Manufacturing

Articles

The new line has the ability to aseptically fill powder, liquid, suspension, and combination forms into vials in clinical or commercial batch sizes. 

Evonik Qualifies Filling Line for Parenteral Drug Products at its Alabama Facility 

Lucelys Caton is a technical service scientist with Gaylord Chemical Company.

Ashley Jones is analytical chemist with Gaylord Chemical Co, LLC.

Andrew Johnson is analytical specialist with Gaylord Chemical Co, LLC.

Dimethyl sulfoxide is increasingly used in high-risk parenteral and medical device applications that must be manufactured as sterile products in their finished form. A study evaluated the effects four sterilization techniques have on the product quality of this ingredient. 

Suitable Sterility Methods for Dimethyl Sulfoxide USP, PhEur

The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.

Samsung Biologics Expands Manufacturing Facilities and Launches Cell Line Technology

The agreement will combine Rentschler’s experience in drug substance manufacturing and Vetter’s expertise in aseptic fill/finish and secondary packaging.

Vetter and Rentschler Team Up for Strategic Collaboration

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

Grand River Aseptic Manufacturing Opens Large-Scale Injectable Fill/Finish Facility

Pall has introduced a 24-well filter plate that can perform cell clarification and sterilization in one step.

Pall’s 24-Well Filter Plate Performs Cell Clarification and Sterilization

Madison Hoal is global technical consultant at Ecolab Life Sciences.

Donald Singer is senior microbiology technical consultant at Ecolab Life Sciences.

Consider how to assess risks and understand possible sources of disinfectant residues in pharmaceutical manufacturing.

Why Do Disinfectant Residues Matter?

The companies have entered into a manufacturing agreement for the fill finish supply of lenzilumab for the potential treatment of COVID-19.

Ajinomoto Bio-Pharma Services, Humanigen in Manufacturing Agreement for COVID-19 Biologic

Regulators have exaggerated expectations for simulated media fills. 


Complications in Process Simulation Execution

The right approach to biological safety cabinets, and collaboration between engineers and those who will operate the equipment, is crucial to preventing cell-culture contamination. 

Minimizing Contamination During BioPharm R&D

HHS announces $354 million in funding for private industry to manufacture generic drugs in the US from raw materials to finished product.

BARDA Funds US-based Drug Manufacturing Initiative

Susan Haigney is managing editor of Pharmaceutical Technologyand Pharmaceutical Technology Europe, susan.haigney@ubm.com.

A contamination control strategy can prevent contamination in sterile product manufacturing. The right system, equipment, and personnel training are also essential to mitigate risk.

Considerations in Contamination Control

Pharmaceutical Technology spoke with John Harmer, director, technical sales at Vanrx Pharmasystems about considerations in choosing the best system and equipment for contamination control in pharmaceutical manufacturing.

Best systems and equipment for contamination control

A variety of assays should be used to detect bacterial, fungal, and viral contaminants in the human source cells used for cell therapies.

Detecting Contamination in Cell Therapies

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. 

Organizations involved in aseptic and sterile processing activities must make an effort to comply with current good manufacturing practices.


Good Manufacturing Practices: Aseptic and Sterile Processing

Aaron Mertens is a Microbiologist and Technical Services Manager at STERIS Life Sciences.

Joe McCall, previously with STERIS, is the Associate Director of QA Technical Service at ADMA Biologics.

A well-defined contamination control program is essential to maintain quality through aseptic manufacture of parenteral drug products.    

How a Contamination Control Program Impacts Product Sterility

Jennifer Markarian is manufacturing editor of Pharmaceutical Technology.

Civica Rx plans redundant manufacturing capacity to relieve and prevent shortages of generic, sterile injectable drugs. 

Addressing Drug Shortages

Consider equipment design, transfer systems, and maintenance when operating isolators for sterile manufacturing of pharmaceutical products.

Best Practices in Using Isolator Technology

Agnes Shanley is senior editor of Pharmaceutical Technology.

As mergers continue and operations become more complex, simplifying procedures and training can prevent costly morale, quality, and compliance problems.

Aseptic/Sterile Processing