Manufacturing

Current Trends in Antibody Drug Conjugates (ADCs) Characterization: Expert Paper

We bring you a brand-new paper focused on Current Trends in Antibody Drug Conjugates Characterization, focusing on structure. Comprehensive structural, biophysical, and physico-chemical property characterization in alignment with Chemistry, Manufacturing and Controls (CMC) guidance is a requirement to achieve successful regulatory (IND) submissions. Multiple analytical technologies are required for ADC analysis with a focus on the drug’s critical quality attributes (CQA), with data interpretation conducted by experienced biopharmaceutical analytical scientists. In this review, we discuss the current trends in antibody…

PendoTECH Sensors and Industry 4.0: Integrating a PendoTECH Single Use Sensor System with a Digital Highway

Industry 4.0 refers to the ongoing Fourth Industrial Revolution, which is currently transforming modern manufacturing and production practices through the use of smart technology and artificial intelligence. At a high level, Industry 4.0 has paved the way for the integration of manufacturing execution systems (MES) with enterprise resource plan (ERP) systems and supervisory control and data acquisition (SCADA) systems. Biopharmaceutical manufacturing is currently evolving with the progression of Industry 4.0. The integration of business and manufacturing systems in an intelligent,…

Regulatory Considerations for Excipients used in Lipid Nanoparticles

Lipid excipients and delivery systems such as lipid nanoparticles (LNPs) are essential for a wide variety of therapeutics including chemotherapy, analgesics, gene therapy, respiratory and ocular applications, anti-fungal applications, and vaccines. In many cases, these excipients and delivery systems play an important role in achieving the desired bioavailability. mRNA vaccines, for example, require incorporation of lipids to prevent degradation of the nucleic acid and facilitate cellular uptake of the mRNA which is required for antibody generation. The purity and safety…

The unique properties of gelatin in 3D bioprinting

How to select the right bioink to secure proper cellular characteristics and functionalities in engineered tissues: exploring the benefits of low endotoxin gelatins. Gelatin has long been a trusted excipient in the pharmaceutical industry. For advanced biomedical applications like in-body use, there are strict regulations for endotoxins levels of the final product (medical device) to avoid unwanted side-effects. 3D bioprinting is a very popular tissue engineering technology used in the field of regenerative medicine. In this whitepaper, we explore the…

Time-To-Market Record: Major EPCM Project in Just 24 Months

Boehringer Ingelheim and ZETA have had a long-standing, successful partnership. In 2019, the global pharmaceutical company approached ZETA with a significant challenge. The goal was to implement a major EPCM project at the Boehringer Ingelheim RCV site in Vienna, Austria, in just 24 months. ZETA accepted the challenge and successfully managed the entire project – called G3Leopold – as a one-stop-shop for the customer. Everything was included: from the engineering of the entire plant, the process area, the architecture, and…

Poloxamer: A Simple and Powerful Solution for Accelerating Dissolution

While oral administration remains the most popular route for drug delivery, many of the active pharmaceutical ingredients (APIs) in use and development today exhibit low bioavailability, owing to low solubility which leads to a lower passage through the intestinal membrane, a key step to enter the systemic circulation. As such, formulators have developed a toolkit of enabling formulation techniques to increase bioavailability, including solid-state modification, formulation with lipids, salt formation with meglumine and complexation with cyclodextrins. However, the high degree…

Simplifying Biotherapeutic Manufacturing and Quality Control with Label-Free Biosensor Technology

Bio-Layer Interferometry (BLI) systems are used throughout biotherapeutic discovery, development, manufacturing and quality control (QC) workflows to simplify and streamline measurement of process and product attributes. They offer an excellent alternative to assays performed using time- and labor-intensive methods such as ELISA and HPLC. These label-free assays can be run fully automated, require much less user intervention, and provide a simplified workflow. Following an introduction to the principles of BLI, we highlight how the Octet® BLI platform has been used…

Not All cGMP Transfection Reagents Are Made Equal: Pharmaceutical Versus Medical Device cGMP Manufacturing

cGMP grade transfection reagents should be produced and formulated following strict guidelines. Some suppliers manufacture transfection reagents according to medical devices cGMP standards which makes the reagents suitable for viral vector manufacturing in the United States but not suitable for direct administration into humans. Those are often labelled as “for research use only and further manufacturing. Not for use in humans or animals”. Others comply to pharmaceuticals cGMP guidelines, making the transfection reagent suitable for viral vector manufacturing as well…

Lab Scale Depth Filtration with FILTROSPIN™ 20

FILTROSPIN™ 20 by FILTROX enables you to quickly and efficiently test different depth filters or quickly purify a small amount of liquid. The filters are inserted into standard 50 mL centrifuge tubes (Labcon® SuperClear® 50 mL tubes). The liquid is then filtered using a centrifuge or vacuum. In order to evaluate the most suitable and optimized production process, small-scale trials are the key factor to start with. With the help of laboratory scale trials, errors and other issues can be…

Application of Dry Granulation to Facilitate Raw Material Handling

Pharmaceutical and biopharmaceutical manufacturing relies on the timely and seamless orchestration of many steps to meet aggressive timelines and ensure operational efficiency. A fundamental element of the processing workflow that can impact schedules is the use of multi-ton quantities of bulk raw materials such as buffers, salts and stabilizing chemicals. These raw materials are typically prepared in a just-in-time manner to meet dynamic production needs and enable rapid changeovers.