A Brief Introduction To Environmental Monitoring For Startups
Environmental monitoring is a crucial part of the pharma, biotech, and medical device field to indicate that the microbial particulate content of all cleanroom air and work surfaces is below acceptable levels. For new startups with a small number of employees wearing many hats, you might not have a deep understanding of what kind of monitoring is available, so this article shares an introduction.
Modular And Single-use Tech Driving The Future Of Biomanufacturing
BioPlan's 2023 Biopharmaceutical Manufacturing Report shows an increasing demand for single-use and modular manufacturing systems for traditional biologics like mAbs. It also confirms that these technologies become even more critical for advanced therapeutics where small-scale applications may be the only option.
In Silico Approaches Towards Automated Biomanufacturing
As part of MSAT, in silico approaches such as mechanistic modeling can be used to support and facilitate several activities in the production of biopharmaceuticals at all scales.
Bioprocessing 4.0: Digital Transformation Of Biopharmaceutical Process Development
Discover how, in combination with artificial intelligence, augmented reality, robotics, and digital twins, biopharma 4.0 is changing legacy concepts from the ground up.
Pathways To Bioreactor Process Scaling
Learn how digital standardized tools can simplify your scaling practices, help you better predict and visualize scaling needs, and reduce trial-and-error experimentation.
Simulation Gets Therapies To Patients Faster And Smarter
Access to digital solutions like in silico software products that help to decrease therapeutic time to market and get lifesaving drugs to patients faster and smarter remains a challenge in biopharma.
Legal And IP Protection For New Biotechs
Want to ensure you've got your biotech legal, IP, and patent bases covered? Join Business of Biotech host Matt Pillar and BlueSphere Bio CEO and biotech legal expert Keir LoIacono on 11/13 for the live, interactive, and FREE digital event Legal And IP Protection For New Biotechs.
Understanding The Importance Of Real-time Monitoring For Protein Aggregation
BioSolution’s Danny Chou, Ph.D., Pharm.D., breaks down the advantages of real-time monitoring for protein therapeutics, including how these approaches can accelerate timelines, produce better data, and smooth regulatory compliance.
Drug Delivery Systems: Measurement System Analysis Using Continuous Gage R&R Studies, Part 2
This article, part 2 of a 3-part series, examines the prerequisites phase, development and approval of the study protocol phase, execution sequence, and post-execution of a continuous gage repeatability and reproducibility (R&R) study for drug delivery system measurement system analysis.
How To Improve Lentivirus Polishing Recovery
Explore how we used capture with weak anion exchange and optimized the Capto™ Core 700 chromatography resin polishing step to maximize infectious recovery.
In Silico Optimization Of A Multimodal Chromatography mAb Polishing Step
Achieve process optimization in the multimodal chromatography polishing step of monoclonal antibody manufacturing, doubling process productivity with just six calibration experiments.
Best Practices For Use Of Risk Registers In Bio/Pharmaceutical Manufacturing Operations
Risk registers can be a valuable risk management tool, and having a risk register is increasingly becoming a regulatory expectation. It can be structured as a database or spreadsheet and ensures decision makers have key information about risks. Discussion also includes pitfalls to avoid.
Is ‘Human Error’ The Cause Or The Outcome Of GMP Deviations?
Painting mistakes with the broad human error brush ignores the underlying causes, which can be complex. Amnon Eylath, a veteran GMP consultant, presents a case study that illustrates why he encourages companies to adopt robust processes for uncovering true root causes and reducing deviations.
Here’s Why Outsourcing To CDMOs Doubled In 13 Years
It might surprise no one that BioPlan Associates' 20th annual survey on manufacturing found an increased dependence on contract manufacturing. The sheer rate at which demand has grown, however, is stunning, and the survey found CDMO capacity is only now starting to catch up with supply.
Developing A HIC Polishing Step For The Removal Of mAb Aggregates
Learn in-depth about the development of a flow-through polishing step that employs hydrophobic interaction chromatography for the elimination of monoclonal antibody aggregates.
ABOUT BIOSIMILAR MANUFACTURING
Biosimilars are considered to be low-cost substitutions for pricy, large-molecule biologics. However, biosimilars must meet the same quality, safety, and efficacy as their reference biologic. Manufacturing biosimilars requires a more complicated procedure than that of manufacturing small molecule generics. Companies manufacturing biosimilars are focused on creating a chemical structure that is as close as possible to that of the reference product. Failure rates and operational costs pose a challenge for those companies involved in manufacturing biosimilars compared to those manufacturing small molecule generics.
Small molecule generics are created using the same active pharmaceutical ingredient (API) and, therefore, are chemically identical to that of the originator medicine. The manufacturing process for small molecules comprises only one-fifth of the total in-process tests required to meet Good Manufacturing Practice compared to that of biologic medicines (50 vs. 250 in-process tests). In fact, the manufacturing process for a large molecule is so complex, it cannot be duplicated by two different manufacturers, as the cells used in biologic medicines are unique to the company manufacturing each biologic.
Manufacturing a biologic consists of genetically modifying a cell, which becomes the basis for a cell line used for the production of the necessary protein for the biologic medicine. The protein is then separated from the cells and purified. Biosimilars are created from small alterations to the manufacturing process which creates a molecule that is not identical but closely resembles the reference product. While the differences in the biosimilar molecule might be slight, these changes in the manufacturing process of a biosimilar can affect the efficacy and safety of a biosimilar compared to the reference biologic. Over the past decade, the manufacturing process for proteins has become more standardized and the required technology has become increasingly accessible, leading to reductions in biosimilars production costs. As a result, a greater number of companies have begun manufacturing biosimilars, while reference brand manufacturers are setting their sights on bolstering pipelines and manufacturing biobetters to maintain market share for their soon-to-be-off-patent reference products.