BPI White Papers Archives - BioProcess InternationalBioProcess International

Seven Steps to Build a Productive CDMO/Sponsor Relationship

Once the hard work of selecting a capable biologics CDMO partner is complete, what does it take to build a productive CDMO/sponsor relationship? When evaluating biologics CDMOs, technical capabilities are understandably the primary selection criteria. Once critical technical fit and capacity are known, cultural compatibility becomes an essential ingredient in making the working relationship fruitful. At Bionova Scientific, we’ve built a reputation as a scientifically strong CDMO with the latest tools and infrastructure. But since our early days, we have…

Automated 32×32 Epitope Binning in a Single Assay

by BPI Contributor

The selection of lead candidates in the development of therapeutic monoclonal antibodies (mAbs) is a critical decision. Designing a mAb that exhibits all the desired biological and pharmaceutical properties is challenging, and therefore, this process is primarily empirical. The classification of monoclonal antibodies (mAbs) based on their binding behavior can be a valuable tool for selecting promising candidates for further development. Such classification often involves grouping mAbs with similar epitope binding regions, which are known to share similar biological functions.…

Rapid Discovery and Characterization of Monoclonal Antibodies Against the SARS-CoV-2 Delta Spike Protein

by BPI Contributor

The COVID-19 pandemic has led to a rapid and wide-ranging search for therapeutics to protect against and treat the illness. Besides the vaccines and antivirals that have been developed against SARS-CoV-2, a number of mAbs have been given emergency use authorization (EUA) by the FDA. Unfortunately, the neutralizing effect of mAb therapeutics can be reduced or negated by the evolution of viral variants. For this reason, the expedited discovery and development of new mAbs with neutralizing activity selective for novel…

Your Ultimate Guide to CMC Testing Support for Gene and Cell Therapy

by BPI Contributor

The development of Advanced Therapy Medicinal Products (ATMPs), such as gene and cell therapy products, has made significant progress in the treatment of many diseases, including cancer, genetic, and autoimmune disorders. With the promise to enhance treatment, greatly reduce side effects, and potentially cure many types of diseases and disorders, these therapies are in high demand, and biopharma companies are in a race to the clinic. However, these technologies are very complex in nature and are vastly different than traditional…

Cell Harvesting & Washing: Optimizing Viability and Recovery in Cell Therapy

by BPI Contributor

The cell harvesting step is of utmost importance for cell therapy manufacturers. During this step, high cell viability and recovery are important to maximize yield. Single-use, low shear closed-system centrifuges enable safe and efficient cell therapy manufacturing through the efficient recovery of viable cells. Additionally, in the production of cellular-based therapies, media and buffer are often used to remove unwanted proteins, serums, and debris prior to the eventual administration to patients or for research and treatment purposes. Download this case…

Addressing the Gassing Rate in Bioreactor Upscaling – is vvm a Reliable Parameter?

by BPI Contributor

Common approaches for the scale-up of bioreactors use the gas flow coefficient (vvm) as a criterion for volumetric flow rates. Besides being the most common decisive parameter when it comes to the scaling of the gassing rate, a defined vvm is frequently used in the context of process validation, and therefore considered essential for qualification. ZETA called the reliability of this parameter into question and evaluated the scaling competence of vvm in a study performed in the context of commissioning…

Integrated Solutions for Advanced Therapies

by BPI Contributor

Cell and gene therapies have reached clinical and commercial success as evidenced by the steady number of first approvals over the past four years. Drug developers face mounting challenges linked to rapid increases in demand for the complex modalities while also accounting for the need to drive process efficiencies at scale. Working with the right partner, that offers integrated services, can help ease the increasingly common problems with scale, access to high-demand raw material, viral vector production, and quality requirements.…

mRNA Process and Cost Modeling: A Tool to Optimize Process Development

by kimraff

The COVID-19 pandemic brought into focus the impact that mRNA technology can have on rapid drug development. mRNA is an attractive modality to work with because of its relative simplicity compared to other biologics; it is wholly synthetic and does not require cellular materials. Demand for mRNA-based medicine production in lower income countries continues to increase, as do investments in prophylactic and therapeutic indications such as infectious diseases and cancer. We developed a cost-model to compare all modalities such as…

Eliminate Noisy Oxygen Measurements in Bioreactors for Good and Control Your Process with Ease!

by BPI Contributor

Achieving process consistency is a critical goal in cell culture and fermentation operations. However, one common challenge in these processes is the accumulation of air bubbles on oxygen sensors. This can cause severe signal noise, which in turn can mask the true oxygen level, complicating process control and leading to variability. To avoid this issue, robust aeration control is crucial. You can improve growth, productivity, and product quality by ensuring adequate oxygen supply to cells. However, air bubbles on oxygen…

Critical Factors of Fill Finish Manufacturing for Large Molecules

by BPI Contributor

With the explosion of the large molecule (biologics) market, the industry has entered a new era of drug development. This growth — 10% to 15% each year — is being driven by monoclonal antibodies (mAbs), which are anticipated to have worldwide sales of over $240 billion by 2025. However, with this expanding market comes some considerable challenges for drug manufacturers due to the fragile nature and instability of these large, complex molecules. As compared to small molecules, large molecules generally…