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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
February 02, 2021
The GENiSYS R from AST (pictured) is a modular system that automates aseptic filling and the closing of vials, syringes, and cartridges.
CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.
January 15, 2021
The fill line will work to manufacture high-value APIs for drug product manufacturing to meet the needs of the COVID-19 pandemic.
January 03, 2021
Consider a matrix of factors when choosing what type of cleanroom facility to construct.
December 09, 2020
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.
December 01, 2020
A holistic approach to validation and quality assurance is essential.
November 03, 2020
An optimal engineering design is crucial for aseptic operation and cleaning.
November 02, 2020
Assessing the integrity of filter membranes is critical for maintaining sterile filtration operations in laboratories.
September 09, 2020
The new line has the ability to aseptically fill powder, liquid, suspension, and combination forms into vials in clinical or commercial batch sizes.
September 02, 2020
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.
August 13, 2020
The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.
July 06, 2020
The agreement will combine Rentschler’s experience in drug substance manufacturing and Vetter’s expertise in aseptic fill/finish and secondary packaging.
July 02, 2020
The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.
June 29, 2020
Pall has introduced a 24-well filter plate that can perform cell clarification and sterilization in one step.
June 02, 2020
Consider how to assess risks and understand possible sources of disinfectant residues in pharmaceutical manufacturing.
June 01, 2020
The companies have entered into a manufacturing agreement for the fill finish supply of lenzilumab for the potential treatment of COVID-19.
Regulators have exaggerated expectations for simulated media fills.
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.
May 19, 2020
HHS announces $354 million in funding for private industry to manufacture generic drugs in the US from raw materials to finished product.
May 15, 2020
A contamination control strategy can prevent contamination in sterile product manufacturing. The right system, equipment, and personnel training are also essential to mitigate risk.