FORMULATION FORUM – Considerations in Development & Manufacturing of Complex Injectables for Early Phase Studies
Jim Huang, PhD, explains how a niche CDMO, which has specialized technologies in complex injectable development and adopts GMP practice with a “laboratory setting,” will have greater flexibility regarding changes, timing, and cost for successful manufacture of complex injectables in early phase development of therapeutic drugs.
CELL & GENE THERAPY – End-to-End Cell & Gene Therapy – From Development to Commercialization – Buy or Build?
Aldo Romano and Emily Moran, MBA, discuss how the life science industry must bring technology solutions to the table while at the same time securing the capacity to develop and manufacture groundbreaking cures so patients and society can tap the benefits of cell and gene therapies.
Sridhar Krishnan, Pii’s Senior Vice President, Operations and Strategic Initiatives, discusses how manufacturing is not solely where Pii wanted to be, so the company made a concerted effort to get back to its CDMO roots.
EXECUTIVE INTERVIEW – Pace Analytical® Life Sciences: Delivering Science Better; Advancing Novel Therapies Through the Clinic to Commercialization
Frank Tagliaferri, PhD, Vice President of Pharmaceutical Development at PLS, discusses his experiences with the company and its recent growth.
Developing a new pharmaceutical product is one of the most interesting and rewarding activities to partake in, it is also extremely challenging. It is a given that drug development projects will not….
SPECIAL FEATURE – Outsourcing Analytical Testing: Innovative Drugs Spike Demand for Advanced Analysis
Contributor Cindy H. Dubin asked some of the key analytical testing providers to describe their offerings in several key areas and what advanced analytical testing techniques they can offer to pharma clients.
Tilman Roedle says variation in tub packaging continues to create financial and operational challenges for the entire downstream supply chain, and it’s time for the industry to align on packaging configuration requirements that make tubs fully processable on automated lines.
MULTI-PARTICULATE MANUFACTURING – How Does Experiment Design Affect Multi-Particulates Manufacturing?
Namrata Vora, MS, Danica Cartwright, Karthikeyan Selvaraj, MPharm, and Ryan Larmon, MS, discuss how the careful application of design of experiment studies is an invaluable tool in proving the design space of complex formulations and manufacturing processes.
Richard Vellacott, CEO of BiologIC Technologies, discusses his company’s unique technology and its applications in the future of medicine and wider fields of synthetic biology.
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
EXCLUSIVE ONLINE CONTENT
A pioneer in biotechnological medicines in Brazil, BIOMM is launching Nemera’s Advapen under the trade name Lifepen® for the administration of….
Recipharm Signs Memorandum of Understanding (MOU) for the Fill Finish of Vaccines & Biotherapeutics in Morocco
Global contract development and manufacturing organization (CDMO) Recipharm has recently signed an MOU, along with His Majesty the King of Morocco, Mohammed VI, the Moroccan Government and….
Genedata recently announced that Encoded Therapeutics has chosen Genedata Bioprocess to digitalize their proprietary gene therapy R&D technology…..
Evonik offers an innovative green technology that enables the large-scale synthesis of active pharmaceutical ingredients in water. The “Chemistry in Water” technology has the potential….
InMed Pharmaceuticals Signs Non-Binding Letter of Intent to Acquire BayMedica, a Commercial Manufacturer of Rare Cannabinoids
InMed Pharmaceuticals Inc. recently announced it has entered into a non-binding letter of intent to acquire BayMedica Inc., a private company based in Nevada and California that specializes in the manufacture and commercialization of….