(e-Book) Lyophilization Trends in Pharma & Biopharma Drug Development
This 30-page eBook is exactly what you have been looking for. Find out what is driving the lyophilization market and how working with a CDMO will save time and money and help you comply with increasing regulatory requirements.
SPECIAL FEATURE – Outsourcing Analytical Testing – Timelines, Regulations & Biologics Drive the Sector
Contributor Cindy H. Dubin interviews leading CDMOs to discuss not just their analytical service offerings, but their strategies for meeting regulatory challenges and ensuring faster project timelines.
FORMULATION FORUM – Sterile & Non-Sterile Formulation Capabilities – A CDMO Perspective
Jim Huang, PhD, and Shaukat Ali, PhD, explain how their company is expanding its footprints in sterile manufacturing to handle innovative molecules and leverage its services to emerging and specialty and biopharma companies requiring cGMP materials for preclinical tox and clinical studies.
DRUG-ELUTING IMPLANTS – Sustained-Release Implants – A Targeted Approach to Drug Delivery
Tom Quinci, MSc, believes oncology requires new treatment modalities that are better for patients, and it is time technologies like drug-eluting implants, offering real, achievable advantages, are more widely considered.
ROUNDTABLE DISCUSSION – Which Trends Will Have the Most Impact on Drug Development in 2023?
Contributor Cindy H. Dubin posed this question to life science leaders during a recent roundtable discussion, and one common theme is the focus on sustainability in pharmaceutical development.
FUNCTIONAL EXCIPIENTS – Improving the Water Solubility of Oral Drugs With Amorphous Solid Dispersions (ASDs)
Liliana Miinea, PhD, says with certain polymers, it is possible for drug formulators to take full advantage of the benefits of ASDs, enabling them to overcome formulation challenges to deliver more effective novel drug products capable of transforming the lives of patients.
CLINICAL TRIALS – Historical Controls in Rare Disease Drug Development: Using RWE to Overcome Key Challenges
William Maier, MD, PhD, says the utility of HCs based on RWE should be evaluated for potential applications to increase speed of product approval, reimbursement, and clinical practice adoption.
DISCOVERY PLATFORM – Reverse-Engineering Targeted Immunotherapy
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.
EXECUTIVE INTERVIEW – TC BioPharm: Developing Platform Allogeneic Gamma-Delta T Cell Therapies for Cancer
Bryan Kobel, CEO of TC BioPharm, discusses his company’s upcoming plans, therapeutic clinical trials, and the biotech landscape.
FORMULATION DEVELOPMENT – Understanding CBD Formulation Versus Dosage Format
Gerry McNally, PhD, says there are many misconceptions when it comes to considering the best way or format to consume CBD and get the maximum benefit. Formulation scientists need to consider several factors when developing new formulations of nutraceutical ingredients, especially botanical ingredients and natural materials from various sources.
THERAPEUTIC FOCUS – Addressing the Unmet Need for Improved Treatments of Female Cancers
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.
CLINICAL TRIALS – The Mission to Increase Diverse Clinical Trial Participation
Lauren Chazal, MBA, and Keidra Gaston, MBA, believe clinical trials are critical to advancing medical knowledge and new therapeutics; however, it is important that participants in clinical trials represent their entire communities and the potential recipients of new treatments.
PATIENTS-ON-A-CHIP – Why Artificial Intelligence Will Be the Tipping Point to Remove the Faulty Reliance on Animal Testing in Drug Discovery
Isaac Bentwich, MD, believes Advanced Bio-AI platforms that integrate artificial intelligence and machine learning with patients-on-a-chip, real-time nano-sensing, and stem cell genomic diversity technologies are the future of drug discovery and development.
2023 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
MACHINE LEARNING – Applying Machine Learning Techniques: Gaining Meaningful Life Sciences Insights From Genomics Data
Lucas Glass explains how the predictive capabilities offered by ML solutions can help pharmaceutical and biotech companies shift focus onto additional experiments — providing an opportunity to catch or generate potential options.
EXCLUSIVE WEBINARS
ON-DEMAND WEBINAR – CMC Strategy to Take Bispecifics From DNA to IND in 13 Months* by Lonza
Lonza has applied it’s 35 years of CMC experience in Biologics to develop an end-to-end comprehensive DS/DP DNA to IND strategy in 13 months. This presentation….
WEBINAR – Getting to the Core of Pellet Coating
This webinar is part of The future of solid dosage, an ACG 360 webinar series covering wide-ranging, simple, and transformative ways to achieve smarter pharma formulation, manufacture, and packaging.
WEBINAR – Hot-Melt Granulation Technology for Lipid-Based Pharmaceuticals
Join our experts Dr. Mandar Kodgule, Dr. Rahul Aware, and Dr. Agnivesh Shrivastava live as they take you through compelling case studies, current trends and developments, and insights on mastering the design of hot-melt granulation process.
