Upstream & Downstream Processing

Regeneron and Pfizer sued for ‘unauthorised’ reagent use

Allele Bio says Regeneron and Pfizer’s use of a labelling reagent during COVID-19-related vaccine and therapeutics development infringed on its IP. The San Diego biotech made the claim in lawsuits filed lawsuits against Regeneron and Pfizer this week. It said “both complaints address the infringement of Allele’s patented mNeonGreen reagent.” mNeonGreen is a fluorescent protein used in biological assays. Like Green Fluorescent protein, when mNeonGreen binds a specific molecule it gives off a fluorescent signal that can be used to…

Navigo and Repligen team on COVID-19 vaccine affinity resin

Protein A-derived affinity ligands against the COVID-19 spike protein coupled to chromatography beads can resolve purification challenges in the development of coronavirus vaccines, say Navigo and Repligen. Bringing a vaccine against COVID-19 to market involves numerous challenges, not least on the manufacturing side. In downstream processing (DSP), the speed of purification and the yield of the purified product are key to ensuring supply of a quality vaccine. As such, bioprocess technology firm Repligen teamed with protein engineering firm Navigo Proteins…

CellGenix: Serum-free medium offers faster T-cell therapy manufacturing

Freiburg, Germany-based CellGenix says its T-cell medium – CellGenix TCM – offers a serum-free and xeno-free alternative for rapid expansion of functional human T-cells. Due to stable glutamine in the formulation, the medium is ready-to-use for T-cell cultures without the need for supplementation with human serum or glutamine. Many current T-cell therapy protocols rely on the addition of human serum. Eliminating the use of human serum will reduce the failure rate in your manufacturing process due to the high lot-to-lot…

Sartorius set to acquire BIA Separations for $423m

Sartorius Stedim Biotech has announced plans to buy Slovenian purification tech firm BIA Separations for €360 million ($423 million). The deal will see Sartorius pay €240 million upfront and €120 million in shares. The firm will also pay tranches of earn-out payments over the next five years. The transaction is expected to complete before the end of the year. Ajdovščina, Slovenia-headquartered BIA develops and manufactures products for purification and analysis of large biomolecules, including viruses, plasmids and mRNA. Sartorius CEO…

Astrea continues acquisition path picking up purification firm Nanopareil

A transformative year for Astrea Bioseparations has culminated in a second acquisition in a month. Philip Vanek, CTO of parent company Gamma Biosciences, talks to us about the deal, the company, and the changing bioprocess landscape. In November 2019, investment firm KKR announced its intentions to buy Prometic Bioseparations from Liminal BioSciences. In January, the deal closed with renamed Astrea Bioseparations becoming the first company in KKR’s $200 million Gamma Biosciences portfolio of life sciences tools subsidiaries. Since then, the firm…

Large-scale SUS ‘ideal’ to take on COVID-19 vaccine challenge, says ABEC

ABEC will supply six 4,000 L single-use bioreactors to the Serum Institute of India and says such large-scale systems can produce billions of doses of potential COVID-19 vaccines at reasonable costs. The six Custom Single Run (CSR) bioreactors will be delivered to the Serum Institute’s site in Pune, India and will be used to manufacture Phase II COVID-19 vaccine NVX‑CoV2373. The candidate has been developed by Novavax, which last month inked a deal with the Indian vaccine maker to produce…

Repligen $100m+ CAPEX plan latest example of robust bioprocess sector

Repligen will spend roughly $100 million over the next five years across all its franchises to feed the continued demand for biomanufacturing services and tools. During a recent meeting with Jefferies analyst Brandon Couillard, Repligen CEO Tony Hunt and CFO Jon Sondgres spoke about the benefits of recent expansions in its bioprocess network and said it will be spending upwards of $100 million over the next five years to support its long-term capacity needs. “We shared that we are spending…

Single-use tech “unstoppable” if suppliers can meet soaring demand, says GSK

COVID-19 has further increased already soaring demand for single-use tech according to a GSK expert who says boosting supply is key. Most biopharmaceuticals are made in stainless steel systems. But the past decade has seen interest in using disposable single-use systems increase. Initially the focus was in clinical supply. However, as Weibing Ding, director of GSK Pharma in King of Prussia, Pennsylvania told BPI East virtual conference delegates, a growing number of companies are trialing single-use systems for commercial-scale production.…

Catalent adds early-stage plant to its blooming(ton) fill/finish business

CDMO Catalent says it is looking to serve fill and finish demand for early-phase customers in its $14 million acquisition of a second facility in Bloomington, Indiana. Three years after AB BioTechnologies broke ground on a 23,000 square-foot facility, fellow contract development and manufacturing organization (CDMO) Catalent has acquired it for $14 million – $3.5 million more than the 2017 investment. The facility adds clinical and small-scale commercial manufacturing for injectable drugs to Catalent’s growing fill and finish network and…

Combined Therapeutics wins $250,000 MilliporeSigma Advance Biotech Grant

MilliporeSigma has awarded MIT spin-out Combined Therapeutics a cheque for $250,000 as the winner of its 2020 Advance Biotech Grant. Combined Therapeutics (CTx) is an early stage startup developing next generation virotherapies targeted with nucleic acids. The pre-clinical biotech aims to develop therapies to treat liver cancer using its targeted oncolytic platform. The firm – founded by MIT professors Robert Langer and Dan Anderson, along with entrepreneur Romain Micol – was the prestigious winner Thursday of the MilliporeSigma Advance Biotech…