Market Place
CDMO Activity Tracker: Novo taps Patheon to augment Wegovy supply; Wuxi sets up standalone vaccine plant
The third quarter (Q3) of 2023 was marked by deals and capacity expansions in the contract development and manufacturing organization (CDMO) space. Moreover, the trend of CDMOs increasing their exposure to advanced therapies, such as biologics, cell and gene (C&G) therapies, and highly potent active pharmaceutical ingredients (HPAPIs) continued unabated.
Some of the key players in the CDMO space are Lonza, Catalent, Recipharm AB, Thermo Fisher, Seqens, Curia, Siegfried, Samsung Biologics, Fujifilm Diosynth Biotechnologies, Quotient Sciences and, Piramal Pharma Solutions.
View CDMO Activity Tracker of Q3 2023 (Free Excel Available)
Novo taps Patheon to meet Wegovy supply;
Samsung Biologics-BMS expand deal
Novo Nordisk has been struggling to ramp up supplies of its popular weight-loss drug, Wegovy. Back in October 2021, there were quality issues at the Brussels facility of its key CDMO Catalent that fills Wegovy injection pens. The two companies are hoping to resolve the quality issues at the Brussels facility soon. For now, Novo and Catalent have expanded their supply agreement — Catalent’s Bloomington, Indiana plant will now fill injection pens for Wegovy. According to reports, Novo has also struck a deal with Thermo Fisher's CDMO subsidiary Patheon for manufacturing Wegovy at its Greenville, North Carolina facility.
Samsung Biologics has expanded its strategic agreement with Bristol Myers Squibb (BMS) for large-scale manufacturing of the latter’s commercial antibody cancer drug substance. This drug substance will be manufactured at Samsung Biologics’ facility in Songdo, South Korea.
Polpharma has signed two agreements with Poland’s clinical-stage drug development firm — Ryvu Therapeutics — for manufacturing an active substance (RVU120) used for phase 2 clinical studies in hematology.
In July, French drugmaker Biophytis signed a master agreement with Seqens to produce the active compound in Sarconeos (BIO101), Biophytis’ main drug candidate developed for three indications — severe forms of Covid-19, sarcopenia and Duchenne muscular dystrophy.
A month later, Biophytis signed an agreement with Skyepharma for the production of finished product batches of Sarconeos for severe forms of Covid-19.
Another CDMO, Recipharm, has partnered with start-up Ahead Therapeutics to develop a ground-breaking treatment for myasthenia gravis, a rare autoimmune disease.
View CDMO Activity Tracker of Q3 2023 (Free Excel Available)
WuXi launches standalone plant for jabs in China; Bora opens new facility in Taiwan
WuXi Biologics’ immunization-focused subsidiary WuXi Vaccines has launched its first standalone vaccines contract manufacturing facility in Suzhou, China. This new plant will focus on drug substance and drug product capacity for projects in various stages of development.
Bora Pharmaceuticals has opened a state-of-the-art facility in Taoyuan City, Taiwan, that provides its customers access to extensive ophthalmic manufacturing services. The facility will specialize in ophthalmic products such as sterile solutions, emulsions, creams, ointments and gels.
Skyepharma and clinical-stage biotech MaaT Pharma have completed construction of what will be Europe’s largest manufacturing facility for microbiome ecosystem therapies.
Aurigene Pharmaceutical Services, a subsidiary of Dr Reddy’s Laboratories, will invest US$ 40 million to build a specialized development and manufacturing facility in Hyderabad (India), targeting therapeutic proteins, antibodies, and viral vectors.
View CDMO Activity Tracker of Q3 2023 (Free Excel Available)
EUROAPI acquires BianoGMP; Syngene buys Stelis’ biologics facility
In mergers and acquisitions, EUROAPI bought Germany-based contract manufacturer BianoGMP for €10 million (US$ 10.6 million) to strengthen its expertise in the high-growth oligonucleotide market. SK pharmteco announced it is acquiring a controlling stake in Center for Breakthrough Medicines (CBM), a Philadelphia-based cell and gene therapy CDMO. The move will expand SK pharmteco’s technical expertise, production capacity, and geographic reach.
