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What's Next After FDA's DSCSA Extension?

Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.

EDITOR'S DESK

How Platform Technologies Are Shaping The Gene Therapy Landscape
Leading experts in gene therapy discuss CMC strategy for platform technologies, product lifecycle management, and the role CDMOs play in moving the space forward.

Gene Therapy CMC Experts On Late-Stage Process Changes

At the 2024 Bioprocessing Summit, a panel of CMC experts spoke about the challenges commercializing gene therapies, specifically focusing on considerations for late-stage process changes.

Outsourced Complex Protein Development Demands Special Considerations

Complex protein therapeutic innovators are often orchestrating the work of three, four, or more outsourced manufacturing partners at once. What goes into their selection criteria? Experts from ADC and fusion protein sponsors weigh in, with bonus commentary from a CDMO process development specialist.

Considerations For AI Use In Biomanufacturing

Expert's from this month's Bioprocess Online Live event discuss different use cases for AI and shared their thoughts on the adoption of these technologies.

The Peril Of Analytical Methods Transfer

Scale-up in all its iterations from bench to commercial readiness, tech transfer to an outsourced manufacturing partner, product acquisition, manufacturing equipment or consumables change, and even process development personnel turnover place analytical decisions made early on under a microscope.

GUEST COLUMNISTS

CDER Wants Your Input On Improving Integrated Reviews
CDER recently moved from sharing reviews from individual disciplines in public documents to an Integrated Review, which includes conclusions but much less detail.
Are You Considering Serialization Processes When Choosing Your CDMO Or 3PL?
When choosing your trading partner (CDMO or 3PL), an important element that can be overlooked is serialization and DSCSA compliance. Ensuring these partners can meet requirements is critical.
3 AI Breakthroughs Revolutionizing Pharma Tech Ops At Roche
Roche has pushed through so-called "pilot purgatory" and rolled out artificial intelligence solutions in the real world. Two of its data leaders describe three case studies.
What's In The Leukopak Matters For Cell Therapy Manufacturing
Advanced cell-based therapies are impossible without high-quality leukopaks from high-quality donors.
Survey Says Downstream Biomanufacturing Bottleneck Is Over
BioPlan's 21st annual survey finds that downstream processing capacity constraints are at their lowest reported in years.
The Regulatory Affairs Function Is Evolving. Are You Evolving With It?
The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.
Computer Systems Validation Pitfalls, Part 1: Methodology Violations
When computer systems validation work is not performed according to protocol instructions — by cutting corners on quality outputs with the focus on profit as the main driver — this can result in drug and device companies losing profits and efficiencies.
How Elixirgen Manufactures Hematopoietic Stem Cells At The Bedside
The company uses a mobile manufacturing system to produce autologous stem cell therapy for patients with dyskeratosis congenita and other telomere biology disorders.

BIOPROCESSING WHITE PAPERS

Setting The Standard For Plasmid DNA Production
Discover how Boehringer Ingelheim’s expertise in plasmid DNA manufacturing can propel your innovative therapies forward and transform patient care.

Assessing Liquid Transfer Performance With Reliable, Ready-To-Use Reagents
11/13/2023

See how specially formulated dye-containing solutions replicate the liquid transfer properties of several commercially available PCR master mixes, making them reliable and ready-to-use reagents for determining liquid transfer performance.
Methods For Determining Equipment Capability Of Freeze-Dryers
10/16/2024

Observe two experimental methods for determining choked flow: the minimum controllable pressure method and the choke point method.
Epigenetics Application Guide
10/2/2024

To fully understand biology and disease mechanisms, it is crucial to explore the role of epigenetic factors. Explore how epigenetic regulation works and methods to study these essential components.
Single-Use vs. Stainless Steel Debate In Biopharmaceutical Manufacturing
9/1/2023

Investigate the advantages and disadvantages of single-use technologies and stainless steel systems with a focus on performance, adaptability, and economics.
Comparing Single-Use To Fixed Bioprocessing Systems
9/1/2023

Several life cycle assessments have been conducted comparing the environmental impact of SUTs to conventional fixed systems, leading to results that could inform changes in bioprocess system use.

More Bioprocessing White Papers

BIOPROCESSING APP NOTES & CASE STUDIES

More Bioprocessing App Notes & Case Studies

BIOPROCESS ONLINE CONTENT COLLECTIONS

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This collection of articles, produced through a partnership between MilliporeSigma and Bioprocess Online, highlights the need for ongoing investment in resilient biomanufacturing capacity and supply chains to ensure the reliable delivery of health technologies like vaccines, even during crisis conditions.