Feliza Mirasol

The addition of the two larger-volume bioreactor sizes to Cytiva’s Xcellerex X-platform portfolio will allow scientists and researchers to scale up from 50 L to 2000 L to meet growing demand for clinical trials and regulatory approved products.

With the investment, AstraZeneca will establish a second global strategic R&D center in Beijing as well as support major research and manufacturing agreements to further advance life sciences in the country.

Curia plans to expand its sterile fill/finish capabilities at its Glasgow, UK, site and gives updates on an ongoing expansion at its Albuquerque, NM, site.

Christine Mya-San, global account manager at Roquette Pharma Solutions, discusses the most significant pharma ingredients at play over the past year and looks ahead at ingredient innovation.

Russell Miller, vice-president of Global Sales & Marketing at Enzene, discusses how continuous bioprocessing is at the forefront of changing biologics manufacturing moving forward.

Lidia Serina, PhD, head of Development Services at Simtra BioPharma Solutions, discusses the challenges with maintaining aseptic integrity in the manufacturing of sterile injectable pharmaceuticals.

Under the agreement, Shilpa will undertake development and commercial supply for a novel checkpoint inhibitor for immuno-oncology indications.

In the second half of an interview with Edwin Stone, PhD, CEO of Cellular Origins, Stone discusses how automation in CGT manufacturing can increase productivity without displacing human workers.

The Therapeutic Goods Administration (TGA) of Australia confirmed its initial decision to decline approval of the mAb for treating early Alzheimer’s disease.

Edwin Stone, PhD, CEO of Cellular Origins, offers his unique perspective to the challenges facing CGT manufacturers, drawing on his background in robotics and life science automation.

Advances in automation technologies and bioprocessing equipment are driving fuller adoption of automation in biomanufacturing.

The committee’s recommendation is based on results from a Phase III trial in which Imfinzi demonstrated a reduced risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone.

The investment, led by Foresight Group and secured alongside funding from PARP, will be used to further commercialize uFraction8’s microfiltration technology.

Takeda’s TAKHZYRO (lanadelumab) is now approved in Europe as a subcutaneous injection treatment for hereditary angioedema in patients 12 years old and above and in adults.

RNA modalities will especially benefit from fuller adoption of continuous manufacturing platforms.

FDA has accepted Sanofi’s sBLA for the mAb and granted it priority review status for the targeted treatment of bullous pemphigoid.

The approval provides greater access to insulin treatment options.

Jason C. Foster, CEO and executive director of Ori Biotech, spoke on addressing bottlenecks in CGT manufacturing and what to expect in the CGT manufacturing space moving forward.

Jason C. Foster, CEO and executive director of Ori Biotech, discusses the milestone achievement in commercial-scale CGT manufacturing with the company’s IRO platform.

The value of outsourcing partnerships for next-gen biotherapeutics rests in the expertise and technologies that service providers bring to the table.

The European Commission has approved Biocon Biologics’ YESINTEK, a biosimilar referencing Janssen Biotech’s Stelara (ustekinumab).

Co-led by Andera Partners and Bpifrance, the Series B financing will go toward an ongoing Phase Ib/IIa clinical study for EG 427’s lead candidate and to advance the company’s genetic medicines platform.

This expanded label allows IZERVAY (avacincaptad pegol intravitreal solution) to be used without a limitation on duration of dosing for treating geographic atrophy.

The approval of an ADCETRIS combination regimen is based on positive data from a Phase III trial where the combination regimen demonstrated a clinically meaningful reduction in the risk of death.

The company plans to assess alternate payloads for its gene therapy program, which will shift its timeline.

On the back of FDA’s designation, March Biosciences is preparing to advance MB-105, a CD5-targeted CAR-T cell therapy, to a Phase II clinical trial in early 2025.

The approval makes Susvimo the first and only continuous delivery treatment for diabetic macular edema.

Development of new modalities of biotherapeutic molecules will rely on manufacturing, regulatory, and collaborative support.

Under this early stage R&D collaboration, the companies aim to engineer recombinant biologics for blocking Fc receptors, which play a key role in autoimmune diseases.

The committee’s recommendation was based on results from a Phase III trial that demonstrated a 27% reduction in the risk of death versus placebo.