The first article in this series examined 5 common misconceptions in data integrity (DI). In this article, the author now shares 9 example areas where he has seen significant DI implementation problems in pharmaceutical and medical device companies.
- CMS Restructured The CAR-T DRG – What It Means For Manufacturers & 4 Strategies Forward
- 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
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.
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.
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.
BIOPROCESSING WHITE PAPERS
Flow-Through Chromatography, Adsorptive Depth Filtration For Continuous Applications
This paper examines adaptations to current technologies for downstream processing, such as clarification and chromatography, that facilitate more suitable conditions for continuous bioprocessing applications.
How Can Outsourcing Buffer Preparation Help Meet The Urgent Need For A SARS-CoV-2 Vaccine?11/16/2020
As numerous therapeutic drug and vaccine candidates make their way through human clinical trials, companies are already planning for how to manufacture any successful molecule on a global scale. In this planning, the preparation of process liquids and buffers should be considered.
Intensified Buffer Management For Manufacturing Efficiency, Reduced Cost2/26/2021
This white paper describes a novel, integrated approach to intensified buffer preparation and how this strategy can increase process flexibility, efficiency and reduce costs.
Liposomal And Nanoparticle Technology At Pfizer Melbourne4/22/2021
In recent years, liposome technologies have become an important part of the drug delivery armory, with several marketed products now available for use and many more formulations being evaluated in clinical trials.
Using Software Systems To Drive A Successful CPV Program6/25/2020
An area of life sciences that has recently received significant attention around data, its integrity, and its management processes, is manufacturing. This article covers bio/pharma manufacturing process information management systems, with insights on how purpose-built systems incorporated into your continued process verification (CPV) program helps meet FDA requirements and protect your business.
Guidelines For Developing A High Cell Density Cryopreservation Process8/11/2021
Biopharmaceutical manufacturers are leveraging several approaches to intensify processes with a goal of improving efficiency and productivity and reducing costs — all while ensuring the highest quality standards. The upstream workflow offers several opportunities to apply next generation technologies and methods to achieve these important goals. In this white paper we discuss integration of high cell density cryopreservation (HCDC) in the seed train and explore key considerations for developing a cryopreservation process including choice of cryoprotectant and freezing techniques.
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.
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