Manufacturing Contract Services

Speeding Development and Lowering Costs While Enhancing Quality: A BPI Theater Roundtable at the 2015 BIO Convention

On Tuesday, 16 June 2015, Thomas C. Ransohoff (vice president of BioProcess Technology Consultants) chaired a midday roundtable titled, “Stretching for the Trifecta: Innovative Strategies for Speeding Development, Lowering Costs, and Enhancing Quality.” He brought together a panel of four industry experts: Joanne Beck (senior vice president of process development at Shire Pharmaceuticals) Parrish Galliher (chief technology officer for upstream (Xcellerex) at GE Healthcare) Lynne Frick (director of continuous processing for the Americas at Pall Corporation) Mark Brower (senior research…

The Contractor Perspective: A BPI Theater Roundtable at the 2015 BIO Convention

On Thursday, 18 June 2015, Gil Roth (founder and president of the Pharma & Biopharma Outsourcing Association, PBOA) chaired a midday roundtable titled, “CDMO Challenges and Opportunities.” He brought together a panel of four industry experts: Thomas Thorpe (chief executive officer of Afton Scientific) Michael Riley (vice president and general manager of Catalent Biologics) Victor Vinci (vice president and chief scientific officer for Cook Pharmica) Amit Arora (chief marketing officer at Jubilant HollisterStier) Points of View The Pharma and Biopharma…

Compatibility Assessment of a Model Monoclonal Antibody Formulation in Glass and Blow–Fill–Seal Plastic Vials

PREPRINT October 2015 issue Blow–fill–seal (BFS) technology has been recognized by the industry as an advanced aseptic solution (1–3). Catalent Pharma Solutions has been commercially supplying sterile BFS products to the pharmaceutical industry for decades, primarily in the respiratory and topical ophthalmic markets. Such product formulations range from simple solutions to emulsions with drug substances from classical small molecules to large complex proteins such as biologics. The company also has optimized BFS processes and its Advasept plastic container system for…

Are You Ready for a Tech Transfer? Part 1: Challenges and Critical Factors for Success in Cell Therapy Development

Cell therapies offer enormous promise for treatment of a range of conditions by replacing damaged tissue or leveraging the body’s own resources to heal itself. Not surprisingly, the cell therapy industry is growing rapidly and is poised to have a major impact on healthcare and disease treatment. The Alliance for Regenerative Medicine (ARM) has reported on the robust state of the industry, noting that revenue from cell-derived products grew from US$460 million in 2010 to $1.3 billion in 2013 (1).…

Outsourced Data Integrity: Are Short-Term Financial Gains Worth Long-Term Headaches?

Competitive pricing and continued cost pressures have contributed to the need for many US biopharmaceutical companies to outsource manufacture of active pharmaceutical ingredients (API) and finished products from countries with lower costs for labor, material, and equipment. The main benefit of doing so is lower costs of manufacturing with quality standards comparable to those found in the United States. India and China now account for 80% of API production. But those countries have received media attention because of biopharmaceutical manufacturing…

When Is a Virtual Business Model Suitable for Biopharmaceutical Companies?

Virtual companies are based on the model that all activities are outsourced. Such companies have no (or few) employees, occupy no laboratory space, and use contract service organizations for all activities. Over the past decade, several virtual biopharmaceutical companies have formed (1–4). They are primarily start-up ventures that use contract research organizations (CROs) for R&D and contract manufacturing organizations (CMOs) for product manufacturing. By contrast, a fully integrated biopharmaceutical company is based on the model that all activities are internal to…

Modern Technology Transfer Strategies for Biopharmaceutical Companies

Application of industrial biotechnology has changed dramatically over the past decade. Stainless steel process equipment has largely given way to disposable systems, facilitating easier and quicker process configurations and up-scaling. Suppliers generally made incremental advances in the quality of raw materials and consumables to ensure that those could more readily comply, “off the shelf,” with regulatory expectations. Once out-of-reach analytical equipment such as mass spectrometers and cell analyzers are becoming more common place in development laboratories, which better enables biopharmaceutical…

A Multidisciplinary Approach to Manufacturing Biotherapeutics

Optimizing antibody manufacturing processes has gone beyond the first-order goal of achieving elevated protein titers and now also focuses on understanding biologic and manufacturing process variables that define cellular machinery and protein quality. A holistic approach to biotherapeutic manufacturing incorporates several applied disciplines such as biology, engineering, process control, signal processing, and modeling to reduce the “black-box” model of cell- based protein production into an operational design space. This is in line with the US Food and Drug Administration’s quality…

Build, Buy . . . or “Rent” Capacity? A New GMP Biomanufacturing Business Model

When it’s time to move from preclinical to clinical-phase product testing, many biopharmaceutical companies face a difficult decision: whether to build or buy a biomanufacturing facility for in-house production or outsource the work to a contract manufacturing organization (CMO). Accinov is a new company that straddles the line between those concepts. Its new biomanufacturing center supports client companies toward clinical development in an innovative way. We propose a groundbreaking model for running good manufacturing practice (GMP) biomanufacturing. Our company’s approach…

Bioprocessing Challenges of Antibody–Drug Conjugates

Development of highly potent active pharmaceutical ingredients (HPAPIs) is clearly a pharmaceutical industry trend. Highly potent drug products involve active agents and APIs that are so potent therapeutically (or simply just outright toxic) even in small dose that special precautions are required during their manufacture — particularly when handling the active agents. Such requirements include maximal containment and isolation of the process stream. Worker exposure and environmental release clearly pose problems. The necessity and intensity of containment efforts with HPAPIs…