--- title: CDMO Daily News — August 8, 2026 slug: daily-news-2026-08-08-cdmo site: cdmo post_kind: news byline: BioBM description: August 8 CDMO daily: CPC Scientific Passes FDA Pre-License Inspection for Hepcludex API Manufacturing; Altruist Biologics Completes Commercial PPQ on 20,000L… canonical_url: https://www.cdmo.directory/posts/daily-news-2026-08-08-cdmo published_at: 2026-08-08T00:00:31.506Z last_updated: 2026-08-08T00:03:22.191Z --- ### [CPC Scientific](/companies/cpcscientific) Passes FDA Pre-License Inspection for Hepcludex API Manufacturing - [CPC Scientific](/companies/cpcscientific)'s Hangzhou cGMP facility completed FDA Pre-License Inspection (January–February 2026) for commercial manufacturing of Hepcludex® (bulevirtide-gmod) API, a long-chain synthetic peptide. - The facility now supplies the FDA-approved HDV treatment API and expects validated capability to support future GLP-1 and obesity peptide programs. - Successful inspection validates CPC's 25+ years of peptide manufacturing experience and positions the company for next-generation long-chain peptide regulatory filings. **Operational Impact** [CPC Scientific](/companies/cpcscientific)'s successful FDA inspection and validated commercial API manufacturing for Hepcludex® establishes a qualified long-chain peptide supply source for Gilead and signals capacity readiness for future GLP-1 and obesity peptide programs. *Source: [PharmaSource RSS](https://pharmasource.global/content/news/cdmo-news/cpc-scientific-completes-fda-pre-license-inspection-for-hepcludex-api-manufacturing)* --- ### [Altruist Biologics](/companies/altruist-biologics) Completes Commercial PPQ on 20,000L Bioreactors in Hangzhou - [Altruist Biologics](/companies/altruist-biologics) completed its first commercial PPQ campaign using three consecutive batches on 20,000L stainless steel bioreactors at its Hangzhou site. - Manufacturing costs for monoclonal antibody drug substance fell below $50 per gram through economies of scale, automation, and process optimization. - The company plans to add four 20,000L and six 2,000L bioreactors by 2027, expanding total site capacity from 80,000L to 172,000L. **Operational Impact** [Altruist Biologics](/companies/altruist-biologics)' PPQ completion and sub-$50/gram mAb cost achievement at Hangzhou strengthens its competitive position for commercial-scale biologics manufacturing, while the 2027 capacity expansion to 172,000L adds significant APAC drug-substance supply for clients nearing commercial launch. *Source: [PharmaSource RSS](https://pharmasource.global/content/news/cdmo-news/altruist-biologics-completes-first-commercial-ppq-campaign-on-20000l-bioreactors)* --- ### [Gland Pharma](/companies/gland-pharma) and [Neuland Laboratories](/companies/neulandlabs) Launch Sterile API CDMO Partnership in India - [Gland Pharma](/companies/gland-pharma) will establish a dedicated sterile API manufacturing suite at its Visakhapatnam facility under a long-term partnership with [Neuland Laboratories](/companies/neulandlabs). - The new suite adds ~1,400 kg of annual sterile API capacity and will operate under cGMP, U.S. FDA, and EU standards. - Neuland Laboratories' board approved a ₹40 crore corporate guarantee to support the collaboration, combining both companies' API development and aseptic manufacturing expertise. **Operational Impact** [Gland Pharma](/companies/gland-pharma)'s new sterile API suite in Visakhapatnam adds 1,400 kg annual capacity for complex injectables, expanding APAC sterile API supply options for sponsors developing microparticle and depot formulations. *Source: [PharmaSource RSS](https://pharmasource.global/content/news/cdmo-news/gland-pharma-and-neuland-laboratories-form-long-term-cdmo-partnership-for-sterile-apis)* --- ### [Porton Advanced](/companies/porton-advanced) Gains China NMPA Class C License for Commercial CGT Manufacturing - [Porton Advanced](/companies/porton-advanced) received China's Class C Drug Manufacturing License from NMPA, enabling commercial-scale contract manufacturing of cell and gene therapy products. - The license expands capabilities from process development and clinical production to commercial manufacturing under China's MAH regulations, following successful GMP inspection. - Company reports 200+ global clients, 100% IND submission success rate, and support for 26 approved INDs; currently backing a cell therapy project nearing BLA submission. **Operational Impact** [Porton Advanced](/companies/porton-advanced)'s China commercial manufacturing license adds APAC capacity for cell and gene therapy CDMOs and may reduce geographic bottlenecks for sponsors advancing CGT programs toward BLA submission in China and globally. *Source: [PharmaSource RSS](https://pharmasource.global/content/news/cdmo-news/porton-advanced-secures-china-drug-manufacturing-license-for-commercial-cgt-cdmo-services)* ## References 1. [PharmaSource RSS — CPC Scientific Passes FDA Pre-License Inspection for Hepcludex API Manufacturing](https://pharmasource.global/content/news/cdmo-news/cpc-scientific-completes-fda-pre-license-inspection-for-hepcludex-api-manufacturing) 2. [PharmaSource RSS — Altruist Biologics Completes Commercial PPQ on 20,000L Bioreactors in Hangzhou](https://pharmasource.global/content/news/cdmo-news/altruist-biologics-completes-first-commercial-ppq-campaign-on-20000l-bioreactors) 3. [PharmaSource RSS — Gland Pharma and Neuland Laboratories Launch Sterile API CDMO Partnership in India](https://pharmasource.global/content/news/cdmo-news/gland-pharma-and-neuland-laboratories-form-long-term-cdmo-partnership-for-sterile-apis) 4. [PharmaSource RSS — Porton Advanced Gains China NMPA Class C License for Commercial CGT Manufacturing](https://pharmasource.global/content/news/cdmo-news/porton-advanced-secures-china-drug-manufacturing-license-for-commercial-cgt-cdmo-services) Source: https://www.cdmo.directory/posts/daily-news-2026-08-08-cdmo