BPI White Papers Archives - BioProcess InternationalBioProcess International

The Powers of Odin: Comprehensive Cellular Characterization

Prokaryotic and eukaryotic cells change and adapt to their environments in ways that genomic characterization methods do not fully capture or predict. Even strains of the same species of microbe can show key differences in pathogenicity or sensitivity. Phenotypic analysis provides a complementary method for effectively characterizing the functional properties of cells. Biolog Phenotype MicroArray panels with redox reporter dyes have made this type of analysis possible for many years, as researchers grow their organisms under thousands of different pre-selected…

Scalability from Mobius® 3 L Single-Use Bioreactor to 50 L – 2000 L Mobius® iFlex Bioreactors to Support Intensified Upstream Process Development

by BPI Contributor

Properly scaling from small-scale bioreactors to larger-scale bioreactors for intensified processes is highly dependent on maintaining mixing, oxygenation, nutrient, and process control. To be able to meet these criteria, bioreactor systems need to have a well-characterized design space while considering risks and ways to control hydrodynamic shear. Extensive understanding of the bioreactor design space and the environmental conditions experienced by the cells within the systems’ operating range enables more informed process development and predictable performance across scales. The Mobius® 3…

Your Ultimate Guide to Raw Materials Testing Support

by BPI Contributor

No bio/pharmaceutical product can be manufactured without first establishing the identity, purity and quality of its starting materials to ensure the product is suitable for its intended use. When this critical step in the bio/pharmaceutical manufacturing process is performed successfully, costly production problems and delays can be avoided. Eurofins BioPharma Product Testings’ North America sites offer a comprehensive GMP raw materials testing package supporting compendial & non-compendial analysis, containers testing, characterization testing, metals testing, mycoplasma testing and more. Our extensive…

Simplifying the Antibody Drug Conjugate Supply Chain: One company’s mission to drive efficiencies and mitigate CMC development and manufacturing challenges

by BPI Contributor

There are currently over 250 antibody drug conjugates (ADCs) in global clinical trials. This historically high number says more, perhaps, about drug developers’ belief in these novel, complex modalities than it does about how difficult or expensive it can be to bring them into the clinic. Challenges faced in the process of discovering, engineering, and developing ADCs start with identifying a highly specific antibody with the necessary binding affinity to the disease target, and then coupling the antibody with the…

Automated Aseptic Aliquoting: Unprecedented Flexibility For Good Filling

by BPI Contributor

Automated filling of drug substance is the way to go. Human error is the main cause of operational errors and process deviations in pharmaceutical manufacturing. Automated aliquoting into single-use bags help optimize fluid management significantly. It prevents overfilling, reduces the risk of contamination, shortens operating time and prevents incompatibilities with rigid filling systems. Among all available systems for automated filling of biopharmaceuticals and advanced therapies, RoSS.FILL, a platform for filling and filtration of primary packages, including single-use bags and bottles,…

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

by BPI Contributor

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

by BPI Contributor

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

by BPI Contributor

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

by BPI Contributor

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

by BPI Contributor

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…