Bio Platforms
GENETIC MODIFICATION THERAPIES - Clinical Applications & Technology Platforms
Laurie L. Sullivan and John Bergin, MS, MBA, say the growing interest on the part of large pharma or biotech companies is driving clinical development of genetic modification therapy candidates, and the rich late-stage pipeline for genetic modification therapy candidates is a driving force of growth.
ANTIBODY DRUG CONJUGATES - Expansion of Approved Indications Backs 25% Increase in Global Market
Laurie L. Sullivan and Shalini Shahani Dewan, MS, believe technological advancements, the rising incidence of cancer, and an increasing demand for biologic therapies are all factors driving growth in the global ADC market.
EXECUTIVE INTERVIEW - BriaCell Therapeutics: Recognizing the Power of Targeted Immunotherapies
Dr. William “Bill” Williams, MD, President and CEO of BriaCell Therapeutics, discusses the value of targeted immunotherapies in the biopharmaceutical industry.
DRUG DEVELOPMENT - Cell & Gene Therapies Calling for Innovation in Drug Development
Lev Gerlovin and Pascale Diesel, PharmD, believe there is significant evidence to indicate that we are entering a golden age of gene and cell therapy development, and while industry works to advance these programs, the debate over new approaches in both structuring and financing clinical research is likely to continue.
DRUG DELIVERY - Targeted Delivery of Submicron Particle Cancer Chemotherapy: Helping Shift the Immunotherapy Paradigm
Marc A. Iacobucci says that with much attention and research investment into IOT, NanOlogy is shaping a new paradigm for cancer treatment by attempting to improve the safety and effectiveness of tried and true CT through local delivery.
ANTIBODY DISCOVERY - Why Understanding Immune Dysregulation is the Key to Drug Development
David S. Johnson, PhD, provides a unique insight into immune dysregulation through a proprietary technology known as Surge – a platform that quickly characterizes every cell in complex immune systems so that natural immune repertoires can be translated into medical treatments.
PEPTIDE DELIVERY - The Endometriosis Enigma – Why Can't There Be a Pill for That?
Joel Tune, MBA, says for those peptide therapeutics that meet the necessary criteria, advances in formulation technologies coupled with favorable market dynamics will continue to drive interest across the entire prescription drug spectrum for safe and effective orally administered peptide therapeutics.
PERSONALIZED IMMUNOTHERAPY - Off-the-Shelf Personalized Immunotherapy for Breast Cancer: The BriaCell Solution
William V. Williams, MD, Markus Lacher, PhD, and Charles L. Wiseman, MD, explain how there is a clear need for ways to stimulate effective cancer-specific immune responses while avoiding time-consuming and costly individualized manufacturing.
THERAPEUTIC FOCUS - Antisense Drug Shown to Significantly Reduce Triglyceride Levels in Patients With Severe Hypertriglyceridemia
Ioanna Gouni-Berthold, MD, provides results from a clinical study indicating antisense technology can result in significant reductions in triglyceride levels in patients with hypertriglyceridemia.
MULTIPARTICULATE SYSTEM - Advances in Lipid Multiparticulate Technologies for Controlled Release
Jaspreet Arora, PhD, Samantha Saville, and Brett Waybrant, PhD, focus on a controlled-release LMP formulation to identify optimum annealing conditions and to better understand the annealing mechanism.
EXCLUSIVE ONLINE CONTENT
Biolojic Design Announces Nektar Therapeutics Has Exercised its License Option to Develop an AI-Designed Agonistic Antibody Targeting TNFR2 for the Treatment of Autoimmune Diseases
Program is the Product of a Research Collaboration between Biolojic Design and Nektar entered in 2021….
Cellares & Bristol Myers Squibb Announce $380-M Worldwide Capacity Reservation & Supply Agreement
Cellares, the world’s first Integrated Development and Manufacturing Organization (IDMO), will allocate multiple Cell Shuttles and its fully automated, high-throughput Cell Q systems across its IDMO Smart Factories in the US, EU, and Japan for Bristol Myers Squibb’s use ….
Neurolentech Signs Technology Access Partnership With Kaerus Bioscience
Kaerus Bioscience will access Neurolentech’s NDD Drug Discovery Platform to support development of its preclinical asset pipeline for numerous genetic syndromes….
Palisade Bio Enters Strategic Collaboration With Strand Life Sciences to Advance Precision Medicine Approach
Partnership marks a significant value-driving milestone in Palisade Bio’s mission to redefine UC treatment through targeted interventions based on PDE4-related biomarkers….
