This past year has seen remarkable progress in the growth of cell and gene therapies. Advances in cell reprogramming, genetic editing, and manufacturing mean affordable cell & gene therapies will be available for a range of diseases and uses. However, the pathway ahead will need planning. This article reviews six major issues affecting the cell & gene therapy space and provides recommendations for companies to be successful.
- 5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations
- 4 Keys To Winning FDA Breakthrough Therapy Designation
- Biotech Patenting: 4 Tips & Personal Experiences
- FDA Issues Final Rule On Intended Use For Drugs & Devices After A Complicated History
- New ADC Linker Tech Shows Efficacy, Safety Advantages
- Harnessing Lab Deviations For Performance Transformation In Vaccine Manufacturing
- How To Find & Manage Biotech Consultants Effectively
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.
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.
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.
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.
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.
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
Bio4C ProcessPad 21 CFR Part 11 Compliance White Paper
Learn how Bio4C ProcessPad meets 21 CFR Part 11 requirements including unique usernames and passwords, timestamped audit trails, and secure storage of all records.
Osmolality Is A Predictor For Model-Based Real Time Monitoring Of Concentration In Protein Chromatography12/23/2020
The bottleneck for real time control and real time release is lack of product-specific in-line sensors or fast at-line
methods suitable for model-based prediction of process outcome. Learn how osmolality as an at-line method is an excellent predictor together with UV280 and UV260 for protein quantity in model-based prediction using partial least squares methodology.
Speed To Market: The Optimal Program For Your Candidate10/22/2020
With a variety of gene to IND programs on the market, it is important you carefully assess which program matches your technical expectations as well as your risk adversity profile.
Turn Your Supply Chain Into A Competitive Differentiator10/27/2019
The concept of variabilization—transforming fixed costs to variable costs— can help biotech companies leverage their supply chain to free up valuable resources for new product launches or other initiatives.
Three Options To Viral Vector Manufacturing Capacity9/1/2020
A recent Virtual Think Tank focused on the challenges and trends influencing design considerations for viral vector manufacturing facilities, and how they can impact companies developing cell and gene therapies.
Fast And Effective Digital Transformation2/2/2021
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.
BIOPROCESS ONLINE CONTENT COLLECTIONS
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.More Content Collections
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SPOTLIGHT JOB OPENING: TARSUS
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.