EDITOR'S DESK

  • SOTIO’s Quest To Build A Global Biopharma

    While many clinical-stage biopharmas consider the “end” an “exit,” PPF-backed SOTIO’s intention is to build an oncology-focused biopharma company that stands on its own broad and diverse pipeline. Its CEO sat down with the Business of Biotech podcast to share the company’s strategy.

Manufacturing A mAb For Congenital Hyperinsulinism

Rezolute Inc. CEO & Founder Nevan Charles Elam, J.D. shares an update on the company’s effort to address congenital hyperinsulinism with the human monoclonal antibody RZ358, addressing pandemic-fueled CDMO capacity constraints and capitalizing on Rare Pediatric Disease Designation along the way. 

Beating Herpes: Inside X-VAX’s Vaccine Candidate

An inside look at preclinical stage biotech, X-VAX, which is preparing to engage the FDA with data on an HSV vaccine candidate that could have therapeutic impact on a virus carried by the majority of the world’s population. 

BeiGene, FDA, ACPHS Announce Pharmacovigilance Fellowship

BeiGeine, the FDA, and Albany College of Pharmacy and Health Sciences are setting a new standard for collaborative cultivation of next-gen life sciences talent by breaking down barriers between academia, industry, and the Agency. We go inside their innovative Fellowship model. 

The Placental Stem Cell Advantage

As Celularity makes its most significant clinical progress to date, the company is putting theories born of 20 years of postpartum placental stem cell research into practice. Could the production platform it’s building be the key to accessible, affordable allogeneic cell therapy?

GUEST COLUMNISTS

  • Patenting Antibodies: The 4 Tactics To Use In 2021

    With epitope claims less available post-Amgen v. Sanofi, this article examines four useful approaches that you and your antibody patent lawyer can implement in order to improve your chances of obtaining valid antibody claims with functional attributes.

  • What Do Artificial Intelligence And Continuous Validation Have In Common?

    Validation documentation can be reduced by applying automated testing and deployment. This article discusses ISO standards that address risk management, IT alignment with software engineering, opportunities for continuous lifecycle management, and how artificial intelligence (AI) can help.

  • Outlook: Biotech In 2021 & Beyond

    Biopharma companies have responded in an astounding manner to the COVID-19 pandemic through vaccines, therapies, diagnostics, and variant tracking. For those efforts, the industry is seeing some amazing investor awareness, political support, and increased public perception. This article focuses on the U.S., but also includes some worldwide numbers.

  • Synthetic Oligonucleotides: Regulatory, Analytical & Manufacturing Considerations

    In early March 2021, more than 300 professionals in regulatory, industry, and academic roles attended the USP's virtual Workshop on Therapeutic Peptides and Oligonucleotides. Building on regulatory considerations and control strategies, the workshop explored innovative techniques being used to analyze synthetic oligonucleotides, ensure quality, and reduce waste. 

  • Statistical Methods For Comparing Small-Scale Models To At-Scale Biopharmaceutical Manufacturing

    As the final article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model (SSM) justification, this article discusses statistical methods for comparing SSM outputs to at-scale outputs and covers descriptive statistical methods, inferential methods, difference tests, equivalence tests, and more. 

  • A LIMS Audit Framework: What To Audit & How To Prepare

    Laboratory information management systems (LIMS) are inevitably the subject of regulatory focus and audit. This article considers what to audit and how to audit a LIMS, presenting a framework useful to those planning to undertake a LIMS audit and for laboratory managers who need to prepare. 

  • The Next Decade In Gene Therapy Innovation — 6 Critical Questions (And Answers)

    What's ahead for gene therapy in the next decade? This article highlights six key questions and recommendations for the future of the industry. For example, what technologies should gene therapy companies evaluate beyond delivery vehicles, and how should a gene therapy be priced?

  • Planning & Executing Small-Scale Model Qualification For Upstream & Downstream Biopharma Processing

    As the second article in a three-part series that summarizes the discussions and exchanges of a BioPhorum Development Group workstream on small-scale model (SSM) justification, this article covers the current opinion on how to execute small-scale model qualification for both upstream and downstream SSMs and analytical setup. 

BIOPROCESSING WHITE PAPERS

  • Pairing Data Connectivity, Automation Ease Tech Transfer/Scale-Up
    2/11/2020

    In biopharma, process data is used in many ways throughout process development and production phases. This article outlines how connectivity and comprehensive automation ease tech transfer and scale up.

  • Simple Western With Jess Uncovers Possible New Strategy To Prevent And Treat COVID-19
    2/4/2021

    As the global death toll from the COVID-19 pandemic approaches 1 million, the scientific community has jumped into high gear to understand and treat SARS-CoV-2 infection. It is understood that SARS-CoV-2 entry into host cells involves the binding of the viral spike protein to the human ACE2 receptor. Read more about how Simple Western, the automated Western blot platform from ProteinSimple, can detect and quantify ACE2 and the associated protease TMPRSS2 in human cells.

  • Flow-Through Chromatography, Adsorptive Depth Filtration For Continuous Applications
    1/14/2020

    This paper examines adaptations to current technologies for downstream processing, such as clarification and chromatography, that facilitate more suitable conditions for continuous bioprocessing applications.

  • Nanoparticles Drive The Nanotechnology Revolution
    2/26/2021

    Nanotechnology has been referred to as potentially being the next technical revolution that could change the modern world. Perhaps the developments seen to date do not yet match this build up, but the combined investment by governments, universities, and industry is significant with global government investment exceeding $9 billion annually and growing. The United States government alone has invested over $27 billion since from 2001 – 2019.2 The global nanotechnology market has been estimated to be between $10 – 50 billion annually depending on definitions and sources.

  • Industrializing Autologous Adoptive Immunotherapies: Manufacturing Advances And Challenges
    11/26/2019

    Cell therapy has proven to be a burgeoning field of investigation, as evidenced by hundreds of clinical trials being conducted worldwide across a variety of cell types and indications. There is now a more concerted effort among manufacturers to utilize traditional bioprocess principles to close, automate, and control these processes to ensure critical quality attributes (CQA) of the cell product are consistently maintained and manufacturing processes are cost-effective and risk-mitigated. This focused review will look at current solutions across a typical autologous or patient-matched manufacturing workflow and highlight remaining challenges toward industrialization of these processes.

BIOPROCESS ONLINE CONTENT COLLECTIONS

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One of the many lessons learned in the wake of the COVID-19 pandemic is that we can move fast. Really fast. Much faster than we ever thought possible. But will it last? Have the efficiencies, synergies, and collaborations forged over the past 16 months set new precedents for the way the FDA works, and new expectations on how biopharma companies work with the agency? In this e-book, we’ve compiled recent assessments from the foremost FDA consultants and analysts in the space.

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SPOTLIGHT JOB OPENING: TARSUS

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Tarsus, a late clinical-stage biopharmaceutical company focused on the development and commercialization of therapeutic candidates to address large market opportunities, is hiring a VP Manufacturing Operations & Supply Chain Management. Reporting to the COO, you will be accountable for the overall CMC development, manufacturing and supply chain strategy for clinical and commercial supply of drug substance, drug product and IMP.

Sound interesting?

Read the Job Posting to learn more.

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