2022 Archives - Page 3 of 6 - BioProcess InternationalBioProcess International

Smart, Real-Time Quality Insights Boost Life Sciences Manufacturing

The COVID-19 pandemic has shone a light on restrictive business processes, information silos, and poor supply-chain visibility in many sectors. In biopharmaceutical manufacturing, for example, difficulties associated with product-quality management have been exposed and starkly felt. However, public healthcare measures over the past 18 months have put physical distance between team members, thereby hampering the usual form-filling, manual sign-offs and spreadsheet-based recordkeeping associated with monitoring traditional manufacturing processes. In some cases, a lack of formal face-to-face discussions in the workplace…

Mycotoxin Risk Determination: Measuring the Potential for Patient Exposure with Antithrombin Alfa Sourced from Transgenic Goat Milk

by Greg Allard and Sean Evans

Antithrombin alfa is a recombinant human antithrombin developed as an anticoagulant treatment for people with hereditary antithrombin deficiency who are undergoing surgical or childbirth procedures (1). Marketed under the ATryn brand name by LFB SA (Les Ulis, France), antithrombin alfa was approved for use in adults by the US Food and Drug Administration (FDA) in February 2009 (2). Antithrombin alfa is expressed in the milk of transgenic goats and purified through a multistep downstream process encompassing both filtration and chromatography.…

Supplementing Gamma Sterilization with X-Ray and E-Beam Technologies: An International Industry and Academia Collaboration

by Nathalie Dupuy, Sylvain R.A. Marque, Leonard S. Fifield, Matt Pharr, David Staack, Suresh D. Pillai, Larry Nichols, Mark K. Murphy and Samuel Dorey

Ionizing-technology–based industries are growing rapidly around the world. The expansion is driven mostly by the technology’s myriad applications, including polymer crosslinking, medical device sterilization, food pasteurization, and phytosanitary treatment. Ionization also is used in the manufacture of some healthcare products such as medical devices and biopharmaceuticals. Industrial sterilization methods render single-use products and manufacturing components safe and ready for their intended use. ISO11137-1 describes the validation and routine control of a sterilization process for medical devices and mentions the three…

Removing Aggregates and Fragments of Recombinant IgG1: Evaluating a Process Change to Implement Appropriate Chromatographic Media

by Vidya Kant Tiwari, Pranav Gupte, Mahesh Gavasane, Tushar Bhabal, Saher Cheulkar and Saurabh Patwardhan

High–molecular-weight (HMW) and low–molecular-weight (LMW) product variants are critical quality attributes (CQAs) for monoclonal antibodies (MAbs) because they can cause severe immunogenic responses in human recipients. Aggregation is a common problem that can compromise the quality, efficacy, and safety of therapeutic proteins. It can occur at different stages in a biomanufacturing process: during cell-culture–based production, downstream process purification, drug-substance formulation, and storage of bulk drug substances or formulated drug products. Hence, the removal and control of MAb aggregates and fragments…

Improving the Performance of Tried-and-True Chromatography Technology

by Ian Scanlon

Efficient and effective downstream processing of biopharmaceuticals reduces manufacturing costs and time. Chromatography is the primary purification method for traditional recombinant proteins, monoclonal antibodies (MAbs), plasmid DNA, and viral vectors. Although interest in membrane separation technologies is growing, traditional resin-based solutions continue to be preferred when high-resolution purification is required. Ion-exchange chromatography (IEC)(e.g., cation and anion-exchange chemistries) and hydrophobic-interaction chromatography (HIC) are established bioseparation technologies. Cation-exchange resins are used widely for MAb polishing and aggregate clearance steps. Anion-exchange (AEX) resins…

Mind the Gap: Managing Relationships Between Upstream and Downstream Intensification

by Priyanka Gupta and Katy McLaughlin

Process intensification (PI) describes an integrated framework of strategies to maximize the output of a unit operation, a process, or an entire facility. By implementing PI strategies, biomanufacturers can accomplish their productivity goals by increasing production speeds and titers, reducing facility footprints, and cutting costs. Overall, such changes improve production efficiency and flexibility. Collectively, the biotherapeutic industry has made multiple advancements in intensifying upstream processing. PI strategies include using high-density cell banks, implementing seed-train intensification (n – 1 perfusion), and…

A Missing Link to Achieving Higher Vaccination Rates in Developing Countries

by Shea Vincent

Puerto Rico is leading COVID-19 vaccination efforts in the United States, with 89.7% of adults already fully vaccinated (1). However, many other regions are struggling to gain that level of traction, if any. Less than 1% of people in developing countries are fully vaccinated (2). Because Pfizer–BioNTech’s and Moderna’s respective mRNA-based SARS-CoV-2 vaccines still require ultracold temperatures for long-term storage, vaccine distribution in remote locations is arduous without appropriate cold-chain infrastructure. Puerto Rico’s success in vaccinating its population demonstrates how…

eBook: Sensors — Process Analytics for Modern Biopharmaceutical Workflows

by Brian Gazaille, Mason A. Chilmonczyk and Andrei G. Fedorov

To achieve quality by design in biopharmaceutical production, manufacturers need tools that can ensure the stability of critical process parameters (CPPs) and other performance indicators related to product critical quality attributes (CQAs). Over the past couple of decades, sophisticated process analytical technologies (PATs) have emerged to address such needs. Offerings are now abounding for single-purpose sensors that measure temperature, pressure, pH, glucose, protein concentration, or dissolved oxygen. New in-line formats are enabling such instruments to provide data in real time,…

Increasing the Integrity of Closed Systems: Advantages Offered by Single-Use Connectors

by Todd Andrews

Due to the complexity of biologic development and manufacturing and the business pressures of the biopharmaceutical industry’s landscape, the margin for error in today’s industry is small. That is why minimizing the threat of contamination is critical when using a closed system for drug development and manufacturing. Yet the traditional method of connecting each step in a closed process can present other risks to the integrity of your product. Therefore, it is important for you to be confident in selecting…

Bench to Bedside: Why Successful Drug Development Requires a Team Approach

by Mark Lane

The process from drug development to market approval takes many years and requires both integration and orchestration of several activities based on deep scientific and commercial expertise. We tend to think of drug development as a sequential, phase-driven process during which a product is taken methodically from discovery through preclinical studies, clinical development, and ultimately commercial launch. In reality, development of new drugs is not linear; rather, it requires integrated coordination between collaborators from different functions and stakeholders — from…