Business

From Supplying Components to Providing Total Solutions: Overviewing Supplier Side Capabilities

Only a thin line now separates biopharmaceutical manufacturers and suppliers because the latter are increasingly becoming the process knowledge owners in the biopharmaceutical industry. As a result, suppliers are racing to become the most efficient “total solutions” provider. In the 1990s, leading players in the industry such as Pall, Millipore, and Sartorius all supplied membrane filters for upstream and, to some extent, downstream processes with their crossflow and final filtration offerings. Pharmacia (which became GE Healthcare) was the major force…

The First Quantitative Industry Assessment of Single-Use System (SUS) Reliability: Raising the Bar for BPSA’s Value to Industry

Over the past 24 months, the leadership of the Bio-Process Systems Alliance (BPSA) has initiated a pilot program to demonstrate the joint feasibility of collecting and sharing pertinent industry business data. We began with “quality-complaint data” centered on the premise that product complaints are tightly associated with product-quality defects in single-use systems (SUSs). This approach can be viewed as “risk assessment 101.” BPSA’s Representation of the Single-Use Industry BPSA is an industry organization primarily comprising drug manufacturers, single-use system suppliers,…

Streamlining the Path to Clinical Manufacturing

Careful consideration of lot size is crucial for multiyear success of a cell therapy business. RoosterBio’s product design and acceleration business works with the company’s customers to help make plans that are appropriate for their stages of product and clinical development. We use the following major considerations in creating a sound multiyear strategy with intermediate milestones: Understand what the future looks like and work backward Use reasonable to conservative assumptions to estimate a range of needs Invest in the right…

Demystifying the Patent Search Process — Revisited

One of the first steps toward understanding how to patent an invention, invalidate someone else’s, or enter a new area of research is conducting a patent search. Knowing whether your invention is similar to those that already have been reported is critical before applying for a patent or beginning research. If your invention has been patented already or has been described or published anywhere in the world, then it is considered “prior art,” and your patent will be denied. Numerous…

Biopharmaceutical Growth in China: Bioprocessing Challenges Are Creating CMO Opportunities

In the past decade, the world has seen rapid growth of more than 15% in China’s biopharmaceutical market (1). According to the second edition of BioPlan’s Advances in Biopharmaceutical Technology in China, the most populous country in the world — with the largest patient groups — has a growing economy with its GDP second only to that of the United States. Rapid urbanization and greater access to national healthcare insurance puts China in second place after the United States for…

Toward Standardized Sample Collections: UK Government Seeks to Expand Cell and Gene Therapy Use

The SAMPLE program — a Standard Approach to ATMP Tissue collection — is intended to help build capacity for the UK National Health System (NHS) to expand the use of next-generation cell and gene therapies for both cancer and noncancer illnesses. Now it has been given the green light by Innovate UK (IUK), the United Kingdom’s technology strategy agency. An award through the Industrial Strategy Challenge Fund is supporting the program for standardizing how cell and gene samples are collected…

Good Manufacturing Practice in China: Equipment Strategy and Quality Management to Compete with the West

Although the concept of good manufacturing practice (GMP) was created about half a century ago in the United States, the history of GMP biomanufacturing is relatively short in China, with the first version of GMP rules issued by the Ministry of Health in 1998. In 2010, the ministry issued its fourth version of China’s GMP rules, which came into effect in March of 2011 (1). According to a recent report from BioPlan Associates, the 2010 version raised the standards to…

eBook: Vaccines – Industry Collaborations to Increase Uptake

Vaccines save millions of lives every year, and the continuing increases in the number of administered doses and worldwide distribution of vaccines for long-standing diseases such as polio and malaria have contributed to the improvement in public health. Vaccine developers and manufacturers are partnering with private and government agencies to raise global vaccine uptake by addressing remaining challenges with production capacity, distribution, safety, and accessibility. And the implementation of new technologies such as virus-like particles and cell/DNA-based vaccines are helping…

Why Conducting Marketing Due Diligence Early in Product Development Is Important

To be successful, a company needs two main ingredients: good science and good business/ marketing. Without good science, a product won’t work, and without a good marketing strategy, a product won’t sell. Two important questions should be addressed: When should marketing groups be involved in product development, and how important is that? The answer to the first is as early as basic research. Why? After a product is launched, a biomanufacturer doesn’t want to discover that its product applies only…

Breaking Through the Noise: An Approach to Differentiating Your Business

When multiple businesses sell the same type of item, why do customers buy from one supplier rather than another? How are vendors able to break through the “white noise” of an industry to stand apart and get noticed? The current bioprocessing and cell therapy vendor markets, about 50,000 vendors are selling to biomanufacturers, universities, and research institutions (www.bioz.com). How do those suppliers get noticed? Market-leading suppliers have established brands that allow them to cross-sell, up-sell, and engage in deep selling.…