Supplier News: Cambrex, Recipharm, Adare & More
The latest from CDMOs, CMOs, and suppliers featuring Cambrex, Recipharm, Adare Pharma Solutions, Hovione, Thermo Fisher Scientific, Serán Bioscience, BioCentriq, Quotient Sciences, Lifecore Biomedical, and Biocair.
Chemicals/Chemical API Manufacturing
* Cambrex Adds Liquid-Phase Peptide Synthesis Mfg Technology
Biologics Manufacturing
* Hovione Forms New Cell & Gene Therapy JV
* BioCentriq Names New CEO
Formulation Development/Drug Product Manufacturing
* Serán Bioscience Investing $200-M in New Finished Dose Mfg Facility
* Recipharm Adds Blending, Tableting & Hard-Capsule-Filling Suites
* Adare, Laxxon in 3D Printed Oral Dosage Drug Pact
* Lifecore Biomedical Adds New Isolater Filler for Fill-Finish
* Quotient Sciences, Vasa Therapeutics Partner
General
* Thermo Fisher To Add New Bioanalytics Lab
* Logistics Company Biocair Expands German Facility
Chemicals/Chemical API Manufacturing
Cambrex Adds Liquid-Phase Peptide Synthesis Mfg Technology
Cambrex has announced that Snapdragon Chemistry, a Cambrex company, has successfully developed a new liquid-phase peptide synthesis (LPPS) technology that utilizes traditional active pharmaceutical ingredient (API) batch reactors and continuous flow. The company says the technology materially reduces solvent demand and the need for excess reagents compared to standard solid-state peptide synthesis processes.
The technology supports peptides up to 12 residues long, with larger peptides then assembled in liquid phase, using a convergent fragment coupling approach. Processes developed with its LPPS technology can be scaled in the same way as traditional small molecules. In addition to the LPPS, Cambrex developed capabilities in peptide and protein crystallization, including a crystallization screening platform specifically for the discovery of crystalline forms of peptides and proteins.
Source: Cambrex
Biologics Manufacturing
Hovione Forms Cell & Gene Therapy JV
Hovione, a CDMO of drug substances and drug products, and iBET (Instituto de Biologia Experimental e Tecnológica), a private not-for-profit research institute, have formed a new joint venture, ViSync Technologies, based in Lisbon, Portugal.
The joint venture combines Hovione’s expertise in pharmaceutical development, particle engineering, and industrialization of pharmaceutical technologies and iBET’s research in biotechnological sciences. One of the first focus areas of ViSync will be to develop technologies that improve delivery and stabilization of new modality therapies.
Source: Hovione
BioCentriq Names New CEO
BioCentriq, a Newark, New Jersey-based CDMO of cell therapies, has appointed Syed T. Husain, formerly Chief Commercial Officer at Resilience, a CDMO of biologics and advanced therapies, as its new CEO and as a member of the company’s Board of Directors. He has more than 20 years of strategic management experience and in addition to Resilience, he held leadership CDMO roles in Emergent BioSolutions, Alcami, and Lonza. BioCentriq has three facilities based in New Jersey: two in Newark and one in Monmouth Junction.
Source: BioCentriq
Formulation Development/Drug Product Manufacturing
Serán Bioscience Investing $200-M in New Finished Dose Mfg Facility
Serán Bioscience, a Bend, Oregon-based CDMO, has announced an investment of more than $200 million in a new finished dose manufacturing facility and related capabilities.
Bain Capital Life Sciences led the recent investment, and the company’s existing investor, Vivo Capital, remains a key shareholder in the company. The partnership will support Serán’s build-out of a new commercial-scale manufacturing facility across multiple drug-delivery and final dose formats from early development to commercial supply.
The new facility will be completed in 2026 and will support oral, pulmonary, and nasal delivery modalities with commercial-scale particle engineering services, including spray drying, hot-melt extrusion, nano-milling, and fluid-bed manufacturing, as well as finished-dose capabilities including granulation, tableting, coating, encapsulation, powder filling, including for modified-release products. An adjacent facility, already under construction, will enable packaging, labeling, serialization, and distribution capabilities.
