EDITOR'S DESK

  • Semper Fi: What The Marines Taught A Biopharma CEO

    Before earning his law degree and crafting a career as a biotech entrepreneur, Daniel O’Connor, J.D. was Marine Captain Daniel O’Connor. He earned that rank in Saudi Arabia, where he was deployed to serve Operation Desert Shield just days following Iraq's invasion of Kuwait. On a recent episode of the Business of Biotech podcast, he shared how being a Marine prepared him for leadership of a blossoming biopharma company.

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. 

GUEST COLUMNISTS

  • The “Resiliency Roadmap” — Next Steps For FDA Inspections

    More than a year into the COVID-19 pandemic and FDA’s abrupt suspension of on-site inspections in March 2020, the agency released the Resiliency Roadmap for FDA Inspectional Oversight in May 2021. This article examines how this news affects the pharmaceutical, biotech, and medical device industries.

  • From Pharma To Biopharma — Education & Workforce Training Programs Converge To Meet Industry Needs

    The biopharmaceutical industry is poised for a new era of growth, particularly for manufacturing biologics. Workforce development remains a significant limitation, however. This article highlights how the industry workforce training model isn't enough, and what the Albany College of Pharmacy and Health Sciences is doing to address the need for the next-generation workforce.

  • Qualification Considerations For A “Factory-in-a-Box”

    The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive due to the limited manufacturing space and number of personnel required, while capacity is not easily scalable and is limited by processing time. Enter the "factory-in-a-box," which can be a game-changer for the industry.
     

  • 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. 

BIOPROCESSING WHITE PAPERS

  • Industrializing Autologous Adoptive Immunotherapies: Manufacturing Advances And Challenges

    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.

  • Addressing The Evolving Information And Automation Needs Of Biopharma
    10/26/2020

    A dramatic increase in the information available, in parallel with a reduction in the cost of obtaining, processing, and transmitting information, is changing the way biopharma manufacturers operate. 

  • Shifting The Biomanufacturing Paradigm: Intensifying Upstream Processes
    9/2/2019

    Demand for mAbs creates pressure to accelerate development, improve flexibility, and reduce costs while sustaining or improving drugs.This paper explores upstream strategies to increase protein titers, which can translate into higher throughput, improved flexibility, and compressed timelines.

  • Fast And Effective Digital Transformation
    2/2/2021

    We identify common challenges when deploying traditional customized solutions, contrast that with the benefits of an out-of-the-box approach, and cover the critical role of change management. 

  • Quality System Overview For GMP Manufacturing
    11/26/2019

    When you think about cell and gene therapies (CGTs), what most often comes to mind is the early stage scientific innovation responsible for finding new ways to treat diseases. Unfortunately, what is sometimes overlooked or left to the last minute is the less-than-glamourous, but still critical, manufacturing steps that ensure a new, potentially lifesaving treatment reaches patients in a safe and reliable form. Following is an overview of the mandatory quality systems and functions that are required within a standard GMP facility to comply with ICH Guidelines including Q7 and EU ATMP guidelines, Canadian GMP (C.002) and U.S. FDA, PHS Act section 351/361 and CFR 21 Parts 210/211 and Part 11 as they apply to cell and gene therapy. Other guidelines are considered, as required, such as ISO 9001:2015 certification.

  • Process Characterization And Validation For Biologic Processes
    4/3/2020

    Using a risk-based approach to generate an appropriate control strategy will help assure your product meets characterization and validation requirements, enabling timely approval and launch to market.

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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