QSAM Biosciences & RLS Announce Clinical & Commercial Supply Agreement for Promising Clinical-Stage Metastatic & Primary Bone Cancer Treatment May 16, 2023

Mekonos Announces Research Collaboration With bit.bio to Advance Cell Engineering May 10, 2023

New collaboration combines Mekonos’ novel ex vivo delivery platform with bit.bio’s unique opti-ox™ precision cellular reprogramming technology to accelerate the development of human cells for research, drug discovery and….

SPECIAL FEATURE - Parenteral Drug Delivery: Could a Dose of AI Improve Development? May 1, 2023

Contributor Cindy H. Dubin speaks with several innovative companies to highlight the strides they are currently making toward improving dose accuracy, integrating design safety, and accelerating time to market.

PLATFORM TECHNOLOGY - An Alternative Solution for Peptide Drug Formulation April 3, 2023

Michael Neely introduces a unique technology platform and provides examples of how it has solved difficult formulation problems while adding significant commercial value to the resulting drug products.

SPECIAL FEATURE - Solubility & Bioavailability: Difficult Beasts to Tame March 1, 2023

Contributor Cindy H. Dubin highlights the services many of these outsourced providers offer to enhance solubility and bioavailability and get their clients’ projects to market faster and cost effectively – while maintaining critical quality attributes.

EXTRACTABLES & LEACHABLES - Detecting the Unknown With Extractables & Leachables Analysis March 1, 2023

Derek Wood, Xiaochun Yu, PhD, and Aaron Lamb review how a new generation of extraction, identification, and quantification tools, now recognized as approved methods by regulatory bodies, are changing the E&L testing landscape.

DISCOVERY PLATFORM - Reverse-Engineering Targeted Immunotherapy January 16, 2023

Bob Lechleider, MD, explains how by applying a patient-first technology and looking for clues in the immune system, a powerful tool can be harnessed – the human body – to identify and produce new molecules to make medicines for cancer patients.

THERAPEUTIC FOCUS - Addressing the Unmet Need for Improved Treatments of Female Cancers January 16, 2023

Martin Lehr, MA, explains how his company is advancing a pipeline of innovative products designed to address treatment resistance in breast, ovarian, and endometrial cancer, which, if approved, could provide patients with a much-needed new treatment options.

EXECUTIVE INTERVIEW - Owen Mumford & Stevanato Group: Collaborating to Produce Aidaptus® Auto-injector October 3, 2022

Michael Earl, Director of Pharmaceutical Services at Owen Mumford, and Steven Kaufman, Vice President for Drug Delivery Systems at Stevanato Group, discuss their collaboration in producing the innovative Aidaptus auto-injector.

SPECIAL FEATURE - Injection Devices: Three Trends Influencing Development & Delivery September 1, 2022

Contributor Cindy H. Dubin showcases in this annual feature how various innovative device manufacturers are addressing the current trends in their injection designs.

Fate Therapeutics Announces Preclinical Publication Highlighting Derivation of CD8αβ T Cells From TCR-CAR+ Induced Pluripotent Stem Cells August 9, 2022

2022 Respiratory Drug Development eBook - Demand Accelerates Devices July 8, 2022

This fourth annual Drug Development & Delivery Respiratory eBook highlights the pMDI development path, as well as the importance of a holistic approach to that development that includes the patient and all stakeholders across the product’s life cycle.

AUTOINJECTOR TECHNOLOGY - De-risking Biosimilar Development With a Clinically Validated & Commercially Proven Disposable Autoinjector June 1, 2022

Victoria Meyer, MBA, explains how for many biopharmaceutical customers, BD and the BD Physioject™ Disposable Autoinjector have offered the appropriate combination of technology, documentation, and resources required for timely success.

CLINICAL TRIALS SOLUTIONS - Cracking Down on the Rising Costs of Drug Development: How Pinpointing the Complexity of Individual Patients Can Improve Success Rates June 1, 2022

Dominique Demolle, PhD, and Erica Smith, PhD, say taking a more holistic, patient-centric approach by considering patients’ individual psychology, perceptions, and beliefs provides drug developers the opportunity to quantify these interpersonal differences between patients and address this source of variability in data analysis and interpretation.

SPECIAL FEATURE - PFS & Parenteral Drug Delivery: Self-Injection is Very Much the “New Normal” May 2, 2022

Contributor Cindy H. Dubin showcases how leading CDMOs and drug delivery developers are responding to current market trends to create ergonomic technologies that are patient friendly, easy to use, reduce needle anxiety, and feature improved packaging materials.

FORMULATION FORUM - Oral Formulation Approaches for Different Stages of Clinical Studies April 4, 2022

Jim Huang, PhD, says it is of the utmost important task to utilize a phase-appropriate formulation development approach for early and later-stage commercial development of oral dosage forms.

PERMEABILITY STUDIES - Onion Epithelial Membrane as a Model for Predicting Intestinal Absorption of Drugs April 4, 2022

Antoine Al-Achi, PhD, Mounika Nangineedi, MS, Chaitali Koli, MS, et al, study 19 drugs with varying partition coefficient, water solubility, and molecular weight values to compare their diffusion through the middle epithelial membrane of onion with that of their Caco-2 cell line.

FORMULATION DEVELOPMENT - Impact of Excipients & Manufacturing Process on Solubility-Enhanced Ritonavir Tablet Size & Weight Reduction March 1, 2022

Gayatri Khanvilkar, MPharm, Ajit Bhagat, and Tejas Gunjikar, PhD, investigate bulking agents and disintegrants to develop efficacious Rotonavir tablets with improved in vitro release.

ImmunityBio Expands Vaccine Program to Accelerate Use of “Mix-and-Match” Technologies in Developing & Manufacturing Next-Generation COVID-19 Vaccines November 18, 2021

ImmunityBio, Inc. recently announced the expansion of the company’s cancer and infectious disease vaccine programs to include self-amplifying self-adjuvating RNA (SASA-RNA), recombinant protein vaccine candidates, and potent adjuvant formulations that….

BD Launches BD UltraSafe Plus™ 2.25-mL Passive Needle Guard Enabling Patient Ease of Use & Safety November 17, 2021

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