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In November 2020, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced it was appointing an Expert Working Group (EWG) to update the quality [...]

Multi-unit pellet systems (MUPS) and intelligently encapsulated mini-tablet systems (EMTS) have unique combinations of advantages compared to conventional oral formulations. The drug release from MUPS and EMTS can be modified [...]

If celebrity investment is a barometer of the health of a particular industry, then men's grooming must be entering a winning streak. 2024 has already seen new business ventures from [...]

The use of psychedelic substances in ritual healing experiences reaches far back into human history. Ancient cultures from all over the world used different psychoactive compounds as a means of [...]

In November 2020, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced it was appointing an Expert Working Group (EWG) to update the quality [...]

Multi-unit pellet systems (MUPS) and intelligently encapsulated mini-tablet systems (EMTS) have unique combinations of advantages compared to conventional oral formulations. The drug release from MUPS and EMTS can be modified [...]

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 [...]

Cosmetic ingredients to boost hair growth and curb hair loss are seeing strong demand, so what options are available? Asks Julia Wray Hair density cosmetics, which promise to boost hair [...]

The landscape of treatment for medical conditions and illnesses has become tailored and rich thanks to advances in personalized medicine, artificial intelligence (AI), and emerging modalities. Cell and gene therapies [...]

Cefpodoxime proxetil (CFPD PRXL) is a third-generation cephalosporin antibiotic with broad-spectrum activity. However, its bitter taste often leads to poor patient compliance. This study aimed to develop a taste-masked drug [...]

In 2020, the International Council for Harmonisation (ICH) published a concept paper (1) that outlined a limited revision to the published guideline ICH Q9 Quality Risk Management (QRM) (2) to [...]

This article originally appeared in the March issue of Contemporary Pediatrics[R] and has been lightly edited. Attention-deficit/hyperactivity disorder (ADHD) is a neurobehavioral disorder most commonly seen in children that may [...]

In 2022, the US Supreme Court ruled on Dobbs v Jackson Women's Health Organization, revoking the constitutional right to abortion established 50 years ago in the landmark Roe v Wade [...]

Whether it's the discovery of a hot challenger brand, or a highly anticipated breakthrough from a long established leader, no beauty category gets beauty consumers' pulses racing quite like skin [...]

Maya Kansagra is the winner of the Cosmetics Business prize for the best essay on the 2023 SCS Diploma in Cosmetic Science course. This is an abridged version of her [...]

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 [...]

Cefpodoxime proxetil (CFPD PRXL) is a third-generation cephalosporin antibiotic with broad-spectrum activity commonly prescribed in both solid and liquid forms to treat various bacterial infections, including upper respiratory infections, ear [...]

In 2020, the International Council for Harmonisation (ICH) published a concept paper (1) that outlined a limited revision to the published guideline ICH Q9 Quality Risk Management (QRM) (2) to [...]

With the rise of nucleic acid-based therapeutics, such as the mRNA vaccines, biopharma developers are working toward the next big breakthrough in personalized medicines. Over the past couple of years, [...]

Beauty bars were predicted to take off at the start of the decade, so why is the format struggling to gain altitude? Cast your mind back to 2020 when Gamier [...]

The underlying concept for acceptance value (AV) in Uniformity of Dosage Units (UDU) is based on that of tolerance interval (Tl). Its maximum allowed acceptance value (L1) is declared not [...]

The US Food and Drug Administration (FDA), as well as other regulatory agencies around the world, have for many years been encouraging drug makers to switch from batch to continuous [...]

Pharmaceutical compounding comprises activities associated with preparation of dosage forms that are not commercially available from major pharma industry. Compounded dosage forms have traditionally been prepared in response to individual [...]

Prof. Steffen Thirstrup is a medical doctor with a PhD in pharmacology and broad clinical experience in general internal medicine. He has a track record of working with the European [...]

Pharmaceutical compounding comprises activities associated with preparation of dosage forms that are not commercially available from major pharma industry. Compounded dosage forms have traditionally been prepared in response to individual [...]

The underlying concept for acceptance value (AV) in Uniformity of Dosage Units (UDU) is based on that of tolerance interval (TI). Its maximum allowed acceptance value (L1) is declared not more than (NMT) 15; therefore, meeting the limit will just imply that the lower the value the higher the degree of quality conformance. Due to the formula for L1 or AV (i.e., AV = |M - [bar.x]| + ks [less than or equal to] 15, the condition for |M - [bar.x]| is not justified, and so, compromising that, the AV results will easily pass the limit of NMT 15 most of the time. If recognized by United States Pharmacopeia, such a compromization will continue for official use in a new proposal on "Batch Release Testing for Ensuring Compliance with Uniformity of Dosage Units". One of the solutions for such a compromization issue is to simply implement the TI technique to demonstrate that at least 95% or more of the dosage units in routine batches will fall within the range 85-115% of label claim. The technique will provide useful data for batch releasing rather than depending on AV parameter alone., The US Pharmacopeia's Pharmacopeial Forum (PF) includes a proposal of a new United States Pharmacopeia (USP) Chapter Batch Release Testing for Ensuring Compliance with Uniformity of Dosage Units (1), addressing [...]

