BPI White Papers

Standardization is Key: Unlocking the Potential of Data-Driven Maintenance

Efficient maintenance is an important factor in pharmaceutical manufacturing to assure production capacity and avoid unplanned downtime. For a data-driven approach to prescriptive maintenance, three types of data are relevant: time-based, condition-based, and metadata. To exploit the full potential of such an approach, all three types of data must be accessed and fully utilized. ZETA is driving digitalization and aims to develop practical solutions with added value for the pharmaceutical industry. In a cross-company working group, ZETA experts tested an…

Xeno-free T cell Expansions in PBS Mini Vertical-Wheel® Bioreactor Using CellGenix® reagents

Cell and gene therapies continue to be the fastest growing area of therapeutics, with several new therapies available to patients and hundreds more in development. Sustaining such innovation requires biopharma companies to solve many operational challenges, particularly in manufacturing and scaling up therapies. Cell and gene therapies typically require a substantial amount of cells per dose, which means that bioreactor-based expansion of therapeutically active cells is key. This is the first study that demonstrates the cultivation of T cells in…

Current and Emerging Technologies to Optimize mRNA Manufacturing

Messenger RNAs (mRNAs) represent a fast-emerging class of biotherapeutics. They hold considerable promise, offering new opportunities for targeted treatment and flexible manufacturing, as demonstrated by the rapid development of mRNA-based COVID-19 vaccines. However, the field is still in its infancy, and the clinical potential of mRNA extends beyond vaccines. To date, there have been more than 348 clinical studies involving mRNA as an active ingredient or an enabler for cell and gene therapies such as CRISPR-Cas9 derived therapeutics. Lonza has…

Regulatory role of Biophysics in Biologics CMC

Biophysics-driven understanding of higher order structures (HOS) and corresponding critical quality attributes (CQA) are imperative for drug regulation. HOS modulates the functional repertoire of biologics which mainly comprises proteins. On the other hand, critical quality attributes (CQAs) are the physical, chemical, biological, or microbiological properties or characteristics that should be within an appropriate limit, range, or distribution to achieve the intended product quality (Source: ICH Q8 R2). CQAs typically relate to the drug component’s excipients, intermediates (materials in the process),…

Lonza Shapes Biotherapeutics Development Programs around Different CMC Paths

Getting to the clinic is a major milestone for biopharmaceutical companies. The drug development journey is long, expensive, resource straining, and risky due to high attrition rates. A large amount of data must be generated, collected, interpreted and correctly integrated for the First-in-Human (FIH)-enabling data package. When developing more complex formats such as bispecific antibodies, fusion and recombinant proteins, you are probably facing even tougher technical challenges which can lead to longer timelines. As a biopharmaceutical company, you also face…

Use of DOE Screening to Select Resins for Monoclonal Antibody Purification

Screening resins for monoclonal antibody (mAb) purification is complicated both by the number of resins available and the myriad variables that must be considered to optimize a purification workflow. Using a systematic screening approach, such as design of experiments (DOE), can simplify resin selection by enabling a comprehensive evaluation of multiple input factors and their impact on desired outputs. Read this whitepaper to learn more about: The limitations of a templated approach How to optimize chromatographic separations using DOE screening…

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

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

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

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…