BioPharm

www.biopharminternational.com October 2018 BioPharm International eBook 7 consistent met hods w i l l a l low trending analysis and a proper 'apples-to-apples' comparison of raw material test results. B r o w n e ( A l m a c ) : A l l m a n u - fac t u rers must show t hat t hey understand the critical material attributes of their raw materials and which of those affect vari- ability as well as how to control variability. They must show that appropriate analytical methods are used to characterize raw materials. ANALYTICAL BEST PRACTICES BioPharm: W hat analy tical best prac t ices a re c u r re nt ly i mple - mented in the lab to ensure the quality and purity of raw materials to be used in biologic production? Foehr (Pacific BioLabs): In order to ensure quality of raw materials, it is important to use qualified or validated methods and rigorous q u a l it y c o nt r o l (Q C )/q u a l it y a ssu ra nce (QA) rev iew. United States Pharmacopeia or European P h a r m a c o p o e i a m o n o g r a p h s are a good place to start when testing for identity or potency of common raw materials used in biomanufacturing. E s t a b l i s h e d l a b s f o l l o w i n - h o u s e g e n e r a t e d s t a n d a r d operating procedures for common procedures (pH, appearance, UV/ VIS, osmolality, etc.) to assess raw material quality attributes. When doing so, testing labs should use qua l i f ied i nst r u mentat ion a nd good documentation practices, and they should have an independent QA review. For more complex assays, it is recommended to have state-of-the- art instrumentation (high-perfor- mance liquid chromatography, gas chromatography, liquid chroma- tography-mass spectrometry) and highly trained personnel. Browne (Almac): It is essential that supplier certificates of analysis are provided, but also that the raw material is tested and verified in a good manufacturing practices lab- oratory with associated control and procedures. Tests must include, at minimum, testing for identity. Bulpin (MilliporeSigma): Applying the same principles and technolo- gies used to test critical quality attributes of final drug products for raw materials ensures they meet the standards needed for the production of biologics. Real-time inventory tracking and access to raw-material testing data also provide the trans- parency needed to identify and resolve issues almost instantly. ANALYTICAL ADVANCES B i o P h a r m : H a v e t h e r e b e e n a d v a n c e s r e c e n t l y i n e i t h e r analytical equipment, technique, met hodolog y, or approac h for testing raw materials? B r o w n e ( A l m a c) : Te s t i n g r aw materials is a routine requirement; therefore, fingerprint technology including near-infrared and Fourier- transform infrared spectroscopy are commonly used to assure the iden- tity and quality of raw materials. These techniques allow a high vol- ume of samples to be tested in an economical and reliable way. B u l p i n ( M i l l i p o r e S i g m a ) : Advancements and cost efficiencies in employing analytical methods/ technologies now permit the use of orthogonal methods to assess factors that can be quantified and compared during the testing of raw materi- als. In addition, evolution of meth- ods that allow for high-throughput assessment and automation of many tasks allow for raw material testing to be scalable at production levels. Foehr (Pacific BioLabs): Many raw mater ials used in manufac t ur- ing may be analyzed using rou- t i ne met ho d s a nd com mon ly available instrumentation. However, in this age of personalized medi- cine, stem-cell therapeutics, and immune-oncology drugs, the man- ufacturing of raw materials may include growth factors or cytokines. These raw materials require more advanced analysis and instrumen- tation to ensure proper safety and quality. Manufactures may also use advanced instrumentation to track cell growth and the status of growth conditions using multiplexed analy- sis of dozens or hundreds of markers. New gene t herapy tec h nolo - g ies may requ i re soph ist icated mole c u l a r b iolo g y te c h n ique s to characterize the product and raw materials. Nucleic acid-based therapeutics such as oligonucle- otides, RNAi, and CRISPR-based therapies are advancing through t h e a p p r o v a l p r o c e s s a n d required biomanufacturing sup- port. Techniques to st udy v iral vectors, such as adeno-associated virus, and the raw materials used in their production are becom- ing more important as new-gene therapy dr ugs enter the market a nd a re h ig h ly sc r ut i n i ze d by regulators. BP "Testing raw materials is a routine requirement; therefore, fingerprint technology including near-infrared and Fourier-transform infrared spectroscopy are commonly used." —Browne, Almac Sciences Biopharma Laboratory Best Practices Raw Materials Testing

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