WuXi Plans Mfg Facility; Alcami’s New CEO; Lonza and 3D Bioprinting
The latest from CDMOs, CMOs, and suppliers featuring Lonza, WuXi Biologics, Alcami, Sharp, Berkshire Sterile Mfg, Tedor, Packaging Technology Group, and Jones Packaging.
WuXi Biologics Signs Lease for a Clinical Mfg Facility in the US
WuXi Biologics, a contract biologics manufacturer, has signed a 10-year lease for a clinical manufacturing facility in Cranbury, New Jersey.
The new clinical manufacturing facility will consist of 6,000-L bioreactors, process development and quality control labs and supporting functions. The 66,000-square-foot facility is expected to become operational in late 2020 and will bring in up to 100 jobs to the region.
The news follows WuXi Biologics’ recent purchase of land to build a new 107,000-square-foot clinical and commercial manufacturing facility in Worcester, Massachusetts, and the lease of a 33,000-square-foot site to establish a process development lab in King of Prussia, Pennsylvania.
Source: WuXi Biologics
Evotec, ABL Enter $318.5-M US Gov’t Contract Clinical Supply Pact
Evotec SE’s Seattle, Washington-based subsidiary, Just–Evotec Biologics, has entered into an agreement with Advanced BioScience Laboratories (ABL), a CDMO, for a project under a $318.5-million contract from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services.
Under the agreement, Just–Evotec Biologics will design a manufacturing process required for the production of Phase I cGMP clinical supply of a broadly neutralizing antibody against HIV. Just–Evotec Biologics will support ABL by designing scalable development processes capable of producing a suitably scaled production run under cGMP conditions acceptable for human clinical trials. Under the agreement, Just–Evotec Biologics will also design a product formulation suitable for clinical infusion and provide assay development and release and stability testing services.
Lonza, Cellink in Pact for Complete 3D Cell Culture Workflows
Lonza and Cellink, a Gothenburg, Sweden-based biotechnology startup that designs bio-inks and bioprinters for culturing different cell types, have partnered to offer a 3-dimensional (3D) bioprinting solution designed to optimize and increase access to complete 3D cell-culture workflows. The solution integrates Cellink’s 3D bioprinting instruments and bio-inks with Lonza’s selection of human-derived primary cells and supporting culture media.
Under the agreement, Cellink will be delivering the complete 3D bioprinting solution through its global sales channels, supported by Lonza’s logistics processes.
Lonza reports that cell-biology laboratories are increasingly adopting 3D over 2-dimensional (2D) cell-culture approaches as they more closely resemble the cells’ in vivo environment to provide a more accurate and reliable means of predicting and analyzing cell behavior.
Cellink provides 3D bioprinting systems that are designed to offer improved levels of sterility, precision and versatility. The company’s bio-ink is a universal bio-ink designed to print complex 3D human tissue constructs with any 3D bioprinting system.
Formulation Development and Drug-Product Manufacturing
Berkshire Sterile Mfg Secures $16.5 M to Expand Facility
Berkshire Sterile Manufacturing, a Lee, Massachusetts-based a fill–finish contract manufacturer for injectable medications, has secured $16.5 million in financing from Berkshire Bank and Lee Bank to expand its operations in Lee.
This financing will be used to add manufacturing capabilities, including an additional robotic line for producing sterile drug products in vials, syringes, and cartridges. Berkshire will also install a new pharmaceutical-grade water system, add additional testing capabilities in its microbiology and analytical labs, expand its warehouse, and double the size of its cleanrooms.
Berkshire is placing orders for the new equipment, which is being built by companies in the US and Europe. The new equipment will arrive over the next year and a half (as reported on June 1, 2020) and will be fully operational by early 2022.
Source: Berkshire Sterile Manufacturing
Tedor, Cardinal Health Enter Pact for Integrated Solutions
Tedor Pharma, a Cumberland, Rhode Island-based CDMO, has entered into an agreement with Cardinal Health Regulatory Sciences, a Dublin, Ohio-based healthcare services and products company, to deliver integrated solutions to the biopharmaceutical industry. These solutions will use the regulatory consulting of Cardinal Health and Tedor’s oral solid-dose manufacturing capabilities and exclusive North American drug-delivery technologies.
Under the business agreement, Tedor Pharma will provide its technology and will work collaboratively with Cardinal Health to deliver integrated regulatory solutions to meet the needs of the manufacturing compliance environment.
Source: Tedor Pharma
Packaging Technology Group Expands
Packaging Technology Group (PTG), a Boston-based provider of thermal packaging products for the biopharmaceutical and life-sciences sector, has opened a new facility in Louisville, Kentucky called PTG Kentucky.
The 42,000-square-foot facility will primarily serve as the production backbone of sustainable thermal materials for PTG.
PTG offers temperature-sensitive thermal shipping solutions for pharmaceutical and biologics companies and develops, qualifies, and rolls out both custom and off-the-shelf shipping solutions. PTG recently launched its product line of thermo-efficient, 100% Curbside Recyclable, and environmentally sustainable solutions, TRUEtemp Naturals Cellulose. The TRUEtemp Naturals Cellulose shippers are designed with a curbside recyclable insulating fiber composed of layers that protect against impact and temperature fluctuation. In addition to the Cellulose line, PTG offers a full suite of reusable options, including quality polyurethane and vacuum insulated panels.
Source: Packaging Technology Group
Sharp Enters Agreements to Launch Direct-to-Patient Service
Sharp Clinical Services, part of UDG Healthcare and a provider of global clinical supply services, has signed a central pharmacy partnership deal with Hubertus and developed a holistic patient support program with its sister company, Ashfield.
The agreement with Hubertus will support Sharp’s direct-to-patient logistics service for its clinical trial clients in Europe and neighboring nations. It is the second such agreement for Sharp, which has a similar partnership in place in the US.
Sharp has partnered with the Patient Solutions business unit of its sister company, Ashfield to provide clinical educator-led ministering in areas such as injection training, infusions and blood- pressure monitoring to patients in their own home. This service can be delivered either through in-person visits in Europe or remotely in both the US and Europe as part of a holistic and compliant solution for clinical trial sponsors.
Source: Sharp Clinical Services
Jones Packaging Invests in High-Performance Packaging Line
Jones Packaging, a provider of advanced packaging and medication-dispensing product and services, has announced a investment in its packaging services offering by including a fully integrated two-lane Uhlmann blister packaging line.
The highly automated equipment will enhance the firm’s capacity to manage demand surges and unique blister combinations as more complex pharmaceutical dosage forms and regimes evolve clinically and commercially.
The new line will be installed at the company’s Brampton, Canada facility and is anticipated to be operational early next year (2021).
Source: Jones Healthcare Group
Alcami Appoints New CEO
Alcami, a CDMO of active pharmaceutical ingredients and drug products, has announced the appointment of Walter J. Kaczmarek III as Chief Executive Officer (CEO).
Mr. Kaczmarek has served in executive roles at multiple pharmaceutical companies, including as President of the Multisource Pharmaceuticals, a division of Mallinckrodt Pharmaceuticals, Chief Operating Officer of Aceto Corporation, and most recently, as President and CEO of Cosette Pharmaceuticals. Mr. Kaczmarek is an industry veteran with more than 30 years of experience a spanning the entire value chain from development and manufacturing to sales and marketing.