Newsletter | May 30, 2023

05.30.23 -- A Primer On ICH M13A: Bioequivalence For Immediate-Release Solid Oral Dosage Forms
 
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Featured Editorial
A Primer On ICH M13A: Bioequivalence For Immediate-Release Solid Oral Dosage Forms
 
By Md. Saddam Nawaz, ACI HealthCare Limited

The International Council for Harmonisation’s (ICH’s) reflection paper, Further Opportunities for Harmonisation of Standards for Generic Drugs, released back in 2018, is currently in the public consultation stage and slated for adoption in November 2023. It provides recommendations on conducting bioequivalence studies during development and post-approval phases for immediate-release solid oral dosage forms.
Industry Insights
Securing Today’s Biomanufacturing Supply Chain Using Transformative Supply
Article | By Sofie Stille and Elles Steensma, Cytiva

Managing today’s supply chain complexity begins by transforming historically transactional relationships to those that drive suppliers to value-added status, working toward shared customer goals.
De-Risking A Bioconjugate’s Development Path From Discovery To Clinic
Article | By Raphael Frey and Sandro Holzer, Lonza

Understanding the obstacles you may face during bioconjugate development, as well as the tools available to help overcome them, can help streamline your product’s path to market.
Overcoming The Challenges Of Cell Therapy Manufacturing
Article | By Evan Zynda and Aditi Singh, Thermo Fisher Scientific Bioproduction

Learn more about how allogeneic approaches have the power to revolutionize the use of CAR T-cell therapies.
An Introduction To MES For Cell And Gene Therapy Manufacturers
White Paper | By Kelly Stewart, Apprentice

What are manufacturing execution systems, and why are they so crucial for cell and gene therapy manufacturing?
High-Throughput Developability Assessment Enables Efficient Formulation
Case Study | By Heonchang Lim and Derrick Katayama, Samsung Biologics

The industry is focused on maximizing the effectiveness of early-stage candidate assessments to predict a molecule’s chances of success before investing heavily in that molecule.
How Successful Tech Transfer Can Help Fast-Track NDA Approval
Case Study | Syngene International Ltd.

Examine the first-time-right tech transfer and Phase 3 registration batch manufacturing process thar led to a biotech receiving NDA approval for its novel compound followed by a successful commercial manufacturing partnership.
HPAPI Drug Product Development And Manufacturing Using Micronization Technology
Webinar | Catalent

Learn how to classify HPAPIs in early development and about recommendations for safe product handling, from clinical manufacturing to commercialization.
Solutions
Powder Rheology Accessory
TA Instruments
The Composition And Value Of A Portfolio Analysis
Premier Consulting
High-Shear Batch Mixers For Dispersions And Emulsions
Charles Ross and Son Company
Single Screw Pharmaceutical Feeders
Coperion & Coperion K-Tron
Containment Equipment For Pharmaceutical Contract Manufacturing Organizations
Flow Sciences Inc.
Pharmaceutical Serialization Systems
Wipotec
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