 million. Mayne Pharma Group is the seller.
Catalent has announced it will spend $350 million over several years to expand biologics drug substance and drug product manufacturing capabilities at its Bloomington, Indiana, USA, headquarters. Ultimately, the additions are expected to add more than 1,000 new jobs to the site’s workforce.
Biomanufacturing for both traditional biologics and new modalities, such as cell and gene therapies, continues to be an active area of investment for CDMOs/CMOS. Some of the major investments by the larger CMDOs/CMOs are outlined in this article.
Catalent has acquired a 174,000 m2 biologics development and manufacturing facility currently being built by Vaccine Manufacturing and Innovation Centre UK (VMIC) on the Harwell Science and Innovation Campus south of Oxford, England.
US CDMO Catalent plans to expand its facility in Shanghai, China, doubling capacity for the temperature-controlled storage and distribution of clinical supplies and adding secondary packaging capabilities. The expansion is expected to be completed by the middle of this year.
CDMO Catalent has completed a $10 million project to install large-scale isolator units at its sites in Dartford, UK, and Malvern, Pennsylvania, USA. The facilities will provide advanced containment capabilities for the micronization of highly potent drug compounds.
Catalent has announced a $230 million expansion project that will add three more commercial-scale viral vector manufacturing suites and associated support facilities and services to its US gene therapy campus in Harmans, Maryland. The CDMO said the investment is designed to meet growing customer demand.
As part of a drive to complement its consumer health technology platform with a wider range of technologies and ready-to-market product libraries, as well as a variety of packaging options, US CDMO Catalent has announced plans to acquire Plano, Texas-based US company Bettera Holdings for $1 billion. The all-cash transaction, it said, is “subject to customary adjustments.”
DisperSol Technologies, a clinical-stage pharmaceutical company developing new treatments for oncology and rare diseases, has linked up with CDMO Catalent on a strategic manufacturing collaboration to accelerate the development of multiple DisperSol pharmaceutical products.
Catalent has kicked off the first phase of a two-phase $100 million expansion to add biologics drug substance production at the Anagni, Italy, plant it acquired from Bristol Myers Squibb in January 2020. This, the US-based CDMO said, will support the growing European market demand for biologics manufacture and supply.
Catalent has announced plans to acquire RheinCell Therapeutics, a German developer and manufacturer of GMP-grade human induced pluripotent stem cells (iPSCs), a type of cell that can be differentiated into various cell types to address a wide range of therapeutic indications.
After losing Emergent BioSolutions as a Covid-19 vaccine production partner, AstraZeneca has been looking for a new CDMO to fulfil its $1.2 billion contract with the US Biomedical Advanced Research and Development Authority (BARDA). Citing people familiar with the matter, the newspaper New York Times reports that the Anglo-Swedish drugmaker is now in talks with the US government about transferring dose manufacture to Catalent.
Under an expanded agreement, US contract manufacturer Catalent is dedicating a new high-speed vial filling line at its Bloomington, Indiana, biologics facility to the manufacture of Moderna’s Covid-19 vaccine and potentially to other investigational programs.
With the backing of the US government, Johnson & Johnson has taken over “full responsibility" for manufacturing at the Bayview plant operated by its Baltimore, Maryland-based vaccine ingredients supplier, US biotech Emergent BioSolutions.
With the race to vaccinate populations against Covid-19 going full steam, health agencies such as the World Health Organization (WHO) and the Serum Institute of India (SIL), world’s largest vaccine maker, have raised alarm that nationalism and protectionism could lead to an international vaccine trade war that in particular could disadvantage countries with insufficient resources.
Leading US gene therapy CDMO Catalent is buying all shares of another CDMO in the same field, plasmid DNA (pDNA) specialist’s Delphi Genetics, headquartered at Gosselie, Belgium. Concurrently, the New Jersey-based company is launching pDNA development and manufacturing services at its Rockville, Maryland, facility.
US-based CDMO Catalent has agreed to buy the powder inhaler spray drying, capsule manufacturing and packaging operations of Acorda Therapeutics, a biotech specializing in developing therapies for neurological disorders. Financial terms of the deal, which is expected to close in the first quarter of 2021, were not disclosed.
US-based CDMO Catalent has agreed to acquire Bone Therapeutics’ cell therapy manufacturing subsidiary, Skeletal Cell Therapy Support (SCTS), in Gosselies, Belgium, for $14 million.
US-based CDMO Catalent is joining forces with compatriot drug discovery company Exelixis to develop multiple antibody-drug conjugates (ADCs). The company’s Redwood Bioscience subsidiary will use its proprietary SMARTag site-specific bioconjugation technology to build ADCs using monoclonal antibodies from Exelixis’ preclinical pipeline.
So far, the pharmaceutical industry — including CMOs/CDMOs — has responded well to the outbreak of the Covid-19 pandemic.
Catalent Gene Therapy, a unit of US-based CDMO Catalent, is spending $130 million on five new Phase 3-through commercial-scale manufacturing suites at its gene therapy campus in Harmans, Maryland, near Baltimore Washington International (BWI) airport. The company said the investment is in reaction to a growing customer pipeline and market demand.
Catalent Biologics is investing $50 million in an additional high-speed vial filling line at its Bloomington, Indiana, USA, facility to support the growing pipeline of clinical programs and commercial launches at the site.
Catalent Cell & Gene Therapy, a unit of US-based CDMO Catalent, has signed on to provide drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine candidate, known as AZD1222. Financial details were not disclosed.
US biotechs Catalent and Humanigen are extending their standing collaboration on lenzilumab, Humanigen’s proprietary anti-human granulocyte macrophage-colony stimulating factor (GCM-CSF) monoclonal antibody, with a new supply agreement covering Phase 3 clinical studies.
US-based CDMO Catalent has agreed a collaboration with US biotech Moderna for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate (mRNA-1273) at Catalent’s biologics facility in Bloomington, Indiana, USA.
To save manufacturing space for its growing vaccines plans, Pfizer has said it will outsource production of some of its pharmaceutical portfolio. The work is planned to be shared out with a network of 200 contractors in the US and Europe.
As part of a plan to establish a network of manufacturing partners to help boost capacity ahead of a potential FDA approval of a Covid-19 vaccine, US healthcare giant Johnson & Johnson (J&J) recently signed agreements with two US companies.