Syngene is acquiring a manufacturing facility in Bengaluru, India, from Stelis Biopharma for INR 7.02 billion (US$ 86 million), to enhance its biologics drug substance manufacturing capacity. And Sharp, a leader in pharmaceutical packaging and clinical trial supply services, has acquired Berkshire Sterile Manufacturing, a specialized CDMO focusing on sterile injectable products.
View CDMO Activity Tracker of Q3 2023 (Free Excel Available)
AGC Biologics augments C&G capacities; CordenPharma upgrades peptide unit
The quarter saw several CDMOs expand their facilities, including AGC Biologics, Fermion, Porton Pharma Solutions and Evonik.
AGC Biologics expanded its program to provide lentiviral vector (a type of retrovirus) support for advanced therapies to drugmakers focused on rare diseases. The company added three new cell therapy suites to its Colorado facility. It also expanded its C&G therapy facility in Milan, Italy, to meet demands for GMP viral vector manufacturing projects.
After bagging a potential US$ 1 billion, multi-year contract to manufacture large-volume peptide at its Colorado facility earlier this year, CordenPharma has upgraded its commercial peptide production capacity. This unit is now the world’s largest solid-phase peptide synthesis (SPPS) manufacturing facility.
Meanwhile, Fermion has increased its manufacturing capacity for APIs at its Hanko site in Finland and Porton Pharma Solutions has expanded its capabilities in New Jersey, with a new 40,000-square-feet drug development facility under its US subsidiary, J-Star Research.
CDMO Axplora has announced the installation of a new cGMP pilot flow chemistry unit at its Leverkusen site (Germany). Additionally, Evonik and Heraeus Precious Metals have tied up to expand their range of services for HPAPIs.
View CDMO Activity Tracker of Q3 2023 (Free Excel Available)
Curia, Touchlight tie-up for doggybone DNA; MilliporeSigma opens new mRNA sites
Several CDMOs advanced their messenger RNA (mRNA) drug substance facilities during the last quarter. Leading CDMO Curia has tied up with Touchlight, a company that specializes in making DNA using enzymes. This collaboration will offer Curia’s clients access to Touchlight’s special DNA vector, known as “doggybone DNA” (dbDNA), which can be used as a template for making mRNA therapies. The pact expands Curia’s existing mRNA production offerings with another differentiated source of DNA raw material that’s “immediately” available to its customers.
MilliporeSigma inaugurated two new mRNA drug substance manufacturing sites in Germany — at Darmstadt and in Hamburg. The two sites will tackle a full range of mRNA services, from preclinical to commercial-scale projects. Similarly, Ardena and RiboPro have forged a strategic alliance to provide solutions for the production of advanced mRNA and lipid nanoparticles. And American CRO and CDMO PackGene BioTech and an mRNA CDMO Kudo Biotechnology have tied up to provide customized mRNA manufacturing services for drug and vaccine development.
View CDMO Activity Tracker of Q3 2023 (Free Excel Available)
Our view
The start of Q4 saw leading CDMO Lonza strengthen its collaboration with a key biopharmaceutical partner to scale up the filling of antibody-drug conjugates. Moreover, Advent International and Warburg Pincus completed their US$ 4.25 billion acquisition of Baxter’s BioPharma Solutions business, which will now be known as Simtra BioPharma Solutions.
Overall, the year’s developments have strengthened our belief that the global CDMO market will grow considerably in the coming years. Research and Markets puts that number at US$ 246.6 billion by 2026, up from US$ 172.7 billion in 2022.
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Image Credit : CDMO Activity Tracker of Q3 2023 by PharmaCompass license under CC BY 2.0
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