Lonza Biologics Inc.

Lonza extends collaboration with a global biopharmaceutical partner for ADC commercial-scale manufacture, including new bioconjugation suite construction in Visp (CH) and mAb manufacturing for a new ADC therapy. The suite, operational in 2027, will support highly-potent modalities and create 100 new jobs.

The North America Cell and Gene Therapy Manufacturing QC Market is projected to grow from USD 1,081.20 million in 2025 to USD 6,569.31 million by 2033, at a CAGR of 25.3%. Key drivers include increasing clinical trials and investments, rising therapy approvals, and advanced biopharmaceutical companies. High QC infrastructure costs are a restraint, while expansion of contract QC services offers opportunities.

The biotech and pharmaceutical industries impact lives and economies, employing over 1,500 facilities across the U.S. with high-paying jobs. Despite recent revenue drops post-pandemic, innovation and M&A activity are driving future sales. Frederick County, Maryland, is a thriving hub for life sciences, offering proximity to key research institutions, a skilled workforce, and business-friendly policies.

Advances in precision medicine have transformed NSCLC treatment, with broad molecular testing now recommended. HER2 mutation, present in 3% of NSCLC patients, is associated with aggressive disease and brain metastases. No first-line HER2-targeted therapies are approved; current options include immunotherapy and platinum doublet. Zongertinib and BAY 2927088, oral HER2-targeted TKIs, show promise in pre-treated patients, with zongertinib demonstrating a 66.7% ORR and BAY 2927088 showing a 72.1% ORR. Both agents have been granted breakthrough therapy designation by the FDA.

The mRNA synthesis & manufacturing market is projected to reach USD 738.3 million by 2029, driven by mRNA vaccine development and technology advancements. Consumables dominate the market, with pharmaceutical and biotechnology companies leading as end users. Asia Pacific is expected to grow fastest due to increased healthcare expenditure and investments in biopharmaceuticals.

Research adheres to ethical regulations, with animal experiments approved by UC Berkeley's ACUC. Plasmid construction involves pCold vector-based Cas protein expression, with specific tags and cleavage sites. Nucleic acids and lipid materials are prepared and quality-controlled. IVT sgRNA production and directed evolution of GeoCas9 are detailed. Protein expression and purification methods are described, including use of Ni-NTA and heparin affinity columns. Cell lines and culture conditions are specified for various experiments. RNP assembly, genome editing, flow cytometry, and LNP delivery are outlined. In vivo genome editing and immunogenicity assessment methods are also detailed.

Pheast partnered with Lonza for PHST001 manufacturing, enabling clinical trial supply. PHST001 targets CD24, a 'don’t eat me' signal in cancers. Pheast’s origins trace to Amira Barkal’s research at Stanford, leading to CD24’s therapeutic development. CD24 differs from CD47, offering a more potent effect. Pheast’s discovery process involved diverse models, resulting in a suitable clone. The company looks to CD47 programs for scaling guidance but acknowledges dosing uncertainties. Protein engineering efforts yielded a well-expressed antibody, positioning Pheast for clinical demands.

Forbion raises €2 billion across two new funds, Growth Opportunities III and Ventures VII, exceeding targets and bringing total AUM to €5 billion. The funds will invest in 15 companies each, focusing on biotech innovation in Europe and North America.

Cherwell, a cleanroom microbiology solutions expert, will participate in the Pharmaceutical Quality Assurance and Technical Services (QATS) Symposium in Birmingham on 17-18 October 2024. New Microbiology Product Specialist, Yoggya De Silva, will discuss environmental monitoring (EM) for pharmaceutical manufacturing at stand 64. De Silva, with extensive experience in microbiological solutions, will showcase Cherwell’s products, including Redipor® prepared media solutions and air samplers for EM, and the new BAMS real-time, airborne microbial monitor.

Recent news includes Pfizer’s withdrawal of Oxbryta, Vertex partnering with Lonza for Casgevy, Emergent BioSolutions’ $400 million BARDA contract for mpox vaccine, and Bristol Myers Squibb’s approval of Cobenfy for schizophrenia. Discussions also cover ARCH Ventures’ $3 billion biotech fund and Flagship Pioneering’s $3.6 billion raise, along with COVID-19-associated childhood myopia and patent thickets.