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

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.  

Viewpoint: Precompetitive Collaboration Drives Pharma Industry Innovation

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi and a member of BioPharm International's Editorial Advisory Board, Tel. +91.9650770650, asrathore@biotechcmz.com.

Narendra Chirmule, PhD, is CEO at SymphonyTech Biologics.

Himanshu Malani is a graduate student at the Indian Institute of Technology, Delhi.

Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.

Julie Lippke works in analytical research and development at Pfizer Inc. (Groton, CT).

Joseph Mongillo works in analytical research and development at Pfizer

Thomas Cullen works in analytical research and development at AbbVie Inc. (North Chicago, IL).

Chase Waller works in quality, both at AbbVie Inc.(North Chicago, IL).

Katria Harasewych works in quality at Merck & Co., Inc. (Kenilworth, NJ).

Zahid Muhammad works in quality at Merck & Co., Inc. (West Point, PA).

John Bennett works in quality at Boehringer Ingelheim Pharmaceuticals Inc. (Ridgefield, CT).

A data-integrity risk assessment tool has been developed for use with standalone R&D data-acquisition and processing software. 

Assessing Data Integrity Risks in an R&D Environment 

The acquisition will support the accelerated commercialization of Kyslecel (autologous pancreatic islets), Koligo’s personalized cell therapy for treating pancreatitis.

Orgenesis to Acquire Koligo Therapeutics

Moderna and Chiesi Group are collaborating on the discovery and development of mRNA therapeutics to treat pulmonary arterial hypertension.

Moderna, Chiesi Group Collaborate on Discovery and Development of mRNA Therapeutics

The collaboration will expand the manufacturing capacity for lenzilumab, a COVID-19 therapeutic candidate, in advance of a potential Emergency Use Authorization in 2020.

Lonza, Humanigen Partner to Expand Manufacturing of Lenzilumab for Potential COVID-19 Therapy

The agreement will Increase global manufacturing capacity for Novavax’s vaccine candidate, NVX-CoV2373, to more than two-billion annualized doses when at full capacity in 2021.

Novavax in COVID-19 Vaccine Manufacturing Agreement with Serum Institute of India

The agreement between the two companies will significantly increase global supply capacity for Lilly's potential COVID-19 treatments.

Lilly and Amgen in Manufacturing Collaboration for COVID-19 Antibody Therapies

The companies will focus on the development and commercialization of Seattle Genetics’ ladiratuzumab vedotin and TUKYSA (tucatinib).

Merck Announces Two Oncology Collaborations with Seattle Genetics

Catalent’s Redwood Bioscience subsidiary will develop antibody-drug conjugates (ADCs) for Exelixis using Catalent’s proprietary SMARTag site-specific bioconjugation technology.

Catalent and Exelixis to Collaborate on ADC Development 

As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.

Vaccine Developers Pledge to Stand with Science

The companies have entered into a strategic partnership for the CMC development and manufacturing of Ansun’s biologics pipeline.

HJB and Ansun Biopharma Partner on Biologics CMC Development and Manufacturing

Amid high expectations for a COVID-19 vaccine, biopharma readies production capacity, weighs external pressures.

Biopharma Gears Up Pandemic Response

The collaboration includes an integrated program that encompasses formulation development, drug substances, and drug product manufacturing.

Piramal Pharma Solutions to Partner with Epirium Bio 

The register supports cross-functional teams of chemists and biologists in developing non-natural, chemically-modified therapeutics for drug discovery.