Felicity Thomas

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on how to respond to defective vials in a batch and how to prevent future problems in secondary packaging.

The acquisition will provide Roche with access to Poseida’s GMP manufacturing capabilities and R&D portfolio assets, including cell therapy candidates.

GSK’s Biologics License Application for belantamab mafodotin (Blenrep) as part of a combination therapy has been accepted by the US regulatory body for review.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the new chapter, Chapter <86> Bacterial Endotoxins Test Using Recombinant Reagents

Eisai Europe and Biogen have received a positive opinion for the monoclonal antibody therapy to be used as a treatment of adult patients with early Alzheimer’s disease.

Shannon Hinsdale from Revvity presented data at the Advancing Gene + Cell Therapies for Cancer conference demonstrating that base-editing systems are safe and effective for complex engineering in both T cells and iPSCs.

In this episode of the Ask the Expert video series, Peter Walters, Fellow of Advanced Therapies at CRB Group, discusses how facilities used for solid dosage manufacturing may be retrofitted into sustainable cell and gene therapy production facilities.

At CPHI Milan, Zaim Gashi, area sales manager of Steriline, discussed the evolution of aseptic processing equipment to stay compliant with current regulations.

At CPHI Milan, Stacey Treichler, senior director of global marketing and strategy, Purolite, an Ecolab company, spoke about current trends in the biopharma industry and innovations in purification resins .

In this episode of the Ask the Expert video series, Peter Walters, Fellow of Advanced Therapies at CRB Group, discusses factors to be considered in constructing a new facility for cell and gene therapy production as well as using an existing facility to expand cell and gene therapy pipelines.

As the field of bioanalytical testing evolves, it is important for drug developers to stay at the forefront of the advancements to ensure they remain competitive.

In the second episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice-president, Technical, at Parexel, discuss the quality requirements needed when incorporating AI in bio/pharmaceutical development and manufacturing.

The addition of BIOVECTRA’s biologics capabilities to accelerate drug development and manufacturing will allow Agilent to expand its end-to-end offerings for biopharma services.

In the premiere episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, vice president, Technical at Parexel, discuss the challenges involved in changing an excipient supplier.

Technological advances are aiding manufacturers to streamline aseptic processes and improve time-to-market.

Pharm Tech Group looks at the challenges surrounding the development and manufacture of ATMPs in more detail with Agne Vaitkeviciene, CEO of Memel Biotech.

Pharm Tech Group sits down with Bernard Sagaert, CEO of etherna, to examine the role of mRNA in the treatment of autoimmune diseases.

BioPharm International chats with Dr. Monika Paulė, CEO and co-founder of Caszyme about the evolution of CRISPR.

Broken String Biosciences and the Francis Crick Institute will collaborate on research into how genome stability impacts ALS.

Progression in biopharmaceutical drug development and manufacturing is being boosted by technological advances.

GSK’s supplemental Biologics License Application for its PD-1-blocking antibody therapy has been accepted for review by FDA.

The new Verafit products from STERIS are designed to help manufacturers conform to regulatory requirements laid out in Annex 1.

The health data science division of Optima Partners, bioXcelerate, has released a tool aimed at accelerating the drug discovery process.

Given the criticality of fill/finish processes, it is clear that automation is the next technological step.

AstraZeneca has completed its acquisition of Icosavax, gaining the IVX-A12 vaccine candidate that targets RSV and hMPV.

GSK is expanding its respiratory biologics portfolio with its acquisition of Aiolos Bio and its novel therapy, AIO-001.

NICE has recommended the use of AbbVie's Tepkinly as a treatment option for eligible adults with diffuse large B-cell lymphoma.

Despite slow growth over recent years, the CAR-T cell therapy space is expected to see considerable advancements in the near future.

IMU Biosciences has secured £11.5 million in its Series A financing round.

The acquisition marks a pivotal expansion for the company into the US market.