Formulation and Drug Delivery

The biggest hurdle is developing palatable formulations that are efficacious and patient friendly.

A comprehensive understanding of what makes mRNA vaccines tick is crucial in charting the future of the market.

Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.

Janssen has received a positive opinion from the EMA for two novel bispecific antibodies, TALVEY (talquetamab) and TECVAYLI (teclistamab), which the company is developing to treat blood cancer.

EMA looks to focus on mRNA vaccines because their classification depends on the target and/or whether they are obtained chemically or biologically.

The acquisition will continue to strengthen the area of conjugate vaccines and bioconjugate drugs and will expand Biosynth’s capabilities from good manufacturing practice facilities located in Berlin, Germany.

When evaluating a drug’s risk assessment for elemental impurities, one must consider all aspects of its lifecycle.

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

Sample dilution, sensitivity, excipient interference, and containment are key issues that must be addressed.

Chris Spivey, editorial director, speaks with Sean Hart, CEO and SCO of LumaCyte, on percent transduction for AAV measured.

World leaders have set ambitious goals to respond more swiftly to the next pandemic, including the US goal to design, test, and review a new vaccine just 100 days after a pandemic declaration.

invoX Pharma has made a second tranche of investment in pHion Therapeutics to support further development of next-generation mRNA vaccines.

Nanotech-based delivery technologies are receiving significant attention.

A partnership between Rentschler Biopharma and Ikarovec will support the accelerated development of novel gene therapies for the treatment of eye diseases.

API supplier Olon has started construction of a new manufacturing facility in Milan, Italy, which will be dedicated to production of cytotoxic payloads and linkers for ADCs.

Sandoz’s marketing authorization applications for a proposed biosimilar to denosumab are supported by a comprehensive analytical and clinical data package.

Alvotech and Advanz Pharma have signed a strategic partnership agreement for the supply and commercialization of five biosimilar candidates in Europe.

Shabbir Mostafa, head of Business Development — Advanced Delivery Systems, Recipharm, sat down with Grant Playter, associate editor, during DCAT week to discuss the current state of inhalations forms and drug delivery.

This deal would help the companies merge to work on future projects and conduct research together.

The data, published in the scientific journal Nature, demonstrated that half of patients developed T cells that could potentially fight pancreatic ductal adenocarcinoma.

Dr. Ulrike Lemke, Head of Sterile Fill Finish at Recipharm, sat down with Grant Playter, associate editor, to discuss drug delivery forms.

The new partnership between Sandoz, a Novartis division, and Just – Evotec Biologics will aim to develop and manufacture multiple biosimilars.

These models are useful in predicting whether an unknown substance of abuse can permeate the BBB to produce effects predicted by the Public Health Assessment via Structural Evaluation (PHASE) approach.

Vibha Jawa, executive director at Bristol Myers Squibb, discusses foreign epitopes recognition from what should be fully human antibody therapies.

The market potential of nucleic acid-based therapies have been pushed into the spotlight following the success of the COVID-19 vaccines.

E&L analytical testing methods can be determined through pointed consideration of the differences small- and large-molecule drug products.

Process control is essential for using continuous hot-melt extrusion to enhance solubility.

Gregor Kawaletz, head of Oral Solid Dose Business Unit at Recipharm, discusses the immediate future of oral biologics

Jaeger notes that the program is focused on addressing specific scientific questions that will produce immediate impacts on how CDER and FDA make drug approval decisions.

The recent success of mRNA vaccines has opened the door for further and future development of nucleic acid-based therapies.