Industry Insights
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Choosing The Right Packaging For Biologics & Biosimilars
8/7/2017
Large molecule proteins present some unique challenges due to their intrinsic nature and properties. In particular, contaminants derived from the packaging, including leachables like metal ions or organics, silicone lubricants, etc., can have some effect on the protein.
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The FDA/EU Mutual Recognition Agreement — What You Need To Know
12/7/2017
The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections to help determine whether statutory and regulatory requirements of the respective authorities have been met.
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Advancing Precision Medicine With Patient-On-A-Chip
3/8/2024
Emulate and Cedars-Sinai Medical Center have partnered to develop a Patient-on-a-Chip program that combines their stem cell expertise and Organs-on-Chips technology to advance precision medicine.
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FDA’s Digital Health Technologies Framework Addresses Important Challenges
5/16/2023
In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.
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Laboratory Plate-Based Freezer
2/3/2020
Biopharma manufacturers are increasingly using single use tech for storage, shipping, and transfer of substances. Aabandoning cost-intensive and bulky platforms can save considerable amounts of money.
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4 Lessons Learned Developing Cancer Immunotherapy Treatments
3/3/2023
The ability to build up cancer-attacking T cells in cancer patients remains a major limitation of current immunotherapy approaches. PDS Biotech's CEO and CSO share four lessons they have learned along the way in developing their lead product, PDS0101, an immunotherapy targeting HPV-positive cancers.
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The Evolution Of Single-Use Systems And The Emergence Of Unmet Needs
12/22/2021
The bioprocess boom of 2020, which continues unabated, has attracted many players into this space. More and more integrators are entering the market, one that's far from easy to master.
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The Small Pharma–CDMO Marriage: How We Can Make It Even Better
3/13/2017
Unlike Big Pharma, which may outsource internally developed processes and formulations, small and midsize pharma/biotech firms are dependent on contract development and manufacturing organizations (CDMOs) for much of their product development and GMP manufacturing activity.
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How To Establish Sample Sizes For Process Validation Using Variable Sampling Plans
11/28/2016
The first article in this series, Risk-Based Approaches To Establishing Sample Sizes For Process Validation (June 2016), provided and established the relationship between risk and sample size. This article will demonstrate the use of variable sampling plans to establish sample sizes for process validation.
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Considerations For Successful Upstream Manufacturing Process Scale-Up
A CDMO’s ability to scale seamlessly between bioreactor sizes is critical when adopting a client’s manufacturing process.