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Biopharma Partnerships: The Key To Filling The Life Sciences Innovation Gap
The life sciences industry is facing a significant slowdown due to patent expirations. Many organizations have not established a robust enough pipeline to overcome the revenue to be lost. To bridge this innovation gap, pharma CEOs will need to expand their use of alliances, in tandem with bolt-on M&A, as a pipeline booster strategy.
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Key Considerations For Decarbonizing Your Biotech Facility
Biopharmaceutical manufacturing processes do not directly utilize fossil fuels, but fossil fuels are used in the generation of raw materials, consumables, packaging, and in supplying energy to building systems and manufacturing equipment. This article looks at key facility decarbonizing considerations using a case study with quantification of estimated costs.
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Demonstrating ROI For Increased Digital Plant Maturity
Cytiva has partnered with the independent software company, Biopharm Services (BPS), to model the costs and associated benefits of increasing digital maturity for monoclonal antibody processes in a biopharma plant utilizing single-use technology.
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Liposomal And Nanoparticle Technology At Pfizer Melbourne
Specializing in oncology, anti-infective and complex formulations, the facility provides end-to-end services from development through to commercial manufacture of sterile dosage forms.
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The Single-use Bioprocessing Bottleneck & Looking Ahead
Are you asking, What happened to the bags promised for my product? The single-use system bag market had been seeing strains as early as 2018, and COVID-19 made the demand worse. This article looks into the factors contributing to the demand. Normalization of the supply chain may continue to be delayed, but it will eventually even out.
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Optimizing Feed Strategies: A Scalable Process
We present an optimized feeding strategy and demonstrate how a new, easy-to-hydrate, single-part, pH neutral feed can support optimal cell growth and high productivity of CHO cell lines.
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Chemically Defined Cloning Medium For Quality, Regulatory Risk Mitigation
We review the performance and stability of a novel, chemically defined cloning medium that accelerates clone isolation, reduces the risk of variability in protein quality, and reduces impurities.
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Quantitation Of Retrovirus-Like Particles (RVLPs) In CHO Derived Products
Review key methods which are applied to ensure safety of such recombinant proteins, with a focus on alternate and superior methods to the standard transmission electron microscopy (TEM) method.
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A Multi-Scale Approach To CHO Media Benchmarking
In this study we apply a multi-scale approach to efficiently screen combinations of chemically defined commercial media and various CHO production clones using benchtop bioreactor systems.
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Factory/Site Acceptance Testing & Commissioning Responsibilities
Execution of factory acceptance testing (FAT) and site acceptance testing (SAT) is a business-critical activity when it comes to commissioning of a new system or equipment. FAT is conducted at the equipment manufacturer’s site and SAT is conducted at the final site of installation. This article shares best practices.
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High-Throughput mAb Purification With Fibro Chromatography
Rapid cycling, using Fibro PrismA units together with an ÄKTA pure™ system and an autosampler, offers new opportunities in high-throughput purification for screening of lead candidates and process conditions.
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Strategies For Clarifying Harvest Feed Streams In Viral Vector Bioprocessing
The goal of clarification is to prepare the cell culture feed stream for downstream chromatography and purification. In this poster, we explore data driven strategies for clarifying harvest feed streams.
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Facilities Remediation, Renovation & Reconstruction: When Does It End?
We sit at the beginning of 2022 amid the industry’s frantic and hurried effort to acquire, expand, and prepare more aseptic plant capacity — and to make it useable, compliant, and productive. This article provides a deep-dive on planning and design for your project, including walls, floors, ceilings, interstitial and mechanical spaces.
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White Paper: Process Analytical Technology (PAT) Using Next Generation Raman For Real-Time Bioprocess Monitoring
In this white paper, we describe applications and share case studies using Raman technology for real-time, inline monitoring of cell culture process parameters.
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FDA Proposes Inspection Of Injectable Products For Visible Particulates
FDA and CDER have released a draft guidance addressing the development and implementation of a holistic, risk-based approach to visible particulate control incorporating product development, manufacturing controls, visual inspection, particulate identification, investigation, and corrective actions. The public comment period ends Feb. 15, 2022.
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.
BIOSIMILAR DEVELOPMENT NEWS
- BD And Mitsubishi Gas Chemical Have Signed A Letter Of Intent (LOI) To Discuss A Partnership Agreement To Explore New Ways To Advance Biologic Drug Delivery
- Viatris And Biocon Biologics Launch Abevmy® (Bevacizumab), Their Third Oncology Biosimilar, In Canada
- United Kingdom First To Grant Licence For Teva’s Ophthalmology Biosimilar Ongavia (ranibizumab)
- Alvotech Announces Positive Results From A Pharmacokinetic Similarity Study For AVT04, A Proposed Biosimilar To Stelara
- JSR Life Sciences Launches 'Similis Bio' To Help Partners Accelerate Biosimilar Development