CUSTOM DEVICE SOLUTIONS – Device Design Will Act as Competitive Distinguisher in a Post-Patent Expiry Biosimilar Market
George I’ons dissects the different factors that will determine biosimilars’ adoption and pace of advancement against their original counterparts, namely clinical confidence in the biosimilar and patient confidence in the drug delivery device.
Contributor Cindy H. Dubin interviews several leading companies and highlights trends in autoinjectors, pen injectors, wearable devices and connectivity, and prefilled syringes.
Jim Huang, PhD, says successful translation of discovery compounds into first-in-human and first-in-patient is one of the key challenges facing the pharmaceutical industry, and to achieve this, a rational formulation development strategy will be critical to avoid costly development failures, while speeding up the development timeline in a cost-effective manner.
DEVICE DEVELOPMENT – Mapping the Regulatory Strategy to Better Navigate Electronic Drug Delivery Device Development for Patient Safety & Security
Ahmed Mallek, Hadrien Gremillet, and Audrey Chandra say that along with technology advancement in the medical industry, the behaviors and needs of different stakeholders also evolve, resulting in a clear interest in electronic drug delivery devices for a variety of reasons.
John S. Vrettos, PhD, says numerous technologies are currently in development that are designed to enable the oral delivery of peptides. Though each has its unique set of properties and capabilities, all must overcome key obstacles to successfully deliver peptides via the oral route.
Tom McLean says combination drug development pipelines continue to rapidly expand and diversify with differentiated molecules and formulations, which can call for nuanced as well as significant packaging and delivery system requirements.
2020 Respiratory Drug Development eBook – Inhaled Medications for Treating Unconventional Respiratory Diseases
This second annual Drug Development & Delivery Respiratory eBook focuses on a few companies that are taking inhalation devices to a new level in drug delivery.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Specialized Capabilities for Small & Large Molecules
Contributor Cindy H. Dubin interviews key players in the CDMO market who present case studies about how they are helping pharmaceutical and biopharma companies overcome a variety of formulation and manufacturing challenges.
Anish Parikh charts the twin rise of biologics and PFS, outlines some of the common challenges associated with filling and dispensing, and discusses how a patient-centric partnership approach can help biopharmaceutical companies shorten the development pathway and ensure a reliable supply of safe, effective medicines for the people who need them.
Dieter Lingelbach, MBA, discusses the history and science of viral vectors, their current applications, and why they are a vital component in contemporary gene therapy development.
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Recipharm Announces Signature of Letter of Intent for Aseptic Fill-Finish Manufacturing of Moderna’s COVID-19 Vaccine Candidate
Recipharm, a leading contract development and manufacturing organization (CDMO), recently announced that it has signed a letter of intent with Moderna, a US-based biotech company, to formulate, fill, and….
WHITE PAPER ALERT – Considerations in Support of Achieving Successful Double Blinding and Removing Bias With Over Encapsulation
Despite the relative simplicity of over-encapsulation, proper planning, and careful execution are still fundamental to success — full consideration must be given to every detail from capsule color and size selection to having a well-trained team dedicated to the process…..
Croda International Plc recently announced it has entered into an agreement with Pfizer Inc. to supply novel excipients used in the manufacture of a COVID-19….
Dolomite Microfluidics & MilliporeSigma Collaborate to Release Off-the-Shelf Microfluidic Device Kits for the Fabrication of PLGA Particles
Dolomite Microfluidics and MilliporeSigma have partnered to create a range of off-the-shelf NanoFabTx™ microfluidic device kits for the production of….
Emisphere Technologies, Inc. recently announced it has entered into a definitive agreement with Novo Nordisk, whereby Novo Nordisk will acquire Emisphere, on a cash-free, debt-free basis, for….