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IVT-JVT Journal Archive

Journal of Validation Technology Archive Vol. 28, Issue 2, Apr 2022 Calculations Roundtable #1: Invitation to Participate Authors: Brad Bartels, Paula L. Pluta Compounding Forum #1: Invitation to Participate Authors: Nishant B. Thakar, Paula L. Pluta Vol. 28, Issue 1, Feb 2022 Shadows of Missed Opportunities In Learning Excellence Author: Lori Richter SR #3. Data Variance, Central Tendency, and Measurement Calculations (Continued) Author: Alan M Golden VCS #10. Cleaning Validation Equipment Sampling Locations Author: Paul L. Pluta Mycoplasma and Cell…

IVT Journal Archive

IVT Network Archive The Journal of Validation Technology, The Journal of GXP Compliance, and the IVT Network have served proudly for nearly 30 years as a global knowledge base for validation and compliance professionals in FDA-regulated industries. To make peer-reviewed validation resources available to the broader biomanufacturing community, the IVT Network is joining sister publication BioProcess International. Starting in July 2022, articles from the past two years of JVT and GXP can be accessed here on the BioProcess International website.…

IVT – GXP Journal Archive

Journal of GXP Compliance Archive Vol. 26, Issue 2, Mar 2022 Avoiding Errors With The Batch Release Process: Best Practice CGMPs Author: Tim Sandle Medication Safety – Pharma Industry Considerations Questions From Readers #2 Author: Paul L. Pluta Calculations Roundtable #1: Invitation To Participate; Nishant B. Thakar Author: Paul L. Pluta FDA Seek Comments on Quality System (QS) Regulations Amendments Author: IVT Staff Quality Plans for Pharmaceuticals and Healthcare: Checking the Maturity of Your Quality System Author: Tim Sandle Critical…

Univercells partners with CBET to prep students for CGT space

The partnership will see Univercells Technologies provide support to prepare Albany College of Pharmacy and Health Sciences (ACPHS) students for careers in cell and gene therapy. APHS’ Stack Family Center for Biopharmaceutical Education and Training (CBET) provides research and training solutions for the biopharmaceutical manufacturing space and is Univercells first US-based training partner. Under the terms of the deal, of which financial details have not been divulged, Belgian-based firm Univercells is set to give on-site access and training on cutting…

For resins, supply chain resilience is key, says Purolite

As the demand for resins rises in the bioproduction space, BioProcess Insider spoke to Hans Johansson, global applications director at Purolite to find out the challenges they face and what they are doing to overcome them. BioProcess Insider (BI): Let’s get right back to basics. What are bioprocess resins and how are they made? Hans Johansson (HJ): Depending on the molecule requiring purification, chromatography resins are typically leveraged to optimize purity and yield. Chromatography in bioprocessing aims to accomplish three…

List forks out $125m+ for microbiome Indiana plant

List Therapeutics will increase manufacturing capacity for live biotherapeutics products (LBPs) with its $125+ million investment in Indiana, US. List Therapeutics, whose parent company is South Korean firm Genome & Company, will invest in the city of Fishers, Indiana to build a 110,000 square-foot  outsourcing  facility. According to the firm, the facility will be commissioned by the end of 2023 and will be located at the Fishers Life Science and Innovation Park. The plant expands List’s offering of end-to-end manufacturing…

HPNE to hire 150+ to support Rhode Island facility

High Purity New England (HPNE) will hire more than 150 employees as part of a larger strategic plan for the firm. HPNE, a supplier of equipment and solutions for the biopharmaceutical sector, will begin to immediately hire 150+ employees in what the company is dubbing as a “substantial hiring push” as it prepares to open its facility in early December. The firm has invested more than $10 million at its plant in Smithfield, Rhode Island – just 50 minutes south…

Sartorius expands presence in North America with Michigan plant

Sartorius plans to build a plant in Ann Arbour, Michigan expanding its business operations in North America. German life sciences firm Sartorius is expanding its presence in Michigan with plans to open an 130,000 square-foot facility in the Tech Loop at Ann Arbor Research Park by the end of 2023, creating a flag ship plant for the firm in North America. In total, the firm has purchased over 15 acres of land at an undisclosed price, providing it with sufficient…

Polyplus reagent aims to ease CGT manufacturing issues

Polyplus has added a reagent to its existing product line developed specifically to enable large-scale viral vector manufacturing. The French-biotech said the reagent has been developed to complement its existing FectoVir-AAV reagent line. “FectoVIR-AAV is a transfection reagent, hence a key component of upstream manufacturing of viral vectors used for gene therapy,” a spokesperson for Polyplus told BioProcess Insider. “FectoVIR-AAV transports plasmid DNA across the cell membrane. In gene therapy viral vector manufacturing, three plasmids are transfected at the same time…

Autologous CAR T Cell Manufacturing Using a Semiautomatic, Closed, Modular Workflow

Cell-based chimeric antigen receptor (CAR) T cell therapies have rapidly advanced in recent years, with a variety of targets in clinical research and several FDA approved products already on the market. There has been tremendous effort to make CAR T cells more effective, safe, and persistent when treating patients. On the manufacturing side, however, errors, lot-to-lot variation, and contamination can be associated with open processes and manual handling of CAR T cells. Cell isolation, gene editing, expansion, and cryopreservation are…