One aspect of biopharma continuous manufacturing (BCM) often overlooked is its environmental impact compared to that of a similar batch process. In comparing the two, there is much that needs to be considered. This article is the first in a two-article series and discusses key considerations of both processes and provides a deep-dive into water usage.
- 3 Strategies For Optimal Oversight Of Your Outsourcing Partner
- Bioprocessing Sees Continued Improvements In Batch Failure Reductions In 2022
- FDA Seeks Comment On ICH Q9(R1) Quality Risk Management
- Market Tumult And The Need For Creative Funding For Life Sciences
- Mold Investigations Using Biofluorescent Particle Counting Systems
- FDA Updates Guidance For Investigating OOS Test Results
- Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem
3 Strategies For Optimal Oversight Of Your Outsourcing Partner
Building strong relationships with chosen biopharma outsourcing partners, namely CDMOs and CROs, relies on a solid outsourcing framework. This article discusses three key areas that should be built into your outsourcing framework and agreements.
Bioprocessing Sees Continued Improvements In Batch Failure Reductions In 2022
Bioprocessing is generally doing better than ever in terms of minimizing batch failures. In BioPlan Associates’ 19th Annual Report and Survey on Biopharmaceutical Manufacturing Production and Capacity, we discovered the leading cause of batch failures and more insights.
FDA Seeks Comment On ICH Q9(R1) Quality Risk Management
ICH has revised Q9 Quality Risk Management, providing principles and tools that can be applied throughout the product life cycle of drug substances, drug products, biological, and biotech products. The FDA, a founding member of the ICH, plays a major role in the development of ICH guidelines, which FDA then adopts and issues as guidance to industry.
Market Tumult And The Need For Creative Funding For Life Sciences
Life sciences companies have not been immune to the upheaval in the financial markets, casting a pall over equity financing in the sector. Your company will need to be creative in raising capital. This article also covers M&A, synthetic royalty agreements, convertible debt, and covenants. Will there be a reckoning?
Mold Investigations Using Biofluorescent Particle Counting Systems
In the world of environmental monitoring in pharma manufacturing, it is common to rely on methods requiring media and subsequent incubation to detect microorganisms. For more extensive contamination events (e.g., mold occurrence), it is common to perform additional evaluations that can lead to extended downtime.
FDA Updates Guidance For Investigating OOS Test Results
FDA's CDER has released a guidance sharing the agency's recommendations on how to evaluate out-of-specification (OOS) test results, including the responsibilities of lab personnel, the lab phase of the investigation, additional testing that may be necessary, when to expand the investigation outside the lab, and the final evaluation of all test results.
Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem
I posit that only pluralistic democracies committed to the rule of law can support the kind of investment and innovation our industry requires to thrive, while autocracies can’t make the same claim.
BIOSIMILAR WHITE PAPERS
Guidelines For A High Cell Density Cryopreservation Process
A discussion on the integration of high cell density cryopreservation in the seed train andkey considerations for developing a cryopreservation process including choice of cryoprotectant and freezing techniques.
Accelerate CHO Cell Characterization With The Blazar™ Rodent Panel2/24/2021
The Blazar Rodent Panel allows biopharma to move away from traditional in vivo antibody production assays when characterizing cell banks of rodent origin used in the production of biologicals.
Secure The Cell Therapy Supply Chain From Bench To Bedside10/4/2021
While current approaches can manage the existing volume of cell therapy shipments, scaling these treatments up and out will increase pressure on cryogenic logistics networks.
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.
Getting Your Investigational Drug Regulatory Ready12/1/2020
Here, we map out basic information to help you approach regulatory policies and offer helpful strategies to facilitate efficient regulatory review and drug approval.
Outstanding Sensitivity For Confident SPR Interaction Analysis7/20/2022
Explore how surface plasmon resonance (SPR)-based analyses with a high sensitivity instrument can provide greater data precision and better confidence in your results interpretation.