WuXi, Sterling Pharma Expand; Vetter In Industrial Robot Pilot

By Emily Forster -

October 31, 2019

The latest news from CDMOs, CMOs, and suppliers featuring news from WuXi Biologics, Lonza, Vetter, Sterling Pharma Solutions, and Bio-Techne.

Chemicals/Chemical API Manufacturing

Sterling Pharma To Invest $1.5 Million in Small-Scale Mfg and QC

Sterling Pharma Solutions, a contract service provider of small-molecule active pharmaceutical ingredient development and manufacturing, is investing $1.5 million into a phased expansion of its facility in Research Triangle Park, North Carolina. The facility supports development and manufacturing for preclinical and early-phase clinical supply for volumes from milliliters up to 100-liter batches.

The investment follows the acquisition of the former US CiVentiChem site earlier this year (2019). Over the next three years, the company plans to expand the cGMP production suites, add a non-GMP scale-up production facility, expand its quality control laboratory, and increase the site’s R&D capacity.

The investment plan will also allow Sterling to expand its quality assurance team to provide more support for cGMP projects, increase its team of chemists, and put measures in place to help it secure its US Drug Enforcement Administration (DEA) Schedule I manufacturing approval. This recruitment drive, along with the initial facility expansion, forms the first part of the phased investment.  

Source: Sterling Pharma Solutions


Biologics Manufacturing

WuXi Biologics To Build Vaccine-Manufacturing Facility in Ireland

WuXi Biologics has received approval to build a 15,520-square-meter vaccine-manufacturing facility in Dundalk, County Louth, Ireland. The new facility will be located directly north of WuXi’s biopharmaceutical campus that is currently under construction.

The facility will be a three-story building with a roof-mounted plant and equipment stacks. It will include a four-story administration and laboratory building as well as a two-story modular support laboratory. A single-story boiler unit will also be included in construction.

Construction is expected to be completed by June 2024.

Source: WuXi Biologics, Louth County Council

Lonza Agrees to Expand Cell Therapy Mfg as Part of Supply Pact

Lonza has agreed to expand its Singapore cGMP facilities if required to meet long-term growth and capacity needs for the allogeneic cell therapy candidate, remestemcel-L, from Mesoblast, a developer of allogeneic cellular medicines.

The companies entered into an agreement for commercial manufacture of remestemcel-L, which is used to treat pediatric steroid-refractory acute graft versus host disease. Mesoblast expects to complete filing of a rolling biologics license application submission to the US Food and Drug Administration by the end of 2019. If approved, the US launch of remestemcel-L is expected to occur in 2020.

Source: Lonza

Bio-Techne To Invest $40 Million-$50 Million for Protein Production

Bio-Techne, a developer and manufacturer of GMP-grade raw materials and ancillary reagents, has committed to invest between $40 million and $50 million to expand its GMP-grade protein production capacity.

The company says the investment will fund a new facility that is specifically dedicated to large-scale production of GMP-grade materials, including E. coli-derived recombinant proteins.

Bio-Techne says it is anticipating and preparing for growing demand of raw materials to support new filings for autologous and allogeneic cell therapies.

Source: Bio-Techne


Packaging

Vetter Completes Pilot Using Industrial Robots in Secondary Packaging

Following a successful pilot project, which included the use of a dual-arm robot in secondary packaging, Vetter reports it is now planning the purchase of additional robots. 

The collaborative dual-arm robot YuMi (You and Me) has been supporting automated secondary packaging processes at Vetter since 2018 by inserting finished drug products and components into folding boxes. Employees supply its work station with the required material and define its specific sequence of moves.

With the first collaborative robot now having been successfully deployed in a pilot project lasting more than a year, the company says it will be acquiring two more models. The first model will be used to assemble a prefilled syringe barrel with plunger rod and finger flange. After its successful implementation in secondary packaging, the second model will be used for speed-bin-picking in aseptic production, where prefilled syringes are placed into trays after terminal sterilization.

Source: Vetter