BPI White Papers Archives - Page 2 of 35 - BioProcess InternationalBioProcess International

Responding to a Changing Drug Product Global Supply Chain

Of the many lessons learned during the pandemic, one overriding realization was that utilization of the primary, single-location manufacturing site, although the simplest and potentially most cost-effective strategy, can have significant consequences to the availability of critical life-saving biologics and vaccines. This scenario not only applies to drug product but also to drug substance and the wide range of raw materials used throughout the manufacturing supply chain. Thus, the need for ongoing production from multiple drug substance (DS) and drug…

Rapid and Efficient Measurement of Critical Quality Attributes and Parameters Using Octet® Bio-Layer Interferometry (BLI) Systems

by BPI Contributor

Critical quality attributes (CQAs) are defined as a physical, chemical, biological, or microbiological property or characteristics that should be within an appropriate limit, range, or distribution to ensure the desired product quality. These essential measurements include product-specific attributes such as size, charge, and glycosylation patterns as well as process-related impurities including host cell proteins and residual Protein A from chromatographic purification. CQAs must be identified early in the discovery process, reflect the target product profile of the drug candidate, and…

Magnetic Agitators Score on Climate Friendliness

by BPI Contributor

A major advantage of magnetically coupled agitators is the hermetic separation of the sterile vessel interior from the agitator motor. As no mechanical seal system is required, the risk of contamination entailed by such a system is avoided. There is no requirement to lubricate the seal and no need for energy-intensive pure steam condensate: a sign of the climate friendliness of magnetic mixing technology! Elimination of steam lubrication reduces CO2 footprint Steam generation requires a lot of energy, usually from…

From Concept to Cure: Using AAV in Gene Therapy

by BPI Contributor

Because viruses efficiently insert nucleic acids into host cells upon infection, they are attractive vehicles for gene delivery. In the past, many viral gene delivery agents were unsuitable for clinical applications due to their high immunogenicity and propensity to cause cancer. To bring gene therapy to the clinic, scientists now use adeno-associated viruses (AAVs) for safe and effective gene delivery. Download this ebook from Bio-Rad to learn about Techniques for developing safe and effective AAV vectors for gene therapy Characterizing…

Solving Cost and Supply Challenges in Biopharma Downstream Processing

by BPI Contributor

In only five years, the number of FDA approvals for monoclonal antibody (mAb) therapies has more than doubled. These therapies continue to lead resource investment as biopharmaceutical companies drive to get these innovative, life-changing therapies to market faster. Yet mAbs downstream processing — which accounts for roughly 60% of the production cost of a biologic drug — hasn’t kept up with advances in upstream processing. Much of this challenge stems from downstream processing’s need to move biological materials through a…

Leading Biopharma Uses Linkit® AX: Here are the Results

by BPI Contributor

A Leading Biopharma was looking for a way to speed up their CAR-T media preparation. Their manual aliquoting process was time intensive, had a high risk of error and inaccuracy, and lacked a strategy for scaleup to a GMP environment. Sartorius developed a semi-automated media blending and aliquoting solution – the Linkit® AX Aliquoting Solution – that has been implemented and is now part of a GMP CAR-T manufacturing process. Read about how they used Linkit® AX to achieve 10x…

Intensified Biomanufacturing: Achieving 3-4-Fold Higher Titers of mAbs Using Syngene’s Intensified Fed-Batch Process

by BPI Contributor

Mammalian cell lines are predominantly used to produce mAbs. The current commercial production method uses fed-batch processes that exhibit productivity titers from 1- 5 g/L. Productivity is measured by the volume of products made in each batch. In the fed-batch process, the media and/or feeds are constantly supplied to the bioreactor during the cultivation, where the desired cells produce the product of interest. Productivity variation arises depending on the nature of the antibody and the specific cell line used. Higher…

Drug Development – Developing Biologics for Respiratory Delivery

by BPI Contributor

We bring you an informative on-demand drug development webinar, focusing on developing biologics for respiratory delivery. With drug discovery programmes increasingly focused on biological drug substances for both respiratory and systemic targets, the need to develop effective solutions for nasal and inhaled delivery is becoming increasingly vital for the industry. In this workshop, we will discuss the challenges and solutions alongside examples from real-world projects. Biologic and DNA-based modalities such as oligonucleotides, proteins, antibodies, and a range of other complex…

Critical Steps to Consider During Customized Host Cell Protein (HCP) ELISA Development

by BPI Contributor

The manufacturing of recombinant drugs requires comprehensive monitoring of process-related impurities, such as HCPs, as they may pose a significant health risk to patients. EMA and FDA approval relies on robust analytical data to prove acceptable HCP clearance. The enzyme-linked immunosorbent assay (ELISA) is the gold standard method for monitoring HCP content during product development and batch release testing within clinical and commercial phases. Supporting data from various orthogonal methods, including 2D Western Blot/2D DIGE analysis and mass spectrometry, should…

From Integrated Engineering to Integrated Operations: Solutions For Live Operation

by BPI Contributor

From Integrated Engineering to Integrated Operations: This innovation step extends the digital value chain to include the operational phases of a pharmaceutical plant. In the last few years, ZETA has developed a digital toolbox and methodology and established the Smart Engineering Services. Faster time to market, greater cost-effectiveness and competitive capacity are the customer’s motivations for prompting ZETA to develop this proposal. End-to-end engineering, feasibility studies, concept, basic and detailed engineering up to fabrication and qualification are included in the…