EDITOR'S DESK

  • Inside KKNA’s Uncommon D&I Success

    How Kyowa Kirin North America is strategically leveraging an incredible growth spurt to fuel its diversity & inclusion initiatives, attracting and retaining biotech talent that’s as diverse as its therapeutic portfolio.

Resetting The Immune System With Protein Therapeutics

Revolo Biotherapeutics is reaching for its share of the massive autoimmune disorder and allergy markets with novel protein-based therapies designed to reset the immune system. CEO Jonathan Rigby sat down with us on the heels of an IND approval for Revolo’s fourth Phase 2 clinical trial.

Alzheimer’s Therapy Takes A Cue From Oncology

INmune Bio CEO RJ Tesi, M.D. shares strong opinions on the Agency’s Aducanumab ruling, his belief in the promise of protein biologics that decrease neuroinflammation by targeting TNF, and why his company is mimicking the oncology space in its R&D and clinical approaches.

Cell Therapy Logistics: Challenged By COVID-19

Kite Pharma was in the midst of a global cell therapy manufacturing expansion initiative when the first wave of the COVID-19 pandemic hit. This conversation with Charles Calderaro covers challenges faced scaling cell therapy manufacturing and accessibility worldwide and how Kite is developing competitive advantage in a nascent space.

The Precarious Promise Of Biopharma PR

Matt Middleman, MD has made a career and built a company out of guiding emerging biopharma companies to the public relations promised land. On a recent episode of the Business of Biotech podcast, he discussed the value of the good, the peril of the bad, and offered insight for biopharma PR rookies.

GUEST COLUMNISTS

  • Biotech Patenting: 4 Tips & Personal Experiences

    When you file for patent protection for your discoveries, keep these 4 tips in mind. I also share some of my personal experiences with patenting from over the course of the last 28 years, from when I cofounded 180 Life Sciences through now.

  • FDA Issues Final Rule On Intended Use For Drugs & Devices After A Complicated History

    On Sept. 1, 2021, the FDA’s final rule on intended use for drugs and devices became effective. The rule has a complicated history and has been the subject of controversy over the last 6 years. The final rule provides clarity to manufacturers, but many stakeholders are still unsatisfied with the evidentiary standard for determining intended use, perhaps forecasting legal challenges to the regulation.

  • Harnessing Lab Deviations For Performance Transformation In Vaccine Manufacturing

    Deviations in the pharmaceutical process generally lead to non-compliance and issues meeting demand, so they require careful tracking, monitoring, and remediation. The presence of deviations may seem inevitable, yet COVID has brought to light the question of how vaccine manufacturing sites can manufacture more vaccines, more efficiently. This article explains how.

  • 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.

  • 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?

  • 3 Successful Strategies For Protecting Your New Biopharma’s IP

    Intellectual property is the lifeblood of new biopharma entities. Patent protection is necessary to secure investment, to build a solid foundation with opportunity for future growth, and to establish viability within a highly competitive landscape. This article addresses key patent-related considerations for startups and small or early-stage players in the life sciences arena.

  • How To Advance Continuous Bioprocessing Using Continuous Countercurrent Tangential Chromatography

    Continuous countercurrent tangential chromatography (CCTC) addresses the inherent limitations of column-based systems by conducting the chromatographic operations (binding, washing, elution, stripping, and regeneration) on a flowing slurry, with inline static mixers used to ensure good contacting between the resin slurry and the clarified cell culture fluid/required buffers.

  • 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.

BIOPROCESSING WHITE PAPERS

BIOPROCESS ONLINE CONTENT COLLECTIONS

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With the combination of market potential, rapidly improving manufacturing technology, and intense competition comes the necessity for biopharma companies to ensure the patent protection of their molecules early, and to plan strategically for protection beyond commercialization. To provide context and direction, we've procured this collection of fresh thought leadership columns from biopharmaceutical patent experts.

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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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