FDA, as well as other regulatory agencies around the world, have for many years been encouraging drug makers to switch from batch to continuous processing due to the many benefits [...]

Messenger RNA (mRNA) molecules are inherently unstable and readily degrade when exposed to ubiquitous enzymes such as RNase and undergo pH-dependent hydrolysis of phosphorus-oxygen bonds when exposed to water. That [...]

In the first of a two-part series, leaders of industry associations present their expectations for pharmacy operators for this year. The views of other organizations will appear in the next [...]

Each year, BioPharm International[R]'s sister publiations, Pharmaceutical Technology[R] and Pharmaceutical Technology Europe[R] survey audience members to see what has remained the same and what has shifted, regarding pharmaceutical workforce attitudes [...]

Cell culture process transfer requires a good understanding of the physicochemical conditions within a bioreactor. This includes the hydrodynamic environment induced by the agitator and the mass transfer capability of the spargers at different gas flow rates. Cell culture processes need to operate in a design space where the oxygen supply and carbon dioxide removal can match cellular metabolism. In addition, prohibitive high shear stress and high gas flow rates can create bubble damage or foaming issues and should be avoided. Identifying the boundaries of a design space for a robust process is difficult due to the extensive characterization data needed and the diversity of single use bioreactor design. The authors show that in-silico models can be used to determine ranges in the design space for agitation and gas flow rates that fulfill the requirements of oxygen transfer and carbon dioxide stripping. Furthermore, the design space can be explored by locking one or two input variables and using the model to calculate acceptable ranges for the remaining parameters. With this methodology, it is possible to navigate the design space, understand correlations of the operating parameters in silico, and build understanding about the limits for all operating parameters., To achieve a successful cell culture process transfer between bioreactors of different design and/or scale, a consistent bio-reactor environment needs to be maintained. Figure 1 describes a bioreactor and cell [...]

Each year Pharmaceutical Technology[R] and Pharmaceutical Technology Europe[R] survey audience members to see what has remained the same and what has shifted, regarding pharmaceutical workforce attitudes toward their jobs, their [...]

In 2009, the pharmaceutical and biopharmaceutical industry's quality risk management (QRM) journey was still in its infancy. The industry had begun performing risk assessments, lots of risk assessments. Consider, for [...]

At the beginning of 2023, inflation represented a significant thorn in the side of global economies and exacerbated the challenges raised by the tumultuous preceding 12 months--encompassing the tail end [...]

Cell culture is fundamental to biomedical research and can be categorized into two major platforms: adherent and suspension. Both approaches are suitable for a range of diverse research applications, including [...]

In 2009, the pharmaceutical and biopharmaceutical industry's quality risk management (QRM) journey was still in its infancy. The industry had begun performing risk assessments, lots of risk assessments. Consider, for [...]

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 [...]

There are two main threats posed by extractables and leachables (E&L), contamination from unwanted impurities such as nitrosamine or chromium causing toxicity issues and diminution of drug efficacy or potency [...]

The bio/pharma manufacturing industry is an ever-growing and evolving landscape, where emerging modalities and shifts in the field drive technological innovation. Advances in the field are clear to see from [...]

Industrial interior design is inspired by industrial buildings and elements such as exposed pipes, metal, concrete and brick. 'Industrial style in interior design can be best described as the grunge [...]

The make-up brush remains an understated but vital beauty tool. Alessandro Carrara explores how manufacturers are pushing the needle forward for sustainability and design in 2024 Although straightforward in design [...]

The world of beauty and hair care is continually evolving, and social media platforms like TikTok provide a fantastic space for sharing and discovering new trends and products. For those [...]

Pharmacists are emerging as crucial players in ensuring access to safe reproductive care, especially as changes in abortion legislation create a thorny landscape of access. These health care professionals are [...]

In early February, an article published by the American Medical Association (AMA) began making the rounds on social media. In it, the author makes sweeping claims about the role of [...]

There are two main threats posed by extractables and leachables (E&L), contamination from unwanted impurities such as nitrosamine or chromium causing toxicity issues and diminution of drug efficacy or potency [...]

Prefilled products, particularly prefilled biologies, 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 [...]

The bio/pharma manufacturing industry is an ever-growing and evolving landscape, where emerging modalities and shifts in the field drive technological innovation. Advances in the field are clear to see from [...]