This past year has seen remarkable progress in the growth of cell and gene therapies (C>s). Advances in cell reprogramming, genetic editing, and manufacturing mean affordable C>s 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 C> space and provides recommendations for companies to be successful.
- Biotech Patenting: 4 Tips & Personal Experiences
- FDA Issues Final Rule On Intended Use For Drugs & Devices After A Complicated History
- Harnessing Lab Deviations For Performance Transformation In Vaccine Manufacturing
- How To Find & Manage Biotech Consultants Effectively
- What’s The Role Of Interim Consultants In The Life Sciences & How Do We Use Them Effectively?
- 3 Successful Strategies For Protecting Your New Biopharma’s IP
- How To Advance Continuous Bioprocessing Using Continuous Countercurrent Tangential Chromatography
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.
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End-To-End Thinking During Drug Product Development
In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.
Can You Afford Not To Outsource Buffer Preparation?2/6/2020
The decision whether or not to outsource buffer preparation is not clear-cut, but provides an opportunity to balance risk with reward. This column examines the benefits of outsourcing.
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.
Using Parallel Evaporators To Escalate COVID-19 Test Kit Preparation8/25/2020
An issue for all countries now is how to obtain a sufficient supply of COVID-19 testing kits, when the international demand for them has never been higher. As laboratories around the world scale up their production of PCR test kits to aid the global fight against the virus, improvements to the workflow for producing testing kits are urgently needed to increase the efficiency of test kit production. Centrifugal evaporators offer an ideal solution to improving the efficiency of test kit production.
Challenges And Practical Solutions For Switching To Prefilled Syringes For Injectables9/1/2020
To achieve the benefits of moving a final product presentation from vials to prefilled syringes, it is important to understand the challenges during this solution as well as practical solutions.
Seamlessly Transition From Transient Protein Expression To Bioproduction3/16/2020
As competition and growth in the biotherapeutic industry continues, the need to reduce cell line development costs and decrease time-to-market is more crucial than ever.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
Since the pandemic began, we’ve seen disruptions to regulatory inspection and enforcement. What has this looked like, and what has been the impact to the pharmaceutical industry? In this e-book, we dive in specifically to the regulatory agencies of the FDA in the U.S. and the MHRA in the UK.More Content Collections
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LIFE SCIENCE CONNECT 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.