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…

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…

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…

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…

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…

New molecular entities (NMEs) are becoming larger, more crystalline and more lipophilic and, as a result, less soluble. While approximately 40% of active pharmaceutical ingredients (APIs) currently on the market show poor solubility, it is estimated that between 60 and 90% of compounds in development have solubility challenges.1,2 For an oral formulation, API solubility and permeability are critical factors for absorption in the gastrointestinal tract. As a result of this, solubility-enhancing formulation techniques have become an area of focus for…

Vaccines have been protecting against disease since the late 1700s. They function by triggering the immune system to generate short-term and long-term responses. Because there are many pathogens, there are also many vaccines. They can be classified by antigen character, but the manufacturing flows used to produce them are relatively similar. Read now our Vaccine Bioprocessing Handbook to learn more on similarities and differences on Vaccine processes for: viral vaccines, Virus-Like Particle (VLP) Vaccines, Polysaccharide Conjugated Vaccines, Viral Vector Vaccines…

Granulation steps as wet granulation are applied before the final step of tableting in order to achieve content uniformity, flowability and compressibility. Wet granulation applies water and therefore needs a drying step. To omit this for reasons of cost and API stability dry granulation or roller compaction is a compromise to achieve the desired content uniformity without having water involved and a subsequent drying step. Studies available in literature mostly focus on the use of MCC and lactose in this…

Learn about the basics of fragment-based drug discovery (FBDD), one of the most valuable approaches to small molecule screening and now even more widely used today by pharma companies than high-throughput screening (HTS) HTS’s main limitations — low success rates for more challenging targets, high level of false positives, and the size of the compound libraries — are propelling the use of FBDD. This change is also driven by the rise in the number of explorative targets, which demands not…

Vaccine developers are in need of more efficient and cost-effective approaches to manufacturing. To achieve this, we actively collaborate with academia, researchers and manufacturers to develop and optimize innovative tools, processes and strategies to resolve bottlenecks and accelerate the availability of vaccines to the global population. This e-book contains a series of case studies highlighting our recent collaborations with organizations and thought leaders on the front lines of the battle against challenging pathogens. From proof-of-concept to full commercial-scale manufacturing, discover…