Manufacturing, Parenterals and Injectables

Takeda’s TAKHZYRO (lanadelumab) is now approved in Europe as a subcutaneous injection treatment for hereditary angioedema in patients 12 years old and above and in adults.

Lilly will expand its recently acquired manufacturing facility in Wisconsin with a $3 billion investment, and Amgen will expand its North Carolina facility with a $1 billion investment.

With this $3.6 million investment, the CDMO will strengthen its advanced labeling, automated visual inspection, and fill/finish technology.

Novo Nordisk plans to invest $4.1 billion in a second fill/finish manufacturing facility in Clayton, N.C., boosting its current 2024 investments into production to $6.8 billion.

Given the criticality of fill/finish processes, it is clear that automation is the next technological step.

The company’s Itasca, Ill., facility will offer chemistry, manufacturing, and controls analytical testing support.

The newly established business under Advent International and Warburg Pincus will be named Simtra BioPharma Solutions.

Use of a small-scale filler can result in increased filling efficiency.

Gerresheimer and Nelson Labs will work together to conduct extractables and leachables testing on upcoming primary packaging solutions.

Recipharm’s new high speed filling line, designed for pre-filled syringes and cartridges, is expected to be operational by May 2023.

Lubrizol has launched Apisolex technology to improve solubility and simplify the manufacturing of parenteral drug products.

Takeda’s TAKHZYRO prefilled syringe is now available for patients with hereditary angioedema aged 12 years and older in the United States.

Eli Lilly and Company is investing $1 billion to establish a new manufacturing stie in Concord, N.C., to manufacture parenteral products and devices.

Build into the chemistry, manufacturing, and control strategy the ability to pivot and be flexible should the course change.

Baxter will invest $100 million in new lyophilization equipment and an additional aseptic syringe filling line at its Halle/Westfalen (Germany) location.

A coating technology for a staked needle prefillable syringe reduces the potential risks associated with silicone oil as a lubricant.

In this collaboration, Takeda will utilize Poseida's biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of gene therapies.

Lilly’s insulin, lyumjev, receives FDA approval for an expanded label.

Terumo Blood and Cell Technologies and PhotonPharma announced a collaboration to develop a novel tumor-specific immunotherapy for solid tumors.

Glenmark Pharmaceuticals has partnered with SaNOtize to manufacture, market, and distribute NONS to India, Singapore, Malaysia, Hong Kong, and more.

GSK announced that FDA has approved a new indication for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5.

In combination with etoposide and either carboplatin or cisplatin, Imfinzi has been approved in the first-line setting of ES-SCLC by China’s National Medical Products Administration.

Amgen’s greenfield facility near Columbus, Ohio to assemble and package vials and syringes is expected to be operational by 2024.

Container and equipment innovations expand applications.

A best practices approach to pharma’s most challenging-to-inspect container.