Supplier News: SHL, Resilience, AGC Biologics, Incog BioPharma & More
The latest from CDMOs, CMOs, and suppliers featuring AGC Biologics, Incog BioPharma Service, SHL Medical, Kindeva Drug Delivery, National Resilience, Artis BioSolutions/Landmark Bio, Benuvia, and LBB Specialties.
Chemicals/Chemical API Manufacturing
Benuvia Awarded NIH Contract for GMP Synthesis of Psilocybin
Biologics Manufacturing
* Artis BioSolutions Launches as New CDMO, Acquires Landmark Bio
* AGC Biologics Launches New Cell and Gene Therapy Division
Formulation Development/Drug Product Manufacturing
* SHL Medical Opens $220-M Autoinjector Mfg Facility; Partners with Kindeva
* Incog BioPharma Services Expanding Sterile Injectables Capabilities
* LBB, Kerry Group Partner for Pharmaceutical Lactose
Packaging
* National Resilience to Expand Device Assembly, Packaging & Storage Capacity
General
* ProBioGen Appoints new CEO
Chemicals/Chemical API Manufacturing
Benuvia Awarded NIH Contract for GMP Synthesis of Psilocybin
Benuvia, a CDMO of drug substances and drug products, including controlled substances, has been awarded a five-year contract by the National Institute on Drug Abuse, a component of the US National Institutes of Health (NIH), for the GMP synthesis of psilocybin and other bulk drug substances.
The NIH contract will support the research and development of active pharmaceutical ingredients for substance-use disorders and mental health conditions. Benuvia will initially focus on the synthesis and scale-up of psilocybin, a Schedule I substance under the Controlled Substances Act that was granted breakthrough therapy designation by the US Food and Drug Administration for major depressive disorder in 2019 and treatment-resistant depression in 2018. As part of the contract, Benuvia will manufacture and deliver GMP-grade psilocybin for NIDA’s preclinical toxicity studies and clinical trials.
Source: Benuvia
Biologics Manufacturing
Artis BioSolutions Launches as New CDMO, Acquires Landmark Bio
Artis BioSolutions, a company founded for the discovery, development and production of genetic medicines, has launched as a company, and with that, has acquire Landmark Bio, a Watertown, Massachusetts-based CDMO of biologics.
Landmark Bio, formed in 2021 from a consortium of Harvard, MIT, Cytiva, Fujifilm, and Alexandria Real Estate Equities, is a cell and gene therapy manufacturing company specializing in translational research, process development, and manufacturing technologies. As a part of Artis, Landmark Bio will continue to operate as a distinct entity, focused on accelerating therapeutic development from preclinical through commercialization.
Source: Artis BioSolutions
AGC Biologics Launches Cell and Gene Technologies Division
AGC Biologics, a CDMO of biologics, has launched a Cell and Gene Technologies Division. The AGC Biologics Milan Cell and Gene Center of Excellence will be the central location for this new Division
The 140,000-square-foot facility offers end-to-end services, including research and development (R&D) and innovation teams supporting initial development and early clinical phases, expanded large-scale viral vector suites with scales up to 2,000 L, new cell-therapy suites, and a dedicated floor for quality control. The new Cell and Gene Technologies Division features expanded global capabilities, including the company’s Longmont facility in Colorado and the new Yokohama facility, in Japan, which will begin cell therapy operations in July 2025.
Luca Alberici, currently General Manager of the company’s Milan Cell and Gene Center of Excellence, has been appointed Executive Vice President of the Cell and Gene Technologies Division. He will report directly to Alberto Santagostino, the company’s President and CEO, and join the company’s executive leadership team. Alberici will oversee this new Division’s global strategy, operations, and commercial development, and he will keep his current role as General Manager of the Milan Cell and Gene Center of Excellence.
