Manufacturing

Articles

The GENiSYS R from AST (pictured) is a modular system that automates aseptic filling and the closing of vials, syringes, and cartridges.

Robotic Modular System for Small Batch Filling

Feliza Mirasol is the science editor for 

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

Meeting Fill/Finish Challenges for COVID-19 Vaccines

The fill line will work to manufacture high-value APIs for drug product manufacturing to meet the needs of the COVID-19 pandemic.

LSNE Adds New Aseptic Fill Line to New Hampshire Facility

Consider a matrix of factors when choosing what type of cleanroom facility to construct.

Choosing a Cleanroom Infrastructure Technology

The company is investing in expansion at four sites in the United States, United Kingdom, and Italy, which will include construction of new facilities and addition of sterile and lyophilized filling lines.

Thermo Fisher Scientific Expands Sterile Drug Product Development and Commercial Manufacturing

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

A holistic approach to validation and quality assurance is essential.

Prepping Fill/Finish Systems to Ensure Quality Output 

Richard Denk is Head Sales Containment at SKAN AG, www.skan.ch, Richard.Denk@skan.ch.

An optimal engineering design is crucial for aseptic operation and cleaning.

Understanding the Impact of Annex 1 on Isolator Design

Joseph Baaklini is the director of the Scientific and Laboratory Services Global Technical Support group for Pall Corporation and leads the Pall Laboratory and Food & Beverage technical division globally.

Assessing the integrity of filter membranes is critical for maintaining sterile filtration operations in laboratories.

Understanding the Critical Role of Integrity Testing in Laboratory Sterility Filtration

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.

Aseptic/Sterile Processing