In Vitro Manufacturers - Greer

Customized Source MaterialsMeet the Needs of In Vitro ManufacturersGREER TOUCHPOINT #43“I use the same raw materials monthafter month. I need consistency fromlot-to-lot.”In Touch. Within Reach.

In Touch withIn Vitro ManufacturersEach customer’s challenge is different, so the GREER ®Source Materials team starts by listening. Then weput our experience and knowledge to work to find thesolutions that help you meet your objectives. GREERprofessionals work alongside customers to providepersonalized support on many levels. We can tailor theraw materials and manufacture them to customerdefinedspecifications under cGMPs.GREER Provides Source Materialsin Useful FormulationsNatural Non-defatted DefattedEach formulation is available in:Powdered Liquid Lyophilized(Freeze-dried)

GREER ® Offers a Wide Arrayof Allergenic Source MaterialsSOURCEMATERIALDESCRIPTIONFEATURESMitesGREER ® offers house dust mites,formulated to meet customer-specifiedpurity levels up to 99% pureHouse dust mites are raised by GREER on acontrolled medium to ensure consistency inits dedicated facilityEpithelia,Hair, Feathers& DanderGREER offers danders, hair and epitheliaof dog, cat, and many other speciesAll danders, hairs, epithelia, and feathersare collected from animals certified to behealthy and free from diseasePollensGREER offers a wide range of grass,tree, weed, and flower pollen, all microscopicallyinspected to ensure identityand purityGREER pollens are collected via ourworldwide network of experienced in-houseand external collectorsFungi & SmutsGREER offers a wide range of fungi,prepared to meet customers’ specificationsfor cellular and culture filtrateGREER fungi are grown on site fromcontrolled seed cultures to assurelot-to-lot consistencyVenomsGREER venoms are formulated to containclinically relevant species and lyophilized(freeze-dried) to ensure stability andlabeled potencyConsistency of product quality and potencyis controlled by laboratory tests forprotein, hyaluronidase, and phospholiphaseactivity, and comparison to in-housereference preparationsFoodsGREER offers a wide variety of fruits,vegetables, meats, seafood, egg, anddairy productsGREER food materials are obtained fromsources that operate under food safety,USDA or FDA regulationsInsectsOur extensive collection network enablesGREER to offer a variety of insect species,all verified by GREER scientists foridentity and purityGREER insects are collected live and thenfrozen immediately or laboratory-raised ona controlled diet to ensure consistency

Within Reach with Quality SolutionsFor greater control of what exactly is collected and for access tohard-to-find pollens, GREER ® combines in-house and outsourced expertise.• Extensive experience requirements for all collectors• Exclusive collection capabilities in the US and Europe to accessregionally-appropriate pollen speciesSource Material Pollen Collecting ProcessPollenCollectors• Pollen is sent along with documentation of the collection process, such as date,time, area, and method• The pollen is received into quarantine and assigned a computer-generated lot numberPollenTestingPlaced IntoInventoryFurtherProcessing• Moisture test; specification

GREER TOUCHPOINT #526“Working with a sourcematerials partnerwho understands ourregulatory requirementsmakes my job mucheasier.”Integrity is IntegralGREER ® is an FDA-licensed allergenic extract manufacturerthat understands the regulatory requirements you face.GREER prides itself on meeting domestic and internationalindustry standards for quality, including current goodmanufacturing practices (cGMPs). In fact, many sourcematerials supplied to GREER customers are the samematerials used to manufacture finished GREER allergenicextracts. In addition, GREER is prepared to provide supportfor registration submissions. Other GREER points ofexcellence include:• Pre-samples for customer evaluation• Testing for heavy metals and pesticidesupon request• QA/QC oversight of product manufactureand release• cGLP development & cGMP operations• Lot-specific Certificates of Analysis• Thorough documentation of processes andtest results• Source identities ensured by GREER scientists• Confidential R&D project supportThis level of control allows GREER the flexibility to addresseach customer’s unique challenges.

In Touch with In Vitro ManufacturersThe GREER ® Source Materials Group works as a confidential and trustedpartner to develop solutions for our source materials customers. Solutions like:• A breadth of high-quality allergenic source materials that help meetyour varied needs• A variety of formulations to fit your specific project• Custom products– Manufactured to customer-defined specifications under cGMPs– Lyophilized extracts, free of preservatives or buffer salts,available for any of the GREER raw materials– Vialing and lyophilization of customer-supplied products• Custom services– Antibody production, such as Anti-Amb a, to meet project needs– Analytical testing for total protein, moisture, endotoxin, or othercustomer-requested tests– Analytical testing for specific allergen content, such as Der p 1, Der f 1,Amb a 1, Fel d 1, Can f 1Your GREER team is comprised of accomplished researchers who understandyour challenges. We will use this collective experience and knowledge to findthe solutions that fit each research challenge.For more information on how the experienced and knowledgeable GREERprofessionals can help you and your business, get in touch with GREER.Call the GREER Customer Service Representatives toll free: 800.378.3907or write to sourcematerials@greerlabs.com.Do you have a challenge or questionyou need help with, right away?Get in touch with GREER. Now.P: 800.378.3907 (Toll Free)P: 828.759.7859F: 828.754.0616E: touchpoints@greerlabs.comGREER Source MaterialsP.O. Box 800639 Nuway Circle NELenoir, NC 28645800.378.3907www.greerlabs.com© GREER 2011. All Rights Reserved. MPN 012711G303 03.11 500