Newsletter | February 8, 2024

02.08.24 -- How To Speed Up Time To Market With CMC Knowledge Management



How To Speed Up Time-To-Market With CMC Knowledge Management

Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.


Accelerate Successful Transfer Of Recombinant Protein Analytical Assays

Learn how a CDMO that is experienced in producing and characterizing diverse recombinant proteins is essential when accelerating the successful transfer of recombinant protein analytical assays.

Correlating Laser-Based Headspace Analysis To Helium Leak Rate Testing

Laser-based headspace analysis is a nondestructive and rapid method for testing container closure integrity. We demonstrate that headspace analysis is equally as sensitive as helium leak rate testing.

Biopharma Tech Transfer: Facility Fit And Process Gap Assessments

Biopharmaceutical tech transfer, critical to the successful development and manufacture of an asset, requires careful planning and evaluation to meet project timelines for scale-up and GMP.

Three Steps To Digital Transformation In Life Sciences Manufacturing

Explore trends that are transforming the industry, some common speedbumps on the road to innovation, and how a new platform offers unprecedented process transparency and continuous improvement.

Increasing Bioavailability With Amorphous Solid Dosage Formulations

Discover the challenges associated with pH-dependent solubility for oral tyrosine kinase inhibitor drugs and how leveraging ASD formulation can help create more effective, patient-friendly drug products.

Paving The Way For Tomorrow’s Medicines

Recent advances in nanoparticle engineering technology promise to improve the success rate of new drug candidates and help push novel therapies to market.

Compliance: Framing Success Utilizing PIC/S And EU GMP

Understand the differences between the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP Guide and the EU GMP Guides, and the teamwork between the FDA, MHRA, and PIC/S.

Pursuing Growth Strategies And Aggressive Advocacy

Review what the president and CEO of a clinical-stage genomic medicines company had to say about growth strategy and his progress in the pursuit of gene therapies to address inherited retinal diseases.

Spray Drying To Enable New Inhaled Drug Products

The formulation and spray-drying process can help manufacture a stable, highly respirable powder and deliver products that require a high drug load, biologic, or rapid onset therapeutic.

Steps For Proper Cleaning Validation

Examine the steps of cleaning validation for both low-volume and high-volume manufacturers and the important role these studies play.

An Easy-To-Swallow Depression Drug For Elderly Patients

Discover how an innovative formulation approach helped a developer create a version of their drug that promotes treatment compliance within the geriatric population.

Lung Cancer Treatment By Inhaled Formulations

Explore the formulation and manufacturing of a topotecan inhaled dry powder and its use in decreasing tumor size in an animal model.


Tech Transfer And Commercial Manufacturing Of Tablets And Capsules

Pharmaceutical Cleanroom Pre-Engineering And Preconstruction Services

A High Sensitivity Solution For Pharma CCIT

cGMP Aseptic Manufacturing And Sterile Fill/Finish

Detect Label Data And Quality Defects On Round Product

All-In-One, Genderless, Single-Use Connection Technology

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