ON-DEMAND WEBINAR – Exploring Pectin & the Advancement of Delayed Release Technology
In this webinar, experts will provide an overview of why the properties and structure of pectin are well suited for site-specific delivery to the colon. In addition, experts will also provide insights into how softgel capsules, formed by the combination of both pectin and gelatin, are used in OptiGel® DR, a new delayed release delivery technology for pharmaceutical applications.
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….
EXCLUSIVE WHITEPAPERS
WHITEPAPER – Case Study-Improving Bioavailability Using PBPK Modeling & Parallel Formulation Screening
A team of bioavailability experts at Catalent used the in-house bioavailability enhancement platform, OptiForm® Solution Suite, to optimize and develop….
WHITEPAPER – Infographic-Zydis® Orally Disintegrating Tablet (ODT) vs. Standard Tablets (ST)
Catalent’s proprietary Zydis® ODT platform is backed by a large number of clinical studies. This infographic provides a high level summary of studies comparing Zydis ODT against traditional oral tablets…..
WHITEPAPER – Maintaining Sustainable Business Practices During the Energy & Supply Crisis
As we come to the end of another year, our global economy faces many significant challenges. Recently, a colleague asked me, “As a biopharma executive, which of today’s major issues are the ones that keep you up at night?”
WHITEPAPER WORKSHOP – Soft Mist Inhalers
Soft mist inhalers (SMIs) are a versatile technology suitable for the delivery of both small and complex large molecules, optimising lung deposition whilst minimising oropharyngeal deposition…..
WHITEPAPER – Accelerated API Manufacturing by Combining Early-Stage and Late-Stage Process Development
Traditionally, early-stage and late-stage process development have been done separately, with early-stage mostly focused on material production and late-stage on process intensification. As more….
EXCLUSIVE ONLINE CONTENT
Stevanato Group Collaborates With Transcoject to Provide Pre-Fillable Syringe Polymer Options for Pharma
Leading drug containment provider to release a unique offering including both COP and COC pre-fillable syringes (PFS), adding to its existing glass PFS portfolio, providing customers with the broadest choice for PFS….
Revive Therapeutics Enters Research Collaboration Agreement With PharmaTher for Development of MDMA Transdermal Patch
Revive Therapeutics Ltd. recently announced it has entered into a research collaboration agreement with PharmaTher Holdings Ltd. to evaluate the delivery of 3,4-Methylenedioxymethamphetamine (MDMA) using PharmaTher’s novel microneedle….
Purple Biotech Expands Pipeline of First-in-Class Therapeutics With Acquisition of Immunorizon & Its Portfolio of Tri-Specific Antibodies for the Treatment of Cancer
Purple Biotech Ltd. recently announced it has entered into an agreement for the acquisition of Immunorizon Ltd., a private company developing potential multi-specific T and NK cell engager oncology therapies that….
Volta Medical Announces Completion of Patient Enrollment in TAILORED-AF Clinical Trial for Treatment of Atrial Fibrillation
First randomized controlled clinical trial to evaluate VX1-guided ablation compared to conventional anatomical ablation approaches to treat persistent atrial fibrillation….
X-Chem & Kymera Expand Existing Partnership
X-Chem recently announced the expansion of its collaboration with Kymera Therapeutics, Inc. With the expanded agreement, X-Chem will serve as the primary provider of DNA-encoded….
Start-Up Innovation at Pharmapack 2023
Pharmapack Europe 2023 returns to its traditional February timing for the first time since the start of the pandemic and provides the industry with a vital early window into many of tomorrow’s technologies that improve patient experience, adherence, and delivery…..
BioAegis Therapeutics Announces FDA Clearance of IND for its Inflammation Regulator Protein for the Treatment of ARDS
BioAegis Therapeutics, Inc. recently announced the US FDA has approved its Investigational New Drug (IND) application for recombinant plasma gelsolin to proceed for the….
Ocuphire Announces Topline Results From Phase 2 Trial of Oral APX3330 in Diabetic Retinopathy & Plans for End-of-Phase 2 Meeting With FDA
Ocuphire Pharma, Inc. recently announced topline efficacy and safety results from its ZETA-1 Phase 2 trial evaluating oral APX3330 for the treatment of diabetic….
Brand New State-of-the-Art Nemera Manufacturing Facility Inaugurated in Poland
Based in Szczecin, this facility will significantly boost Nemera’s manufacturing capabilities and bring more drug delivery device solutions to patients…..
Alvotech & Bioventure Announce Approval of AVT02 (Adalimumab) as Simlandi in Saudi Arabia
AVT02 as Simlandi is the first biosimilar approved under the strategic partnership between Alvotech and Bioventure….
MARKET NEWS & TRENDS
