Replies to post #158508 on Avid Bioservices Inc (CDMO)

[volgoat]

They are going to need 2 pages.

[stoneroad]

The number of conferences/presentations PPHM has in March is crazy. Obviously, they have reason to be shouting from the mountain top IMO.

[jimsgtx]

My 49th birthday is March 27th... This my be a birthday I'll never forget.... Something huge is gonna come out of all this March madness!!!

[swg_tdr]

WOW, listings keep you busy today

thanks for all the updates, every one.

time for The $treet to wake up

;-)

[4OurRetirement]

CP, regarding: PPHM @NY Academy of Sciences Symposium...

one line jumps off the page to me and that is the Presentation Title:

"Immune Checkpoint Inhibitors; Assessing the Activity of Bavituximab"

Could this presentation show how PPHM plans on testing Phase III subjects to determine they are benefiting?
If so, to me that will be the day they explain why they won't need 2 to 3 years to show the benefit of bavi in Phase III

Perhaps they will only need a couple months? That is why they will need Hockey Stick Patient Enrollment :-)

Thoughts?

GLTA SHareholders, cancer Patients, and their families!!!

[biopharm]

CP, regarding Peregrine applying for BLA:

Wouldn't the latest job opening for a "Software Validation Engineer" be part of the requirements that are mandatory within that BLA filing?

4.7. SOFTWARE VALIDATION AFTER A CHANGE

Due to the complexity of software, a seemingly small local change may have a significant global system impact. When any change (even a small change) is made to the software, the validation status of the software needs to be re-established. Whenever software is changed, a validation analysis should be conducted not just for validation of the individual change, but also to determine the extent and impact of that change on the entire software system. Based on this analysis, the software developer should then conduct an appropriate level of software regression testing to show that unchanged but vulnerable portions of the system have not been adversely affected. Design controls and appropriate regression testing provide the confidence that the software is validated after a software change.

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm085281.htm#_Toc517237942

---------------------------------------------------------------

We can take a look possibly at DNDN's BLA filing process... just to see how "software validation..." is part of a BLA filing


pg. 2 of 65 - Two inspections of the Dendreon manufacturing facility in New Jersey were conducted on February 2007 and January 2010. All of the pre-license inspection-related issues from the CR letter have been adequately resolved. The second inspection confirme
d that the sponsor has implemented the required changes to their
manufacturing and product testing and tracking procedures. Due to the complex logistical nature of the manufacturing process of this autologous product in coordination with shipping times and patient scheduling it is important to demonstrate that the entire process was built around operating parameters that ensure product quality from the point of cell collection through delivery of product for infusion. The sponsor has justified the
underlying assumptions in the manufacturing process and provided data demonstrating their ability to manufacture quality product.

Reasons for issuing CR letter comments after review of the original submission On May 8, 2007 the sponsor was issued a CR letter that included seven product related items. These included both inspection items that were not adequately resolved in the sponsor’s response to the presented 483 items, and CMC issues
uncovered during the BLA original submission review. The areas of concerns were improper product sample tracking within the QC lab; inadequate process validation within the cGMP modules; inadequate demonstration of sterility method equivalence; and inadequate assay validation, insufficient demonstration of adequate product shipping conditions, a lack of demonstration that the product can be distributed asintended, and questions surrounding apheresis stability.

pg. 49 of 65 - Laboratory Information Management Systems (LIMS) Software. LIMS was implemented in the QC lab as QC sample management and sample tracking tool. LIMS replaced a more manual system based on Microsoft Excel spreadsheets and paper forms. LIMS was put into use as a response to to a 483 item where there was concern about how the chain of identity of samples in the QC lab was being maintained and how samples were being tracked. LIMS, in conjunction with bar code readers at each analysis workst ation, both maintains the COI and keeps track of which assays have been completed or are in-process. Being an electronic system it also allows much faster information retrieval on already comp leted asssays and lots. LIMS was described in amendments 24, 32, and 47.

http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM214542.pdf
-------------------------------------------------------------

I do believe those previous "Avid" protein characterization jobs were also part of paperwork related to the BLA and right up to our latest Avid job posted:

Software Validation Engineer

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=96238203&txt2find=job|posting|avid

.... Finally, all of Michael Molony contributions are significant. I know the paperless laboratory was mentioned in the past, but that means more "software" chain of custody type of electronic records that must be a big part of that BLA filing.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=95187627&txt2find=michael|molony

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=96284523&txt2find=michael|molony

... for those who have not seen the quick resume building going on, here is Michael Molony.. whom I strongly believe is at Peregrine/Avid to support the BLA filing and overall success of Bavi production

BIOTECHNOLOGY SCIENTIST & DIRECTOR
Results-driven, goal-oriented Biotechnology Scientist and Manager with 25 years of broad-based management experience in contemporary laboratory operations, advanced analytical and experimental procedures, and the effective support of successful biotechnology development efforts. Strong working knowledge of modern analytical methodologies, automation systems, and statistical experimental design techniques. Exceptional ability to concurrently manage complex, multi-step laboratory experiments while meeting rigorous procedural standards, tight time-frames, and design/write/execute operational protocols. One of three principle scientific and engineering personnel responsible for setting up a Process Analytical Technology program

Specialties:Protein Chemistry: HPLC, microsequencing, amino acid analysis, Gel Imaging, Electroblotting, Binding Kinetic studies, peptide synthesis, carbohydrate analysis, MALDI-TOF, ESI-MS, ELISAs, Robotic Liquid handling, capillary electrophoresis, residual process impurities, direct and competitve binding by FRET/Delphia.

-----------------------

Director, QC
Avid Bioservices
June 2013 – Present (8 months)Orange County, California Area

Manage daily QC operations for a contract manufacturing service. Responsibilities include process improvement to streamline the department with the concepts of lean manufacturing and six sigma processes. Oversight of greater than 6 clients release and stability testing services. Successfully expanding QC service offerings to include client method development, protein characterization services and expanded in-house raw materials QC testing. Actively look for and engage potential new clients with Business Development group to grow business. Modernized the QC laboratories with equipment upgrades as well as implementation of paperless laboratory.

•Lead team of 18 for raw materials, lot release and stability testing for several high profile clients
•Team member involved in providing input into ‘Request for Information’ and ‘Request for Proposal’ for prospective clients.
•Member of the Leadership Board for business governance to increase profitability of Avid Bioservices
•Sponsor six sigma, lean manufacturing and continuous improvement efforts to streamline daily operations in QC
•Participate in Peregrine Pharmaceuticals CMC team as a consultant/individual contributor for lead Phase III candidate
•Overhaul QC Stability program: SOP Improvement; OOS and OOT procedures to include relevant statistical analysis criteria and outlier detection, Stability SOP to reflect current ICH guidelines, increase internal capability by expanding 'submission ready' stability reports for clients as well as increase storage solutions meeting all four world climactic zones for solid dose formulations

... I say impressive for on the job for 8 months!

http://www.linkedin.com/pub/michael-molony/5/7a8/bb5