Manufacturing

Enhancement of Tablet Coating Using an Innovative Functional Excipient

During formulation of solid dosage forms, film coating is used to improve the appearance and stability of tablets, make them easier to swallow, mask the taste, modify or sustain release, protect the drug from the harsh gastric environment, protect from moisture and/or oxidation and, as a result, to improve the stability and overall therapeutic effect of the final drug product. Depending on the individual needs, a polymer with appropriate properties is chosen during formulation development to serve as film-coating matrix.…

CAP®Ad – A Versatile Platform for RCA-free, Industrial Scale Adenoviral Vector Production

Adenoviral vectors are frequently used as gene delivery tools for various medical applications. In most cases, replication-incompetent adenoviruses are employed, which, once they have infected a target cell, cannot spread further in the patient‘s body. In such applications, regulatory guidelines require that the formation of replication-competent adenoviruses (RCA) in the production process must be minimized. Since the risk of RCA occurrence depends on the adenoviral vector and the cell line used for generating the virus stock and for manufacturing the…

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

Biopharmaceutical manufacturing is currently evolving with the progression of Industry 4.0. 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. This is especially appealing to the biopharmaceutical industry, where production can be a long, meticulous, complex processes, and optimizing manufacturing procedures is critical for success. As a leading supplier of single use technology for the biopharmaceutical industry, PendoTECH has recently explored how its products can…

Successful Drug Development with Synthetic Lipids: Critical Aspects and Strategies

Currently gaining enhanced momentum due to their vital role in the development of vaccines against COVID-19, lipid-based formulations and lipid nanoparticles have shown a lot of promise in drug development and delivery particularly because of their ability to enhance active pharmaceutical ingredient (API) stability by protecting the API from immune response, proteases and other factors; boost the solubility and bioavailability of drugs with poor water solubility; passively target inflamed or tumor tissues due to their leaky vasculature, known as the…

Reagents Matter – Osmolality Testing in Gene Therapy Manufacturing

Osmolality testing provides a versatile measure of solute concentration that is an important consideration in the manufacture of gene therapies. This white paper discusses how monitoring osmolality of media during upstream viral vector production and reagents during downstream purification processes can influence quality of the final product. The dependence of multiple biological processes on osmolality, coupled with the usefulness of its measurement in vector quality control, means that osmolality testing is a powerful method to support a high yield of…

Ensuring Quality Oversight in Plasmid DNA Manufacturing

The landscape of today’s biopharmaceutical industry is changing rapidly with the introduction of novel drug products, such as personalized medicines. However, while this sector of the market is expected to have a major impact on patient care in the coming years, it also presents significant challenges during development and manufacturing. One such area is a gap in GMP quality plasmid DNA (pDNA) supply, an essential building block for viral vector and even mRNA based vaccines and therapies ― the latter…

Optimizing Control of Pump-Related Biopharma-Production Processes

In biopharma production, pumps are used in a variety of critical processing steps, most notably for liquid transfer that requires the creation and adherence to a required flow rate and pressure level. While this can be done manually through the reading of a pressure gauge and adjusting the motor speed if the pressure should venture outside of the acceptable range, this way is time-consuming and lacks the precision that an automated system can provide. Automated pumps became viable after they…

Optimizing the Accuracy of Biopharma Flow-Measurement Applications With the BioProTT™ FlowMeasurement System

The BioProTTTM FlowMeasurement System for the non-invasive measurement of volumetric flows within flexible tubing systems is suitable for both industrial and laboratory applications. It always consists of an evaluation device and a sensor. To ensure the highest possible accuracy, each sensor is adjusted and calibrated according to certain parameters based on the customer’s application. In addition, there are also external factors that impact the accuracy. This document will highlight and explain these factors so that system integrators and operators are…

Strategies for Successful Formulation Development of Lipid-Based RNA Delivery and Vaccines

Nucleic acid therapy using RNA and DNA as the active pharmaceutical ingredient (API) has the potential to cause a paradigm shift in the way diseases are addressed. This innovative therapy targets the source of the disease at the genetic level and can be used to modulate the expression of one or more proteins simultaneously – a unique advantage over conventional biologics or small molecules. Given this mode of action, RNA and DNA therapeutics are a powerful means to treat, and…

Shaping the Future of Formulation Development with Melt-based 3D Printing Technologies

Three-dimensional (3D) printing is a powerful technology that has wide-ranging applications, including many in the pharmaceutical industry. Among the approaches that are being explored in the production of pharmaceutical dosage forms powder-based systems which utilize either drop-on-powder or selective laser sintering and liquid-based systems which use drop-on-drop deposition or stereolithography are frequently applied. With liquid-based technology, either UV, laser energy or high temperature is used to induce polymerization and build the 3D structure. The process of 3D printing offers the…