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Validated cleaning approaches, especially legacy processes, are challenging to modify. To make the case for change, strategies such as the use of digital twins and continuous monitoring enable return-on-investment calculations and real-time quality assessment to mitigate risk. Embracing these strategies is a means to drive out waste and improve the overall cleaning process. The authors explored the elimination of a water rinse and blow down following the caustic wash step, examining the potential safety considerations, the effect on the quality of the cleaning process, and the potential benefit of implementing the change., A standard pharmaceutical or biopharmaceutical process equipment cleaning cycle consists of an initial rinse, caustic wash, intermediate rinse, acid wash, and then a series of post-acid rinses ending with a [...]

Space-time yield is a metric to analyze upstream process yields throughout a production campaign. This metric enables distinct methods for protein production, such as batch, fed-batch, or continuous fermentation, to [...]

Biologics and other complex biomolecule modalities present challenges to fill/finish steps. Being able to ensure a sterile environment during aseptic processing is one of them. The aseptic/fill finish process for [...]

Single-use biomanufacturing is a rapidly growing industry. In recent years, single-use centrifuges have become viable alternatives to traditional filters, promising 90% reductions in waste materials and improvements in process time and yield. However, these systems often have several fluid paths with different materials, complicating extractable studies This case study describes how the risk assessment of the first-to-market single-use disc-stack centrifuge was conducted. This study shows how a dramatic modification of the surface-area-to-volume extraction ratio was required for the single-use system and how this was considered during interpretation of the results respecting industry best practice. Furthermore, it's demonstrated how the detection of volatiles can vary depending on the approach of analysis, surface coatings, and where analytical study design should be considered to mitigate missing volatile extractables., Single-use systems (SUS) have revolutionized biomanufacturing and often replace traditional stainless-steel equipment. Presterilized SUS are considered 'safer, greener, cheaper, and faster' compared to traditional biomanufacturing systems (1) due to the [...]

Filtration is widely used during biologics manufacturing to remove process impurities and contaminants (particulates, viruses) and for bioburden control. Successful filtration operations are therefore essential to successful biotherapeutic production. As [...]

Single-use (SU) technologies increasingly find use today at all phases of the drug development cycle from preclinical to commercial manufacturing. As the biopharmaceutical market continues to expand and reliance on [...]

Cell-culture media formulations comprise the ingredients required by cells to survive, grow, and function as needed for the intended cell-culture application. The exact formulation depends on the nature of the [...]

The COVID-19 pandemic has given the bio/pharma industry lessons on being prepared to manufacture parenteral formulations for human use in emergency situations. Vaccines, remdesivir injection and amphotericin injection, are such [...]

Glycan modifications of recombinant proteins and antibodies can impact their function and stability and thus the safety and efficacy of drug products based on these molecules. Understanding these important critical [...]

Biopharmaceutical manufacturing largely involves biomolecules whose stability depends on temperature. Antibodies, insulin, and, more recently, messenger RNA (mRNA)-based vaccines are examples of biotherapeutics that require cold storage. This article explores [...]

It is well-known that developing a drug from the discovery through to commercialization is a costly endeavor, with market analysis showing that the average R&D cost to develop an asset [...]

Despite their track record of demonstrating significant therapeutic efficacy, biologics still face daunting challenges in their drug delivery. Biologics such as monoclonal antibodies (mAbs) and some vaccines are largely administered [...]

Industrial manufacture of biotherapeutic drugs and recombinant therapeutic proteins relies predominantly on mammalian cell lines, notably Chinese hamster ovary (CHO) and human embryonic kidney (HEK) 293. The HEK293 cell line [...]

Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracetic acid, or ethylene oxide) is [...]

Pneumococcal infections, stemming from Streptococcus pneumoniae, present a substantial health risk, especially among vulnerable populations. To counter this, vaccines employing bacterial capsular polysaccharide (CPS) have been developed. However, the purification of CPS is a pivotal vaccine manufacturing step, with the clarification process playing a crucial role in achieving optimal product yield and purity. This research focuses on refining the clarification step by assessing the performance of various depth filters. The study explores both conventional cellulose-based and innovative synthetic depth filters, utilizing pneumococcal fermentation harvests from two challenging serotypes. Evaluation criteria include hydraulic performance, throughput, and filtrate turbidity. Employing the constant flow rate sizing method for scale-up, the study determines that synthetic depth filters with suitable pore sizes demonstrate low resistance and high throughput, suggesting their efficiency in impurity removal. Overall, optimizing the clarification step is crucial for improving downstream processing of pneumococcal polysaccharide conjugate vaccines, and this study provides valuable insights into selecting and optimizing depth filters for efficient clarification, ensuring high product quality and process efficiency in vaccine manufacturing., Pneumonia is caused by Streptococcus pneumoniae (S. pneumoniae), a gram-positive coccus that also causes, otitis media, meningitis, and bacteremia in pediatric, elderly, and immunocompromised populations (1). The leading cause of [...]

'Primary engines of value creation'--this is the role that leading market commentators see biologic drugs playing in the evolving biopharmaceuticals market (1). Demand for protein-based, large-molecule therapies has been growing [...]

Affinity ligands play an exciting role in the ever-growing sphere of downstream processing. In speaking with BioPharm International[R], Phillip Elliott, PhD, associate director of Process Development, BioCina; Jan Bekker, PhD, [...]

Single-use technologies (SUTs) offer many advantages in biologics manufacturing, both for upstream and downstream processing. They provide flexibility to quickly scale out, scale up, or scale down to accommodate rapid [...]

