Biologics

16
Jul
Where Will All the Funding Come From - blog

Where Will All the Funding Come From?

With the recent news of cuts in FDA funding (most recently reported by Zachary Brennan in an Endpoints News story entitled, “House Committee Raises Concerns on CDER-CBER Misalignment Amid 2025 Funding Markup” (here, subscription required), the question of FDA being asked to do more must be asked, as it now appears it will have to […]

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28
Jun
Distributed vs. Point of Care Manufacturing for Cell and Gene Therapies - Lachman Blog

Distributed vs. Point of Care Manufacturing for Cell and Gene Therapies

The manufacturing landscape for cell and gene therapies is evolving rapidly, driven by the need for greater flexibility, efficiency, and proximity to patients. Two prominent models have emerged: Distributed Manufacturing (DM) and Point of Care Manufacturing (POC-M). Both approaches have unique benefits and challenges, particularly concerning quality control and regulatory compliance. This blog explores the […]

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11
Jun
Interesting Facts from Fiscal Year 2023 Report on the State of Pharmaceutical Quality - Lachman Blog

Interesting Facts from Fiscal Year 2023 Report on the State of Pharmaceutical Quality

Each year, the Office of Pharmaceutical Quality (OPQ) releases a report on the state of pharmaceutical quality. This year’s report was released yesterday and can be found here. Every year we try to pick out key issues and highlight some of the statistics outlined in the report, and this year is no different! Some important […]

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30
May

The Future of Visual Inspection 

It’s fascinating to see the evolution and potential future of visual inspection in the pharmaceutical industry. The shift from manual methods to cutting-edge automated systems with artificial intelligence has significantly improved efficiency, accuracy, and reliability in product inspections. By leveraging AI technology in visual inspections, pharmaceutical companies can benefit from enhanced defect detection capabilities, greater […]

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01
May
Are You Still Using Your Grandma’s Container-Closure Integrity Approach - Lachman Blog

Are You Still Using Your Grandma’s Container-Closure Integrity Approach?

Container Closure Integrity (CCI) testing is a central aspect of contamination control for a product. Contamination control strategy begins with the design, qualification, and validation of a facility, equipment, and processes. Product containers and closures are a crucial element of contamination control. Package integrity is the ability of the package to prevent loss, maintain sterility, […]

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24
Apr
Revised QA Document on Promotional Activities for Biosimilars Released by FDA - Lachman Blog

Revised Q&A Document on Promotional Activities for Biosimilars Released by FDA

Today, the FDA released a draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers (here). Try saying that without taking a breath! This draft is a revision of the initial draft guidance issued on February 4, 2020 (85 FR 6201) (the 2020 draft guidance). The […]

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27
Mar

Will you be joining us at the American Biomanufacturing Summit?

You’re invited to visit with Lachman at Booth #47. We hope to see you at the 10th Anniversary American Biomanufacturing Summit, one of the can’t-miss events of the year. It’s taking place on April 10-11, 2024, at the Hyatt Regency San Francisco Airport, San Francisco, CA. The American Biomanufacturing Summit is one of the most senior-level […]

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18
Mar
FDA Continues Execution of HHS AI Strategy - Lachman Blog

FDA Continues Execution of HHS AI Strategy

The U.S. Department of Health and Human Services’ (DHHS) strategy for artificial intelligence (AI) is clearly continuing in earnest into 2024. This AI strategy states, “HHS divisions will continue to lead in identifying opportunities for mission-driven AI solutions, mitigating risks appropriately, against a shared framework of federal and HHS guidance.” In alignment with this strategy, […]

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13
Mar

We Hope to See You at the 2024 PDA Week

Visit with Lachman Consultants at Booth 635 PDA Week is a must-attend event for professionals in the biopharmaceutical and pharmaceutical industries. This year’s event is taking place from Monday, March 25th to Wednesday, March 27th in Long Beach, CA. As a leading forum for knowledge-sharing and networking, this year’s event promises to deliver insights into […]

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01
Mar
AI Laws on the Move - Lachman Blog

AI Laws on the Move

Is your firm preparing for the wave of AI regulations, laws, white papers, and regulatory guidances? As reported in a previous Lachman blog, EU Artificial Intelligence (AI) Act: Impact on Pharma and MedTech, laws are emerging, but can companies keep up with the pace? Last year, the EU did what the U.S. has not been […]

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