Contract Development And Manufacturing Organizations (CDMO)

Topics • Strategy

Siegfried Demonstrates Biologics Expertise in Hameln

The Fill & Finish of biologic drugs is expensive and poses special technological challenges for CDMOs. At the German site in Hameln, Siegfried has successfully proven these capabilities over the past two years by producing Covid-19 vaccines and a significant number of clinical batches for several biological companies. By investing in its competencies, capacities and flexibility, the company intends to further expand this demanding but promising business area.

Topics • Strategy

"We Want to Be a Big Fish"

The CDMO (contract development and manufacturing organizations) business has a bright future, of that Siegfried CEO Wolfgang Wienand is certain. The economic advantages alone speak for this compared to in-house production by the pharmaceutical companies themselves. Although Siegfried has already reached sufficient critical size within its industry, he sees the company continuing on its growth path. The goal is to take over an even larger share of the value chain from pharmaceutical companies in the future.

Olon Expands API Production

Olon, an Italian CDMO and API producer, is investing a total of €100 million in 2023 to increase production capacity, in particular at its site in Mulazzano, Lodi province.

Siegfried Takes Majority Stake in Dinamiqs

Swiss CDMO Siegfried has acquired a 95% stake in Dinamiqs, a compatriot biotech focused on developing and manufacturing viral vectors for cell and gene therapies.

CordenPharma Expands at US Site in Colorado

CordenPharma is expanding strategically into synthetic oligonucleotide manufacturing at its plant at Boulder in the US state of Colorado. The two-phase investment is designed to provide innovative biotech and pharma customers with a fully integrated API to Drug Product service offering.

WuXi STA Expands Capabilities at Changzhou Campus

WuXi STA has added two reactors at its Changzhou campus in China, enhancing capacity and capability at its TIDES contract research, development and manufacturing platform for oligonucleotide, peptide and related synthetic conjugates. The reactors have capacity of 2,000 liters each, taking total volume for solid-phase peptide synthesizers to more than 10,000 liters.

Catalent Starts Schorndorf Expansion

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.

News • Strategy

Delivering Quality with Speed for European Market

In this interview, Jinling Chen, head of WuXi STA’s drug product business, and Jamie Andrews, site head of WuXi STA’s Couvet facility, explain the company’s strategy and the goals of the European expansion.

Aenova Appoints Hanno Scheffczik as Managing Director of its Marburg Site

Hanno Scheffczik has been appointed as the new Managing Director of Temmler Pharma, a member of the Aenova Group. Effective Mar. 1, 2023, he succeeds Alfred Veit, who is retiring.

Topics • Innovation

Axplora Aims to Make Pharmaceutical Supply Chains More Stable

Interview with Sylke Hassel, previous CEO of PharmaZell and current CEO of Axplora following the merger with Novasep.

Canada’s Biodextris Builds Biologics Facility

Canadian CDMO Biodextris plans to build a new industrial-scale vaccine and biologics facility in Laval, Quebec. The company said the cGMP biomanufacturing center and its analytical capabilities will be an asset in its development as a world-class CDMO.

Lotte Outlines Plans to Become Major CDMO Player

Lotte Biologics, part of South Korean conglomerate Lotte, has detailed expansions plans for the business as it embarks on a path to become a top 10 CDMO by 2030.

Catalent Opens Cell Therapy Facility in Belgium

Catalent has opened a new commercial-scale cell therapy manufacturing facility at its European center of excellence for cell therapies in Gosselies, Belgium.

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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.

Catalent Completes Shanghai Plant Expansion

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

Change of Ownership for US CDMO Alcami

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.

Curia Begins Work on New Mexico Expansion

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.

Recipharm Bolsters Blow-Fill-Seal Capabilities in France

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

Symeres Strengthens US Foothold with Exemplify Buy

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 to Invest $12 Million at Kansas City

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

News • Strategy

The Future of Outsourcing

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.

Topics • Chemistry

Investing in Growth Through Innovation

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.

CDMO Adragos to Buy Sanofi Site in Japan

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.

News • Innovation

Bachem Innovates its Manufacturing Capabilities

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

Topics • Chemistry

Ensuring API Supply Capacities for Europe and Beyond

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

Olon Expands Indian API Capabilities

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 Buys US CDMO Tapemark

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.

Arxada Expands at Visp to Continue Supplying DSM

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 Appoints Mark Caswell as Vice President, US Facility Site Head

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.

Grace Expands Michigan Fine Chemicals Site

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 Invests $1.6 Billion for Cell Culture Expansion

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

Lonza Builds Swiss Fill & Finish Facility

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.

Expansion at SK Biotek API Plant to Cost $35 Miilion

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.

Olon Establishes Central R&D Hub near Milan

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 Poised to Shake up European CDMO Scene

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.

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