eBooks

eBook: Chromatography Column Packing — Best Practices and Considerations from Laboratory to Manufacturing Scale

Column chromatography is a powerful separation tool for biopharmaceutical research and industry, with applications ranging from laboratory bench-scale purification to process development and commercial-scale manufacturing of biotherapeutics. Ensuring the highest quality of separations depends on many factors, including the technique used for packing the chromatography column. Well-packed columns provide for the best chromatographic separations. Successful column packing ensures proper mobile-phase distribution and resin contact. Scaling up to large columns can introduce many challenges. Manufacturers of chromatography media provide best-practice advice…

eBook: Cryopreservation — Special Considerations for Cell Therapies

Freezing is an established approach to maintaining bulk drug substances/products for several biopharmaceutical modalities. Regardless of product type, a cryopreservation process requires extensive testing, monitoring, and control of freezing and thawing conditions. However, because living cells are significantly larger and more complex than monoclonal antibodies (MAbs) and other protein-based biologics, cell therapies raise distinctive concerns for cryopreservation processes. In this eBook, BPI’s managing editor speaks with Erik Wood (cofounder, chief science officer, and senior vice president of Ossium Health) to…

eBook: Vaccines — From Disease Prevention to Treatment

For over two years, the biopharmaceutical industry has revolved around rapid development, manufacture, and rollout of vaccines in response to the COVID-19 pandemic. Now as the world reverts to some sense of normality, demand has plummeted for the likes of J&J’s viral vector vaccine and Moderna’s messenger RNA (mRNA) vaccine, resulting in the lowering of financial forecasts, ending of manufacturing contracts, and freeing of production capacity. But where do vaccines — the great pharmaceutical success story of the past few…

eBook: BPI Lab — Contemporary Approaches to Data and Organization

Laboratories provide essential support functions in biopharmaceutical development: from cell-line development through process validation, environmental monitoring, and preclinical analyses . . . to product characterization, formulation, and stability testing. Regulatory compliance is important across the gamut of such laboratory work. Modern companies are implementing lean concepts that facilitate organization and workflows in laboratory operations. And companies around the world can use the latest technology to ensure data integrity for their analytical results. Included herein are two articles that originally appeared…

eBook: Chromatography — Addressing Pain Points To Mitigate Downstream Bottlenecks

Compared with significant advances in upstream production of recombinant proteins, downstream purification processes have undergone far less development over the past twenty or thirty years. Technologies are emerging for continuous-mode and/or multicolumn chromatography (MCC) operations, but commercial-scale biomanufacturing operations still rely on chromatography equipment and processes that closely resemble those used at the advent of monoclonal antibody (MAb) manufacturing. Thus, chromatography operations generally have not kept pace with upstream gains, resulting in manufacturing bottlenecks at purification stages. Compounding that concern…

eBook: Drug-Delivery Systems — Measurement-System Analysis Using Gauge R&R Studies

When a biological product requires a specialized delivery device, the resulting combination product can introduce new types of quality evaluation. Product development brings together regulatory requirements for biologics and drug-delivery systems, and for many people on the biopharmaceutical side, that includes a number of unfamiliar terms, processes, and procedures. Among those are gauge repeatability and reproducibility studies for measuring variations that arise from measurement devices and the operators using them. This eBook introduces the concept of attribute-data gauge repeatability and…

eBook: MSC-Derived Extracellular Vesicles Challenges in Production, Scale-Up, and Characterization

The discovery of extracellular vesicles (EVs) as an intercellular communication medium has led to explorations of their therapeutic potential. EVs constitute a heterogeneous mixture of several different vesicle populations that may be similar in size but different in content, or vice versa. The vesicles can contain RNAs and proteins as well as DNAs and lipids as biological cargoes. Those cargoes can exist either intraluminally within EVs or on their surface, adding complexity to analytical considerations. EVs are classified into subpopulations…

eBook: Factors Affecting Scalability of Cell Therapies

The number of cell and gene therapies in different phases of development is increasing. The industry currently needs to increase commercial good manufacturing practice (GMP) capacity to keep up with current and future demands. Cell and gene therapy scale-up from clinical to commercial capacity levels can reduce cost of goods and thus price per dose.  An optimized bioprocess facilitates scale-up from hundreds (clinical scale) to thousands of doses (commercial scale). Different approaches for increasing scale can be taken. For example,…

eBook: Biopharmaceutical Training — Designing Effective Adult-Learning–Based Programs

Biopharmaceutical industry training is imperative not only to ensure patient safety, but also to develop a skilled workforce that can support successful businesses. Current good manufacturing practice (CGMP) skills and behaviors are needed so that products being developed, manufactured, and delivered are compliant and within specifications. Individuals who fulfill roles within development, manufacturing, and delivery processes need some level of education to develop all the necessary skills and behaviors. Adult earners have unique needs and requirements that must be incorporated…

eBook: A Dynamic Control Strategy for Downstream Continuous Bioprocessing

Continuous processes can have many sources of variability. In downstream unit operations, changes can arise because of feed material variability, resin fouling in chromatography columns, column compression or failure, membrane fouling, depth-filter clogging, and so on. The US Food and Drug Administration’s guideline for continued process verification encourages biomanufacturers to monitor their processes and keep them under a steady state of control. One way to achieve that in continuous downstream processes is to implement a dynamic control system that adapts…