The Milan site offers 30 years of experience in cell and gene therapy, with nine commercial approvals and hundreds of GMP batches produced successfully. Within the last 12 months (as reported on April 2, 2025), the Cell and Gene Center of Excellence achieved two FDA commercial approvals: Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel) for treating children with pre-symptomatic late infantile, pre-symptomatic early juvenile and early symptomatic early juvenile, referred to as early-onset, metachromatic leukodystrophy (MLD), and Autolus’ Aucatzyl (becabtagene autoleucel) for treating adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Source: AGC Biologics
Formulation Development/Drug Product Manufacturing
SHL Medical Opens $220-M Autoinjector Mfg Facility; Partners with Kindeva
SHL Medical, a contract provider of drug-delivery services and devices, has opened a new $220-million autoinjector manufacturing facility in North Charleston, South Carolina. The new 360,000-square-foot facility will manufacture SHL Medical’s autoinjectors, which are used in areas such as endocrine and metabolic disorders (including GLP-1 therapies), dermatology, musculoskeletal diseases, and other therapy areas.
Separately, SHL Medical has partnered with Kindeva Drug Delivery, a CDMO and drug delivery expert, offer fill–finish and pre-validated final assembly services for SHL Medical’s Molly autoinjector platform at Kindeva’s Bridgeton and Maryland Heights facilities in Missouri.
Source: SHL Medical and SHL Medical (Kindeva Drug Delivery)
Incog BioPharma Services Expanding Sterile Injectables Capabilities
Incog BioPharma Services, a CDMO specializing in sterile injectable biopharmaceuticals, has announced strategic expansion projects for 2025. These efforts include the physical expansion of its facilities in Fisher, Indiana, scaling up of filling capabilities, adding new finishing capabilities, and strategic.
Last September (September 2024), the company broke ground on its second building, adjacent and connected to the current manufacturing facility, on its Fishers, Indiana, campus. The 113,000-square-foot facility expansion will enable the company to provide device assembly capacity in support of autoinjectors, pens, wearable injectors, and syringe accessorizing. The addition will also support new labeling and final packaging capabilities.
Additionally, the high-speed Optima syringe and cartridge filling line that was delivered last November (November 2024) is installed and is being prepared for qualification. The new filling line adds 100,000,000 units of syringe and cartridge capacity and will be GMP-ready this September (September 2024(.
The 2025 expansion also includes a strategic hiring initiative, which will bring total employment to more than 350 employees by the end of summer (summer 2025), including manufacturing, quality assurance, and client support services.
Source: Incog BioPharma Solutions
LBB, Kerry Group Partner for Pharmaceutical Lactose
LBB Specialties, a specialty chemicals and ingredient distributer, has announced a new partnership with Kerry Group, a taste and nutrition partner for the food, beverage, and pharmaceutical markets with specialty ingredients. Through this collaboration, LBB Specialties will become Kerry’s preferred distribution partner in the US. Kerry’s Sheffield brand offers a range of pharmaceutical lactose excipients in various forms, grades, and particle sizes to provide formulators with optimized solutions for diverse pharmaceutical applications.
Source: LBB Specialties
Packaging
National Resilience to Expand Device Assembly, Packaging & Storage Capacity
National Resilience, a CDMO of biologics and advanced therapies, has announced it is bolstering its presence in West Chester, Ohio, while also expanding operations in Blue Ash, Ohio. The planned expansion into the 190,000-square-foot Blue Ash location will add additional automated device assembly and packaging capabilities for drug product filled at the West Chester location. Additionally, the Blue Ash location will add cold and ambient storage capacity to support both locations.
Source: National Resilience
General
ProBioGen Appoints new CEO
ProBioGen, a Berlin, Germany-based CDMO of biologics, has appointed Alfred Merz, PhD, as its Chief Executive Officer (CEO), effective April 1, 2025. Dr. Merz, who previously served as Chief Operating Officer and interim CEO, now assumes full leadership of the company.
Dr. Merz joined ProBioGen in 2024 from Bayer Pharmaceuticals, where he held the position of Senior Vice President and Head of Product Supply Medical Devices. With over 30 years of international experience in manufacturing, operational excellence, and strategy development, Dr. Merz has worked for pharmaceutical and biotech companies, including Bayer and Novartis.
Source: ProBioGen
