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Time to competency must be reduced to get to market faster, says Virtuosi

Talent shortages and training issues were identified at Advanced Therapies 2022  as one of the challenges restricting ATMPs pathway to commercialization.   The difficulty to recruit highly-skilled individuals in the advanced therapy space has been heavily documented, and companies such as Lonza, SwedenBIO, and MilliporeSigma have expressed their talent shortage concerns to this publication at different times over the past couple of years. With its high cost and potential to affect time-to-market, it was no surprise that recruitment was at the forefront of…

CEPI’s 100-day vaccine mission takes aim at future pandemics

Every single step of the vaccine process needs shortening says CEPI, which is developing a strategy to produce safe and effective vaccines against future threats in just 100 days. Face-to-face events are well underway, and BioProcess Insider headed to BPI Europe in Vienna, Austria where Anna Särnefält, CMC lead at the Coalition for Epidemic Preparedness Innovations (CEPI), said the key to responding to epidemics and pandemics is preparedness. The 100 Days Mission is a project that aims to  produce safe…

Bavarian Nordic to respond to monkeypox threat with vaccine supply

Bavarian Nordic will supply its smallpox vaccine Imvanex to at least two countries as cases of monkeypox surge in Europe and elsewhere. The surge of cases of monkeypox outside west and central Africa have alarmed health authorities over the past few weeks. While some commentators claim the outbreak is nothing to be too concerned about, some governments have looked to secure vaccinations in order to mitigate against a potential epidemic. There is no official vaccine for monkeypox in Europe, but…

Lilly lays out $2.1bn for two plants in Indiana

Eli Lilly is investing $2.1 billion to build two manufacturing facilities in Indiana to expand its services for active ingredients and therapeutic modalities. Lilly will construct the two manufacturing sites at LEAP Lebanon Innovation and Research District in Boone County, Indiana and said the decision to expand its network reflects the firm’s commitment to strengthening its portfolio. “More than 146 years after our founding, Lilly remains committed to investing and innovating in Indiana,” said David Ricks, Lilly’s CEO. “These new sites will add capacity in…

Moving Beyond PEI: Improved Transfection Processes for AAV and LV Manufacture

GMP-compliant nucleic acid delivery to HEK 293 cells is often a critical first step in the manufacture of advanced therapies, utilizing recombinant adeno-associated virus (AAV) or lentivirus (LV) to facilitate delivery of a therapeutic transgene to patients. Accordingly, the need for safe and reproducible large-scale viral vector manufacture processes has never been greater. Mirus Bio has developed a fully synthetic, innovative transfection formulation to enable higher titer AAV and LV generation and reduce the cost of therapeutic development and manufacture…

Hanmi makes move into the mRNA CDMO space

Hanmi Fine Chemical says the COVID-19 pandemic has increased the demand for RNA raw materials, causing it to launch CDMO services in relevant fields. Hanmi Fine Chemical (Hanmi FC), a subsidiary of Hanmi Pharmaceutical Group, specializes in active pharmaceutical ingredients (APIs) development and production but is launching a new business to expand into the contract development manufacturing organization (CDMO) space. The company noted that the decision to move into the CDMO space has been driven by the COVID-19 pandemic, which…

Podcast: Opening the gates for women in biotech

There is no lack of talented women in the biotech space but the gates blocking their progression must be open for them to fully realize their potential, says consultant Nadine Ritter. Companies’ Diversity, Equality, and Inclusion (DEI) policies are too often just an exercise in box-checking, said Nadine Ritter, president and analytical advisor at Global Biotech Experts and long-time member of BioProcess International’s editorial board. “If it’s just virtual signaling on a website then I don’t care… show me the…

High cost of complex biomanufacturing ‘a problem worth solving,’ says Waters

With the cost of manufacturing accounting for as much as 70% for cell and gene therapies, industry must look to bioprocessing efficiencies and collaboration, says Waters Corporation. Waters Corporation is an analytical instruments, software, and service company. At the firm’s 2022 investor day last week, CEO Udit Batra spoke about the difference between producing small molecules, where “you get approval to produce a product with specific chemical and physical properties,” and the present biomanufacturing landscape, where the approval is for…

Moderna: ‘Speed to market approach’ for mRNA flu vaccine success

Inherent challenges to traditional flu vaccine manufacturing can easily be overcome with messenger RNA (mRNA) says Moderna, which is moving a candidate into Phase III trials. The success of its COVID-19 vaccine Spikevax has encouraged Moderna’s pipeline of mRNA vaccines and therapeutics. Having already spoken brightly about the modality’s potential in tackling latent diseases – herpes, HIV, cytomegalovirus, for example – the company has lauded mRNA’s potential to overcome the “premature picking” issues seen in the yearly influenza vaccine production…

Introduction: Cell-Line Engineering and Development at BPI West

Critical to the manufacturing of biotherapeutics is development of robust and stable cell lines that express high-quality products in large quantities. Chinese hamster ovary (CHO) cells are the “workhorse” expression host for manufacturing glycoprotein-based therapeutics — from antibodies to enzymes and hormones and beyond — making them the subject of most industry discussion regarding both cell-line development (CLD) and engineering. Most methods, technologies, and strategies apply regardless of the type of protein to be expressed or the type of cells…