Author Archives: Millie Nelson

FDA rejects early approval for Lilly’s Alzheimer’s drug

The US FDA has declined to grant Eli Lilly accelerated approval of monoclonal antibody drug, donanemab. Eli Lilly said the complete response letter (CRL) received from the US Food and Drug Administration (FDA) has been issued due to the limited number of patients with at least one year of drug exposure data provided in the application and stated that no other deficiencies have been identified. The FDA specifically requested that Lilly provide data from a minimum of 100 patients who…

Pfizer to acquire Abzena’s NC manufacturing plant

Pfizer is set to acquire a drug substance facility in Sanford, North Carolina from Abzena to expand capacity and support its CentreOne clients. British contract development manufacturing organization (CDMO) Abzena announced the addition of a sixth global site in the US in January 2021. Three months later, the firm revealed it had selected Sanford, North Carolina as the site of a biologics manufacturing facility, which would cost the firm over $200 million and be equipped with 12x 2,000 L bioreactors.…

Catalent and Avantor ink multi-year supply and services deal

Avantor will supply Catalent with clinical and production materials, services, and laboratory supplies. Avantor, a company that provides products and services to clients in the life sciences space, has entered into a multi-year supply and services agreement with contract development manufacturing organization (CDMO) Catalent. No financial details of the deal are being disclosed but the partnership will see Catalent work with Avantor across more than 50 facilities situated across the globe. “Avantor is an existing supplier to Catalent,” a spokesperson…

Resilience steps out of North America to build UAE facility

Resilience has signed a deal with its investor Mubadala Investment Company PJSC to establish a secure supply chain and will construct a facility in Abu Dhabi, UAE. Under the terms of the deal, Abu Dhabi sovereign investment firm Mubadala will be responsible for the build-out of the manufacturing facility. However, the plant will be operated by National Resilience to produce specific biopharmaceutical-related products in the United Arab Emirates (UAE). “As many other governments across the globe, Mubadala has recognized the…

Hospira experience will aid Abzena success, says new CEO

The experience of leading the operational turnaround at Hospira provides a robust framework for advancing Abzena’s success, says newly appointed CEO Matthew Stober. Contract development manufacturing organization (CDMO) Abzena, which focuses on antibody drug conjugates (ADCs) and biologic molecules, announced this month that Stober would replace Jonathon Goldman as CEO. Most recently, Stober held position of CEO at CastleVax and Istari Oncology. However, while all of his past job roles are undoubtedly influential, his experience of leading the turnaround of…

Argonaut to expand fill/finish capabilities in California

CMO Argonaut Manufacturing Services will use capital investment led by Telegraph Hill Partners to expand its manufacturing capabilities in Carlsbad, California. Contract manufacturing organization (CMO) Argonaut serves the life sciences, biopharma, and molecular diagnostics space. While specific financial details have not been disclosed, the firm said the investment will be focused on expanding its Carlsbad manufacturing facilities by installing a fill/finish line. According to Argonaut, the addition of a fill/finish line will expand the CMO’s footprint on the west coast…

2023 is the year for plug-in manufacturing, says BioNTech

BioNTech will make the first mRNA vaccines in Africa this year using its plug-in manufacturing tech, the firm told JP Morgan Conference delegates. Last week, CEO of BioNTech Ugur Sahin described to JPM delegates how the learnings of the pandemic highlighted that “poor countries didn’t get vaccines doses.” However, Sahin offered up a solution to this, saying “the only way to change that is to implement manufacturing technology.” In particular, he drew upon the company’s activity in Rwanda, Africa but…

Vector Bio and iBET team to scale-up gene delivery processes

The project aims to develop Vector BioPharma’s gene delivery platform using iBET’s bioprocess and analytical methods.   The partnership between the two parties is in support of Vector Bio’s CMC (chemistry, manufacturing, and controls) development and the announcement follows the Swiss firm’s $30 million Series A fundraising in August 2022. To begin with, the multiphase partnership aims to advance an analytical method suitable for full-to-empty capsid ratio quantification from in-process as well as final purified samples. “Vector’s proprietary technology uses a…

Valo selects Exothera to develop oncolytic adenovirus

Valo Therapeutics Oy (ValoTx) has selected CDMO Exothera to develop a large-scale production process for clinical development of its oncolytic adenovirus, VALO-D102. ValoTx’s VALO-D102 is an oncolytic adenovirus, which the firm says is an essential component of its immuno-oncology platform PeptiCRAd (Peptide-coated Conditionally Replicating Adenovirus). “We take an oncolytic adenovirus (VALO-D102) and add immunogenic positively charged tumor peptides, which are adsorbed onto the negatively charged viral capsid to create PeptiCRAd,” a spokesperson for ValoTx told us. The platform works by…

Astrea adds chromatography offering through Delta buy

Astrea Bioseparations has acquired Delta Precision, a manufacturer of chromatography columns for the biopharma space. The deal, of which financial details remain undisclosed, sees Astrea Bioseparations acquire Delta Precision. The firm says the acquisition will enable its product offering to include an entire range of chromatography columns for biomanufacturing. Astrea claims Delta’s products are recognized in the field for their wide range of applications, protein purification, vaccine production, drug development, and ease of use. A spokesperson for Astrea told BioProcess…