CDMO Activity Tracker: Q3 sees increased dealmaking, expansion in CDMO space
Since the start of the pandemic, the pharmaceutical industry has increased its reliance on contract development and manufacturing organizations (CDMOs) to speed up the development of clinical candidates, candidate registration, market authorization and manufacturing. That trend continued through the third quarter (Q3) of 2022, as CDMOs increased capacities, entered into more alliances and deals and worked on new and innovative products. However, drop in demand for Covid vaccines did hit some CDMOs, as they saw their supply deals come to an abrupt end.
Samsung’s ‘super plant’ starts operations; Catalent, Fujifilm, PCI in expansion mode
One of the biggest expansions was undertaken by — in October, it operations at its plant 4, which is the world’s largest single bio-manufacturing plant. Construction of this plant, situated at its Incheon, South Korea hub, began in November 2020. This facility is as large as its other three facilities combined.
Catalent biologics cGMP analytical capabilities at its flagship facility in Kansas City, Missouri, with the addition of two new analytical development laboratories to support the growing demands of assay development. It also expanded facility in Singapore.
Fujifilm Diosynth Biotechnologies US$ 1.6 billion expansion of its site at Hillerod in Denmark to strengthen its cell culture manufacturing. It has also on the expansion of its large-scale microbial manufacturing facility in Billingham, UK, while also embarking on the addition of a new cGMP production .
Catalent acquires Metrics Contract Services, Samsung signs deal with GSK
The CDMO space saw several alliances, acquisitions and deals. Catalent acquired Metrics Contract Services from for . The takeover will bolster Catalent’s expertise in developing oral solid formulation and expand its capacity to manufacture highly potent compounds. During the last quarter, Catalent also announced a drug with Awakn Life Sciences.
Samsung Biologics manufacturing deal with GSK. The CDMO also signed a deal worth with .
In October, agreed to in Sisslerfeld from . The new site will become of this decade and will house a production building for peptides and oligonucleotides. This will be Bachem’s third Switzerland. The CDMO has also signed worth CHF 25 million (US$ 25.9 million) and CHF 150 million (US$ 155.4 million) for supplying large volumes of peptides in 2023 and 2024, respectively.
CDMO giant Lonza a deal with to expand production and distribution of the biotech’s doggybone DNA platform. Lonza will gain access to Touchlight’s technology that eliminates bacterial sequences. Lonza has also with Singzyme. It will gain access to Singzyme’s enzymatic conjugation platform, enabling the site-specific binding of payloads with peptidic linkers to proteins of interest.
of and in April 2022 has given rise to a new brand. Three brands — , Novasep and PharmaZell — have now been unified under a single brand, . And private equity firm has launched Cohance Lifesciences for its . Cohance will comprise three formerly acquired companies — , and .
plans with to create a new global drug-device combination product CDMO. The new company will have a wide range of drug delivery capabilities, with expertise and technology in parenteral, inhalation, transdermal and intradermal routes of administration.
Drop in demand for Covid jabs leads to termination of supply deals
Owing to low demand vaccines, has terminated a supply deal with its CDMO partner Fujifilm Diosynth Biotechnologies. In a securities filing, Novavax said it will pay up to US$ 185 million in a settlement tied to the “termination of manufacturing activity” at Fujifilm.
The CDMO sector also faced some regulatory setbacks. The US Food and Drug Administration (FDA) issued a warning letter to for its Camden manufacturing Baltimore, Maryland. Since early-2021, the company has been in news for the quality issues it faced while manufacturing Covid-19 vaccines for and . Similarly, Catalent’s manufacturing site in Brussels, Belgium, a Form 483 with nine observations following an inspection by the FDA in August.
In news, announced that two of its drug substance facilities and a drug product facility in Wuxi city have received regulatory approvals from the European Medicines Agency (EMA) and the FDA. The company also announced the GMP phase I drug substance clinical manufacturing facility in Cranbury, New Jersey.
CDMOs increase exposure to cell therapy; Lonza, Bora work on innovative new drugs
The sector is witnessing considerable innovation. One such area is cell and gene therapy (CGT) — the CGT CDMO market is expanding at a compounded annual rate of 25 percent, and is estimated to reach US$ 5 billion by 2025.
Lonza is process and analytical development laboratories in Houston (US) and Geleen (the Netherlands) for CGT. Recently, L cell and gene therapies – Zynteglo and Skysona – will be manufactured at its Houston site.
This month, Charles River Laboratories said it is expanding its cell therapy CDMO facility at Memphis, Tennessee, to cell therapy developers to streamline and accelerate their programs. The Memphis facility is the in North America to receive approval from the EMA to commercially produce allogeneic cell therapy drug products.
and announced a to deliver clinically-proven products and manufacturing processes for advanced therapies. In August, and Kun Tuo established a in CGT R&D, manufacturing and clinical services to accelerate the development and industrialization of innovative drugs.
and RD-Biotech signed a in cell and gene therapy GMP manufacturing. This collaboration brings together RD-Biotech’s plasmid DNA GMP manufacturing services with ABL’s viral vector GMP manufacturing to offer a new and flexible end-to-end service to CGT developers.
Several CDMOs are working on innovative new products. For instance, Lonza has launched a called Capsugel Enprotect for acid-sensitive APIs. Similarly, Bora Pharmaceuticals with to manufacture CVM-1118, a new small molecule chemical entity being developed by TaiRx as a potential anti-cancer agent. And has partnered with to novel acid-blocker, .
CDMOs increase focus on parenteral drug manufacturing, HPAPIs
Increased demand for biologic-based drug development is a that is driving the demand for parenteral drugs (i.e. drugs given by routes other than the digestive tract) manufacturing. Several CDMOs, such as , and , are capacities to cater to the increased demand for parenteral drugs.
Last month, Curia of its expanded campus in Albuquerque, New Mexico, to house an advanced isolated high-speed fill-finish vial line and two lyophilizers for the high-speed fill-finish line. Recipharm has in a new high-speed filling line for pre-filled syringes and cartridges at its sterile manufacturing facility in Wasserburg, Germany. The company has also bolstered its sterile filling capabilities by investing in low volume blow-fill-seal (BFS) in Kaysersberg, France.
In September, WuXi STA opened oral drug product manufacturing facility at its site in Wuxi, China. The facility offers multiple formulation processes, including wet and dry granulation, tablet compression and coating, in addition to capsule filling, with an annual production capacity of 400 million tablets and 200 million capsules. WuXi STA is also slated to open a new high-potency sterile parenteral in the third quarter of 2023 at Wuxi.
In September, Lonza of its HPAPI multipurpose manufacturing suite at Visp, Switzerland. The expansion adds development and manufacturing capacity for ADC payloads, supporting the entire development and manufacturing pipeline.
The CDMO space is growing at a healthy pace, with many outfits opting to expand their facilities to focus on cell and gene therapy, innovative new drugs, parenteral drugs and HPAPIs. In future too, we see technological advancements and the need to differentiate creating more opportunities for the sector.