• How Do We Achieve The Promise Of Using Digital Health Measurement? DATAcc Leads The Way

    Digital health measures are redefining our understanding of health and disease by changing what we measure and how we measure it. It is the perfect time for the field to build the digital health measurement toolbox with intention – and build it right. The Digital Health Measurement Collaborative Community is a new pre-competitive collaboration dedicated to this, and you can get involved!

  • 5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations

    Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.

  • How To Find & Manage Biotech Consultants Effectively

    The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.

  • Designing Agile Manufacturing With An Integrated Drug Substance/Drug Product Ecosystem

    Companies that want to accelerate their biomanufacturing operations and use their resources efficiently need access to technologies and solutions that can safely and efficiently complete their workflow from idea to injection.

  • What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively?

    When life sciences companies need new talent, they typically have two options: bring in a consultant or hire a full-time employee. Usually, this decision is dictated by the permanence of the role, but sometimes, timelines complicate things. In this situation, an interim consultant can be the solution. But what is the interim consultant's role, really, and how do we use them effectively?

  • Comparison Of HIC Monolithic Support For Sample Displacement Chromatography Of pDNA

    Competing adsorption in sample displacement chromatography utilizes the chromatographic resin's binding capacity more efficiently and increases the chromatographic step's productivity. This application note investigates three monolithic chromatographic supports with different hydrophobicities regarding their applicability for sample displacement of pDNA. CIMac™ C4 HLD (butyl, high ligand density) as a commercial product and pyridine and histamine as custom immobilised columns are compared.

  • Increasing Productivity Of pDNA DSP Using Sample Displacement Chromatography

    Plasmid DNA (pDNA) as a pharmaceutical product has stringent purity and efficacy requirements, and often one or more chromatographic steps are used in the downstream process. High ligand density butyl-modified chromatographic monolith (CIMmultus® C4 HLD, part of CIMmultus® HiP² Plasmid Process Pack™ ) is currently employed in the polishing step of a pDNA purification process. This application note presents a comparison of two different polishing processes employing monoliths, namely bind-elute (BE) and the more recently described sample displacement purification (SDP).

  • Best Practices For Raw Material Supplier Change Notifications: New BioPhorum Guidance

    Managing the large volume of supplier change notifications while safeguarding the continuity and compliance of a complex and tightly regulated supply chain is a resource-intensive task. To address the challenges, the BioPhorum Raw Material Variability Workstream has developed a guidance document designed to streamline the process without straying from essential and strict risk mitigation procedures.

  • Process Intensification: Key Considerations And Expert Insights

    As current biological product pipelines become more diverse, product demand and cost pressures are increasing. To meet these demands, manufacturers often move towards process intensification. Multiple intensified process schemes for upstream and downstream processes are being developed by the bioprocess industry to fulfill these and other market demands. In this ebook industry leaders that partnered with us discuss their experience of implementing process intensification strategies as they relate to unique organizational goals. Their insights provide readers with a holistic perspective, but also outline the top considerations to factor into your internal calculations, deliberations, and decision making.

  • Prefilled Syringes: Best Practices For Using X-Ray Analysis To Assess Container Closure Integrity

    The process of assessing integrity of the filled syringe is generally more complex than the process of assessing glass vials due to the presence of more sealing areas. This article looks at the broad requirement, together with a recent innovation for integrity testing based on X-rays.

  • How Does A Mature QMS = Fewer Drug Supply Chain Disruptions?

    The FDA’s Office of Quality Surveillance launched a voluntary program to evaluate manufacturers’ quality management systems to inform decisions on the future development of an FDA rating system characterized as quality management maturity. This article explains the importance of QMM and what that looks like to the FDA.

  • Single Cell Passaging With NutriStem® hPSC XF On Laminin-521 Without The Need For ROCK Inhibitor

    Human Pluripotent Stem cells (hPSC) are of great potential for cell therapy and regenerative medicine in many severe diseases. Removing xeno components and using feeder-free cultures is necessary to ensure robust and reproducible colonies during culture.This paper explains how the combination of xeno-free media (i.e. NutriStem® hPSC XF), recombinant protein matrices (i.e. LaminStem™ 521) and recombinant trypsin solutions (i.e. Recombinant Trypsin EDTA Solution,) enables single cell passaging without the addition of ROCK inhibitor, while maintaining cell integrity and characteristics.

  • Efficient Transition Of Human Pluripotent Stem Cell Cultures From Essential 8™ Medium Into NutriStem® hPSC XF Medium On Matrigel®

    Establishing ideal culture methods has been a known challenge in human pluripotent stem cell (hPSC) research since the late 90s. Today, there are multiple commercially available serum-free formulations for hPSC maintenance, including Essential 8™, mTeSR™, and StemFlex™ culture media. This paper review the suggested method for adapting hPSCs originally cultured in Essential 8 Medium (E8) to NutriStem® hPSC Medium.

  • From Cells To Organs – The Organoid Stepping-Stone

    In recent years, biomedical research has pushed the limits of 2D cell culture to develop more advanced models for studying developmental biology and disease-modelling and also to identify more efficient tissue-replacement therapies. Of particular interest in these areas is tailored 3D cell culture approaches that give rise to organ-like structures known as “organoids”.

  • Efficient Transition Of Human Pluripotent Stem Cell Cultures From StemFlex™ Medium Into NutriStem® hPSC XF Medium On Matrigel®

    Establishing ideal culture methods has been a known challenge in human pluripotent stem cell (hPSC) research since the late 90s. This paper reviews the suggested method for adapting hPSCs originally cultured in StemFlex™ to NutriStem® hPSC Medium. Read how for this transition, a simple and direct adaptation can be followed with cultures exhibiting similar morphology as well as higher levels of pluripotency when compared to StemFlex™.

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.