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Co-Chair of the 2011 PDA-FDA Joint Regulatory Conference Susan Schniepp talks with Angie Drakulich, senior managing editor of Pharmaceutical Technology, about what to expect at this year's meeting. Schniepp is vice-president of quality for OSO Biopharmaceuticals and a member of  PharmTech's editorial advisory board. FDA's enforcement strategy, compliance, industry best practices and more are addressed.

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Meeting Co-Chair Susan Schniepp provides insight into this year's regulatory conference.

PDA-FDA 2011 to Focus on Compliance

The company’s expanded label for Avtozma (tocilizumab-anoh) now includes the treatment of cytokine release syndrome, aligning the therapy with all indications for which Actemra is approved in the US.

FDA Grants Approval to Celltrion for Expanded Indication of Actemra Biosimilar to Treat CRS

Under the agreement, AstraZeneca will use Alteogen’s proprietary hyaluronidase platform technology to develop and commercialize subcutaneous formulations of multiple oncology assets in its portfolio.

AstraZeneca and Alteogen Sign License Agreement for Developing Subcutaneous Formulations of Oncology Assets

The transaction is expected to enhance Jabil’s development and commercial production of auto-injectors, pen injectors, inhalers, and on-body pumps.

Jabil Completes Acquisition of Pharmaceutics International, Inc.

With this approval, HYQVIA [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] becomes the first and only facilitated subcutaneous immunoglobulin available in Japan to treat these disorders.

Takeda Receives Japanese Regulatory Approval for HYQVIA Subcutaneous Injection for Treating Agammaglobulinemia or Hypogammaglobulinemia

Lilly is investing $3 billion to expand its recently acquired manufacturing facility in Wisconsin, while Amgen is investing $1 billion to expand its facility in North Carolina.

Lilly and Amgen Each Announce Major Expansions of US Manufacturing Sites

DCAT Week Interview with Lee Karras

 announced for the Halo Pharma facility in Whippany, NJ, on March 10, 2025, Noramco Group Chief Executive Lee Karras spoke with 

® on the first day of the 2025 Drug, Chemical & Associated Technologies Association (DCAT) Week on March 17.

The purpose of the investment at the New Jersey site, as Karras detailed in the interview, is to establish sterile injectable manufacturing capabilities, namely ready-to-use syringe, cartridge, and vial filling, to address critical capacity shortages in the injectable supply chain in the United States.

“We have reconfigured some of the plant space to accommodate a commercial, aseptic filling line for vial, syringes, and cartridges,” Karras says in the interview. “That line has been delivered, and we're going through the construction and installation process that will take us into early next year to be ready to produce products. This line represents an investment by The Noramco Group to alleviate products that are on drug shortage [lists] but also work on innovator products as well. So, we're not only going to do clinical manufacturing for NCE [new chemical entity] products, but we're also going to do biologics and small molecules. We're going to do commercial manufacturing domestically, obviously out of New Jersey, to supply the [United States] market, but also have our eyes set on more global regulatory approvals to ship outside of the US.”

DCAT Week is happening March 17–20, 2025 in New York City.

Click the video above to watch the full interview.

Lee Karras, Noramco Group Chief Executive

Mr. Karras joined Noramco in April 2020, as Group Chief Executive. He is responsible for the Noramco Group of Companies, including Noramco, Purisys, Extractas Bioscience, and Halo Pharmaceuticals. Mr. Karras previously served as a director at SK Capital and CEO of Halo Pharmaceuticals Inc. Prior to Halo, Lee was President of IBA Molecular North America, a radiopharmaceutical company that provided PET imaging agents for diagnostic imaging. Prior to IBA, Mr. Karras was President and CEO of AAIPharma Services Company, a drug product CDMO, where he led the company’s transition from bankruptcy to a standalone CDMO/Pharma Services business.Prior to AAI, Lee held various positions at Baxter Healthcare and Cook Medical (Cook and Baxter Pharmaceutical Solutions). He served as General Manager and helped build the pharmaceutical services start up into one of the largest sterile injectable pharma services businesses in the world. Lee holds a bachelor’s degree in chemistry from Indiana University Bloomington and a Master of Science in Environmental Science from Indiana University Bloomington School of Public and Environmental Affairs.

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PharmTech Group interviewed Lee Karras of Noramco live on site at DCAT Week 2025, shortly after the company announced a $25 million investment in sterile injectable manufacturing capabilities at its Halo Pharma facility in New Jersey.

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DCAT Week 2025: Expanding Sterile Injectables Capacity

Visual inspection is an integral process in the production of filled and sealed pharmaceutical products to ensure there are no particles or contaminants in the finished parenteral dosage form. Currently, both manual and automated processes are used for visual inspection; however, automated systems can be expensive to implement and not always accessible for smaller companies dealing with smaller batch sizes.

Accessibility of automated visual inspection solutions is a key focus for Luo Automation, a Dutch company researching, developing, and producing automated visual inspection machines. To learn more about the company and how it is making visual inspection more accessible, 

 spoke with the company’s founder, Joren van der Horst, at CPHI Barcelona 2023.

"We make visual inspection [solutions] for very small batches,” explained Horst. As with all visual inspection technologies, the primary aim is to check the quality of the medicine and make sure there are no foreign particles or contaminants present, he added.

To perform the inspection, the finished dosage form—syringes, ampoules, and vials—are swirled and then any movement of particles within can be detected, Horst continued. “Another cool thing is the [current interest] in artificial intelligence and machine learning,” he said. “We use machine learning algorithms that are pretty new to also detect static defects. So, not only particles but also leakages and such.”

For Horst, a major differentiator for Luo Automation within industry is the focus on smaller-scale inspection. “If you want, you can buy a huge inspection machine that will cost you a couple of million, but then you need to produce 100 million containers per year,” he stressed. “But, if you have clinical trials or personalized medicine, you cannot [perform the inspection] with a huge machine.”

Luo Automation was featured at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023. CPHI Barcelona ran from Oct. 24–26, 2023.

Pharmaceutical Technology Europe® spoke with Joren van der Horst from Luo Automation, a Dutch company focused on automated visual inspection solutions, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

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Making Visual Inspection Accessible with Luo Automation at CPHI Barcelona

Parenterals and Injectables

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