Biologics

Evaluate the requirements for manufacturing biologics

Biologics is a broad term referring to a variety of medications produced using living sources. Biopharmaceutical companies who produce biologics focus on products, such as vaccines, blood, human blood products, toxoids, skin test antigens and allergenic extracts. Today, doctors use biologics for treatment of cardiovascular diseases, rheumatoid arthritis, skin ailments, diabetes, cancer and other diseases.

A company that produces biologics, such as a vaccines manufacturer or antigens manufacturer, knows that a typical biologics manufacturing facility faces more challenges than traditional pharmaceutical production companies do. Since biologic drugs are much more complex, small errors during production can be deleterious to the success of the project. Consequently, the initial learning curve is often harsh.

Before launching into biologics production, consider how your company stacks up against a successful biologics manufacturer. Some characteristics of biologics manufacturers include:

1. Has sufficient capital up-front to finance manufacturing biologics.

2. Capable of withstanding initial financial losses.

3. Positioned as a leader in the field of biologics research.

4. Attracts and retains top talent in the field of biologics.

 

Understand the FDA's role in manufacturing biologics

The regulation of biologics and related products is controlled by the Center for Biologics Evaluation and Research (CBER), which is a division of the Federal Drug Administration (FDA). The development of a biologic drug commences with laboratory and animal tests. Next, it moves into the clinical trial phase for humans, which occurs under an Investigational New Drug Application (IND). Once a biologic drug proves successful in the testing phase, the manufacturer must have a Biologics License Application (BLA) approved in order to introduce the product into interstate commerce. BLA approval requires that the product be safe, pure and potent. In addition, the applicant must allow inspection of production facilities. Finally, each package containing the licensed product must show the license number.
Try: Examine the forms and guidelines posted on the website for the Center for Biologics Evaluation and Research. Forms are also available at the website for Biologics Consulting Group, Inc., a company that focuses on guiding clients through the development and production of biologics products as well as biologics manufacturing facility inspections and audits.

Delve into biologics regulatory affairs

While reviewing the CBER website may give you an overview of the regulatory process, you'll need much more information to be successful. Therefore, it's important to educate your staff on the tedious details of biologics regulations. Various institutions of higher learning and continuing education companies offer advanced training in biologics regulatory affairs.
Try: Contact the University of California Santa Cruz Extension. They offer a certificate in biotechnology, which includes courses pertaining to regulation of biologics. You may also want to contract with the Center for Professional Innovation and Education, since they do on-site trainings, for all of your employees on biopharmaceutical regulation.

Stay current on biologics research

The field of biologics changes regularly as new products come onto the market. Keep current on biologics information by perusing various websites regularly.
Try: Medical Week News, Inc., offers the Biologic Drug Report, which provides up-to-date news about manufactured biologics. Also, check out BioPharm Insight by Infinata. This is another good source for current trends in biologics for any vaccines manufacturer, blood derivatives manufacturer or other biologic professional. You'll find a wide range of research pertaining to drugs at all stages of development.

 

• Consider working with a consulting group that specializes in helping companies develop, produce and market biologics. The staff at these consulting groups consists of experts who guide you through all stages of the process. They'll walk you through FDA committee meetings and set up mock facility inspections. Their expertise may be invaluable if your company is inexperienced in biologic drug development.

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