Photo from Contra Costa Times

Danville High School Student Wins Top Prize in California State Science Fair

Congratulations to Aryo Sorayya for winning the Grand Prize for his project in the California State Science Fair this year!  Aryo’s mentor was Dr. Rajiv Nayar, President of HTD Biosystems, with whom we used to share a building with before they moved their office to Pleasanton.  Aryo is currently a junior at Monte Vista High School in Danville, California and competed against 993 students from about 400 schools statewide.

The goal of Aryo’s project, “Overcoming the Cold Chain: Designing a Novel Freeze-Stable Vaccine,” was to design a vaccine that did not lose its potency upon freezing so it could be used as an alternative to freeze-sensitive aluminum-based vaccines.  This was done by using a lipid blend-complex made of natural, biodegradable lipids because it would be stable after being freeze-dried at -45 degrees Celsius.  All the in-vivo work was done at Pacific BioLabs and his experiment resulted in a significant immunogenic response in mice, which was similar to that of aluminum-based vaccines.

More information about his project can be seen here.  Once again, congratulations Aryo!  PBL is always glad to see students and clients who we've worked with succeed.  We are sure that we will be hearing more great things about your success in the future.

Virtual biotechs have been around for awhile, but in recent years, there have been an increasing number of companies that have emerged.  As the costs associated with performing R&D has continued to rise, the virtual model is very well suited for small startups.  Most everything is outsourced as only a few key members form a team to make sure all the operations run smoothly.  Since much of the work is contracted out to CROs, this significantly cuts down on overhead costs such as personnel and lab space.  This allows them to quickly and more cost effectively advance a drug candidate through the process.

Unlike in the past, easy access to money has been harder to come by as VCs gravitate towards companies who have low fixed costs and an easy exit strategy.  As the management of a virtual biotech usually consists of a few people, VC investments in these types of companies are most likely an investment in the management team.  In order for the model to be successful, there must be adequate trust and communication between the virtual company and the CROs that it works with.  This is why good care is taken to select a CRO that they can work with and trust.  Although virtual companies are currently popular, the fate of their existence will still rely on whether they can successfully develop a drug and can coordinate with a good quality CRO who can perform a majority of the work.

Have no fear! You can access it here in recorded format or as a slide presentation.

To provide more information on reusable device validations, Pacific BioLabs conducted a webinar on reusable devices. The webinar covers an overview of requirements and presents three case studies of validations performed on devices of various complexity.

A great deal of thought goes into the design of any medical device, and engineers should be encouraged to thoroughly examine the ways in which the design of their device can facilitate or hinder reprocessing. The best device design facilitates the use of the device, and also facilitates the reuse of the device. However, some devices, in the initial design, prove so difficult to reprocess that the design must be altered to facilitate cleaning and reuse. By understanding the choices made in creating a reprocessing methodology and how device design and use puts constraints on the reprocessing method, engineers can save significant amounts of time and speed device approval, thereby ensuring that their devices get to market as quickly as possible.

Advancement in diagnostic and therapeutic medicine has led to more sophisticated medical device designs. As these designs become more complex, the process of adequately cleaning and disinfecting and/or sterilizing instruments has become more complex as well. Pacific Biolabs helps manufacturers in the validation of their product claims, and helps ensure patient safety by providing assurance that the product meets FDA requirements. PBL offers a wide range of selections from protocol preparation to validating and performing the routine cleaning and disinfection procedures. PBL will not only validate a given procedure, but will help in designing and creating protocols for a given device.

For a consultation on what is necessary for your device, please visit our website for more information on cleaning and disinfection validation services, and we will also be happy to provide you with a quote on pricing for your specific project.

If you are a medical device or pharmaceutical company that is not using gamma irradiation to sterilize your products, this is something you may want to consider.

Gamma rays, a form of radiation which comes from Cobalt 60, can sterilize products by breaking apart the covalent bonds of DNA in bacteria and other cellular structures, rendering them inactive. These rays can readily pass through the product and packaging, and have many advantages when compared to other methods that are available.  Unlike other forms of sterilization, gamma irradiation does not use heat, steam, and does not require outgassing.  This method can also save you time and money, and the result does not have any residual radioactivity.  For an interesting read, click here for an article that discusses in a little more detail, the methods and validation standards for gamma sterilization.

