Drug Development

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

Articles

Ensuring the quality of data in process monitoring and control systems starts in process development phases. 

Building Data Quality In Generates Quality Data Out

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

Regulators have exaggerated expectations for simulated media fills. 

Complications in Process Simulation Execution

Experience, communication, collaboration, transparency, planning, and prioritization contribute to success.

Ensuring Smooth Tech Transfer of Bioprocesses to Outsourcing Partners

Bioprocessing advances improve product yield, cut costs, and streamline integration between upstream and downstream processes.

Technology Advances Streamline Bioprocessing

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

Pramote Cholayudth previously was the managing director of the Professional Conference Center, Ltd. He currently is a validation consultant to Biolab Co., Ltd., in Thailand. He is the founder and manager of PM consult, cpramote2000@yahoo.com.

The CuDAL-Excel program, based on Microsoft (MS) Excel, has been developed to calculate the United States Pharmacopeia (USP) passing probability of content uniformity and dissolution tests for both sampling plan 1 and sampling plan 2 scenarios and for both immediate release and extended release requirements. The users can obtain the passing probability by simply entering the input variables, with wide applications for process validation/verification and batch release. As a user-friendly program, CuDAL‑Excel should bring more benefits to the industry practitioners than other existing programs/tools.


Determining the Probability of Passing USP Content Uniformity and Dissolution - Immediate and Extended - Tests with CuDAL-Excel

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Analyzing process and equipment data provides insights that can improve quality and productivity of pharmaceutical manufacturing.

Analytics Boosts Manufacturing Capabilities

The technology center is dedicated to developing greener, safer chemistries for manufacturing pharmaceutical raw materials and intermediates.

PharmaBlock Opens New Chemistry and Engineering Technology Center in Zhejiang, China

Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes.

Alternative Cleaning Validation Methods for Biologics

The new patented process results in uniform, scalable production and the ability to deliver cell cargo similar to natural exosomes/extracellular vesicles.

Orgenesis, ExcellaBio Announce Breakthrough Manufacturing Process for Bioxomes

Tackling process development early on can better optimize manufacturing processes for emerging therapies.

Process and Scaling