Action Steps
The best contacts and resources to help you get it done

Attend a biologics information training course

Many biologics training courses and workshops teach safe practices and compliance with regulations for a vaccines manufacturer. These courses focus on areas such as quality control, safe handling practices and how to properly ship biologics. Conferences and training meetings for clinicians and researchers are also available.

I recommend: The Center for Professional Innovation and Education offers a three-day class on biopharmaceutical and biologic compliance in chemistry, manufacturing and controls (CMC) regulations. QD-Quality and Training Solutions also offers three-day workshop designed to teach good clinical practices under the U.S. Food and Drug Administration Code of Federal Regulations for drugs and biologics clinical research. Attend the University of California Santa Cruz Extension two-day biologic workshop geared toward bioscience industry professionals. Check the website of the Center for Biologics Evaluation and Research, which operates under the U.S. FDA, for upcoming training workshops.

Read textbooks that cover specific biologics research and studies

Researchers typically focus their efforts on specific health concerns, resulting in specialized textbooks, such as books covering biologics for treatment of cardiovascular diseases or cancer. Whether working for a biologics manufacturer or researching for a vaccines lab, reading these textbooks provides a deeper understanding of the work at hand.

I recommend: Purchase "Biologic Ionization as Applied to Human Nutrition" from Pike Agri-Lab Supplies. This textbook explains the effect of biologic supplements on a healthy human body. For a textbook that covers the effects of biologics on cancer, read "Principles and Practice of the Biologic Therapy of Cancer," available at Ovid Technologies. This book is for both clinicians and researchers involved in manufacturing biologics for the treatment of cancer.

Take advantage of veterinary biologics training courses and workshops

Animal vaccines are important, not only to the health of pets, but also livestock, which directly affects the quality of health for humans. Because of the importance of animal biologics, several training courses and workshops are available. Often, a background in veterinary medicine isn't required as the training courses focus on cellular growth and research methods.

I recommend: The Institute for International Cooperation in Animal Biologics (IICA) was established by Iowa State University and the USDA Animal and Plant Health Inspection Service to improve the use and safety of veterinary biologics. The organization offers several conferences and training meetings throughout the year, which are on its website. Attend a biotechnology training program offered by Pennsylvania State University. The Animal Cell Culture Methods and Scale-Up Strategies course provides participants with experience using bioreactor systems found in a biologics manufacturing facility.

Helpful advice for making the most of this Guide

• •  Before registering for a training course or workshop, ask what background is needed to fully comprehend the presented training material. Some may require only a basic knowledge of biologics manufacturing, while other workshops may be for researchers.

Action Steps
The best contacts and resources to help you get it done

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.

I recommend: 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.

I recommend: 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.

I recommend: 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.

Helpful advice for making the most of this Guide

• •  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.

Action Steps
The best contacts and resources to help you get it done

Vaccine, vaccination

Vaccination is when a vaccine, an antigenic material, is administered to create an immunization to an infectious disease. Immunization is when the immune system becomes built up against that agent and the recipient is no longer susceptible or has a diminished susceptibility to a disease.

I recommend: Learn more about vaccines from the Centers for Disease Control and Prevention.

Antigens

Antigenic material is that which causes the body to increase antibodies, thus triggering an immune response. They are usually proteins or polysaccharides and can be classified by species.

I recommend: Learn more about antigens from California Lutheran University.

Toxoids

Toxoids are used in vaccines to induce an immune response. They are a weakened version of the original toxin and are sometimes used to increase the response to other antigens.

I recommend: Find out about diphtheria and tetanus toxoids from Drugs.

Allergenic extract

Allergenic extracts are protein-containing extracts used for diagnosis or for hyposensitization therapy of those with allergies.

I recommend: Learn more from the U.S. National Institutes of Health.

CBER

CBER stands for the Center for Biologics Evaluation and Research, a division of the Federal Drug Administration (FDA) that regulates biologics and related products.

I recommend: Visit the Center for Biologics Evaluation and Research. Of particular interest is the proposed and final rules section as well as the forms and/or the guidance sections.

BLA

BLA, or the Biologics License Application, is the licence that has to be approved after a biologic drug has successfully passed its testing phase but before it is produced for commerce.

I recommend: Find out more about the biologics license application administration process from the FDA.