Formulation Development
WHITE PAPER – Making Sub-Visible Particles Visible: Innovative Analytical Techniques for Detection & Identification
The demand for complex, often life-saving drug substances such as monoclonal antibodies, interferons, and peptides is on the rise, creating a greater need for innovative delivery mechanisms to administer these new therapeutics. For a variety of reasons, sub-visible particles….
WHITE PAPER – Poloxamer: A Simple & Powerful Solution for Accelerating Dissolution
This white paper will introduce the concept of dissolution and discuss how poloxamers are a simple yet powerful formulation approach that can enhance dissolution rate, while minimizing resource requirements.
WHITE PAPER: Controlled Synthesis of Lipid Nanoparticles Using the Automated Nanoparticle System
Particle Works’ leading microfluidic technology offers a unique automated nanoparticle generation platform for the production of homogeneous, controllable, and reproducible LNPs….
CELL & GENE THERAPY – State of the Industry – Where is C> Headed?
Bill Vincent believes if the industry wants to keep moving up the steep growth curve, then capacity and raw materials must be readily available. The innovations in therapies, platforms, and processes will all come with time, money, and increasing availability of resources.
SPECIAL FEATURE – Excipients: Exciting Expansion & Innovation
Contributor Cindy H. Dubin speaks with several companies and presents a unique look at how excipients are being used to support current and future innovative active pharmaceutical ingredients.
GLOBAL REPORT – 2021 Global Drug Delivery & Formulation Report: Part 1, A Review of 2021 Product Approvals
In part 1 of this 3-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2021 product approvals.
FORMULATION FORUM – Oral Formulation Approaches for Different Stages of Clinical Studies
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.
EXECUTIVE INTERVIEW – Syner-G BioPharma: A Track Record of CMC Excellence
Prabu Nambiar, PhD, Founder and CEO Syner-G, discusses the company’s evolution, its approach to CMC, and the future of the organization.
PLATFORM TECHNOLOGY – Predictive Medicine, Biomarkers & the Multiple Unmet Needs in Acute Respiratory Distress Syndrome
Joe G.N. Garcia, MD, and Stan Miele believe the unmet need in ARDS is to identify reliable, validated ARDS biomarkers that minimize ARDS heterogeneity and allow for stratification of subject selection for enrollment in clinical trials of tailored therapies. Combined with a more streamlined drug-approval process, biomarker- and genotype-based treatment of specific ARDS endotypes has never been as within reach as it is today.
BATCH RELEASE – The Business Case for Reinventing Batch Release
Aparna Seksaria reviews how for pharmaceutical companies — and pharma supply chains — to bring safe, commercial-ready products to market quickly and profitably, and for them to meet growing demand for highly personalized, batch-size-one types of products, it’s critical that they take steps to de-risk and speed up processes like batch release, and do so without compromising quality, safety or the bottom line.
EXCLUSIVE ONLINE CONTENT
Cullinan Oncology & Taiho Pharmaceutical Complete Agreement for Strategic Collaboration to Jointly Develop & Commercialize CLN-081/TAS6417
Cullinan Oncology, Inc. recently announced the completion of its agreement with Taiho Pharmaceutical Co., Ltd. (Taiho) signed in May 2022. Per the terms of the agreement….
Silo Pharma Expands License Agreement & Patent Portfolio
Silo Pharma, Inc. recently announced that it has expanded its Commercial Evaluation License Agreement (CELA) with the University of Maryland Baltimore (UMB) for its next generation Liposomal Peptide targeting….
Apellis Expands R&D Collaboration With Affilogic to Develop Targeted Complement Therapies for Delivery into the Brain
Apellis Pharmaceuticals, Inc. and Affilogic recently announced the companies have expanded their research and development (R&D) collaboration, which was initially formed in 2018, to include the development of Nanofitins….
Precision BioSciences Announces In Vivo Gene Editing Collaboration With Novartis
Precision BioSciences, Inc. recently announced it has entered into an exclusive worldwide in vivo gene editing research and development collaboration and license agreement with Novartis Pharma….
Pasithea Therapeutics Acquires Alpha-5 Integrin, LLC
Pasithea Therapeutics Corp. recently announced its acquisition of Alpha-5 integrin, LLC, a privately-held preclinical-stage company developing a monoclonal antibody (mAbs) for the treatment of amyotrophic lateral sclerosis (ALS) and….
MARKET NEWS & TRENDS
WEBINARS
WEBINAR – Understanding Patch Composition for Effective Transdermal Delivery
As the advantages of transdermal drug delivery grow, the global market for transdermal patches also is growing. Join DuPont™ Liveo™ Healthcare Solutions and Gattefossé Pharmaceuticals for a complimentary one-hour webinar to explore the current….
On-Demand Webinar: How to Safely Handle Your Antibody Drug Conjugate
Antibody Drug Conjugates (ADCs) have a highly specific mechanism of action which is an advantage for the treatment of several oncology indications…..
Celanese Live Webinar: Engineering Drug Delivery to Improve Therapeutic Outcomes
Celanese and ThermoFisher Scientific have partnered together to present the value of the VitalDose® EVA drug delivery platform and manufacturing through Hot Melt Extrusion (HME) on September 9, 2021.
Where Do We Stand on Poorly Soluble Drugs and Peptides in Oral Delivery?
The Rule of 5 suggests that, for oral bioavailability, a better chance for oral absorption is obtained when the molecules are within the parameters of the Rule of 5’. However, the pharmaceutical industry is achieving oral efficacy with drugs that exceed….
Bespak by Recipharm Webinar: Learn How To Overcome Viscous Formulation Challenges For Parenteral Delivery
There have been many challenges holding back widespread adoption of self-administered injectable formulations. One of the most pressing is the need to develop an auto-injector with a fine enough needle for….
WHITE PAPERS
WHITEPAPER – Protecting Workers and the Environment: Facilities and Processes Key to Safely Making Highly Potent Drug Products
Handling HPAPI drug products requires skill, expertise and knowledge of safety considerations. This whitepaper examines the importance of US based drug product manufacturing and facility requirements to safely and efficiently manufacture solid oral dosage (SOD) HPAPI products….
WHITE PAPER: Bring Quality OINDPs to Market Faster Than Ever Before | Proveris Scientific
Learn how the Proveris by Design(TM) approach is a proven tool for successfully developing nasal spray and inhalation drug products….
WHITE PAPER – Nanoparticles in Drug Delivery & Photothermal Therapies
Download this white paper to learn more about the applications of silica and metal-based nanoparticles in drug delivery and photothermal therapy…..
WHITEPAPER: Optimizing Oral Drug Delivery Using Zydis® Orally Disintegrating Tablet Technology to Address Patient Challenges
Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments…
WHITE PAPER: Selecting In-Vitro Dissolution Methodologies for Amorphous Solid Dispersions
Read about how achieving good in vivo performance is a key attribute for ensuring safety and efficacy of oral solid dosage (OSD) forms intended for systemic delivery.