The latest news from CDMOs/CMOs and suppliers, featuring Siegfried, Olon, dsm-firmenich, Catalent, Incog BioPharma, MedPharm, and Tergus Pharma. Highlights below.

Chemicals/Chemical API Manufacturing
* Siegfried Names New CEO; Completes Acquisition of US CDMO Site from Curia
Biologics Manufacturing
* Olon Acquires Biologics CDMO GTP Bioways
Formulation Development/Drug Product Manufacturing
* Incog BioPharma Expanding Sterile Mfg
* CDMOs MedPharm, Tergus Pharma Merge
Packaging
* Catalent Completes $25-M Expansion of Clinical Supply Facility in Germany
General
* dsm-firmenich To Sell MEG-3 Fish Oil Business to KD Pharma

---

Chemicals/Chemical API Manufacturing

Siegfried Names New CEO; Completes Acquisition of US CDMO Site from Curia
Siegfried, a CDMO of drug substances and drug products, has appointed Marcel Imwinkelried, currently the company’s Chief Operating Officer, Drug Products, as the company’s new CEO, effective September 1, 2024. He will succeed Reto Suter, who has been leading the Siegfried Group as CEO ad interim since May 1, 2024, and will now focus again on his role as chief financial officer.

Imwinkelried joined the Siegfried Group in January 2021 as Multi-Site Head for the Drug Products sites in Barbera del Valle and El Masnou, Barcelona, Spain, and Irvine, California, and was appointed Chief Operating Officer, Drug Products, in October 2021. Previously, he had worked for Novartis since 2005 in various roles with increasing responsibility and was appointed Global Head Technical Operations, Solids, in 2018.

Separately, Siegfried has completed its previously announced acquisition of an early-phase CDMO site in Grafton, Wisconsin, from Curia. The acquisition was announced on June 12, 2024, and was completed on July 1, 2024.

Source: Siegfried (CEO) and Siegfried (Acquisition)

---

Biologics Manufacturing

Olon Acquires Biologics CDMO GTP Bioways
Olon, a CDMO of small-molecule and biologic drug substances, has acquired GTP Bioways, a France-based CDMO of biologics. GTP Bioways provides R&D services, process development, and production of monoclonal antibodies, enzymes, proteins, nanodrugs, antibody drug conjugates (ADCs), and fill–finish services.

GTP Bioways operates a total of four sites in France (Toulouse, Labège, Veyre-Monton, and Saint-Julien-en-Genevois) focused on development, clinical trial material supply, and cGMP manufacturing. The company’s headquarters are based in Toulouse.

Separately, as part of its small-molecule active pharmaceutical ingredient activities, in the third quarter of 2024, Olon will finalize its EUR 25-million ($27-million) investment in a facility for the development and production of ultra high-potent API payloads and payload-linkers for ADCs.

Source: Olon

---

Formulation Development/Drug Product Manufacturing

Incog Biopharma Services Expanding Sterile Mfg
Incog BioPharma Services, a CDMO of sterile injectables, has announced a new investment to expand its site in Fischer, Indiana, with the construction of a second 100,000-square-foot building, set to break ground in August (August 2024). This will increase the company’s commercial-scale device assembly capacity in support of autoinjectors, pens, wearable injectors, and syringe accessorizing while also adding new labeling and final packaging capabilities.

The new investment follows current work to commission and install a second high-speed syringe and cartridge filling line, along with supporting automated visual inspection equipment. The new filling line complements the company’s existing multi-use filling line, bringing the site’s filling capacity to 140 million units per year. The automated visual inspection and autoinjector assembly capabilities are available now, with the additional syringe-filling capacity coming on line in the second quarter of 2025.

Source: Incog BioPharma Services

---

CDMOs MedPharm, Tergus Pharma Merge
MedPharm, a CDMO of topical and transepithelial products, and Tergus Pharma, a CDMO of drug products, have merged, and will operate under the MedPharm name. As part of the transaction, Tergus Pharma’s CEO, Michael Kane, has been appointed CEO of MedPharm while Patrick Walsh will continue to serve as Executive Chairman of MedPharm.

The merged business provides drug development and manufacturing services for topical and transepithelial pharmaceuticals as well as commercial production and serialization, formulation development, in vitro testing, and clinical manufacturing within one integrated organization. Expanded capabilities will also include the development and manufacture of hormone-based and highly potent drugs at MedPharma’s GMP manufacturing facility in Durham, North Carolina.

Source: MedPharm

---

Packaging

Catalent Completes $25-M Expansion of Clinical Supply Facility in Germany
Catalent has completed a $25-million expansion of its clinical supply facility in Schorndorf, Germany. The Schorndorf site provides clinical supply services, including packaging, storage, and distribution.

The expansion increases the site’s footprint by 32,000 square feet and adds storage and handling of clinical trial supply materials at controlled room temperatures between 15 and 25 degrees Celsius. It also creates space in the original building to accommodate the installation of a new bottle filling line, as well as a dedicated area for Catalent’s FastChain supply service.

The Schorndorf site provides comparator sourcing, primary and secondary packaging, labeling, clinical storage and distribution, and returns and destruction. This co-located site also offers late-stage pharma product development and commercial services, including oral solid dose manufacturing and specialty packaging.

Source: Catalent

---

General

dsm-firmenich To Sell MEG-3 Fish Oil Business to KD Pharma
dsm-firmenich has agreed to sell its MEG-3 fish oil business to KD Pharma Group, a CDMO of pharmaceutical and nutritional lipids. As part of the transaction, dsm-firmenich will obtain a minority stake of 29% in KD Pharma’s parent company, O³ Holding GmbH.

Following its strategic portfolio review, as announced on June 3, 2024, dsm-firmenich decided to de-prioritize certain business segments, including the MEG-3 business. This will allow dsm-firmenich to focus its lipids activities on its algae-based Omega-3 portfolio while continuing to offer MEG-3 fish oils for the early-life nutrition markets as well as MEG-3 powders.

The transaction includes dsm-firmenich’s MEG-3 business for the food & beverage, dietary supplement, and pharma markets, together with production facilities in Piura, Peru, and Mulgrave, Canada. The MEG-3 business represented approximately EUR 170 million ($185 million) in sales in 2023, with approximately 200 employees who will transfer to KD Pharma. 

The transaction is expected to be completed toward the end of 2024, and is subject to customary regulatory approvals.

Source: dsm-firmenich