Biologics

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Today, the FDA released a draft guidance titled Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar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 This draft is a revision of the initial draft guidance issued on February 4, 2020 (85 FR 6201) (the 2020 draft guidance).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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20
Feb
FDA Goes Back to Basics with Multiple Observations for Diethylene Glycol and Ethylene Glycol - Lachman Blog

FDA Goes Back to Basics with Multiple Observations for Diethylene Glycol and Ethylene Glycol

In 2022, there were six Warning Letters and five 483 observations for issues relating to Diethylene Glycol (DEG) and Ethylene Glycol (EG). In 2023, there were thirty-six Warning Letters and nineteen 483 observations for DEG and EG concerns. So far this year (mid-February 2024), there have already been three Warning Letters containing observations for DEG […]

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16
Feb
Do You Know Your Product’s Impurity Profile - Lachman Blog

Do You Know Your Product’s Impurity Profile?

ICH Q7 refers to the need to establish the impurity profile for an Active Pharmaceutical Ingredient (API): “An impurity profile describing the identified and unidentified impurities present in a typical batch produced by a specific controlled production process should normally be established for each API. The impurity profile should include the identity or some qualitative […]

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12
Feb
Metal clean shelves in market. 3d rendering

The “Hows” of Drug Shortages 

If there was one theme that was pervasive throughout the discussions and presentations at the recent AAM Access 2024 meeting in Tampa, Florida, it was related to drug shortages.  The issue was touched upon by representatives from AAM, officials from the FDA, CEOs, Doug Long of IQVIA, and others as well.  With different individuals providing […]

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