RNA is easier to manipulate than DNA but challenging to deliver to the right cells.

Can Using RNA Simplify Gene Therapy Development?

Advances in preclinical development can reduce development cost.

Reimagining Affordable Biosimilars

Topic

Articles

Wacker will support production of CureVac’s COVID-19 mRNA-based vaccine candidate at its biotech site in Amsterdam, with production scheduled to start in the first half of 2021.

CureVac and Wacker Sign Manufacturing Contract for COVID-19 Vaccine Candidate

Researchers concluded that the nasal spray should catch and coat the virus inside the nose, preventing it from spreading throughout the body, and it is then removed by nose-blowing or swallowing.

The University of Birmingham Formulates Nasal Spray to Protect Against COVID-19

At the 2020 Bio/Pharma Virtual Congress, experts discuss the importance of characterizing excipients to ensure quality, safety, and effective performance. 

Understanding Excipient Quality and Impact on Formulation

The agreement will provide capacity for the manufacturing of AZD7442, currently being developed for the potential prevention and treatment of COVID-19, at Lonza's Portsmouth, NH site.

Lonza to Manufacture AstraZeneca's COVID-19 Long-Acting Antibody Combination

FDA published guidance for submitting standardized study data in electronic format. 

Guidance on Submitting Standardized Study Data 

Samsung Biologics has adopted Solentim’s cell seeding and cell metric platforms at its new R&D center in San Francisco, CA. 

Samsung Biologics Incorporates Solentim’s Cell Line Development Technology into New R&D Center 

Orgenesis has completed its previously announced acquisition of Koligo Therapeutics with the additional acquisition of Tissue Genesis’ cell isolation technology, Icellator.  

Orgenesis Completes Koligo Acquisition and Gains Icellator Technology in Related Transaction

Bio/Pharma companies are galvanized to develop COVID-19 therapies under FDA’s acceleration program.

Bio/Pharma Industry Works Overtime to Find COVID-19 Therapies

Francesca Speroni is project leader at PTM Consulting and is a member of the AFI process validation working group.

Ilaria Franceschini is in Pharmaceutical Technology at Italfarmaco and is a member of the AFI process validation working group.

Maurizio Valleri is in Pharmaceutical Technology at Menarini and is a member of the AFI process validation working group.

Mauro Silvestri is in Manufacturing Technology at Angelini and is a member of the AFI process validation working group.

Matteo De Nigris is part of Manufacturing Science and Technology at LEO Pharma Manufacturing and is a member of the AFI process validation working group.

in R&D CMC at Chiesi and is a member of the AFI process validation working group.

Alessia Garavaglia is in Good Engineering Practices at Grünenthal and is a member of the AFI process validation working group.

 at Mipharm and is a member of the AFI process validation working group.

Rosa Terribile is in QA at Mipharm and she is a member of the AFI process validation working group.

Stefano Pompilio is in Clinical Trial Manufacturing at Thermo Fisher Scientific and is a member of the AFI process validation working group.

Enrico Modena is in R&D at PolyCrystalLine and is a member of the AFI process validation working group.

Stefano Selva is in Pharmaceutical Technology at Recordati and is a member of the AFI process validation working group.

Lorenza Broccardo is project manager at S-IN Soluzioni Informatiche and is a member of the AFI process validation working group.

Cesare Armetti is an AFI member and participates in the AFI process validation working group.

 is an AFI member and participates in the AFI process validation working group.

AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.

Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms

Margaret M. Faul is vice-president, Drug Product Technologies, Process Development, Amgen.

Carl L. McMillian is vice-president, Toxicology, Drug Disposition, PK/PD, Eli Lilly and Company.

Pierre Boulas is executive director, Product and Technology Development, Biogen.

Reginaldo A. Saraceno is director, Material and Analytical Sciences, Boehringer Ingelheim Pharmaceuticals.

Mary Devlin Capizzi is partner, Faegre Drinker Biddle & Reath LLP.

Maureen T. Cruz is senior manager, Science, Regulation and Policy, Faegre Drinker Biddle & Reath LLP.

The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/pharmaceutical industry.  