
Flow Chemistry
Executives and industry experts share their views on drivers as well as barriers for the use of flow chemistry in pharmaceutical manufacturing and the prospect for this technology in their industry sector.

Executives and industry experts share their views on drivers as well as barriers for the use of flow chemistry in pharmaceutical manufacturing and the prospect for this technology in their industry sector.

US-headquartered CDMO giant Catalent has completed the expansion of its clinical supply facility in the Waigaoqiao Free Trade Zone (FTZ) in Shanghai, China.

UK specialist healthcare investor GHO Capital Partners and US investment firm The Vistria Group have entered into an agreement to buy a controlling interest in US CDMO Alcami from current private equity owners Madison Dearborn Partners (MDP) and Ampersand Capital Partners. Financial terms of the deal were not disclosed.

US CDMO Curia has begun construction on an expansion of its campus in Albuquerque, New Mexico. The facility designed by Burns & McDonnell will be built by BE&K Building Group.

Swedish multinational CDMO Recipharm has bolstered its sterile filling capabilities at its facility in Kaysersberg, France, by installing Lab+ continuous automated technology.

Dutch CDMO Symeres has acquired Exemplify Biopharma, a US-based contract research organization (CRO) based in Cranbury, New Jersey, USA. The deal further strengthens Symeres’ foothold in the US, where it already generates about 50% of its revenues.

Catalent has announced a $12 million expansion program to increase biologics CGMP analytical capabilities at its flagship facility in Kansas City, Missouri.

The increasing complexity in drug development and the highly competitive industry landscape are creating a dramatic shift in how pharmaceutical and biotech companies plan for and execute drug development and production.

Interview with Marc Doyle, CEO of Arxada, which was created following the carve-out and sale of Lonza Specialty Ingredients to private equity firms Bain Capital and Cinven.

Munich-based German CDMO Adragos Pharma said it has signed a definitive agreement with Sanofi’s Japanese subsidiary to acquire a pharmaceutical manufacturing site in Kawagoe, near Tokyo.

Interest in oligonucleotide therapeutics has grown, as has the market demand, since their emergence as a new drug modality two decades ago.

Interview with Karl Rotthier, CEO of the Sanofi spin-off EuroAPI.

Italian API producer Olon has announced plans to install a new high-containment production line at its site in Mahad, India.

Germany’s LTS Lohmann Therapie-Systeme has completed the acquisition of St. Paul, Minnesota-headquartered CDMO Tapemark, a US specialist in transdermal drug delivery systems, oral thin films and unit dose semi-solid drug and iontophoresis products.

Swiss specialty chemicals company Arxada said it will invest 20 million Swiss francs to expand production at its Visp site following the extension of a long-term supply partnership with DSM.

Rentschler Biopharma has appointed Mark Caswell as Vice President and Site Head. He joined Rentschler in July 2022 and is managing all operations at the company’s US facilities in Milford, MA.

W. R. Grace is expanding its fine chemicals contract development and manufacturing facility in South Haven, Michigan, USA. The project is scheduled for completion in January 2024.

Fujifilm is preparing to invest $1.6 billion to ramp up the cell culture manufacturing services of its CDMO subsidiary Fujifilm Diosynth Biotechnologies.

Swiss CDMO Lonza plans to build a large-scale commercial fill & finish facility in Stein. The new facility, to be located on the same campus as Lonza’s existing clinical drug product capabilities, will cost roughly 500 million Swiss francs and should be completed in 2026.

South Korean CDMO SK Pharmteco (SKTP) said it will spend $35 million on the initial phase of a planned expansion at the Dublin, Ireland, API site the conglomerate acquired from Bristol Myers Squibb in 2017. Prior to that, SK had been a BMS supplier for around a decade.

Major API supplier Olon is establishing a €10 million central R&D hub at its headquarters site in Roadano, near Milan. The Italian company said the facility paves the way for a further major expansion and diversification of its expertise in active pharmaceutical ingredients supplied to the CDMO and generics markets.

EureKING, a new special purpose acquisition company (SPAC) steered by former European biopharma executives, launched itself on May 9 and in a subsequent listing on the Paris-based Euronext stock exchange raised €150 million to buy up small European CDMOs that make biologics, cell and gene therapies or live biotherapeutics.

Interview with Giovanna Libralon, Senior Director Commercial Development Small Molecules at Lonza.

Symeres, a Dutch CDMO and contract research organization, has acquired Organix, a US-based specialized organic chemistry services producer that focuses on lipids. The two firms are highly complementary and the combination unlocks significant strategic value, said Symeres, which generates nearly 50% of its revenues in the US.

Asahi Kasei Medical, through a US subsidiary, has agreed to buy biologics CDMO Bionova Scientific for an undisclosed sum. Located in Fremont, California, Bionova provides process development services to biopharmaceutical companies, especially those developing next-generation antibody-based drugs.

Germany’s Merck has signed a definitive agreement to acquire Exelead, a US biopharmaceutical CDMO, for around $780 million in cash. The Indianapolis, Indiana-based company specializes in complex injectable formulations, including Lipid Nanoparticle (LNP)-based drug delivery technology, which is key to mRNA therapeutics and vaccines for indications such as Covid-19.

French CDMO GTP Bioways, a specialist in biotherapies and nanotherapies, is investing €12 million in two new biopharmaceutical production lines at its site in Toulouse. The first line will be dedicated to production using microbial systems (bacteria and yeast), while the second is designed for the culture of mammalian cells at a scale of 10 l.

Avid Bioservices, a biologics-oriented CDMO based in the US state of California, is building a new plant in Costa Mesa, California, as part of a plan to expand its cell and gene therapy portfolio. The purpose-built facility, to be located five miles from its current base in Tustin, California, will be dedicated to viral vector development and CGMP manufacturing.

Germany’s Merck has opened its second production facility for viral vectors at Carlsbad, California, a move the company said significantly expands its global CDMO footprint. The new €100 million plant will more than double the company’s existing capacity to support large-scale commercial and industrial manufacturing for viral gene therapy.

Successfully managing the drug substance manufacturing of Antibody-Drug Conjugates (ADCs) requires a sophisticated understanding of the technological development process and access to a range of large- and small-molecule manufacturing assets.

Yposkesi, a French CDMO specializing in cell and gene therapies, has started building a second commercial bioproduction facility, known as project SKY. The plant is being designed to be cGMP- compliant with both European and US regulations. Operations are expected to start in 2023.

The CPhI executive post-pandemic pharma survey, produced by Informa Markets as part of the CPhI Pharma 2021 Report, predicts that pandemic supply chain issues have further cemented a push for repatriated manufacturing globally. The findings suggest that over the next 5 years, governments and companies will gradually look to reduce complexity and increase regional self-reliance.

Recent studies show that contract manufacturers for the pharmaceutical industry, so-called CDMOs (contract development and manufacturing organizations), have so far been little involved in the production of vaccines. This is changing with the outbreak of the Covid-19 pandemic.

US-based CDMO Regis Technologies has completed a major expansion of its laboratory facilities for development of active pharmaceutical ingredients (APIs) at its site in Morton Grove, Illinois. The project, kicked off two years ago, doubles the company’s capacity to take on new development projects.

Contract manufacturer Aenova has put a third, high-performance tablet press including integrated automatic in-process control into operation at its site in Regensburg, Germany, to expand its production capacity of highly potent oncology drugs.
























