Author Archives: BPI Staff

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…

Pfizer licenses AAV platform for ataxia gene therapy

Pfizer will use REGENXBIO’s adeno-associated virus (AAV) delivery platform for a gene therapy aimed at treating neurodegenerative disease Friedreich’s ataxia. In REGENXBIO’s second quarter 2019, a major milestone was reached with the approval of Novartis/Avexis’ Zolgensma (onasemnogene abeparvovec). The gene therapy uses the NAV Technology Platform, created and validated by REGENXBIO’s founders and collaborators at the University of Pennsylvania, which uses over 100 adeno-associated viral (AAV) vectors to deliver engineered genes to cells. The firm, which is also developing its…

Samsung BioLogics to make third UCB drug substance

CDMO Samsung BioLogics will make a minimum of $70 million worth of three products for UCB from its facilities in South Korea. A spokesperson from Samsung BioLogics told this publication the extended deal with Belgium-headquarters pharma firm UCB means a third drug substance will be made by the contract development and manufacturing organization (CDMO) from its site in Songdo, Incheon. The two companies entered into a master services agreement in July 2018. The latest product to be made by Samsung…

Challenging the vaccine space: The problem with pioneers

With GSK, Merck, Pfizer, and Sanofi dominating the vaccine space, “the only thing pioneers get are arrows in their back,” say a group of industry experts. At BioProcess International Europe in Vienna, Austria in April, Bioprocess Insider hosted a vaccine-focused roundtable. The panel brought together some of the world’s leading luminaries within the space to discuss some of the major challenges within the vaccine industry, from technology challenges to the online army of anti-vaxxers. The group also spoke about the…

Breaking Through the Noise – An Approach to Differentiating Your Business

In this presentation to the BPI Theater at BIO on Wednesday, 5 June 2019, Kiran Chin introduced MKA Insights, a new firm focused on helping bioprocess, life science, clinical diagnostics, and gene therapy companies accelerate their growth. Although there’s no shortage of information on data processes, Chin has found that many companies neglect fundamentals that drive commercialization strategies. Many executives dive in without asking basic questions — ones that Chin brings to the fore: Why do we exist? What are…

DNA Encoded Library Platform at WuXi AppTec

On Wednesday, 5 June 2019, Letian Kuai delivered a presentation to the BPI Theater at BIO about the role of machine learning in drug design. In many cases, Kuai said, drugs are developed by accident. Researchers are beginning to leverage artificial intelligence to make those accidents occur more quickly and predictably. To that end, WuXi has developed a DNA encoded library (DEL) platform based on combinatorial chemistry principles and bolstered by artificial intelligence. This technology, Kuai suggests, could enable unprecedented…