Whether you are currently using gamma irradiation on your products or are considering it, Pacific BioLabs can assist you with your project, big or small.  We provide support testing for sterilization validations and more.  We invite you to contact us to learn more about what we have to offer or to discuss your project with us.

If you have a product that will be on the market, it is advised that you have proof that it is free from microbiological contaminants.  Antimicrobial preservatives are substances added to nonsterile dosage forms of drugs or products to protect them from microbiological contamination.  Microbes can be introduced inadvertently during manufacturing, or during the continual use of a product.  We can help you determine whether or not your product is effective in this area so that you can submit data that is required by the appropriate regulatory agency.

The antimicrobial effectiveness test (AET), also known as the preservative efficacy test, is performed to determine if the chosen preservative is appropriate for a product formulation.  It is also carried out as part of a stability study, to ascertain whether a preservative system is still effective up to the expiration date or a product. Testing is performed according to compendial requirements in USP <51> and EP 5.1.3.

Time Kill Analysis measures the change in a population of microorganisms within a specified sampling time when after exposure to antimicrobial test materials in vitro.  The test is carried out to evaluate an antimicrobial test material or disinfectant and assesses the in vitro reduction of a microbial population of test organisms after exposure to a test material.

To learn more about these tests, click here.  Several options for organism selection and growth, inoculum preparation, sampling times and temperatures can be requested. We will try our best to help you develop a study that meets your needs and look forward to working with you.

With one of the fastest areas of growth for plastics being the Medical Device Industry, there has been an increased demand for biocompatibility testing.  One aspect of evaluating whether a device is safe for use is to test the components of the device.  According to USP (United States Pharmacopeia), there are six plastics classes ranging from I to VI, with class VI being the strictest.  Many plastics manufacturers find that it is beneficial to be USP Class VI certified, especially if the end use is a medical device.  It is often an important level of assurance to give customers who are looking for device component materials.  Additionally, many products not regulated by the FDA as "medical devices" may still be used in a laboratory setting.  The extra assurance given by USP Class VI certification may be important.

There are three in vivo tests involved in the classification of plastics.  The Systemic Injection Test and the Intracutaneous Test are designed to determine the systemic and local biological responses to plastics and other polymers by the single-dose injection of specific extracts prepared from a sample.  The third test, the Implantation Test, is designed to evaluate the reaction of living tissue to a test material.  The testing for the six different class plastics levels is all done using different combinations of these three tests and different extracts.

Pacific BioLabs is able to perform these tests in-house and is more than happy to assist you with your project or answer any questions that you may have.  Click on the links for more info on USP Class VI testing or for a full list of our testing services.  If you have further questions or would like a quote, please do not hesitate to contact us.

Wow, 30 years have passed in the blink of an eye.  Much has happened, many milestones have been reached, and we are grateful to have had the opportunities to work with such great clients over the years.

Pacific BioLabs was founded back in 1982 as Northview Pacific Labs in Berkeley, CA.  In the year 2000, we moved to our current 30,000 sq foot facility in Hercules, about 15 miles north of Berkeley.  Our 30 year history of serving companies worldwide and our commitment to being The Service Leader in Bioscience Testing has driven us to maintain a dedicated staff of scientists and professionals who continue to deliver quality results with fast and friendly service.  We specialize in preclinical toxicology, biocompatibility, sterility, bioassays, and microbiology.  Our client base has grown tremendously over the years and we now serve companies ranging anywhere from small biotech and medical device startups to global pharmaceuticals.  We are continually looking for ways to make processes more efficient so that we can pass on the savings to our clients and value client input as it is important when we make refinements to our quality systems.

It has been a privilege to have worked with all of our clients over the years and wish you the same success that we have had over the past three decades.  We look forward to your continued business and welcome those who we have not worked with yet to see if we are the right CRO for you.

