cGMP Manufacturing

cGMP ManufacturingCBO Admin2020-08-19T15:23:45+00:00

cGMP Manufacturing

HAL’s laboratory facilities and diverse selection of platforms offers a range of biomanufacturing capabilities. Our newly built GLP laboratory and ISO-7 cleanroom spaces enable full cGMP processing services. Choose from a suite of closed-system devices for your cGMP cell selection and culture needs, with technical staff trained on device operation. Let our team supply your cGMP cells and fulfil your small-scale production requirements using first-in-class technologies.

CliniMACS Plus and Prodigy instruments for automated cell selection and culture
G-Rex for T cell Therapy
Validated GMP-grade reagents (basal media, serum/serum replacements, cytokines and growth factors, etc.)
ISO-7 cleanroom and multiple laminar flow BSCs
Cell processing staff trained in manual and automated workflows

BioCytics Successfully Completes a Key Regulatory Milestone with Recent FDA INTERACT Meeting

Huntersville, NC, November 18, 2025—BioCytics is pleased to announce they successfully reached a regulatory milestone for de-risking clinical development plans with a productive FDA INTERACT meeting during which they discussed manufacturing immune cell therapies at the point of care.

This INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs) meeting is a first step in getting feedback from the FDA regarding the feasibility of BioCytics’ cell therapy platform development plans. By accepting this meeting and reviewing the plans, the FDA is indicating that BioCytics’ immuno-oncology tumor treatment protocol efforts, the first of which is called BioCytics Immune Fraction #1 (BCyIF-1), show enough pre-clinical scientific potential to warrant continued research development and upscaling manufacturing efforts. This milestone feedback from the FDA speaks volumes for BioCytics’ work towards a future Investigational New Drug (IND) submission. It solidifies plans of getting to first-in-human clinical trials in 2027, with the ultimate goal of treating solid tumors.

Dr. John Powderly, Oncologist and President of BioCytics said “We are delighted to have received insightful feedback from the FDA regarding development of BioCytics BCyIF-1, a cellular therapy to be manufactured at the point of care. The FDA’s willingness to review our pre-clinical research data and hold the INTERACT meeting with us results in substantially reduced regulatory risk as we move towards a future IND. It is fantastic to have our early research validated and to be able to enter confidently into our IND-enabling and manufacturing efforts.”

About BioCytics, Inc.

BioCytics, founded in 2005, is a privately held health technology company located in Huntersville, North Carolina. BioCytics is researching autologous Adaptive Cell Therapy (AACT) to develop an immuno-oncology platform for treating solid tumors with the patient’s own immune cells. AACT is a revolutionary point-of-care cell manufacturing process designed to generate nongenetically modified effector cell fractions for all stages of all solid tumors. For more information, please visit Biocytics.com or find us on LinkedIn.

About Carolina BioOncology Institute, PLLS

Carolina BioOncology Institute (CBOI), a cancer treatment and clinical trial facility, is co-located with BioCytics, in Huntersville, NC. CBOI is an independent community-based cancer research clinic that serves the Southeast region as a referral hub for metastatic cancer patients’ access to Phase I clinical research trials. For more information, please visit Carolinabiooncology.org or LinkedIn.

**********************************************************************************

Media Contact:

Jennifer Montague

j.montague@biocytics.com

980-441-1150

cGMP Manufacturing

cGMP Manufacturing

We’re ready to support your mission.