Clearing Regulatory Hurdles

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-11-02-2003
Volume 27
Issue 11

The authors propose several models for independent evaluation of new excipients.

External Link - article-75179.pdf

Articles in this issue
FDA Will Drive Changes for Contract Business
In the Spotlight--December
Novemember 2003
FDA Seeks Risk-Based Inspection Program
Routine Sample Size for a Retest Procedure
November 2003
Aseptic Processing Guidelines and Innovative Engineering Boost Appeal of Barrier Isolators
Clearing Regulatory Hurdles
Improving Protein Capture for Transgenic Drug Processing
Recent Videos
Drug Digest: Challenges and Triumphs in Next-Generation Biotherapeutic Development
Related Content
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

FDA Grants Fast Track Designation to Q32 Bio Treatment for Alopecia Areata

Patrick Lavery
April 30th 2025
Article

Bempikibart (ADX-914) is a human anti-IL-7Rα antibody that blocks the IL-7 and TSLP pathways, which have been implicated in driving T cell-mediated pathological processes in autoimmune diseases.

Site Logo

Transformations in Drug Development for Cell and Gene Therapies

PPD;Thermo Fisher Scientific
March 28th 2025
Podcast

As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - stock.adobe.com

CHMP Recommends argenx Treatment for Chronic Inflammatory Demyelinating Polyneuropathy

Patrick Lavery
April 28th 2025
Article

The company said that Vyvgart (efgartigimod alfa) is the first novel mechanism of action for CIDP treatment in more than 30 years.

Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang

Advancing Clinical Trials with Spectral Flow Cytometry: A Conversation with Kevin Lang

PPD;Thermo Fisher Scientific
March 28th 2025
Podcast

As a recognized leader in immunophenotyping for clinical trials, Kevin Lang from PPD discusses how spectral flow cytometry is transforming drug development, particularly in cell and gene therapies like CAR-T. He also dives into his award-winning research, including his 2024 WRIB Poster Award-winning work, and his insights from presenting at AAPS PharmSci360.

Hand shaking which print screen on wooden cube block in front of human icon for business deal and agreement concept. | Image Credit: © Dilok - stock.adobe.com

Debiopharm, Oncodesign Agree to Use Non-Invasive Technology for Preclinical Research

Patrick Lavery
April 25th 2025
Article

The AbYlink technology enables a seamless, reproducible conjugation of payloads to antibodies or ADCs.

Hand shaking which print screen on wooden cube block in front of human icon for business deal and agreement concept | Image Credit: © Dilok – © Dilok - stock.adobe.com

CN Bio Forms Strategic Partnership with Pharmaron to Develop OOC Technologies

Feliza Mirasol
April 25th 2025
Article

Under the partnership, Pharmaron will validate and promote the application of CN Bio’s PhysioMimix technology and will integrate OOC technologies into its R&D platform.