Manufacturing, Parenterals and Injectables

FDA’s EUA provides the first new treatment for COVID-19 patients with severe symptoms.

The industry’s aversion to risk has led to its treating closed aseptic processing systems as miniature cleanrooms, resulting in redundant and expensive practices. This article ponders this impasse, examining new technologies and applications in light of past regulatory guidance and more than 40 years of operating evidence.

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

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

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

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

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.

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

A recent report released by an FDA task force highlights the financial, manufacturing, and policy issues underlying the drug shortages of important prescription medicines in the United States.

US-based SP Industries acquired the sterile filling line assets of Spain-based i-Dositecno.

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

The company will supply its heparin sodium injection in prefilled syringe form.

The companies will work together to produce enFuse, a patient-administered subcutaneous delivery device.

The Pharma Services business of Thermo Fisher Scientific will invest $150 Million at three facilities.

The expansion adds new capabilities and enhances existing service offerings for both oral and parenteral dosage forms.

AuroMedics Pharma issued a voluntary, nationwide recall of two lots of piperacillin and tazobactam for injection, USP 3.375 g due to the presence of particulates identified as glass and silicone material.

Pfizer will invest nearly half a billion dollars to build a sterile injectable facility in Michigan.

The company has run into a snag in producing Kymriah for the diffuse large B-cell lymphoma patient population, the second indication for which the therapy was recently approved by FDA.

The new resin used a combination of “jetting” technology and a high-performance Protein A ligand.

Biosimilars and biobetters have their own unique manufacturing strategies and challenges.

Single-use technologies have become increasingly prevalent in final fill/finish operations for biologics.

Rentschler Fill Solutions and Ultragenyx announce fill and finish agreement for the US commercial supply of Mepsevii.

The companies will partner to develop smart connected monitoring and support solutions for injectable drugs.

The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.

The company will build a high-volume manufacturing facility for their glass packaging product in Durham County, NC.

The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.

The companies have created Syna Therapeutics, a joint venture that will develop biosimilars and new molecules.

RGtimeline/Shutterstock.comParenteral product quality is improving.

Under this agreement, the companies will develop in parallel an antibody drug candidate and cell lines for other potential candidates.