Source: Seran Bioscience
Recipharm Adds Blending, Tableting & Hard-Capsule-Filling Suites
Recipharm, a CDMO of drug substances and drug products, has announced an investment in its Oral Solid Development and Pilot-Scale Center in Zwickau, Germany.
The investment includes three new GMP pilot-scale suites for blending, tableting, and hard-capsule filling, which will complement its existing GMP pilot-scale capabilities in dry granulation and wet granulation and related tools for material characterization and material science.
The investment includes the following: a pilot-scale hard-capsule filler with dual filling and mini tablet dosing capabilities; a Style One EVO compression and compaction simulator; and a pilot-scale tablet press. The new pilot-scale center for dry technologies will be GMP-ready by the first quarter of 2025.
Source: Recipharm
Adare, Laxxon in 3D Printed Oral Dosage Drug Pact
Adare Pharma Solutions, a CDMO of oral dose products, has entered a collaboration with Laxxon Medical, a pharma technology company, to provide cGMP 3D printing capabilities from Adare’s facility in Pessano, Milan, Italy.
Adare and Laxxon will use screen-printed drug technology, licensed from Exentis Group, a Stetten, Switzerland-developer of a 3D printing platform, to create 3D-printed oral dosage forms. The platform enables production of multi-compartment tablets ranging from as small as 200 microns up to centimeters in diameter as well as a direct upscale from lab- to mass-production without changing the production process.
A 3D printing system and a new bulk preparation mixer have been installed at Adare’s Pessano site and will be fully operational by the end of the fourth quarter of 2024. The cGMP suite will permit direct scaling from Laxxon’s laboratory quantities through to clinical trial material volumes.
Source: Adare Pharma Solutions
Lifecore Biomedical Adds New Isolater Filler for Fill-Finish
Lifecore Biomedical, a Minneapolis, Minnesota-based CDMO of fill–finish services, has announced that its multi-purpose 5-head isolator filler is GMP-ready and operational. Lifecore will use the technology for fill–finish services for prefilled syringes, vials, and cartridges. By successfully installing and qualifying the 5-head isolator filler, the company has more than doubled its current capacity.
Source: Lifecore Biomedical
Quotient Sciences, Vasa Therapeutics Partner
Quotient Sciences, a CDMO of drug substances and drug products and a provider of translational pharmaceutics services, reports that the company has dosed, at its facility in Nottingham, UK, the first human subjects participating in a Phase I clinical trial for VS-041, a drug for treating heart failure, developed by Vasa Therapeutics, an Encinitas, California-based bio/pharma company. Quotient Sciences manufactured an immediate-release tablet, and the clinical program and recruitment of healthy volunteers to take part in the Nottingham, UK-based Phase I trial was also performed by Quotient Science.
Source: Quotient Sciences
General
Thermo Fisher To Add New Bioanalytics Lab
The PPD clinical research business of Thermo Fisher Scientific has announced plans to add a new 29,000-square-foot bioanalytical lab in Gothenburg, Sweden.
The new lab will add up to 140 scientists and laboratory support professionals, ranging from entry-level bench positions to general manager. The new lab, which is expected to be completed in the fourth quarter of 2025, will provide bioanalytical assay services across all stages of drug development, from preclinical studies to post-approval studies. Service offerings will include technologies and methodologies such as cell-based assays, chromatography, flow cytometry, immunochemistry and molecular genomics
In addition to the new lab in Sweden, the business operates a global network of GMP central, bioanalytical and vaccine science laboratories with operations based in the following: Middleton, Wisconsin; Highland Heights, Kentucky; Richmond, Virginia; Athlone, Ireland; Brussels, Belgium; Singapore; and Suzhou, China.
Source: Thermo Fisher Scientific
Logistics Company Biocair Expands German Facility
Biocair, a provider of global logistics services for bio/pharmaceuticals, has expanded its facility in Hamburg, Germany, to add additional import, export, pickup and delivery options and expand packaging services for items requiring dry-ice logistics through the addition of a new refrigerator and freezer in an expanded warehouse to facilitate temperature-controlled packaging, ranging from -79°C to -15°C, +2°C to +8°C and +15°C to +25°C.
Source: Biocair