Medical device makers have tentatively agreed to have FDA review fees doubled starting this year. The current five year agreement, set to expire on September 30, 2012, is set at $287 million.  If the new deal is signed off by Congress, the FDA is set to receive $595 million in user-fees over the next five years.  As a result, there will be reductions in total review times, a greater number of pre-market and 510(k) approvals, and more communication with companies during the review process.  The agreement will also require FDA reviewers to meet with the applicants halfway through the process to make sure any concerns are addressed and that goals are being met.

There has been criticism from the industry in the past few years on slow approval times, and last minute safety data requests that can cost companies a lot of money.  This can hinder innovation because the process has become so cumbersome and unexpected costs make it unpredictable.  Even with this proposed increase, medical device companies will still be paying a smaller portion of the FDA’s review budget.  Drug companies currently pay about 60%, while device companies will be paying about 35% of the budget after the increase.

If you would like to learn more about how to plan for biocompatibility testing, and for detailed information on ISO and FDA regulations for medical devices, download the 26-page booklet on Assessing Biocompatibility.

Initial Screening and In Vitro Testing

Usually, testing begins with the characterization and analysis of the components of a device. The device is submerged in extraction media under specified conditions to evaluate whether anything that leeches out from the device materials can be potentially harmful or toxic. Additional tests for cytotoxicity can be done to check for effects on tissue cultures before in vivo testing is done. This is done by placing the test article or an extract of the material onto cells to see whether there are any adverse effects. The viability of cells can also be measured by spectrophotometric methods or by counting the number of colonies formed after exposure to the test material.

Sensitization Assays

Various types of in vivo testing exist and are often required by federal agencies for approval of a device depending on its intended use. Sensitization studies tell us whether or not the device contains chemicals that can cause an adverse local or systemic effect after prolonged exposure. It screens for substances that would cause an allergic reaction in humans. Types of sensitization assays include the Guinea Pig Maximization Test, the Closed Patch Test, and the Murine Local Lymph Node Assay. Irritation studies evaluate local irritation on skin and mucus membranes. These include Intracutaneous, Primary Skin Irritation, and Mucous Membrane Irritation tests, which are performed depending on the route of exposure and duration of contact of the intended device.

Toxicity Testing

Systemic toxicity tests involve testing extracts of the device to evaluate whether leachables from the device produce toxic effects. Acute toxicity results in an immediate reaction after an exposure (<24 hours) and also evaluates the potential of materials to cause a pyrogenic, or feverish, effect. Subacute toxicity evaluates products with prolonged (24 hours to 30 days) exposure, while subchronic and chronic toxicity measures results for long term to permanent devices over several weeks or months. Implantation tests are often performed in addition to the previously mentioned tests for devices that will come in contact with living tissue other than skin. After the appropriate time has passed, histopathological examination must be done. Tissue from the surrounding area of the implant is examined for adverse reactions.

Genotoxicity, Hemocompatibility, and Carcinogenesis

Genotoxicity testing evaluates whether a certain material has the potential to affect the integrity of DNA by making it mutagenic or cancerogenic. Hemocompatibility tests range from hemolysis to coagulation to prothrombin time assays and is assessed for devices which will come into contact with blood. It is an evaluation of the amount of damage a device or material can cause to red blood cells. Depending on the intended use and placement of the device, carcinogenesis bioassays and pharmacokinetic studies may also be needed.

Many of these tests are done in-house at our facility in Hercules, CA but some of them are subcontracted as needed. The chart below lists which tests are done in house and which ones are subcontracted (for more information and a list of services provided visit http://www.pacificbiolabs.com/testing_services.asp):

Pacific BioLabs is proud to announce that we now have a certified PhD Diplomate of the American Board of Toxicology on staff. He recently was awarded this pretigous distinction from the world's premier certifying body for toxicology competency.

More than 20% of the staff members of Pacific BioLabs' Toxicology Department are PhDs, and we are happy to continue to be able to offer a high level of expertise to our valued clients.

Happy New Year and here's to a fantastic 2012!