MONOCLONAL ANTIBODIES – The Development of Therapeutic Monoclonal Antibody Products: A Comprehensive Guide to CMC Activities From Clone to Clinic
Howard L. Levine, PhD, and Brendan R. Cooney, provide a guide to product development companies, service providers, investors, and analyst as they work their way through the complex and rapidly evolving world of therapeutic monoclonal antibodies.
EXECUTIVE INTERVIEW – MilliporeSigma: Accelerating the Development & Manufacture of Gene Therapies, Immunotherapies & Viral Vaccines
Dave Backer, Head of Virus & Gene Therapy Strategic Initiatives at MilliporeSigma, talks about his company’s expanding GMP capacity to speed development and manufacture of gene therapies, immunotherapies, and viral vaccines.
Contributor Cindy H. Dubin explores 3D printed drugs in the wake of a milestone in the pharma industry when Aprecia Pharmaceuticals’ Spritam (levetiracetam) tablets became the first FDA-approved prescription drug product manufactured using 3D printing technology.
Peter Nielsen, MBA, explains how his company’s candidates are differentiated from those in development at other companies by the type of modification to the antisense molecule and the method by which it is conveyed to its target cell.
EXECUTIVE INTERVIEW – NanOlogy: Submicron Particle Platform Transforms Systemic Chemotherapy Into Local Delivery
Marc Iacobucci, Managing Director of NanOlogy, discusses his company’s technology, clinical program, and efforts to transform cancer therapy.
Contributor Cindy H. Dubin speaks with several innovative companies on their science, techniques, and technologies aimed at improving bioavailability and solubility.
Susan Rosenbaum, JD, and Irwin Hollander, PhD, present a unique and novel solution to this greatest challenge in medicine for brain disease treatment, considered the “Holy Grail of Neuroscience,” with their breakthrough innovation.
Thomas Del’Guidice, PhD, Nancy Messier, PhD, and David Guay, PhD, present the Feldan Shuttle technology, a peptide-based delivery method that could provide efficient and safe intrabody delivery in mammalian cells.
GENE-EDITING TECHNOLOGY – How CRISPR-Cas9 Technology Will Play a Vital Role in the Future of Human Therapeutics & Drug Discovery
Kevin Holden, PhD, explores how this technology can be utilized in research efforts toward the development of new therapies and how it will play a vital role in the future of biopharma and drug discovery.
Omid Vafa, PhD, MBA, reviews unique technologies, including a transgenic rat platform expressing human heavy chain antibodies, and a state-of-the-art sequence-based discovery engine, to create novel multispecific antibodies for various therapeutic indications.
EXCLUSIVE ONLINE CONTENT
Molecular Templates Announces Agreement With Takeda for Joint Development of Protein-Based Oncology Therapy
Molecular Templates, Inc. recently announced an agreement with Takeda Pharmaceutical Company Limited for the joint development of CD38-targeted engineered toxin bodies (ETBs) for the treatment of patients with diseases such as multiple myeloma.
Biothera Pharmaceuticals, Inc. recently announced a clinical collaboration with AstraZeneca to evaluate whether the combination of Biothera’s Imprime PGG and AstraZeneca’s durvalumab (IMFINZI) can decrease tumor volume in patients with primary untreated locally advanced head and neck cancer prior to surgical resection.
Reata Pharmaceuticals, Inc. recently announced it has received a $30-million milestone payment from its licensee, Kyowa Hakko Kirin Co., Ltd. following the initiation of AYAME, a Phase 3 clinical trial to assess the efficacy and safety of bardoxolone methyl (bardoxolone) for the treatment of diabetic kidney disease in Japan.
Australian stem cell and regenerative medicine company Cynata Therapeutics Limited recently announced that CYP-001, its lead Cymerus mesenchymal stem cell (MSC) product candidate, met all clinical endpoints in a Phase 1 trial for the treatment of steroid-resistant acute graft-versus-host disease (GvHD).
CCAB Partners With ImmunoBiochem as it Launches New Co-Development Strategy to Advance Early-Stage Biotech Companies
The Centre for the Commercialization of Antibodies and Biologics (CCAB) and ImmunoBiochem Corporation have announced an agreement that will see CCAB provide a new investment to help advance ImmunoBiochem’s novel breast cancer therapeutic candidate one step closer to the clinic.