Manufacturing

IDBS described benefits and best practices for laboratory electronic data systems.

This article presents a general strategy for authorship of deviation investigations, with primary focus on regulatory inspection success.

The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.

While the measurement of the toxicity of leachables is not always a required parameter, the information collected during these studies could inform future bioprocessing runs.

Single-use bags containing toxic or hazardous materials required special handling.

CDER’s Janet Woodcock endorses modern drug manufacturing to ensure access to safe and reliable medicines.

The authors present a shift toward more integrated purification processes.

Perfusion processes can attractive for biologics drug manufacturing; however, obstacles remain.

Continuous processing of 100 g of monoclonal antibody in 24 hours has been demonstrated using lab-scale equipment.

The company has broken ground on a R&D and process development facility in Missouri.

Quattroflow’s EZ-Set Pump Chamber Replacing System for its single-use pumps allows users to change chambers quickly by hand.

Two recently-signed agreements will transfer Takeda’s measles and acellular pertussis vaccine technologies to India-based multinational company Biological E. Limited to develop low-cost combination vaccines including diphtheria, tetanus and acellular pertussis (DTaP), and measles-rubella (MR) vaccines.

Traditional planar culture formats are being superceded by microcarriers for large-scale cell therapy manufacturing.

Fagron Sterile Services has voluntarily recalled three lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level.

A loan from the European Investment Bank will give BiondVax resources for Phase III trials and a manufacturing facility for its universal flu vaccine.

The company successfully produced cell-based influenza vaccines at a commercial scale in its facility in NC.

The annual meeting of the Honeywell Users Group for the Americas will discuss industrial automation.

The company has voluntarily recalled Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level because of a lack of sterility assurance.

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.

FDA sent a warning letter to drug compounder DCA, Inc. dba Beacon Prescriptions for failing to ensure sanitary conditions.

The new UPS facility in Columbia will serve the growing pharmaceutical, biopharma, and medical device industry in Latin America.

The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.

Although widespread adoption of continuous bioprocessing has been slow, some processes have been an exception.

This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.

Approval of breakthrough therapies requires expedited quality assessment.

As more companies decouple drug substance from finished drug manufacturing operations, an integrated approach can ensure safe, reliable logistics for frozen storage and shipping.

An increase in biologics raises awareness of particle generation and its role in negative patient outcomes.

Microdermics will focus on product development and clinical activities of new drug delivery methods, while Vetter’s primary role will be in the fill and finish aspect.

BioVectra will open its new microbial fermentation and complex chemistry site, including the capability to handle high-potency APIs, by the end of 2017.

A recent survey suggests that 36% of pharmaceutical companies and contract development and manufacturing companies have not started working on serialization, and that those who are working on it are focusing on basic compliance rather than potential long-term business benefits.