In the rapidly evolving landscape of healthcare, nucleic acid therapeutics have emerged as a promising frontier. These innovative treatments, which include modalities such as antisense oligonucleotides, messenger RNAs (mRNAs), small [...]

There are more than 60 peptide therapeutics approved around the world and hundreds currently in clinical studies (1). A peptide is a polymer consisting of less than 100 amino acids [...]

The growing demand for adeno-associated viral (AAV) vectors in therapeutic applications emphasizes the need for scalable and more efficient manufacturing methods. Establishing proprietary cell lines offers substantial opportunities for achieving [...]

The harvest step in a monoclonal antibody downstream purification process removes biomass, particulates, and other material from the cell culture to generate a product stream suitable for purification by liquid chromatography. In a widely employed, two-step harvest process, coarse solids and intact cells are first removed using a centrifuge, and the resulting centrate is further clarified by depth and membrane filtration in series. Conversely, direct depth filtration has the potential to greatly simplify the overall harvest process by directly loading the cell culture broth on high-capacity depth filters and consequently removing the need for centrifugation. The authors evaluated this potential of direct filtration for multiple biopharmaceutical candidates to understand the underlying mechanisms that define fouling and the resulting capacity limitations in these filters. Here, the authors present a methodology to assess the contribution of individual filters to overall capacity of the direct filtration train, and elucidate how capacity is affected by characteristics of the cell culture broth and process parameters, including for enhanced upstream processes such as those incorporating high cell density perfusion. The findings highlight the limitations of direct filtration when implemented in large-scale facilities for high cell density processes. Ultimately, increased understanding of the fundamental principles that govern depth and membrane filtration can aid in moving from a trial-and-error to a more predictive and methodology-based approach for harvest development. This article is Part 2 of the study., In Part 1 of this study, previously published in the February 2024 issue of BioPharm International (1), the materials and methods, and study results for fouling Mechanisms of coarse depth [...]

Although neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) remain leading causes of vision loss, the treatment landscape continues to evolve with advanced options for managing these conditions. [...]

Contract organizations offer sponsor companies flexibility by providing capacity, expertise, knowledge, and cost savings. Contract manufacturing organizations (CMOs), contract development and manufacturing organizations (CDMOs), and other contract organizations can also [...]

Viral vectors continue to grow as a major category for biomanufacturing processes based on the growing clinical programs for gene therapies. Optimizing the manufacturing process for viral vectors starts with [...]

The evolution of automation in biopharmaceutical development and manufacturing continues to move forward. Technologies have advanced from possibilities to realities in recent years, according to David Sheedy, head of Life [...]

COMMERCIAL AND TECHNICAL CHALLENGES The clinical success of cell therapies is placing pressure on biopharma companies to achieve clinical milestones and regulatory approval as quickly as possible. However, the high [...]

Murtaza Adam, MD Partner Physician Chair, Clinical Research Committee Colorado Retina Associates Adjunct Clinical Associate Professor Rocky Vista University Denver, CO Disclosures: Consultant: Genentech, Regeneron, Regenxbio; Speakers' Bureau: Apellis Pharmaceuticals, [...]

Prefilled products, particularly prefilled biologics, are a growing sector in the pharmaceutical industry. 'Prefilled syringes and pens offer precise dosing, reducing the risk of errors during administration. They also eliminate [...]

Chronic illnesses or non-communicable diseases that affect the health of the global population are on the rise and, in turn, attributing to a large proportion of deaths and a higher [...]

2024 NOV 23 (NewsRx) -- By a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a [...]

2024 NOV 23 (NewsRx) -- By a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a [...]

2024 NOV 23 (NewsRx) -- By a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a [...]

2024 NOV 23 (NewsRx) -- By a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a [...]

These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include:ÃÂ Exicure (XCUR),... To see the rest of the story [...]

LIfT BioSciences, a rapidly emerging biotech company preparing to start clinical trials for its first-in-class allogeneic innate cell therapy, announces the expansion of its manufacturing and clinical operations with the [...]

Global Banking News-November 19, 2024-Cytokinetics and Bayer partner on aficamten for Japanese HCM patients (C)2024 ENPublishing - http://www.enpublishing.co.uk US-based cardiovascular biopharmaceutical company Cytokinetics Inc (Nasdaq:CYTK) and German pharmaceutical and life [...]

2024 NOV 16 (NewsRx) -- By a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a [...]

2024 NOV 16 (NewsRx) -- By a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week -- A new study on science is now available. According to news originating [...]

2024 NOV 16 (NewsRx) -- By a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a [...]

Flatiron Health reported its planned presence at the International Society for Pharmacoeconomics and Outcomes Research Europe (ISPOR Europe) 2024 Annual Meeting, including five accepted abstracts for poster presentation and participation [...]

Archon Biosciences, a biotechnology company advancing computationally designed Antibody Cages (AbCs) to unlock powerful therapeutic targets beyond the reach of existing modalities, reported its emergence from stealth with $20 million [...]

Moderna, Inc., a leader in the creation of the field of mRNA medicine, announced Health Canada has approved mRESVIA (Respiratory Syncytial Virus mRNA vaccine) for active immunization for the prevention [...]

2024 NOV 9 (NewsRx) -- By a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a [...]

2024 NOV 9 (NewsRx) -- By a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a [...]

2024 NOV 9 (NewsRx) -- By a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week -- According to news reporting originating from Washington, D.C., by NewsRx journalists, a [...]