Lonza, KBI Biopharma Expand; Fareva Acquires Sterile-Mfg FacilitiesBy
The latest from CDMOs, CMOs, and suppliers featuring Lonza, Fareva, KBI Biopharma, Sterling Pharma, Bora Pharmaceuticals, and Idifarma.
Chemicals/Chemical API Manufacturing
Sterling Pharma Partners with ADC Bio for Bioconjugation Services
Sterling Pharma Solutions, a Dudley, UK-based CDMO of small-molecule active pharmaceutical ingredients (APIs) and intermediates, has formed a strategic partnership with ADC Biotechnology (ADC Bio), a Chester, UK-based CDMO of antibody drug conjugates (ADCs), with the intent to acquire ADC Bio.
Under partnership, Sterling will make an investment in ADC Bio with a view to acquiring ADC Bio in the first quarter of next year, subject to due diligence. The partnership/potential acquisition combines Sterling’s small-molecule expertise with ADC Bio’s bio-conjugation capabilities.
The announcement follows Sterling’s acquisition of a small-molecule API manufacturing facility in Germantown, Wisconsin from Alcami, a CDMO of APIs and drug products, in September (September 2020).
Source: Sterling Pharma Solutions and ADC Biotechnology
KBI Biopharma To Invest $150 M for New Biomanufacturing Facility
KBI Biopharma, a Durham, North Carolina-headquartered biopharmaceutical CDMO, has announced a $150-million investment to establish a new commercial manufacturing facility in Research Triangle Park, North Carolina.
KBI says it expects the 140,000-square-foot facility to be operational by the first quarter of 2022. KBI is co-investing in the facility with an undisclosed pharmaceutical partner to support manufacturing of their therapeutic protein programs. In addition to providing biologics manufacturing for its co-investor, KBI will also use the new facility as a commercialization option for its existing and future partners. The new commercial facility is located in close proximity to KBI’s mammalian drug-development laboratory in Research Triangle Park.
The new facility will house up to six 2,000-liter, single-use bioreactor systems and associated harvest and purification equipment, which can produce more than 100 commercial batches annually. In tandem with the manufacturing operations, KBI says it will employ advanced analytical services for commercial product characterization and release-testing services to support commercial launch and routine supply. The site will have more than 200 technical positions in operations and quality assurance.
The investment follows recent announced expansions by the company. In October (October 2020), the company announced it was adding a new 5,600-square-meter biologic bulk drug- substance manufacturing facility in Geneva, Switzerland. That facility is scheduled to be operational by mid-2022 and will create more than 200 positions in development, operations, and quality assurance.
Source: KBI Biopharma
Lonza To Add Mfg Suites for Antibody-Drug Conjugates
Lonza has announced a long-term, strategic collaboration for bioconjugation with an undisclosed biopharma company for the commercialization of antibody-drug conjugates (ADCs) at its site in Visp, Switzerland.
Under the terms of the agreement, Lonza will construct two bioconjugation suites totaling 1,500 m2 of active manufacturing space within a pre-existing shell.
The high throughput bioconjugation suites will be capable of handling highly-potent materials for cancer therapies and will initially manufacture two therapies. The new dedicated facility will employ around 200 staff, with operations expected to start from the end of 2022.
Formulation Development/Drug-Product Manufacturing
Lonza To Expand Particle-Engineering, Drug-Product Mfg Capacity
Lonza has announced an expansion for particle engineering and drug-product manufacturing capacity (development and clinical scale) at its site in Bend, Oregon.
New suites for the development and clinical manufacture of drug-product intermediates and drug products using spray-drying, hot-melt extrusion, and melt-spray-congeal processing are slated to be completed by May 2022. The first suite will expand early-phase spray-drying, tableting, and encapsulation capability and is expected to be on line by December 2020.
The new suites will incorporate early-phase cGMP manufacture and include additional storage, gowning, and a customer in-plant viewing corridor. Non-cGMP capability for formulation and process development will also be expanded with one new suite.
The expansion can support immediate-release tablets, multiparticulates, and dry-powder encapsulation for oral solid and inhaled applications.
Fareva Completes Acquisition of Two Sterile-Mfg Sites
Fareva has completed its acquisition of two sterile-manufacturing sites in Idron, France and Saint Julien-en-Genevois, France from Pierre-Fabre Group.
The Idron, France site has 200 employees and is dedicated to the manufacture of sterile injectable forms (pre-filled syringes and lyophilized and liquid-filled vials). The facility has 10 commercial lines and a pilot plant that is slated to be operational in 2022. The core business of the site is to handle highly potent and biologics entities.
The site in Saint Julien-en-Genevois, France manufactures monoclonal antibodies and conjugated monoclonal antibodies with high potent actives.
Last month (November 2020), Fareva announced negotiations with Merck & Co. and Novartis to acquire two sterile-manufacturing sites in Mirabel, France and Unterach, Austria, respectively.
Bora Pharmaceuticals Completes Acquisition of GSK Canadian Facility
Bora Pharmaceuticals, a CDMO of oral solid-dose, liquid, and semisolid products, has completed its acquisition of GlaxoSmithKline’s (GSK) manufacturing facility in Mississauga, Ontario, Canada. The transaction also included a minimum five-year supply agreement with GSK.
Initially announced in March (March 2020), the site represents Bora Pharmaceuticals’ first manufacturing facility in North America and will become home to its North American headquarters. The company has two manufacturing facilities in Taiwan.
Bora says it will retain the vast majority of the workforce at the site and plans to hire additional employees. With the acquisition of the facility, the company now has over 900 employees.
Source: Bora Pharmaceuticals
Idifarma Partners for Spray-Drying, Particle-Engineering Expertise
Idifarma, a Navarra, Spain-based CDMO of oral solid dosage forms, has formed a partnership with Stefano Console, Senior Advisor with the Swiss life-sciences consultancy, Oriento SA, to serve as Idifarma’s scientific advisor focusing on spray-drying technology and particle-engineering. Idifarma is a CDMO of niche and highly potent drugs with a focus on oral solids for oncology.