Manufacturing, Parenterals and Injectables

The investment will expand and upgrade manufacturing capacity and technology for pre-fillable syringes and will also includes a new manufacturing facility in Europe.

Gerresheimer now offers its Gx RTF syringes with SG ITC (Integrated Tip Cap) twist-off closure from Stevanato Group.

A holistic approach to validation and quality assurance is essential.

An optimal engineering design is crucial for aseptic operation and cleaning.

Tjoapack is investing in fully automated lines, including a PFS line with an initial capacity of 7 million syringes per year and a vial line with an eventual capacity of more than 12 million vials per year.

The new line has the ability to aseptically fill powder, liquid, suspension, and combination forms into vials in clinical or commercial batch sizes.

Alcami will provide services for Trevena’s OLINVYK (oliceridine) injection, an opioid approved for the management of acute pain severe enough to require an intravenous opioid analgesic in adults.

Stevanato Group’s Vision Robot Unit uses AI-based machine learning capabilities for particle and cosmetic inspection of biopharmaceutical drug products.

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

SiO2 Materials Science has received $143 million from the US government to accelerate capacity scale-up of its advanced primary packaging platform.

Regulators have exaggerated expectations for simulated media fills.

Wavelength Pharmaceuticals expanded production of APIs for certain pharmaceutical products needed to manage respiratory critical care patients in the COVID-19 pandemic.

Civica Rx plans redundant manufacturing capacity to relieve and prevent shortages of generic, sterile injectable drugs.

If approved, the therapy may become the first-choice treatment for relapsing multiple sclerosis patients and will be the first B-cell therapy that can be self-administered using an autoinjector pen.

The company will showcase the syriQ BioPure syringe in a 2.25-mL format for autoinjectors at Pharmapack in Paris, France from Feb. 5¬¬–6, 2020.

Consider equipment design, transfer systems, and maintenance when operating isolators for sterile manufacturing of pharmaceutical products.

The facility will produce parenteral products and delivery devices and is set to create 460 new jobs.

Schott and W.L. Gore introduced a prefillable, silicone-free glass syringe system, which won an award at CPhI Worldwide.

West introduced NovaPure 3-mL Cartridge components and the SmartDose Gen. II 10-mL injector.

The company showcased its compact robotic nest filling machine at CPhI Worldwide 2019 on Nov.–7 in Frankfurt, Germany.

Trends affecting primary pharmaceutical packaging include the shift to more complex drug-device combination products.

The company introduced its new advanced elastomer, the 4040/40 formulation, and a new line extension of its AccelTRA component program, AccelTRA Select, at CPhI Worldwide from Nov. 5–7 in Frankfurt, Germany.

Through a partnership with the Sobti family, the CDMO will expand is injectable dosage form capabilities.

The companies plan to promote and manufacture Maverick, an emergency-use, cartridge-based auto-injector.

Gerresheimer enlarged a cleanroom, installed a high-performance furnace, and automated testing and packaging systems for pharmaceutical glass packaging in Essen, Germany.

The new device can inject a range of drugs of different viscosities up to 35cP and different fill volumes up to 1mL.

Ready-to-use components help compounders and manufacturers of small batches overcome economy-of-scale limitations in aseptic GMP manufacturing.

Optima Packaging explains its approach to process design.

Automated fill/finish and inspection equipment displayed at the 2019 Healthcare Packaging Expo improves quality and efficiency.

Advances in fill/finish for parenteral packaging address demands for efficiency and product safety.