Development

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.

Articles

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

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Many antibody-drug conjugate therapies are in the pipeline; only a handful have been approved. What are the bottlenecks?

Formulating an ADC Development Solution

The European Commission has approved Lynparza (olaparib) for use in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer within the European Union.

European Commission Approves Lynparza for BRCA-Mutated Metastatic Pancreatic Cancer

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

Can Using RNA Simplify Gene Therapy Development?

Data and science must guide FDA in making pressure-filled COVID-19 vaccine and therapy approval decisions.

Navigating Uncharted Waters

Therapies for early and late treatment and passive immunization of COVID-19 are needed and can be developed using antibodies from recovered patients.

Plasma-Based Antibody Therapies Battle Against COVID-19

With the acquisition, Orgenesis will combine TamirBio’s ranpirnase antiviral platform with its Bioxome technology.

Orgenesis to Acquire Tamir Biotechnology for Broad Spectrum Antiviral Platform

As a result of the rising use and development of biological drugs, the biopharma industry is witnessing an increase in the adoption of prefilled syringes.

On Point: Biologics Drive Growth in Pre-Filled Syringes

Contract service organizations can offer biopharma companies early insight into dangers that may hinder a drug’s later development.

Seeking Early Answers to Formulation Questions

The companies have entered into a global licensing and collaboration agreement to commercialize ReForm excipients used in biotherapeutic formulations.

MilliporeSigma and ReForm Collaborate on Excipient Commercialization

Editor of Pharmaceutical Technology Europe

Biologics raise unique formulation and development challenges, and industry is still on a learning curve to get the best out of these diverse and complex therapies.

Fresh Thinking in Biologic Drug Formulation

This study aims to use plant-leaf extract for the green synthesis of gold nanoparticles and to evaluate their antibacterial and antioxidant activity.

Therapeutic Potential of Green, Synthesized Gold Nanoparticles

The new Technology Excellence Center, located in Boston, MA, will further the company’s presence in the United States biopharma drug development landscape.

Stevanato Group Breaks Ground on New Technology Excellence Center

BASF launches digital solutions for the pharma industry during CPhI Worldwide 2019.

Online Tools Assist Formulation and Product Selection

The companies will develop innovative formulations for drugs to treat rare diseases using Catalent’s oral disintegrating tablet technologies.

Cycle Pharmaceuticals, Catalent Partner on Rare Disease Treatment

CHMP has recommended that Ervebo (rVSVΔG-ZEBOV-GP), a vaccine for active immunization against Ebola, be granted conditional marketing authorization in the EU.

First Ebola Vaccine Gains Conditional Marketing Authorization Recommendation

On Tuesday, Nov. 5, 2019, Karima Yadi from Becton Dickinson & Co. will present the challenges of using, and necessity for, shorter needles and integrated systems with high viscosity drugs, such as biologics, to improve the patient experience at CPhI Worldwide.

Improving the Patient Experience with High Viscosity/High Volume Drugs

Leveraging automation and a step-by-step approach are keys to success.

Best Practices for Selecting a Top-Quality Cell Line

FDA has approved Novo Nordisk’s Rybelsus (semaglutide), a glucagon-like peptide receptor protein treatment in oral tablet form for type 2 diabetes.

FDA Approves First Oral GLP-1 Treatment for Type 2 Diabetes

Innovation in manufacturing technologies must occur to ensure the availability of gene and cell therapies.