APIs and Excipients

Sara Fathollahi, PhD, product application specialist at DFE Pharma, makes the case of how excipient suppliers can support the transition from batch to continuous manufacturing.

Pharmaceutical Technology Europe® spoke with Dr. Rainer Schmidt from Galvita AG, an excipient manufacturer based in Switzerland, at the inaugural Start-Up Market on the show floor at CPHI Barcelona 2023.

Spark Therapeutics and SpliceBio have formed a collaboration to develop a gene therapy that can treat an inherited retinal disease.

The California Institute for Regenerative Medicine has partnered with Forge Biologics, which will manufacture AAVs to help accelerate gene therapy programs in California.

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."

All members of the pharmaceutical supply chain must implement reliable sourcing and manufacturing strategies that balance quality and costs to ensure the uninterrupted supply of high-quality medicines to patients worldwide.

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

Under an expanded agreement, Cellares will provide proof-of-concept manufacturing for a second CAR-T cell therapy from Bristol Myers Squibb.

Salipro Biotech and Icosagen have entered into a multi-target collaboration to discover and characterize monoclonal antibodies.

Roche will gain exclusive worldwide rights to develop, manufacture, and commercialize Ionis’ investigational RNA-based therapeutic candidates for Alzheimer's and Huntington's disease.

Eli Lilly and Company has received a complete response letter from FDA for its anti-dermatitis biologic therapeutic, lebrikizumab.

Twin-screw granulation process insight is growing as researchers employ new analytical technologies and investigate new ways to use the equipment.

Sustainability advances are being made, but more investment is needed.

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.

The companies plan on targeting the production of abundant, low-cost messenger RNA from C1-cells.

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.

Under the collaboration, Orionis will receive $47 million upfront to leverage its Allo-Glue platform to discover small-molecule monovalent glues.

The EMA’s Committee for Medicinal Products for Human Use has given a positive opinion on Sandoz’ biosimilar trastuzumab for breast and gastric cancer.

Colorcon provides customers with Opadry complete film coating systems, which intends to help reduce complexity with delivering high-quality products and ingredients.

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

Coprocessed excipients save time and cost while improving performance in a widening array of dosage forms.

The collaboration partner for Willow is focused on more sustainable methods to manufacture intermediates and APIs at reduced cost and less waste, in addition to looking for Willow’s expertise in developing and scaling key ingredients.

The deal is worth up to $36 million with an initial upfront consideration of $14 million, with an additional $22 million in contingent value rights (CVRs) that is payable upon achieving certain milestones.

FDA has halted enrollment in clinical studies for Gilead Sciences’ magrolimab, a biologic treatment in development for acute myeloid leukemia.