11.24.20 -- System Impact Assessment: A Risk Management Framework For A COVID World

Meeting the needs of the modern biomanufacturing landscape requires a combination of technology and digital solutions working together to effectively and efficiently meet your goals.

There are no shortcuts to growing capacity that delivers results faster, and maintaining it is difficult. The key ingredient in growing enterprise value is sustainability. Learn how, by applying the principle of sustainability using its four dimensions, finite resources are more wisely used with extraordinary results, lead time from concept to commercialization is greatly improved, and patients receive better medications faster.

Pharmaceutical companies need CDMO partners that provide solutions at fair value. This CMO has a long history of investing in new technologies with innovators to help their customers achieve their goals, and one recent example is the construction of a new Hastelloy spray-drying unit.

The result of regulatory compliance with quality standards is binary, but the processes employed to get there don't need to be rigid, inefficient, and expensive. Learn how innovation drives efficiencies.

Using quality risk management (QRM) gives a company the ability to maintain compliance while also identifying product issues that could be harmful to the consumers, some being susceptible patients.

Despite the benefits of blow/fill/seal (B/F/S) over glass, some pharmaceutical companies refuse to make the switch because of several objections.

The limited solubility of many modern drugs frequently translates to low bioavailability, making improved solubility a primary goal of oral dosage formulation development. Low aqueous solubility can be combated through preparation of an amorphous solid dispersion (ASD). This article explores spray drying and hot melt extrusion (HME), which are among the most widely applied technologies for producing ASDs.

Key considerations need to be made when selecting a single-use technology (SUT) supplier to ensure your choice best meets your needs and allows you to scale to your target operation sizes.

Powder handling plays a major role in the design and the operation of an API facility and can often become the “bottleneck” of the plant. The constantly increasing toxicity and reactivity of products in recent years, as well as the ever more demanding production standards with regard to quality, have made closed powder handling an unavoidable factor as manual handling has become obsolete. Selecting a suitable technology has become vital for the development of a project since it can largely influence the entire design.

The dye ingress test method continues to be a widely used test method for container closure integrity (CCI) within the pharmaceutical industry. Even with recent research attempting to support its use, this paper explains why the dye ingress test method is not a suitable approach.

An emerging modality of therapeutics called PROteolysis TArgeting Chimeras (PROTACs) could enable the design of new drugs targeting “undruggable” proteins, which comprise up to 85% of the proteome. This article introduces PROTACs and the benefits they can offer to the drug discovery field, and then discusses how the issues with their synthesis can be overcome.

Next-generation drug products are more targeted and patient-specific by nature, causing batch sizes to be much smaller. This paradigm shift paves the way for more flexible manufacturing solutions.

A significant concern in tablet manufacturing is speed-to-market. Moving too quickly, however, may cause delayed production, lost product, and missed deadlines. To reduce potential headaches, companies are embracing the principles of quality by design (QbD) and utilizing automated data gathering and tablet analysis during research and development. This allows organizations to reduce product development and delivery stress and loss.

Light scattering is deflection of a light beam from its path by irregularities in a medium. To obtain measurement methods based on light scattering, the instrument records the deflected light, which contains a large amount of information on the particles that have scattered it. This white paper focuses on the means necessary to record and translate this detected light into the different physical properties of the particles.

The potency and effectiveness of antibody-drug conjugates (ADCs) are dependent upon engineered nanoparticles (ENPs), but little is known about the environmental and human health hazards posed by ENPs.

Tubing is arguably one of the earliest components in pharma to be associated with single-use technology. This paper espouses active risk mitigation and cleaner materials in single-use tubing applications.

How an integrated pharmaceutical development platform can meet the needs of both analytical development and QC teams through shorter turnaround times, fewer repeats, and higher quality.

Processing powder blends can present several challenges: component powders may be poorly flowing in the process, the blends may be susceptible to segregation, or the formation of agglomerates may affect homogeneity. It is essential to identify powder properties that can be applied to characterize dry granulates in a relevant way and to optimize dry granulation processes. This application note investigates how process parameters influenced the properties of the dry granulate of a placebo formulation.

A GMP manufacturing suite was developed that included a custom-designed and constructed clinical manufacturing cleanroom core for producing PENN Medicine's cell and gene therapy candidates.

At Lilly Deutschland GmbH, particular emphasis is placed on safety and quality, as physicians and patients need to be able to rely on the effectiveness and safety of medicines. Due to the increasing number of counterfeit products in the pharmaceuticals market, Eli Lilly was looking for a precise and reliable serialization solution that would enable the company to continue guaranteeing the traceability and, thereby, the safety of its pharmaceutical products.

Perfusion is a process that keeps cells in a bioreactor while continuously exchanging culture medium. This ebook explains perfusion, its advantages, and the different types of perfusion available.

This webinar focuses on applications where flexible isolators have been used, including containment assessments to confirm performance and ergonomic benefits. 

Antibodies have become prominent therapeutic agents, but they are costly to develop. Existing approaches to predict developability depend on structure, which requires extensive laboratory or computational work to obtain. To address this issue, we developed a machine learning model to predict developability from sequence alone by extracting physicochemical and learned embedding features.