Outsourcing

In the latest of a series of warning letters to India-based API manufacturers, FDA issued a warning letter to Aspen for deviations in CGMP in the production of APIs.

The Biotechnology Innovation Organization’s new membership survey said that 90% of US biotech companies rely on imported components for at least half of their FDA-approved products.

With a completed €40 million (US$43 million) investment in Slovenia, Novartis has opened its first specialized viral vector production facility in Europe, following earlier significant investments in R&D that has led to the growth of Slovenia’s workforce.

PharmTech Group sat down with Anil Kane of Thermo Fisher Scientific live on site at DCAT Week 2025, to talk about technologies and digital solutions companies are using to meet demand across the bio/pharma industry.

PharmTech Group interviewed Lee Karras of Noramco live on site at DCAT Week 2025, shortly after the company announced a $25 million investment in sterile injectable manufacturing capabilities at its Halo Pharma facility in New Jersey.

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

Pharmaceutical Technology® chats with Simon Wright from Almac Pharma Services about shifting demand for commercial manufacturing services and how service providers are adapting to meet demand.

The Member Company Announcement Forum is the kickoff event of the annual DCAT Week in New York City, which is being held from March 17–20.

This model is being positioned by Shilpa as a dual approach that offers comprehensive discovery, clinical, and commercial outsourcing services in addition to commercially ready, “off-the-shelf” novel formulations for b2b licensing.

As part of our coverage of this year’s DCAT Week, Pharmaceutical Technology® spoke with Hamilton Lenox, chief commercial officer at LGM Pharma about the expanding pharma market and the challenges such demand creates.

In an interview with Pharmaceutical Technology®, Ian Lafferty from Upperton discusses the trends and challenges facing sterile manufacturing and how partnering with CDMOs can help innovators progress to the market.

The company plans to add 16,000 pallet spaces to the 13,000 it already has on site, making for a total of 68,000 pallet spaces covering various temperature requirements.

The multi-year strategic partnership is intended to support commercial demand of Viking Therapeutics’ GLP-1 candidate, VK2735.

The company’s 100,000-sq.-ft. space is expected to enhance its capabilities for commercial oral dose treatment manufacturing in a variety of therapeutic areas.

The investment is intended for the Halo Pharma facility in Whippany, NJ, and aims to help relieve capacity shortages in the injectable supply chain in the United States.

The €4 million (US$4.3 million) project is current good manufacturing practice compliant, and includes an accompanying cartoning machine.

More and more contract manufacturers have been looking not at what the state of the supply chain is right now, but what it may be in the next three to five years.

The company first announced its intention to build the state-of-the-art facility as part of a €900 million investment in July 2024.

The company now performs product-sterility testing through rapid microbiological methods at two laboratory sites in the United States and one in Germany.

Contract manufacturers have special expertise in the characterization and validation of biopharmaceutical manufacturing processes.

Sponsor companies and contract development and manufacturing companies must ensure that the suppliers they use are following sustainability guidelines to truly produce ‘green’ products.

Contractors are working with sponsor companies to establish and maintain sustainable manufacturing practices in pharma.

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

With 2025 now in full swing, this article presents a review of the latest developments in outsourcing services, new facilities, and M&A activity thus far this year.

Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, looks at what is involved in developing modern ADCs.

Christian Morello, vice president and head of the Bioconjugates Business Unit at Lonza, discusses the challenges and unmet needs in bringing ADCs to market.

Developers save money and time while accessing expertise.

The optimization of processes for the development and manufacture of biopharmaceuticals is pivotal for producing quality products.

CDMOs who have integrated technologies can help further the advancement of ADC development.

Pharmaceutical Technology® spoke with Andy Burns, vice president, MDI Business Development at Kindeva, about how sustainability requirements are impacting contract development and manufacturing organizations, specifically for the development and manufacture of inhalation drugs.