Author Archives: BPI Staff

Lonza to make ‘NET’ antibody for Citryll

Citryll BV has partnered with CDMO Lonza to help develop and supply final drug product for its Neutrophil Extracellular Trap (NET) biology targeting antibody candidate. Under terms of the deal, financials of which have not been divulged, Swiss contract development and manufacturing organization (CDMO) Lonza will provide Dutch biotech firm Citryll in silico preclinical services used to assess manufacturability and immunogenicity, and final drug product in finished format for clinical material. Citryll’s candidate CIT-013 is a tACPA therapeutic antibody targeting…

Berkeley Lights takes Beacon workflow tech to China

Berkeley Lights has opened an office in Shanghai to expand the reach of its automated biological workflow platform for cell line development and antibody discovery. The office, located in Pudong, Shanghai, will provide Berkeley Lights regional marketing and pre-sales service in China and the Asia Pacific (APAC) region. The decision to open an office in the region reflects the importance of the Chinese market for the bioprocessing space, said Yue Geng, head of Asia Pacific at Berkeley Lights. “China represents…

Batavia selects CHO platform for Zika Ab on the Horizon

A collaboration led by Batavia Biosciences will use Horizon Discovery’s CHO cell technology in the development of an antibody against Zika. Batavia Biosciences, working with Vanderbilt University Medical Center (VUMC) and IDBiologics, is looking to develop a therapy based on a Zika virus neutralizing antibody that was discovered three years ago. Accessing Horizon Discovery’s GS knockout Chinese hamster ovary (CHO) K1 cell line expression system will allow the development of high yield antibody-expressing cell lines, Batavia CEO Menzo Havenga told…

Celyad going to clinic with tweaked CAR-T manufacturing platform

Celyad expects to treat the first patients with its autologous CAR-T therapy CYAD-01 using the updated manufacturing process by the end of September. CYAD-01 is an autologous chimeric antigen receptor (CAR) T-cell therapy in development by Celyad for hematological malignancies and solid tumors. The immunotherapy has the ability to bind to eight different ligands that are naturally expressed by cancer cells. In July, the firm announced regulators accepted a proposal to change the candidate’s manufacturing process to use its proprietary…

Lineage granted stem cell production patent for cancer vax

The patent validates a system for production of antigen presenting dendritic cells from human embryonic stem cells (hESCs), used in Lineage Cell Therapeutics’ cancer immunotherapy program VAC2. The United States Patent and Trademark Office (USPTO) issued Patent No. 10,344,262, entitled ‘Differentiation of primate pluripotent stem cells to hematopoietic lineage cells,’ to Lineage Cell Therapeutics in July. The patent was filed by Asterias Biotherapeutics in February 2017. Asterias was acquired by clinical-stage biotech BioTime in March 2019, and since then BioTime…

BPI Theater at CPhI 2019 and BIO 2019

Biopharmaceutical industry leaders got the chance to present some truly innovative work at this year’s CPhI North America and BIO International conferences on the BioProcess International Theater stages. In this month’s Featured Report, BioProcess International gathers key insights from the presentations delivered at CPhI’s and BIO’s installments of the BPI Theater. This digital edition also features access to online archives with recordings of each presentation.  Follow the links below to learn more about the exciting range of discussions. CPhI North…

EU thumbs up for Biocon biosimilar insulin plant

A Biocon insulin production site in Malaysia, the subject of a recent US FDA Form 483, has received a Certificate of GMP compliance from the European Medicines Agency (EMA). Ireland’s Health Products Regulatory Authority inspected the facility in Malaysia in May this year resulting in the issuing of the certificate, meaning the insulin drug substance, drug product and delivery devices made there comply with the EMA’s good manufacturing practice (GMP) guidelines. “The recombinant human Insulin (rh-Insulin) and Insulin Glargine manufactured…

Halix completes Dutch viral and protein product plant

Operations at the facility will begin later this year to feed the demand for proteins and viral vectors from small to midsize biotechs says CDMO Halix. Construction on the 6,700 m2 plant began a year ago and this month the contract development and manufacturing organization (CDMO) announced it is ready to produce biopharmaceutical drug substances. The facility, located in the Leiden Bio Science Park, The Netherlands, boasts a viral vaccine and viral vector manufacturing line along with a separate a separate…

Commercial N-1 perfusion carried out by Samsung BioLogics

CDMO Samsung BioLogics has used an Alternating Tangential Flow (ATF) system to perform N-1 perfusion at its 180,000 L facility in South Korea. Contract development and manufacturing organization (CDMO) Samsung BioLogics opened its number 3 facility at its site in Songdo, Incheon last year, boasting 180,000 L of commercial stainless steel bioreactor capacity. This month, the firm has announced it has successfully carried out N-1 perfusion with an Alternating Tangential Flow (ATF) system at the 3,000 L scale to supply…

AskBio buys Synpromics, plans expansion

Asklepios BioPharmaceutical (AskBio) has bought Synpromics bringing gene control synthetic promoter technology to its AAV gene therapy programs. Under terms of the deal, Edinburgh, UK-based Synpromics will will bring synthetic promoter technology, along with bioinformatics and intelligent data-driven design, to North Carolina’s AskBio’s gene therapy pipeline. AskBio has its own capsid library and a proprietary adeno-associated virus (AAV) manufacturing platform called Pro10 which it uses in its gene therapies. Its lead candidate is in Phase I/II for Pompe Disease. “For…