Formulation and Drug Delivery

Chris Spivey, editorial director, hosts a wide ranging discussion on the COVID-19 pandemic response, future government communications, and healthcare funding for mRNA with experts Dr. Kate Broderick, Chief Innovation Officer, Maravai LifeSciences and Dr. Tom Madden, President & CEO at Acuitas Therapeutics. Highlights include supply chain modalities, ensuring a fully trained manufacturing workforce, combining delivery with gene editing innovations, epigenetic approaches to modulate gene expression moving toward the clinic. We conclude with the huge potential for RNA expression of monoclonal antibodies and protein replacement applications.

Sander Van Gessel, MEng, Business Unit Director, DFE Pharma, discusses the important components of nitrosamine impurities from a manufacturing point of view as a part of his session, "Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer's View."

Sander Van Gessel, MEng, Business Unit Director, DFE Pharma, discusses the recent findings of nitrosamine impurities in human drugs as a part of his session, "Reducing Nitrosamines Without the Use of Scavengers: The Critical Role of Excipients - An Excipient Manufacturer's View."

Model informed formulation development uses in-silico modeling and simulation to identify and/or refine promising formulations faster and cheaper, support formulation strategy and increasingly, demonstrate virtual bioequivalence and obtain biowaivers.

A new generation of interactive formulation development platforms can leave trial and error in the formulation process in the past.

The Start-Up Market at CPHI Barcelona will bring together 27 start-ups, innovators, and small enterprises from across the pharma landscape.

When considering manufacturing and the growth of drug formulation, it is evident that there has been change and many new advancements introduced to make processes more efficient.

Sherma Ellis Daal, brand director, Pharma at Informa Markets, gives a preview of CPHI Barcelona 2023.

CPHI’s Annual Report predicts huge impact of AI on drug development and manufacturing.

The companies will co-promote GSK’s shingles vaccine, Shingrix, to healthcare professionals and points of vaccination in China.

The draft guidance document discusses quality considerations for topical ophthalmic drug products.

POINT is a radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies in development for the treatment of cancer.

Pfizer has entered into a collaboration with Ginkgo Bioworks to discover novel RNA molecules across priority research areas.

Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.

The European Commission has granted approval for Tyruko (natalizumab), a biosimilar developed by Polpharma Biologics for treating multiple sclerosis.

In this episode of Drug Digest, Pharmaceutical Technology’s European/Senior Editor, Felicity Thomas, discusses small-molecule APIs, excipients, and formulation advances, including a discussion about novel approaches and solutions to pediatric formulations and taste-masking, a rundown of the fundamental stages of gaining a certificate of suitability for APIs, and a deliberation on the biggest trends impacting the industry and key sessions to visit while at CPHI, with several key industry experts.

BenevolentAI will leverage its suite of AI chemistry design tools in combination with its fully equipped wet lab facility in Cambridge, UK, to deliver small molecule drug development candidates into the Merck pipeline, according to the press release.

The company is currently developing EVX-101 as an adjunctive treatment for MDD due to patients experiencing an inadequate response to first-line antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors SNRIs.

According to a press release, the implications go to the extent that within the next 10 years, more than 50% of approved drugs will involve AI in their development and/or manufacturing.

It was noted that there was participation by multiple new investors including M&G plc, in addition to two of the largest US public pension plans and the existing investor, Rock Springs Capital. Further, the financing significantly adds to the $195 million previously raised by the company, according to the press release.

Seagen will be responsible for conjugating these degraders to antibodies to make DACs and advancing these DAC drug candidates through preclinical and clinical development and commercialization.

The results showed that PathoQuest’s proprietary NGS approach is an effective, more robust replacement to in vivo adventitious virus testing of cell substrates used in the production of biologics, like monoclonal antibodies, vaccines, cell, and gene therapies.

Optibrium announced on Aug. 31, 2023 the acquisition of BioPharmics to further expand the 3D drug design and modelling offering and to focus on research and development and application science.

Excipients should be treated equally when it comes to quality management, risk assessment, and testing.

Tumour-infiltrating lymphocyte (TIL) therapies offer a new route to target cancer.