Evaxion Announces Phase 2 Clinical Trial Update: First Patient Completed Dosing With Personalized Cancer Vaccine
Significant Phase 2 clinical trial progress obtained with first patient finalizing EVX-01 vaccine dosing….
MARKET NEWS & TRENDS
WEBINARS
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…..
WHITE PAPERS
WHITEPAPER - Use of a Platform Formulation Technology to De-Risk Solid-State Variation in Drug Development
This white paper describes use of mesoporous silica as a porous carrier formulation technology to stabilize unstable polymorphs and to optimize solid state properties.
WHITEPAPER - Long-Acting Injectable Nanoparticle Formulations
Long acting injectable (LAI) formulations have been the subject of continued interest in the recent past due, in part, to their longer systemic circulation requiring less frequent dosing of drugs.
WHITEPAPER - PLGA Nanoparticles - Bridging the Gap From R&D to GMP
Poly(lactic-co-glycolic acid) (PLGA) has emerged as a promising material for drug delivery and biomedical applications. Its exceptional biocompatibility, customizable degradation and release properties, and versatility have led to….
APPLICATION NOTE: Process Optimization & Preclinical Production Using the ANP System
Particle Works is thrilled to announce the launch of a new Application Note that delves into the advancement of nanoparticles as carriers for targeted drug delivery. Developing nanoparticles for this purpose can be….
WHITEPAPER - Improve Process Economics & Enable High Protein Concentrations
What if you could achieve higher protein concentrations during downstream processing? This whitepaper spotlights how excipient combinations can enhance manufacturability and final concentration of mAb formulations.
What are Bio Platforms?
Platforms (or asset-independent technologies to capture all kinds of capabilities that can be leveraged across many different drug candidate assets rather than just discovery tools that the term ‘platform’ immediately brings to mind) are ubiquitous in modern pharma. They are the product of an arms race, to secure access to the best capabilities in key areas.
Platform technologies are considered a valuable tool to improve efficiency and quality in drug product development. The basic idea is that a platform, in combination with a risk-based approach, is the most systematic method to leverage prior knowledge for a given new molecule. Furthermore, such a platform enables a continuous improvement by adding data for every new molecule developed by this approach, increasing the robustness of the platform.
But it has often been said that access to the latest technological platforms to aid efficient drug discovery and development is limited to Big Pharma, which can more easily justify the costs of creating and operating these platforms.
Benefits of Bio Platforms
Platform technologies have the ability to radically improve upon current products and generate completely novel products. In this sense, they open up new arenas for drug discovery and development, potentially increasing the number of therapeutic options for patients. Once a single compound or therapeutic has been generated and demonstrates a clinical benefit in patients, it is more likely this platform technology can successfully be applied to other therapeutic areas, derisking future compounds/products.
Complex drugs by their very nature are challenging and costly to manufacture. This, in turn, translates into higher costs for patients and other payers. In order to provide safe and effective therapies at a reasonable price, it is necessary for the industry to develop manufacturing technologies that reduce costs and provide a consistent product. While the initial investment may be larger, manufacturing costs will be lower over time as the manufacturing process is solidified.
Scale and Investment of Bio Platforms
Despite the initial upfront costs, platform technologies inevitably provide pragmatic solutions to production challenges, while yielding safer and more effective therapeutic products. It has often been said that one of the key features that distinguishes “Big Pharma” from biotech is access to the latest technological platforms to aid efficient drug discovery and development.
These platforms range from vast chemical libraries, ultra-high throughput screening and huge genetic databases in discovery, to predictive toxicology platforms, cutting-edge ‘omics’ and even deep-seated knowledge of particular therapeutic areas in development. All these platforms have two things in common: They can be used on any (or many) development candidate assets, and they cost huge sums to establish in the first place, and in a few cases each time they are used as well. Hence their restriction to the largest pharmaceutical companies (and a few of the so-called “big biotechs” that are, in many ways, indistinguishable from the old-guard pharma).
Only when you have hundreds of active projects can you justify the cost of creating and operating these platforms. Or so the mantra goes. It is access to these platforms that keeps the big companies ahead in the race to discover and develop the best medicines (or at least counterbalance the disadvantages of being large and slow-moving, depending on your point of view). But is that just an assertion? How much evidence is there to support the proposition that the efficiency gains due to these platforms outstrips the cost of creating and maintaining them?
Keeping these technologies “cutting edge” has become so expensive that increasingly we hear pharma companies talking of “pre-competitive” approaches to develop the next generation. A group of companies might develop a platform capability they then share. The principle goal of such initiatives is to access even grander and more expensive tools than individual companies could afford, rather than to dramatically cut costs (although sharing platforms rather than developing the same thing in parallel in each silo should at least keep a lid on rising costs).